09 September 2020
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Recommendations from the Lothian Formulary Committee (FC) following Scottish Medicines Consortium (SMC) advice, NICE MTA advice,
(FAF3) unlicensed and off-label medicines and (FAF2) medicines not considered by SMC
8 - Malignant Disease and Immunosuppression
In alphabetical order Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
5-aminolevulinic acid hydrochloride
(Gliolan®)
Medac
Local formulary process
To help guide resection of glioblastomas.
Added to the Additional List, for Specialist
Use only.
December 2013
5-aminolaevulinic acid (as hydrochlorid e )
78mg/g gel (Ameluz®)
Biofrontera Bioscience GmbH
12.02.18
SMC Report No. 1260/17 RESUBMISSION
5-aminolaevulinic acid (as hydrochloride) (Ameluz®) is accepted for use within NHS Scotland fo r
treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.
In a phase III study of patients with BCC, up to two cycles of photodynamic therapy (PDT) with 5 aminolaevulinic acid gel was non-inferior to PDT with an alternative photosensitising a g e nt fo r
the primary endpoint, complete clearance, defined as clearance of all treated lesions, assessed visually at 12 weeks after the last PDT.
Not routinely available as local experts d o
not wish to add the medicine to the formulary at this time.
April 2018
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
abemaciclib 50mg, 100mg and 150mg
tablets (Verzenios®)
Eli Lilly and Company
13.05.19
SMC Report No. 2135
abemaciclib (Verzenios®) is accepted for use within NHSScotland for the treatment of women
with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase
inhibitor* as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In a phase III randomised study in women with HR-positive, HER2-negative ad va n ced b re ast cancer, abemaciclib in combination with an aromatase inhibitor significantly increased
progression-free survival compared with aromatase inhibitor monotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of abemaciclib. This advice is contingent upon the continuing availa b il it y of the PAS in NHSScotland or a list price that is equivalent or lower.
*For SMC advice relating to the use of abemaciclib in combination with fulvestrant in this setting, please refer to SMC Report No. 2179
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
March 2020
abemaciclib 50mg, 100mg and 150mg tablets (Verzenios
®)
Eli Lilly and Company
13.05.19 SMC Report No. 2179
abemaciclib (Verzenios®) is accepted for restricted use within NHSScotland.
Indication under review: For the treatment of women with hormone receptor (HR) positive,
human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant* as initial endocrine-based therap y o r in wo me n
who have received prior endocrine therapy. SMC restriction: for use in women who have progressed on or after (neo) adjuva n t e nd o crin e
therapy, or progressed during first-line endocrine-based therapy for advanced breast cancer In a phase III randomised study in women with HR-positive, HER2-negative ad va n ced b re ast
cancer who had received prior endocrine therapy, abemaciclib in combination with fu lve st ra n t significantly increased progression-free survival compared with endocrine monotherapy.
This SMC advice takes account of the benefit of Patient Access Schemes (PAS) th a t imp ro ve the cost effectiveness of abemaciclib and fulvestrant. This advice is contingent upon the
continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting. * For SMC advice relating to the use of abemaciclib in combination with an aromatase inh ib ito r
in this setting, please refer to SMC report No. 2135
Routinely available in line with national guidance. Included on the Additiona l L ist
for Specialist Use only.
March 2020
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
abiraterone acetate 250mg tablets
(Zytiga®)
Janssen-Cilag Ltd
13.08.12
SMC Report No. 764/12 RESUBMISSION
Patient Access Scheme
abiraterone acetate (Zytiga®) is accepted for restricted use within NHS Scotland with prednisone
or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
SMC restriction: abiraterone is accepted for use in patients who have received only one prior chemotherapy regimen.
Abiraterone plus prednisone was associated with significantly improved overall survival compared with placebo plus prednisone in patients with mCRPC previously treated with
docetaxel. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of abiraterone. This SMC advice is contingent upon the con tinuing availability of the patient access scheme in NHS Scotland.
Included on the Additional List, Specia list
Use only for the indication in question.
October 2012
abiraterone acetate 250mg tablets
(Zytiga®)
Janssen-Cilag Ltd
12.10.15
SMC Report No. 873/13 INDEPENDENT REVIEW PANEL
Patient Access Scheme
abirateroneacetate (Zytiga®) is accepted for use within NHS Scotland.
Indication under review: abiraterone acetate is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are
asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
In a randomised, double-blind phase III study of adult men with chemotherapy-n a ive mCRPC, treatment with abiraterone acetate in combination with corticosteroid was associated with a
statistically significant extended progression-free survival and overall survival when co mp a re d with placebo plus corticosteroid.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost-effectiveness of abiraterone acetate. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2015
abiraterone acetate 250mg tablets
(Zytiga®)
Janssen-Cilag Ltd
13.01.20
SMC Report No. 2215 Patient Access Scheme
abiraterone acetate (Zytiga®) is accepted for use within NHSScotland.
Indication under review: abiraterone acetate with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in
combination with androgen deprivation therapy. Abiraterone acetate in combination with prednisone and androgen deprivation therapy
demonstrated superiority over androgen deprivation therapy alone for improving p ro g re ssio n -free survival and overall survival.
This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based,
or a PAS/ list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
March 2020
afatinib 20mg, 30mg, 40mg, 50mg film-coated tablets (Giotrif
®)
Boehringer Ingelheim International GmbH
10.03.14 SMC Report No 920/13
Patient Access Scheme
afatinib (Giotrif®) is accepted for use within NHS Scotland as monotherapy, for the treatme nt o f
epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).
In two phase III studies, in patients with EGFR mutation positive adenocarcinoma o f th e lu n g , afatinib was significantly superior to the chemotherapy regimen comparators for the primary
endpoint of progression free survival. Overall survival data are immature. A mixed treatment comparison provides indirect comparative data versus other tyrosine kinase inhibitors.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of afatinib. This SMC advice is contingent upon the continuing availabilit y
of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
For patients with a specific EGFR mutation, exon 19 deletion:
Included on the Additional List, Specia list Use only for the indication in question.
For all other indications:
Not included on the LJF because the NHS Lothian decision is that the medicine does
not represent sufficient added benefit to other comparator medicines to treat the
condition in question.
October 2014
February 2014
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
afatinib (Giotrif®) 20 mg/30 mg/40 mg/50
mg film-coated tablets Boehringer Ingelheim Limited
11.07.16
SMC Report No 1174/16 NON SUBMISSION
NOT RECOMMENDED: afatinib (Giotrif®) is not recommended for use within NHS Scot la n d a s
monotherapy for the treatment of locally advanced or metastatic non small cell lu n g ca n ce r o f squamous histology progressing on or after platinum-based chemotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
aflibercept 25mg/mL concentrate for
solution for infusion (Zaltrap®)
Sanofi
10.03.14
SMC Report No 878/13 RESUBMISSION
Patient Access Scheme
aflibercept (Zaltrap®) is accepted for use within NHS Scotland in combination with irinote ca n /5-
fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-co n tain in g
regimen. In one randomised, double-blind, phase III study, aflibercept plus FOLFIRI chemotherapy
regimen resulted in statistically significant longer overall survival compared with placebo plus FOLFIRI chemotherapy regimen. However, the effect was of relatively modest clinical benefit.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of aflibercept. This SMC advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
April 2014
alectinib hydrochloride (Alecensa®)
150mg hard capsules Roche Products Ltd
08.05.17
SMC Report No. 1257/17 NON SUBMISSION
NOT RECOMMENDED: alectinib hydrochloride (Alecensa®) is not recommended for use with in
NHS Scotland. Indication under review: As monotherapy for the treatment of adult patients with anaplastic
lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
alectinib hydrochloride (Alecensa®)
150mg hard capsules
Roche Products Ltd
13.08.18 SMC Report No.2012
Patient Access Scheme
Following a full submission assessed under the orphan medicine process, alectinib (Alecensa®)
is accepted for use within NHS Scotland as monotherapy for the first-line treatment of adult
patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lu n g ca n ce r (NSCLC).
Alectinib, compared with another tyrosine kinase inhibitor, significantly improved progression -free survival in treatment-naïve adults with advanced or recurrent ALK-positive NSCLC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of alectinib. This advice is contingent upon the continuing availa b il it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national guidance. Included on the Additional List,
for Specialist Use only.
December 2018
alemtuzumab, 30mg/mL for concentrate for solution for infusion (MabCampath
®)
Bayer plc, Bayer Schering Pharma Division
08.09.08
SMC Report No. 494/08
alemtuzumab (MabCampath®) is accepted for restricted use within NHS Scotland for trea tme n t
of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination
chemotherapy is not appropriate It is restricted to use in patients with previously untreated B-CLL, with the cytogenetic
abnormality 17p-deletion. Compared with an alkylating agent, alemtuzumab was associated with improved progression-free survival in patients with B-CLL. Data in
patients with 17p-deletion are limited; improved survival was demonstrated in a sub-group analysis in 21 patients.
Added to the Additional List, for Specialist use only.
Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
May 2011
alemtuzumab (MabCampath®)
Genzyme
Local formulary process
Immunosuppression for islet cell transplant recipients
Added to the Additional List, for Specialist
Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’. Specialist Use only.
January 2011
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
alemtuzumab (MabCampath®)
Genzyme
Local formulary process
Treatment of relapsed chronic lymphocytic leukaemia (subcutaneous administration)
Added to the Additional List, for Specialist
Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’. Specialist Use only.
April 2012
anakinra (Kineret®) 100mg solution for
injection in a pre-filled syringe Swedish Orphan Biovitrum Ltd
07.12.15
SMC Report No.1116/15 NON SUBMISSION
NOT RECOMMENDED: anakinra (Kineret®) is not recommended for use within NHS Scotland.
Indication under review:Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or
above, including:
• Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile
Neurological, Cutaneous, Articular Syndrome (CINCA)
• Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS)
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
anastrozole 1mg tablets (Arimidex®)
AstraZeneca UK Ltd
12.09.05 SMC Report No. 198/05
anastrozole (Arimidex) is accepted for restricted use within NHS Scotland in the adjuvant
treatment of postmenopausal women with hormone receptor-positive early invasive breast cancer.
Anastrozole has shown benefit over standard anti-oestrogen therapy in terms of d ise a se -f re e survival in this patient group. It offers an alternative to tamoxifen and has a diffe re n t a d ve rse
effects profile. Treatment with anastrozole should be initiated by a breast cancer specialist.
Added to LJF as second choice treatmen t
for patients at risk of early recurrence or with contraindication to tamoxifen.
Routinely available in line with national
guidance. Included in the LJF, for Specialist Initiation.
August 2010
As per LJF
July 2019
anastrozole 1mg tablet (Arimidex®)
AstraZeneca UK Limited
13.11.06 SMC Report No. 322/06
anastrozole (Arimidex®) is accepted for restricted use within NHS Scotland for the adjuvant
treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
In a combined analysis of two trials, switching to anastrozole after 2 years of tamoxifen the ra py rather than continuing with tamoxifen resulted in a 3.1% increase in event-free survival at th re e
years follow-up. It offers an alternative to tamoxifen after initial adjuvant treatment with tamoxifen for 2-3 years and has a different adverse effects profile. Treatment with anast ro zo le
is restricted to initiation by a breast cancer specialist.
‘Not preferred’ in Lothian as suitable
alternatives exist.
August 2010
apalutamide 60mg film-coated tablets
(Erleada®)
Janssen-Cilag Ltd
10.02.20
SMC Report No. 2268 NON SUBMISSION
NOT RECOMMENDED: apalutamide (Erleada®) is not recommended for use within
NHSScotland. Indication under review: In adult men for the treatment of non-metastatic castration-resistant
prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
aprepitant (Emend®)
Merck, Sharpe & Dohme
08.11.04 SMC Report No. 132/04
aprepitant (Emend®) is accepted for restricted usewithin NHS Scotland for the prevention of
acute and delayed nausea and vomiting associated with highly emetogenic cisplatin -based chemotherapy.
The antiemetic regimen incorporating aprepitant was superior to one regimen (where dexamethasone alone was used in the delayed phase of treatment), for the prevention of
cisplatin-induced nausea and vomiting in the acute and delayed phases. It should be in it ia te d only by appropriate hospital based specialists.
Added to the Additional List, for Specialist
Use only.
July 2008
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
aprepitant 80mg, 125mg hard capsule s
(Emend®)
Merck Sharp and Dohme Ltd
07.11.11
SMC Report No. 242/06 RESUBMISSION
NOT RECOMMENDED: aprepitant (Emend®) as part of combination therapy is not
recommended for use within NHS Scotland for prevention of nausea and vomiting a sso cia ted with moderately emetogenic cancer chemotherapy.
Compared with a control regimen, aprepitant has been shown to increase the proportion of patients achieving a complete response in a study of breast cancer patients or experiencin g n o
vomiting in patients with a range of tumour types, when patients were initiated on their first cycle of a moderately emetogenic chemotherapy regimen. However the control regimen was
considered suboptimal for the treatment of delayed symptoms and evidence for use in subsequent cycles is limited.
Overall the submitting company did not present sufficiently robust clinical and economic analyses to gain acceptance by SMC.
NOT RECOMMENDED
aprepitant, 80mg, 125mg hard capsules
and 125mg powder for oral suspension (Emend
®)
Merck, Sharpe & Dohme
10.07.17 SMC Report No. 1241/17
aprepitant (Emend®) is accepted for use within NHS Scotland.
Indication under review: As part of combination therapy, for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in infants, toddle rs a n d
children from the age of six months to less than 12 years (powder for oral suspension ) and adolescents from the age of 12 years to 17 years (hard capsules).
A randomised, double-blind, placebo-controlled study demonstrated that the addition of aprepitant to a 5HT3 receptor antagonist (+/- steroid) in children and adolescents receiving
chemotherapy with a moderate to very high emetogenic risk produced a significant anti -e me t ic benefit.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
July 2017
aprepitant (Emend®) 80mg,125mg hard
capsules aprepitant (Emend
®) 125mg powder for
oral suspension Merck Sharp & Dohme Limited
10.07.17
SMC Report No. 1252/17 PRODUCT UPDATE
ABBREVIATED SUBMISSION
aprepitant (Emend®) is accepted for use within NHS Scotland.
Indication under review: As part of combination therapy, for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy in children, toddlers and
infants from the age of six months to <12 years (powder for oral suspension) and a d o lesce n ts from the age of 12 years to 17 years (hard capsules).
SMC has previously accepted aprepitant for the prevention of acute and delayed n a use a a n d vomiting associated with highly emetogenic cisplatin-based chemotherapy in adults. The
marketing authorisation has since been extended to cover prevention of nausea and vomiting in adults associated with highly emetogenic non-cisplatin based chemotherapy. SMC does not plan
to assess this minor licence extension.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
July 2017
arsenic trioxide 1mg/mL concentrate for
solution for infusion (Trisenox®)
Teva UK Ltd
14.01.19
SMC Report No. 2025
NOT RECOMMENDED: following a full submission assessed under the orphan equivalent
process arsenic trioxide (Trisenox®) is not recommended for use within NHSScotland in
combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and
consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/μl), characterised by the
presence of the t(15;17) translocation and/or the presence of the Pro -Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.
NOT RECOMMENDED
arsenic trioxide 1mg/mL concentrate for
solution for infusion (Trisenox®)
Teva UK Ltd
08.07.19
SMC Report No. 2181 RESUBMISSION
arsenic trioxide (Trisenox®)is accepted for use within NHSScotland.
Indication under review: in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-
intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl),
characterised by the presence of the t(15;17) translocation and/or the presence of the
Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. In a Phase III study in patients with newly diagnosed, low-to-intermediate risk APL, arsenic
trioxide was non-inferior to anthracycline-based chemotherapy (both in combination with tretinoin) measured by event-free survival. A significant difference in overall survival fa vo u rin g
arsenic trioxide was also demonstrated.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only.
July 2020
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
atezolizumab 1,200mg concentrate for
solution for infusion (Tecentriq®)
Roche Products Ltd
12.03.18
SMC Report No. 1297/18
NOT RECOMMENDED: atezolizumab (Tecentriq®) is not recommended for use within NHS
Scotland. Indication under review: As monotherapy for the treatment of adult patients with locally
advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy or who are considered cisplatin ineligible.
In a single arm, open-label, phase II study of patients with locally advanced or metastatic urothelial carcinoma who had received no previous treatment for metastatic dise a se a n d wh o
were ineligible for cisplatin therapy, treatment with atezolizumab resulted in an objective response in 19% of patients.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clin ica l a n d
economic analysis to gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
atezolizumab 1,200mg concentrate for solution for infusion (Tecentriq
®)
Roche Products Limited
08.06.18
SMC Report No. 1336/18 Patient Access Scheme
atezolizumab (Tecentriq®) is accepted for restricted use within NHS Scotland
Indication under review: As monotherapy for the treatment of adult patients with locally
advanced or metastatic nonsmall cell lung cancer (NSCLC) after prior chemotherapy. Pa t ie nts with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma
kinase (ALK)positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
SMC restriction: treatment with atezolizumab is subject to a two-year clinical stopping rule. Atezolizumab, compared with a standard taxane monotherapy, significantly improved overall
survival in adults with advanced NSCLC who had progressed after platinum-based chemotherapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of atezolizumab. This advice is contingent upon the continuing availability
of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Added to the Additional List, fo r
Specialist Use only.
April 2019
atezolizumab 1,200mg concentrate for
solution for infusion (Tecentriq®)
Roche Products Ltd
12.11.18
SMC Report No. 2103
NOT RECOMMENDED: atezolizumab (Tecentriq®) is not recommended for use within
NHSScotland. Indication under review: As monotherapy for the treatment of adult patients with locally
advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy. In a phase III randomised study of patients with locally advanced or metastatic urothelial
carcinoma after prior platinum-containing chemotherapy, there was a small numerical in cre a se in median overall survival for patients treated with atezolizumab compared with chemotherapy.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
atezolizumab 1,200mg concentrate for
solution for infusion (Tecentriq®)
Roche Products Ltd
11.11.19
SMC Report No. 2208
NOT RECOMMENDED: atezolizumab (Tecentriq®) is not recommended for use within
NHSScotland.
Indication under review: In combination with bevacizumab, paclitaxel and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer
(NSCLC). In patients with epidermal growth factor receptor (EGFR) mutant or anaplastic lymphoma kinase (ALK)-positive NSCLC, atezolizumab in combination with bevacizumab,
paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. In a phase III study, the addition of atezolizumab to bevacizumab, carboplatin and paclitaxel was
associated with an increase in median progression-free survival in patients with metastatic no n -squamous NSCLC.
The submitting company did not present a sufficiently robust clinical and economic an a lysis to
gain acceptance by SMC.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
atezolizumab 1,200mg concentrate for solution for infusion (Tecentriq
®)
Roche Products Ltd
09.12.19 SMC Report No. 2254
NON SUBMISSION
NOT RECOMMENDED: atezolizumab (Tecentriq®) is not recommended for use within
NHSScotland.
Indication under review: In combination with nab-paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cance r (NSCL C)
who do not have EGFR mutant or ALK-positive NSCLC. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
avelumab 20mg/mL concentrate for
solution for infusion (Bavencio®)
Merck Serono Europe Limited/Pfizer
07.05.18
SMC Report No. 1315/18
Following a full submission considered under the ultra-orphan and end of life process, avelumab
(Bavencio®) is accepted for use within NHS Scotland.
Indication under review: As monotherapy for the treatment of adult patients with metastatic
Merkel cell carcinoma (mMCC). An uncontrolled phase II study demonstrated that treatment with avelumab for patients with
mMCC who had received prior chemotherapy produced improvements in objective response rate, duration of response and overall survival compared with historical chemotherapy co nt ro ls
from a retrospective cohort study This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
July 2018
axitinib (Inlyta®)
Pfizer
Local formulary process
As a second-line treatment for advanced/metastatic renal carcinoma after pazaponib therapy. Added to the Additional List, for Specialist
Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’. Specialist Use only.
April 2014
axitinib, 1mg and 5mg, film-coated tablets
(Inlyta®)
Pfizer
11.11.13
SMC Report No. 855/13 RESUBMISSION
Patient Access Scheme
axitinib (Inlyta®) is accepted for use within NHS Scotland for the treatment of adult patients with
advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. In a phase III, open-label study, axitinib improved progression-free survival significantly more
than another targeted therapy when used after first-line sunitinib or a cytokine. Th e re wa s n o significant improvement in overall survival.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of axitinib. This SMC advice is contingent upon the continuing availabil it y
of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
Additional tablet strengths are now
available. 1mg, 3mg, 5mg and 7mg tablets are all
included in the Patient Access Scheme.
December 2013
August 2015
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
9/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
axicabtagene ciloleucel 0.4 – 2 x 108 cells
dispersion for infusion dispersion for infusion (Yescarta
®)
Kite Pharma, a Gilead Company
07.10.19 SMC Report No. 2189
RESUBMISSION Patient Access Scheme
axicabtagene ciloleucel (Yescarta®) is accepted for use within NHSScotland.
Indication under review: Treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or
more lines of systemic therapy. Axicabtagene ciloleucel was associated with an objective response rate of 82% in a single-arm,
open-label, phase I/II study in patients with refractory DLBCL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of axicabtagene ciloleucel. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only..
December 2019
azacitidine 100mg powder for suspension
for injection (Vidaza®)
Celgene Ltd
12.09.11
SMC Report No. 589/09 RESUBMISSION
Patient Access Scheme
azacitidine (Vidaza®) is accepted for use within NHS Scotland for treatment of adult patients who
are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate -2 and high -risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute
myeloid leukaemia (AML). Azacitidine therapy produced a significant increase in overall survival compared with
conventional care regimens in previously untreated higher-risk MDS patients. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of azacitidine. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland.
Added to the Additional List, for Specialist
Use only.
November 2011
azacitidine (Vidaza®) 25 mg/mL powder
for suspension for injection Celgene Ltd
11.07.16
SMC Report No: 1175/16 NON SUBMISSION
NOT RECOMMENDED: azacitidine (Vidaza®) is not recommended for use within NHS Scotlan d
for the treatment of adult patients aged 65 years or older who are not eligible for haematopoietic stem cell transplantation (HSCT) with acute myeloid leukaemia (AML) with >30% marrow bla sts
according to the World Health Organisation (WHO) classification. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
basiliximab (Simulect®)
Novartis
Local formulary process
For prevention of acute organ rejection in liver transplant in patients with or at risk of renal dysfunction to allow delayed introduction of calcineurin inhibitors,
in order to reduce incidence of acute renal inpairment.
Not recommended for use in Lothian. Categorised BLACKunder the ADTC
‘Policy and procedures for the use of unlicensed medicines’, for the prevention
of acute organ rejection in liver transplant.
November 2014
belatacept powder for concentrate for solution for infusion 250mg vial and
disposable syringe (Nulojix®)
Bristol Myers Squibb Pharmaceuticals Ltd
11.06.12
SMC Report No. 786/12
NOT RECOMMENDED: belatacept (Nulojix®) is not recommended for use within NHS Scotla n d
in combination with corticosteroids and mycophenolic acid, is indicated for prophylaxis o f g ra f t
rejection in adults receiving a renal transplant. It is recommended to add an interleukin -2 receptor antagonist for induction therapy to this belatacept-based regimen.
Results of two phase III studies have demonstrated comparable graft and patient survival of belatacept versus a calcineurin inhibitor when used as part of a maintenance
immunosuppressive regimen. Indirect efficacy data from a mixed treatment comparison are available for belatacept versus another calcineurin inhibitor, considered the key comp a ra to r in
NHS Scotland. The submitting company’s justification for the treatment’s cost in relation to its hea l t h b e ne f it s
was not sufficient and in addition, the company did not present a sufficiently ro b u st e co no mic case to gain acceptance by SMC.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
10/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
belimumab, 120mg and 400mg powder
for concentrate for solution for infusion (Benlysta
®)
GlaxoSmithKline
08.05.17 SMC Report No.775/12
RESUBMISSION Patient Access Scheme
belimumab (Benlysta®) is accepted for restricted use within NHS Scotland.
Indication under review: Add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-
dsDNA and low complement) despite standard therapy. SMC restriction: patients with evidence of serological disease activity (i.e. positive a n t i-d sDNA
and low complement) and a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥10.
Belimumab, in addition to standard of care, modestly improved disease control in patie nts with SLE in two phase III studies.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of belimumab. This advice is contingent upon the continuing availability of
the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
August 2017
bendamustine hydrochloride 25mg, 100mg powder for solution for infusion
(Levact®)
Napp Pharmaceuticals Limited
11.04.11
SMC Report No. 694/11
bendamustine hydrochloride (Levact®) is accepted for use within NHS Scotland.
Indication under review: first-line treatment of chronic lymphocytic leukaemia (CLL) (Binet stag e
B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Bendamustine showed significantly improved response rates and progression free survival when
compared with another alkylating agent in patients with previously untreated advanced CLL, although the patients studied may have been younger and fitter than those eligib le t o re ce ive
bendamustine in Scottish clinical practice.
Added to the Additional List.
Included on the Lothian Joint Formulary for the indication in question.
Until further evidence is provided, the u se
of bendamustine in combination with rituximab can be undertaken via non-
formulary route.
April 2012
bendamustine 2.5mg/mL powder for concentrate for solution for infusion
(Levact®)
Napp Pharmaceuticals Limited
11.04.11
SMC Report No: 700/11 NON SUBMISSION
NOT RECOMMENDED: bendamustine (Levact®) is not recommended for use within NHS
Scotland.
Indication under review: for the front line treatment of multiple myeloma (Durie -Salmon sta g e I I with progress or stage III) in combination with prednisone for patients older than 65 ye a rs wh o
are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
bendamustine 2.5mg/mL powder for concentrate for solution for infusion
(Levact®)
Napp Pharmaceuticals Limited
11.04.11
SMC Report No: 701/11 NON SUBMISSION
NOT RECOMMENDED: bendamustine (Levact®) is not recommended for use within NHS
Scotland.
Indication under review: for the front line treatment of indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with
rituximab or a rituximab containing regimen. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
bendamustine (Levact®)
NAPP
Local formulary process
In combination with rituximab for relapsed chronic lymphocytic leukaemia.
Added to the Additional List, for Specialist
Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
February 2014
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
11/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
bendamustine 2.5mg/mL powder for
concentrate for solution of infusion vials (Levact
®) (available as 25mg and 100 mg
vials) Napp Pharmaceuticals
Local formulary process
Relapsed and refractory multiple myeloma. Routinely available in line with local or
regional guidance. Included on the Additional List, for
Specialist Use only. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
April 2017
bevacizumab 100mg/4mL and
400mg/16mL solution for intravenous infusion (Avastin
®)
Roche
January 2012 NICE MTA 242 supersedes SMC Report
No. 221/05
NOT RECOMMENDED: NICE MTA 242Bevacizumab in combination with non-oxaliplatin
(fluoropyrimide-based) chemotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy.
NOT RECOMMENDED
bevacizumab (Avastin®)
Roche Pharmaceuticals
09.07.07
SMC Report No. 387/07 NON SUBMISSION
NOT RECOMMENDED: bevacizumab (Avastin®) in combination with paclitaxel is not
recommended for first-line treatment of patients with metastatic breast cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
bevacizumab (Avastin®)
Roche Pharmaceuticals
10.12.07
SMC Report No. 425/07 NON SUBMISSION
NOT RECOMMENDED: bevacizumab (Avastin®) in addition to platinum-based chemotherapy, is
not recommended for first-line treatment of patients with unresectable advanced, metasta tic o r
recurrent non-small cell lung cancer other than predominantly squamous cell histology. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
bevacizumab (Avastin®)
Roche Pharmaceuticals
10.03.08 SMC Report No. 459/08
NON SUBMISSION
NOT RECOMMENDED: bevacizumab (Avastin®) is not recommended for use within NHS
Scotland in combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
bevacizumab, 100mg and 400mg vials
(Avastin)
Roche
09.06.08 SMC Report No.469/08
NOT RECOMMENDED: bevacizumab (Avastin) is not recommended for use within NHS Scotland in combination with fluoropyrimidine-based chemotherapy for treatment of patients with
metastatic carcinoma of the colon or rectum. In a randomised trial standard chemotherapy plus bevacizumab showed a small benefit over
standard chemotherapy alone in terms of progression-free survival. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
12/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
bevacizumab, 25mg/mL, concentrate fo r
solution for infusion (Avastin®)
Roche Products Ltd.
14.05.12
SMC Report No.778/12
NOT RECOMMENDED: bevacizumab (Avastin®) is not recommended for use within NHS
Scotland in combination with capecitabine is indicated for first-line treatment of patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxan es
or anthracyclines is not considered appropriate. In a double-blind, multicentre, randomised, placebo-controlled phase III study in p a t ie n ts with
locally recurrent or metastatic breast cancer, treatment with bevacizumab plus capecitabine was associated with an extended median progression-free survival of 2.9 months compared with
capecitabine monotherapy. However, there was no overall significant improvement in survival. The submitting company did not present a sufficiently robust economic analysis and, in addition,
their justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by the SMC.
NOT RECOMMENDED
bevacizumab, 25mg/mL, concentrate fo r
solution for infusion (Avastin®)
Roche Products Ltd
09.11.15
SMC Report No.806/12 2
nd RESUBMISSION
bevacizumab (Avastin®) is accepted for restricted use within NHS Scotland.
Indication under review: In combination with carboplatin and paclitaxel, for the front-line treatment of advanced (International Federation of Gynaecology and
Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
SMC restriction: In patients with FIGO stage IV disease Addition of bevacizumab to standard chemotherapy with carboplatin and paclitaxel increased
progression-free survival. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, for
Specialist Use only. Categorised REDunder the ADTC ‘Policy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’, for the
indication in question.
Off label dose being used.
April 2016
bevacizumab, 25mg/mL, concentrate fo r solution for infusion (Avastin
®)
Roche Products Ltd
11.03.13 SMC Report No.
853/13
NOT RECOMMENDED: bevacizumab (Avastin®) is not recommended for use within NHS
Scotland in combination with carboplatin and gemcitabine, is indicated for treatment of adult
patients with first recurrence of platinum-sensitive epithelian ovarian, fallopian tub e o r p rima ry peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF
inhibitors or VEGF receptor–targeted agents. A randomised double-blind, placebo-controlled, phase III study demonstrated a significant
improvement in progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer (ROC) treated with bevacizumab in combination with gemcitabine and
carboplatin, compared with gemcitabine and carboplatin alone. The submitting company's justification of the treatment's cost in relation to its health benefits
was not sufficient to gain acceptance by SMC.
NOT RECOMMENDED
bevacizumab 25mg/mL concentrate for
solution for infusion, (Avastin®)
Roche Products Ltd
07.09.15
SMC Report No. 1063/15 Patient Access Scheme
bevacizumab (Avastin®) is accepted for restricted use within NHS Scotland.
Indication under review: in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular
endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents. SMC restriction: to use in combination with paclitaxel.
The addition of bevacizumab to chemotherapy improved progression free survival in patients with platinum-resistant ovarian cancer in an open-label phase III randomised study.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bevacizumab. This advice is contingent upon the continuing availability
of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2015
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
13/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
bevacizumab 25mg/mL concentrate for
solution for infusion (Avastin®)
Roche Products Ltd
09.05.16
SMC Report No. 1135/16 Patient Access Scheme
bevacizumab (Avastin®) is accepted for restricted use within NHS Scotland.
Indication under review: in combination with paclitaxel and cisplatin or, alternatively, p a clitaxe l and topotecan in patients who cannot receive platinum therapy, for the treatment of adult
patients with persistent, recurrent, or metastatic carcinoma of the cervix. Restriction: for use in combination with cisplatin and paclitaxel.
In an open-label, randomised, phase III study, the addition of bevacizumab to combination chemotherapy increased overall survival.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost effectiveness of bevacizumab. This advice is contingent upon the continuing availabil it y o f
the patientaccess scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician and Engag eme n t (PACE)
meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
August 2016
bevacizumab (Avastin®) 25 mg/mL
concentrate for solution for infusion
Roche Products Ltd
12.09.16 SMC Report No. 1190/16
NON SUBMISSION
NOT RECOMMENDED: bevacizumab (Avastin®) is not recommended for use within NHS
Scotland in combination with erlotinib for first-line treatment of adult patients with unrese ctab le
advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
bevacizumab 25mg/mL concentrate for solution for infusion (Avastin
®)
Roche Products Ltd
11.09.17 SMC Report No. 1275/17
NON SUBMISSION
NOT RECOMMENDED: bevacizumab (Avastin®) is not recommended for use within NHS
Scotland.
Indication under review: In combination with carboplatin and paclitaxel for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary
peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
bexarotene capsules (Targretin) Elan Pharma
08.11.02 SMC Report No. 14/02
bexarotene capsules (Targretin) is recommended as a second line treatment for patien ts with advanced (stages Ilb or III) cutaneous T-cell lymphoma. Bexarotene treatment should norma lly be initiated and supervised by haematologists, dermatologists or oncologists and used for
patients who have proved refractory both to local skin directed therapy and to at least one systemic treatment.
Added to the Additional List as a second line treatment for patients with cutan e o us
T-cell lymphoma (stages IIb or III).
May 2003
blinatumomab, 38.5 micrograms powder
for concentrate and solution for solution
for infusion (Blincyto)
Amgen Europe B.V.
13.06.16 SMC Report No. 1145/16
Patient Access Scheme
blinatumomab (Blincyto®) is accepted for use within NHS Scotland for the treatment of adults
with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphobla stic leukaemia (ALL).
In a non-comparative phase II study of patients with relapsed or refractory Philadelphia chromosome-negative B-precursor ALL, blinatumomab was associated with clinically relevant
complete remission rates. Controlled data with clinical outcomes are currently lacking. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of blinatumomab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, Specia list
Use only, for the indication in question.
October 2016
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
14/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
blinatumomab 38.5 micrograms powder
for concentrate and solution for solution
for infusion (Blincyto) Amgen Europe B.V.
08.04.19
SMC Report No. 2148 PRODUCT UPDATE
ABBREVIATED SUBMISSION Patient Access Scheme
blinatumomab (Blincyto®) is accepted for use within NHSScotland as monotherapy for the
treatment of paediatric patients aged 1 year or older with Philadelphia chromo so me n e ga t ive CD19 positive B-cell precursor acute lymphoblastic leukaemia which is refractory or in re la p se
after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
SMC accepted blinatumomab for use in adults following a submission under the end of life a n d ultra-orphan process.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of blinatumomab. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
April 2019
blinatumomab 38.5 micrograms powder for concentrate and
solution for infusion (Blincyto®)
Amgen Ltd
09.03.20 SMC Report No. 2234
Patient Access Scheme
Following a full submission considered under the end of life and orphan equivalent process, blinatumomab (Blincyto
®) is accepted for restricted use within NHSScotland.
Indication under review: As monotherapy for the treatment of adults with Philade lphia chromosome negative, CD19 positive, B-precursor acute lymphoblastic leukaemia (ALL) in f irst
or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
SMC restriction: to patients who are in first complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
In a single arm phase II study of patients with B-cell precursor ALL in first or later complete remission and with persistent or recurrent MRD, blinatumomab was associated with clinically
relevant complete MRD response rates. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not routinely available as local clinical experts do not wish to add the medicine to
the formulary at this time or there is a local preference for alternative medicines.
May 2020
bortezomib (Velcade®)
Ortho Biotech
11.10.04
SMC Report No. 126/04
bortezomib (Velcade) is accepted for use within NHS Scotland for the treatment of patients with multiple myeloma who have received at least two prior therapies, have demonstra te d d ise a se progression on the last therapy and who are refractory to alternative licensed treatments for this
stage of the disease. Bortezomib produced a disease response in approximately one third of these patients in a n
open-label uncontrolled study. Any other use of bortezomib should only take place with in th e context of a controlled study.
The manufacturers are encouraged to mount an observational study in collaboration with haemato-oncologists to gain more information on the benefits and risks of this therapy.
Added to the Additional List, for Specialist Use only.
Bortezomib may be appropriate for
patients who have relapsed after thalidomide treatment according to agreed
protocol.
November 2004
bortezomib 3.5mg powder for intravenous injection (Velcade
®)
Ortho Biotech
09.11.09 SMC Report No. 302/06
2ND
RESUBMISSION Patient Access Scheme
bortezomib (Velcade®) is accepted for use within NHS Scotland as mono-therapy for the
treatment of progressive multiple myeloma in patients who have received at least one prior
therapy and who have already undergone or are unsuitable for bone marrow transplantation. Bortezomib, compared to high dose dexamethasone, prolonged time to disease progression and
improved survival in patients who had progressive multiple myeloma despite previous treatmen t with one to three lines of therapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bortezomib. This SMC advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland.
Added to the Additional List, for Specialist Use only.
December 2011
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
15/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
bortezomib (Velcade®) 3.5mg powder fo r
subcutaneous injection Janssen-Cilag Ltd
10.12.12
SMC Report No. 822/12 PRODUCT UPDATE
ABBREVIATED SUBMISSION Patient Access Scheme
bortezomib subcutaneous injection (Velcade®) is accepted for use within NHS Scotland in
combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marro w
transplant. As monotherapy for the treatment of progressive multiple myeloma in patients who have
received at least one prior therapy and who have already undergone or are unsuitable for b o n e marrow transplantation.
The subcutaneous formulation of bortezomib has been shown to be clinically non-inferior to th e intravenous formulation and is the same price.
SMC previously accepted bortezomib intravenous injection as monotherapy in the treatme n t o f multiple myeloma when the benefits of a Patient Access Scheme (PAS) were taken into
account. The Patient Access Scheme Assessment Group (PASAG) has confirmed that this response-based PAS also applies to the subcutaneous formulation when used in th is se t t in g .
This SMC advice is therefore contingent upon the continuing availability of the pa t ie nt a cce ss scheme in NHS Scotland or a list price that is equivalent or lower.
Bortezomib intravenous injection has also been accepted for use in NHS Scotla n d in sp e cif ic circumstances in the first line treatment of multiple myeloma as Healthcare Improvement
Scotland has endorsed NICE MTA No 228 (Bortezomib and thalidomide for the first line treatment of multiple myeloma) in July 2011. The PAS does not apply to the use of bortezo mib
in this setting.
Included on the Additional List, for
Specialist Use only, for the indication included in PAS.
December 2012
bortezomib 3.5mg powder for solution fo r injection (Velcade
®)
Janssen-Cilag Ltd
13.01.14 SMC Report No. 927/13
bortezomib (Velcade®) is accepted for restricted use within NHS Scotland in combination with
dexamethasone, or with dexamethasone and thalidomide, for the induction treatme nt o f a d u lt
patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
SMC restriction: use as triple therapy in combination with dexamethasone and thalidomide. Bortezomib, used in combination with dexamethasone and thalidomide for the induction
treatment of adult patients with previously untreated multiple myeloma who are eligible for hig h -dose chemotherapy with haematopoietic stem cell transplantation improved response rates
compared with a dual combination regimen.
Included on the Additional List, for Specialist Use only, for the indication in
question.
February 2014
09 September 2020
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16/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
bortezomib 3.5mg powder for solution fo r
injection (Velcade®)
Janssen-Cilag Ltd
07.09.15
SMC Report No. 1075/15
bortezomib (Velcade®) is accepted for use within NHS Scotland.
Indication under review: in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma
who are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone
significantly improved progression-free survival compared to a regimen containing rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone in adults with previously untreated
mantle cell lymphoma who were unsuitable for haematopoietic stem cell transplantation
Included on the Additional List, for
Specialist Use only, for the indication in question.
October 2015
bosutinib 100mg, 500mg film-coated tablets (Bosulif
®)
Pfizer Ltd
09.02.15 SMC Report No. 910/13
RESUBMISSION Patient Access Scheme
bosutinib (Bosulif®) is accepted for use within NHS Scotland for the treatment of adult p a t ie nts
with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia
chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not
considered appropriate treatment options. Major cytogenetic response was achieved in 23/52 patients who represented “u n me t me d ica l
need” within a non-comparative phase I/II study, in which the full population included 546 patients with CP, AP or BP imatinib pre-treated Ph+ CML.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bosutinib. This advice is contingent upon the continuing availabil it y o f
the patient access scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, for Specialist Use only, for the indication in
question.
April 2015
bosutinib 100mg, 500mg film-coated tablets (Bosulif
®)
Pfizer Ltd
13.08.18 SMC Report No. 2109
NON SUBMISSION
NOT RECOMMENDED: bosutinib (Bosulif®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of adult patients with newly diagnosed chronic phase
Philadelphia chromosome-positive chronic myelogenous leukaemia. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
17/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
brentuximab vedotin (Adcetris®) 50mg
powder for concentrate for solution for infusion
Takeda UK Ltd
13.10.14 SMC Report No. 845/12
brentuximab vedotin (Adcetris®) is accepted for restricted use within NHS Scotland for the
treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or
2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and
treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymp h o ma (sALCL).
SMC restriction: treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a
treatment option In an open-label, single-arm study, patients with relapsed or refractory Hodgkin lymphoma
treated with brentuximab vedotin achieved an objective response rate of 75%. Controlle d d a ta with clinical outcomes are currently lacking.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Brentuximab is also indicated for the treatment of adult patients with re lapsed or refractory systemic anaplastic large cell lymphoma (sALCL). SMC cannot recommend use in sALCL as the
company didnot include evidence for use in this indication in its submission.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2014
brentuximab vedotin (Adcetris®) 50mg
powder for concentrate for solution for
infusion Takeda UK Ltd
07.05.18
SMC Report No. 2085 NON SUBMISSION
NOT RECOMMENDED: brentuximab vedotin (Adcetris®) is not recommended for use within
NHS Scotland.
Indication under review: Treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
brentuximab vedotin 50mg powder for
concentrate for solution for infusion (Adcetris
®)
Takeda UK Ltd
10.06.19 SMC Report No. 2202
NON SUBMISSION
NOT RECOMMENDED: brentuximab vedotin (Adcetris®) is not recommended for use within
NHS Scotland. Indication under review: treatment of adult patients with previously untreated CD30 + S ta g e IV
Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland .
NOT RECOMMENDED
brentuximab vedotin 50mg powder for
concentrate for solution for infusion (Adcetris
®)
Takeda UK Ltd
13.01.20 SMC Report No. 2229
Patient Access Scheme
brentuximab vedotin (Adcetris®) is accepted for restricted use within NHSScotland.
Indication under review: The treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
SMC restriction: for the treatment of patients with advanced CTCL, defined as mycosis fungoides stage IIB and above, primary cutaneous anaplastic large cell lymphoma or Sézary
Syndrome. In an open-label, phase III study in patients with previously treated CD30+ CTCL, the obje ct ive
response rate maintained for at least four months was significantly higher in patients who received brentuximab vedotin than physician’s choice of one of two treatments.
This advice applies only in the context of an approved NHSScotland PAS arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list p rice
that is equivalent or lower.
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time or there is a local
preference for alternative medicines.
March 2020
09 September 2020
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18/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
brigatinib 30mg, 90mg and 180mg film-
coated tablets (Alunbrig®)
Takeda UK Ltd
10.06.19 SMC Report No. 2147
Patient Access Scheme
brigatinib (Alunbrig®) is accepted for use within NHSScotland.
Indication under review: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously
treated with crizotinib. Brigatinib was associated with an objective response rate of 56% in a single-arm, o p e n -la b e l,
phase II study in patients with ALK-positive NSCLC who had progressed on first-l in e ta rg e te d treatment with crizotinib.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of brigatinib. This advice is contingent upon the continuing availabil it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting .
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time of there is a loca l
preference for alternative medicines
July 2019
busulfan, 6mg/mL, intravenous
(Busilvex®)
Pierre Fabre Ltd
15.01.07
SMC Report No. 337/06
busulfan for intravenous infusion (Busilvex®) is accepted for use within NHS Scotland as part o f
a combination regimen for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in paediatric and adult patients. The intravenous
preparation offers advantages to patients over the oral formulation in terms of con ve n ie n ce o f administration and predictability of blood levels.
In adults it should be followed by cyclophosphamide (BuCy2) and in children it should be followed by cyclophosphamide (BuCy4) or by melphalan (BuMel).
‘Not preferred’ in Lothian. A submission
has not been made to FC regarding this product for this indication.
June 2008
cabazitaxel, 60mg concentrate and
solvent for solution for infusion(Jevtana®)
Sanofi
12.12.16
SMC Report No. 735/11 2
nd RESUBMISSION
Patient Access Scheme
cabazitaxel (Jevtana®) is accepted for restricted use within NHS Scotland in combination with
prednisone or prednisolone is indicated for the treatment of adult patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
SMC restriction: for use in patients who have received at least 225mg/m2 (three cycles) of
docetaxel and have an Eastern Cooperative Oncology Group (ECOG) performance status o f 0
or 1. In an open-label, multicentre, randomised-controlled, phase III study in patients with metasta tic
hormone refractory prostate cancer, treatment with cabazitaxel plus prednisone/pre d niso lo ne was associated with an extended median overall survival of 2.4 months compared with an
alternative chemotherapy regimen. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of cabazitaxel. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only, for the indication in
question.
April 2017
cabozantinib 20mg and 80mg hard
capsules (Cometriq®)
Swedish Orphan Biovitrum Ltd.
09.03.15
SMC Report No. 1022/15
NOT RECOMMENDED: cabozantinib 20mg and 80mg hard capsules (Cometriq®) is not
recommended for use within NHS Scotland for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
In one pivotal, phase III study, cabozantinib was associated with a significant advantage in progression-free survival over placebo. However, the difference between cabozantinib and
placebo did not reach statistical significance in the subgroup of patients with Rearranged during Transfection (RET) negative tumours. The summary of product characteristics therefore notes
that for patients in whom RET mutation status is unknown or is negative, a possible lower benefit should be taken into account before individual treatment decision.
The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its benefits was not sufficient to gain
acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
19/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
cabozantinib 20mg, 40mg and 60mg film-
coated tablets (Cabometyx®)
Ipsen Ltd.
12.06.17
SMC Report No. 1234/17 Patient Access Scheme
Following a full submission assessed under the end of life process, cabozantinib (Carbometyx®)
is accepted for use within NHS Scotland. Indication under review: for the treatment of advanced renal cell carcinoma (RCC) in adults
following prior vascular endothelial growth factor. Cabozantinib, compared with a mammalian target of rapamycin (mTOR) inhibitor, significantly
increased progression-free survival in patients with advanced or metastatic RCC who had received at least one previous regimen of VEGF receptor tyrosine kinase inhibitor.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of cabozantinib. This advice is contingent upon the continuing availability
of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
August 2017
cabozantinib, 20mg, 40mg, and 60mg
film-coated tablets (Cabometyx®)
Ipsen Ltd UK
11.02.19
SMC Report No. 2136 (previously SMC Report No. 2095 08.10.18)
RESUBMISSION
NOT RECOMMENDED: cabozantinib (Cabometyx®) is not recommended for use within
NHSScotland for advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk.
In a phase II study, in treatment-naïve adults with advanced RCC with intermediate or poo r risk as defined by the IMDC risk group categories, cabozantinib was superior to another tyrosine
kinase inhibitor for progression free survival. The submitting company did not present a sufficiently robust economic analysis to gain
acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
cabozantinib 20mg, 40mg and 60mg tablets (Cabometyx
®)
Ipsen Ltd
11.02.19 SMC Report No. 2160
NON SUBMISSION
NOT RECOMMENDED: cabozantinib (Cabometyx®) is not recommended for use within
NHSScotland.
Indication under review: As monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
canakinumab (Ilaris®) 150 mg/mL, powder
for solution for injection Novartis Pharmaceuticals
08.11.10
SMC Report No. 658/10 NON SUBMISSION
NOT RECOMMENDED: canakinumab (Ilaris®) is not recommended for use within NHSScotland.
Indication under review: Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHSScotland.
NOT RECOMMENDED
canakinumab (Ilaris®) 150 mg powder fo r
solution for injection Novartis Pharmaceuticals Ltd
10.06.13
SMC Report No. 882/13 NON SUBMISSION
NOT RECOMMENDED: canakinumab (Ilaris®) is not recommended for use within NHS Scotland
for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, a d o le sce nts and children aged 2 years and older with body weight of 7.5 kg or above including:
• Muckle-Wells Syndrome (MWS)
• Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
• Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urt ica ria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash
The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
20/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
capecitabine (Xeloda)
Local formulary process
Treatment of early breast cancer following neoadjuvant anthracycline
and/or taxane based chemotherapy with residual diseasein breast or axillary lymph nodes at time of surgery.
Routinely available in line with local or
regional guidance. Included on the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
November 2018
capecitabine (Xeloda) Roche
07.03.03
SMC Report No. 34/03
capecitabine (Xeloda) is accepted for restricted use within NHS Scotland. Capecitabine is recommended for use in Scotland by oncologists with appropriate expertise in tre a t in g lo ca lly
advanced/metastatic breast cancer. It is an orally active treatment which has improved outcomes both as monotherapy in those
previously treated with an anthracycline and a taxane, and in combination with docetaxel in those previously treated with an anthracycline.
Included in the Formulary.
capecitabine 150 and 500mg tablets
(Xeloda®)
Roche
05.08.05
SMC Report No. 193/05
capecitabine (Xeloda) is accepted for use within NHS Scotland for the adjuvant t re a tme nt o f patients following surgery for Stage III (Dukes’ C stage) colon cancer. Oral capecitabine
appears to be as least as effective as standard IV 5FU/FA chemotherapy with the convenien ce of oral administration. It should only be prescribed by oncologists.
It is more expensive than IV chemotherapy regimens. However, its use may allow ch a n g e s to service delivery that have individual patient or organisational benefits.
Added to the Additional List, for Specialist
Use only.
October 2005
capecitabine, 150mg and 500mg tablets (Xeloda
®) No. (401/07)
Roche
10.09.07 SMC Report No. 401/07
capecitabine (Xeloda®) is accepted for use within NHS Scotland for first line treatment of
patients with advanced gastric cancer in combination with a platinum-based chemotherapy
regimen. Capecitabine was non-inferior to continuously infused intravenous 5-FU in terms of progression-
free survival when each was used in combination with a platinum-based drug in patients with advanced gastric cancer. It also demonstrated non-inferiority in overall survival comp a re d with
continuously infused intravenous 5-FU in patients with advanced gastric cancer when each wa s used in a triple regimen containing a platinum-based drug and an anthracycline drug.
Capecitabine is more expensive than 5-FU, however, the convenience of oral administration may allow changes to service delivery that have individual patient or organisational benefits.
Added to the Additional List, for Specialist Use only.
January 2009
capecitabine 150mg and 500mg tablets
(Xeloda®)
Roche Products Limited
13.10.08
SMC Report No.507/08
capecitabine 150mg and 500mg tablets (Xeloda®) is accepted for use within NHS Sco t la n d fo r
the treatment of metastatic colorectal cancer. The convenience of oral administration may allow changes to service delivery that have
individual patient or organisational benefits, though these may be lessened when it is used in regimens whose other components require intravenous administration.
Added to the Additional List – for Specialist
Use only.
August 2009
capecitabine, 150mg, 500mg, tablets (Xeloda
®)
Roche Products Limited
08.08.11 SMC Report No. 716/11
capecitabine (Xeloda®) is accepted for use within NHS Scotland.
Indication under review: The adjuvant treatment of patients following surgery of stage III (Dukes’
stage C) colon cancer in combination with oxaliplatin. At 55 months, disease free survival was significantly increased for capecitabine plus oxaliplatin -
treated patients compared with a recognised regimen containing a fluoropyramidine in the adjuvant treatment of patients with completely resected stage III (Dukes’ C) colon cancer.
Added to the Additional List, for Specialist Use only.
August 2011
capecitabine (Xeloda®)
Roche
Adjuvant use following potentially curative surgery for adenocarcinoma of the pancreas to
replace 5FU/folinic acid given according to the Mayo schedule
Added to the LJF as first choice for use
post-operatively in the treatment of adenocarcinoma of the pancreas, for
Specialist Use only.
January 2007
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
21/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
capecitabine (Xeloda) Roche
Local formulary process
Colorectal cancer Added to the Additional List for use in
secondary care only. Specialist Use only.
Categorised RED under the ADTC ‘Policy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
January 2005
capecitabine (Xeloda®)
Roche
Local formulary process
Pre-operative chemoradiation in patients with locally advanced rectal cancer requiring down staging prior to definitive resection or in patients with good
performance status and low volume metastatic disease requiring durable palliation for unresectable rectal cancer
Added to the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
September 2006
capecitabine (Xelox®)
Roche
Local formulary process
In combination with epirubicin and cisplatin (ECX) for palliative treatment
of advanced oesphagogastric cancer
Added to the Additional List, for Specialist
Use only. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
September 2005
capecitabine/oxaliplatin (Xeloda
®/Eloxatin
®)
Roche
First choice treatment for Dukes B colorectal cancer Added to the Additional List, for Specialist Use only.
July 2007
carmustine 7.7mg implant (Gliadel®)
Link Pharmaceuticals Ltd
12.12.05 SMC Report No. 215/05
carmustine implant (Gliadel®) is accepted for use within NHS Scotland for the treatment of newly
diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. In the pivotal study, the use of carmustine implants was associated with a 29% relative decrease
in the risk of death, which equates to an increase in median survival time of 2.3 months.
Added to the Additional List, for Specialist
Use only.
March 2006
catumaxomab (Removab®) 10 and 50
microgram concentrate for solution for infusion
Fresenius Biotech GmbH
09.04.12 SMC Report No. 788/12
NON SUBMISSION
NOT RECOMMENDED: catumaxomab (Removab®) is not recommended for use within NHS
Scotland for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
carfilzomib 60mg powder for solution for infusion (Kyprolis
®)
Amgen Ltd.
16.01.17 SMC Report No. 1171/16
RESUBMISSION
NOT RECOMMENDED: carfilzomib (Kyprolis®) is not recommended for use within NHS
Scotland in combination with lenalidomide and dexamethasone for the treatment of adult
patients with multiple myeloma who have received at least one prior therapy. Carfilzomib in combination with lenalidomide and dexamethasone improved progression free
survival compared with lenalidomide and dexamethasone in adults with relapsed and / or refractory multiple myeloma who had received one to three prior therapies.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently ro b u st e co no mic
analysis to gain acceptance by SMC. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
22/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
carfilzomib 10mg, 30mg, 60mg powder
for solution for infusion (Kyprolis®)
Amgen Ltd.
07.08.17
SMC Report No. 1242/17 Patient Access Scheme
Following a full submission assessed under the orphan process, carfilzomib (Kyprolis®) is
accepted for use within NHS Scotland. Indication under review: In combination with dexamethasone alone for the tre a tme n t o f a d u lt
patients with multiple myeloma who have received at least one prior therapy. Carfilzomib in combination with dexamethasone, compared with another proteasome inhibitor in
combination with dexamethasone, increased progression free survival in adults with relapsed o r refractory multiple myeloma who had received between one and three previous lines of
treatment. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost effectiveness of carfilzomib and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List, for Specialist Use only.
April 2018
cemiplimab 350mg concentrate for
solution for infusion (Libtayo®)
Sanofi
10.02.20
SMC Report No. 2216 Patient Access Scheme
Following a full submission considered under the end of life and orphan equivalent process
cemiplimab (Libtayo®) is accepted for use within NHSScotland on an interim basis subject to
ongoing evaluation and future reassessment.
Indication under review: As monotherapy for the treatment of adult patients with me ta sta tic o r locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for
curative surgery or curative radiation. In a phase II study of cemiplimab in patients with metastatic or locally advanced CSCC the
objective response rate was 44%. The base-case economic analysis submitted by the company assumed that patients were
treated for a maximum of two years. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List for Specialist Use only.
August 2020
ceritinib 150mg hard capsules (Zykadia®)
Novartis Europharm Limited
07.12.15 SMC Report No. 1097/15
Patient Access Scheme
ceritinib (Zykadia®) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
In two non-comparative studies (one phase I and one phase II) of patients with advanced AL K -positive NSCLC previously treated with crizotinib, treatment with ceritinib was associated with
clinically meaningful tumour responses and median overall survival of approximately 15 to 17 months. Controlled data with clinical outcomes are currently lacking.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost-effectiveness of ceritinib. This advice is contingent upon the continuing availa b il it y o f th e
PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, Specialist
Use only, for the indication in question.
April 2016
ceritinib 150mg hard capsules (Zykadia®)
Novartis Pharmaceuticals UK Ltd
09.04.18 SMC Report No. 1333/18
NON SUBMISSION
NOT RECOMMENDED: ceritinib (Zykadia®) is not recommended for use within NHS Scotland.
Indication under review: As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
23/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
cetuximab 2mg/mLintravenousinfusion
(Erbitux®)
MerckKGaA
10.07.06
SMC Report No. 279/06
cetuximab (Erbitux®) is accepted for restricted use within NHS Scotland in combination with
radiation therapy for the treatment of patients with locally advanced squamous cell cancer of the head and neck.
It is restricted to patients who are not appropriate for or unable to tolerate chemo-radioth era p y and who are of good performance status with no evidence of distant metastases. It is also
restricted to use by specialists in the management of head and neck cancer.
Added to the Additional List, for Specialist
Use only.
September 2006
cetuximab 5mg/mL solution for infusion (Erbitux
®)
Merck Serono
09.03.09 SMC Report No. 547/09
NON SUBMISSION
NOT RECOMMENDED: cetuximab (Erbitux®) is not recommended for use within NHS Scotla n d
for the treatment of patients with squamous cell cancer of the head and neck in combination with
platinum-based chemotherapy for recurrent and/or metastatic disease. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
cetuximab, 100mg/20mL and 500mg/100mL solution for infusion
(Erbitux®)
Merck Serono Ltd.
April 2017
NICE MTA 439 supersedes SMC Report No. 1012/14
Patient Access Scheme
(SMC Report No. 1012/14 superseded SMC Report No. 115/05 and SMC Report
No. 543/09)
NICE MTA 439 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
Cetuximab is recommended, within its marketing authorisation, as an option for previously untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic
colorectal cancer in adults in combination with: 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX), or
5-fluorouracil, folinic acid and irinotecan (FOLFIRI).
Includedon the Additional List, Specialist Use only.
May 2015
cinacalcet 30, 60 and 90 mg film-coated
tablets (Mimpara®)
Amgen Ltd
08.05.06
SMC Report No. 271/06 NON SUBMISSION
NOT RECOMMENDED: cinacalcet (Mimpara®) is not recommended for use within NHSScotland
for the reduction of hypercalcaemia in patients with parathyroid carcinoma. The h o ld e r o f th e marketing authorisation has not made a submission to SMC regarding this product in this
indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
cisplatin/ vinorelbine
Local formulary process
Adjuvant non-small cell lung cancer
Added to the Additional List, for Specialist
Use only.
October 2005
cladribine 2mg/mL solution for injection
(LITAK®)
Lipomed GmbH
09.03.09
SMC Report No. 537/09 PRODUCT UPDATE
ABBREVIATED SUBMISSION
cladribine (Litak®) is accepted for use in NHS Scotland for the treatment of hairy cell leukaemia.
In patients for whom cladribine is an appropriate agent for this indication, the 2mg/mL so lu t io n allows administration by subcutaneous bolus injection over five consecutive days rather than b y
continuous intravenous infusion of the existing 1mg/mL solution for seven consecutive days. This may confer advantages in terms of convenience to patients and service delivery at a lo we r
cost per course.
New formulation of a product already
included in the Additional List.
March 2009
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
clofarabine, 1mg/mL concentrate for
solution for infusion (Evoltra®)
Bioenvision Limited
15.01.07
SMC Report No. 327/06
clofarabine (Evoltra®) is accepted for restricted use within NHS Scotland for the treatment of
acute lymphoblastic leukaemia (ALL) in paediatric patients (= 21 years) who have re la p se d o r are refractory after receiving at least two prior regimens and where there is no other t re a tme n t
option anticipated to result in a durable response. It is restricted to patients in whom clofarabine is being used as a treatment to b rid g e to HSCT
and restricted to use by specialists in paediatric haemato-oncology. It is not cost effective when used for palliation.
Added to the Additional List, for Specialist
Use only.
March 2009
cobimetinib (Cotellic®) 20mg film-coated
tablets Roche Products Ltd
12.09.16
SMC Report No. 1191/16 NON SUBMISSION
NOT RECOMMENDED: cobimetinib (Cotellic®) is not recommended for use within NHS
Scotland in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
crizotinib, 200mg and 250mg, hard
capsule (Xalkori®)
Pfizer Ltd.
07.10.13
SMC Report No. 865/13 RESUBMISSION
Patient Access Scheme
crizotinib (Xalkori®) is accepted for use within NHS Scotland for the treatment of adults with
previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
In a phase III clinical study in patients with previously treated anaplastic lymphoma kinase (ALK)-positive advanced NSCLC, crizotinib significantly increased progression-free survival
compared with standard chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of crizotinib. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or
lower.
Included on the Additional List, for
Specialist Use only, for the indication in question.
November 2013
crizotinib, 200mg and 250mg hard
capsule (Xalkori®)
Pfizer Limited
11.07.16
SMC Report No. 1152/16 Patient Access Scheme
crizotinib (Xalkori®) is accepted for use within NHS Scotland as first-line treatment of adults with
anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). In patients with previously untreated advanced ALK-positive NSCLC, crizotinib significantly
improved progression-free survival compared with a standard systemic anti-cancer therapy. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of crizotinib. This advice is contingent upon the continuing availab il it y o f the PAS in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, Specia list
Use only, for the indication in question.
October 2016
crizotinib, 200mg and 250mg hard
capsule (Xalkori®)
Pfizer Limited
04.05.18
SMC Report No 1329/18 Patient Access Scheme
Following a full submission assessed under the ultra-orphan medicine process.
crizotinib (Xalkori®) is accepted for use within NHS Scotland.
Indication under review: treatment of adults with ROS1-positive advanced non-sma ll ce ll lu n g
cancer (NSCLC). In a small, single arm, open-label, phase I study of patients with advanced ROS1-positive
NSCLC, treatment with crizotinib resulted in an objective response in 70% of patients. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of crizotinib. This advice is contingent upon the continuing availab il i t y o f the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
November 2018
cytarabine 50mg liposomal suspension for injection (DepoCyte
®)
Napp Pharmaceuticals
09.05.05 SMC Report No. 164/05
NOT RECOMMENDED: cytarabine liposomal suspension for injection (DepoCyte) is not recommended for use within NHS Scotland for the intrathecal treatment of lymphomatous
meningitis. Intrathecally administered cytarabine liposomal suspension cleared malignant cells from the
cerebrospinal fluid, however effects on symptom improvement were not well defined and the cost-effectiveness compared to cytarabine solution has not been demonstrated.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
dabrafenib, 50mg and 75mg hard
capsules (Tafinlar®)
GlaxoSmithKline
09.03.15
SMC Report No. 1023/15 Patient Access Scheme
dabrafenib (Tafinlar®) is accepted for restricted use within NHS Scotland as monotherapy
treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
SMC restriction: for use in patients with unresectable or metastatic BRAFV600 mutation-positive metastatic melanoma who have received no prior therapy.
In a phase III randomised open-label study, treatment with dabrafenib extended median progression free survival by 4.2 months compared with chemotherapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dabrafenib. It is contingent upon the continuing availability of the
patient access scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
May 2015
dabrafenib 50mg and 75mg hard capsules (Tafinlar
®)
Novartis Pharmaceuticals UK Ltd
11.02.19 SMC Report No. 2131
Patient Access Scheme
dabrafenib (Tafinlar®) is accepted for use within NHSScotland.
Indication under review: In combination with trametinib for the adjuvant treatment of adult
patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Relapse-free survival was significantly longer in the dabrafenib plus trametinib group compa re d
with placebo in a phase III study of patients with completely resected, stage III mela n oma with BRAF V600E or V600K mutations.
This SMC advice takes account of the benefits of a Patient Access Schemes (PAS) that improves the cost-effectiveness of dabrafenib and trametinib.
Routinely available in line with national guidance. Included on the Additiona l L ist
for Specialist Use only.
May 2019
daclizumab 150mg/mL solution for
injection in prefilled syringe/pen (Zinbryta
®)
Biogen Idec Ltd.
10.04.17 SMC Report No. 1216/17
Patient Access Scheme
In adult patients for the treatment of relapsing forms of multiple sclerosis.
Restriction: for use
• in patients with rapidly evolving severe (RES) relapsing remitting multiple sclerosis (RRMS)
or
• in patients with RRMS with an inadequate response to disease modifying therapy
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time or there is a local
preference for alternative medicines.
May 2017
WITHDRAWN FROM THE MARKET March 2018
dacomitinib 15mg, 30mg and 45mg
film-coated tablets (Vizimpro®)
Pfizer Ltd
09.09.19
SMC Report No. 2184 Patient Access Scheme
dacomitinib (Vizimpro®) is accepted for use within NHSScotland.
Indication under review:as monotherapy, for the first-line treatment of adult patients with lo ca lly advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor
receptor (EGFR)-activating mutations. In an open-label, randomised, phase III study, dacomitinib significantly improved pro gre ssio n -
free survival compared with another EGFR tyrosine kinase inhibitor in adults with locally advanced or metastatic NSCLC with EGFR-activating mutations.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dacomitinib. This advice is contingent upon the continuing availability of
the PAS in NHSScotland or a list price that is equivalent or lower.
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time or there is a local
preference for alternative medicines.
October 2019
dalteparin (Fragmin®)
Pharmacia
Local formulary process
Thromboprophylaxis in patients with oesophago-gastric cancer undergoing pre-operative cisplatin-based chemotherapy prior to surgery with curative intent.
Added to the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
Specialist Use only.
December 2013
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
daratumumab 20mg/mL concentrate for
solution for infusion (Darzalex®)
Janssen-Cilag Ltd
09.10.17
SMC Report No. 1205/17 RESUBMISSION
Patient Access Scheme
daratumumab (Darzalex®) is accepted for restricted use within NHS Scotland.
Indication under review: As monotherapy for the treatment of adult patients with re la p se d a n d refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an
immunomodulatory agent and who have demonstrated disease progression on the last therapy. SMC restriction: for use as a fourth line treatment option
In a pooled analysis of patients in a phase I/II and a phase II study, with heavily pre-treated multiple myeloma, who received the licensed dosing schedule of daratumumab, th e re wa s a n
overall response rate of 31%. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of daratumumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
April 2018
daratumumab 20mg/mL concentrate for
solution for infusion (Darzalex®)
Janssen-Cilag Ltd
13.05.19
SMC Report No. 2191 NON SUBMISSION
NOT RECOMMENDED: daratumumab (Darzalex®) is not recommended for use within
NHSScotland. Indication under review: in combination with bortezomib, melphalan and prednisone for the
treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
daratumumab 20mg/mL concentrate for
solution for infusion (Darzalex®)
Janssen-Cilag Ltd
08.07.19
SMC Report No. 2180 Patient Access Scheme
daratumumab (Darzalex®) is accepted for restricted use within NHSScotland.
Indication under review: In combination with lenalidomide and dexamethasone, or b o rte zo mib and dexamethasone, for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy. SMC restriction: in combination with bortezomib and dexamethasone, for the treatment of a d ult
patients with multiple myeloma who have received one prior therapy only. Progression-free survival was significantly longer in patients who received daratumumab in
combination with bortezomib and dexamethasone compared with those who received bortezomib and dexamethasone in a phase III study in patients with multiple myeloma who h a d
received at least one prior therapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of daratumumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
November 2019
daratumumab 20mg/mL concentrate for solution for infusion (Darzalex
®)
Janssen-Cilag Ltd
10.02.20 SMC Report No. 2269
NON SUBMISSION
NOT RECOMMENDED: daratumumab (Darzalex®) is not recommended for use within
NHSScotland.
Indication under review: In combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for
autologous stem cell transplant. The holder of the marketing authorisation has not made a submission to SMC regarding
this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
darbepoetin alfa (Aranesp®)
Amgen Ltd
November 2014
NICE MTA 323 supersedes SMC Report No. 273/06
NICE MTA 323 Erythropoiesis-stimulating agents for treating anaemia in people with cancer
having chemotherapy erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta, and darbepoetin alfa) are
recommended, within their marketing authorisations, as options for treating anaemia in people with cancer who are having chemotherapy.
If different erythropoiesis-stimulating agents are equally suitable, the product with the lowest acquisition cost for the course of treatment should be used.
Not routinely available there is a local preference for alternative medicines.
December 2014
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
dasatinib 20mg, 50mg, 80mg, 100mg and
140mg film-coated tablets (Sprycel®)
Bristol-Myers Squibb Pharmaceuticals Ltd
12.09.16
SMC Report No. 370/07 RESUBMISSION
Patient Access Scheme
dasatinib (Sprycel®) is accepted for use within NHS Scotland for the treatment of adult patie n ts
with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resista n ce or intolerance to prior therapy including imatinib mesilate.
In patients with chronic, accelerated or blast phase CML, dasatinib produced h ae ma tolo g ical and cytogenetic responses in two phase III dosing ranging studies. In a phase II study dasatinib
was associated with higher haematological and cytogenetic responses relative to another tyrosine kinase inhibitor in patients with chronic phase CML.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dasatinib. This advice is contingent upon the continuing availabil it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2016
dasatinib, 20mg, 50mg, 70mg tablets (Sprycel
®)
Bristol-Myers Squibb Pharmaceuticals Ltd
07.05.07 SMC Report No. 371/07
NOT RECOMMENDED: dasatinib 20mg, 50mg, 70mg (Sprycel®) is not recommended for use
within NHS Scotland for the treatment of adults with Philadelphia chromosome positive (Ph+)
acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. It has been associated with haematological and cytogenetic responses in patients re sista n t o r
intolerant to existing treatment. However, the economic case was not sufficiently robust and the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not
sufficient to gain acceptance by SMC.
NOT RECOMMENDED
dasatinib 20mg, 50mg, 80mg, 100mg and 140mg film-coated tablets (Sprycel
®)
Bristol-Myers Squibb Pharmaceuticals Ltd
12.09.16 SMC Report No. 1170/16
Patient Access Scheme
dasatinib (Sprycel®) is accepted for use within NHS Scotland for the treatment of adult patie n ts
with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia
(CML) in the chronic phase. In an open-label, phase III study, dasatinib was associated with significantly higher cytoge ne t ic
and molecular response rates at 12 months compared with another tyrosine kinase inhibitor. There were no differences in progression-free or overall survival.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dasatinib. This advice is contingent upon the continuing availabil it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower.
Includedon the Additional List, for Specialist Use only, for the indication in
question.
December 2016
dasatinib20mg, 50mg, 80mg, 100mg, 140
mg film-coated tablets (Sprycel) Bristol-Myers Squibb Pharmaceuticals Ltd
08.04.19
SMC report No. 2142 PRODUCT UPDATE
ABBREVIATED SUBMISSION
dasatinib (Sprycel®) is accepted for use within NHSScotland for the treatment of paediatric
patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemiain chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy
including imatinib. SMC has previously accepted dasatinib for use in the treatment of adult patients with newly
diagnosed Ph+ CML-CP (SMC No. 1170/16) and Ph+ CML-CP resistant or intolerant to prior therapy including imatinib (SMC No. 370/07).
Dasatinib was accepted for use in the treatment of adult patients with Ph+ CML-CP resista n t o r intolerant to prior therapy including imatinib (SMC No. 370/07) following a submission under th e
orphan process. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of dasatinib. This SMC advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only
April 2019
dasatinib, 20mg, 50mg, 80mg, 100mg
and 140mg film-coated tablets (Sprycel®)
Bristol-Myers Squibb Pharmaceuticals Ltd
13.05.19
SMC Report No. 2192 NON SUBMISSION
NOT RECOMMENDED: dasatinb (Sprycel®) is not recommended for use within NHSScotland.
Indication under review: the treatment of paediatric patients with newly diagnosed Philad elp h ia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
decitabine (Dacogen®) 50 mg powder fo r
concentrate for solution for infusion Janssen-Cilag Ltd
14.01.13
SMC Report No. 846/12 NON SUBMISSION
NOT RECOMMENDED: decitabine (Dacogen®) is not recommended for use within NHS
Scotland for the treatment of adult patients aged 65 years and above with newly diagn o sed d e novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation
(WHO) classification, who are not candidates for standard induction chemotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
defibrotide, 80mg/mL, concentrate for
solution for infusion (Defitelio®)
Gentium GmbH
09.06.14
SMC Report No. 967/14 Patient Access Scheme
defibrotide (Defitelio®) is accepted for use within NHS Scotland for the treatment of severe
hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
In a phase III open-label study, defibrotide was associated with improved comp le te re sp o n se rate and survival in patients with severe VOD, compared with a historical control group.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of defibrotide. This SMC advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
August2014
degarelix 120mg, 80mg powder and
solvent for solution for injection (Firmagon
®)
Ferring Pharmaceuticals Ltd
17.01.11 SMC Report No. 560/09
RESUBMISSION Patient Access Scheme
degarelix (Firmagon®) is accepted for use within NHS Scotland. Degarelix is a gonadotropin -
releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
In one study that included patients with all stages of prostate cancer, degarelix was shown to be non-inferior to a luteinising hormone releasing hormone (LHRH) agonist in suppressing
testosterone levels over a one year treatment period without an initial testosterone flare. This SMC advice takes account of the benefits of a patient access scheme (PAS) that improve s
the cost-effectiveness of degarelix. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Included on the Additional List for
Specialist Use only and a prescribing note, for use in patients who are at risk of spinal
cord compression.
Routinely available in line with national guidance. Included on the Additional List,
for Specialist Initiation.
August 2012
August 2018
denosumab 60mg solution for injection in pre-filled syringe
(Prolia®)
Amgen Ltd
13.12.10
SMC Report No. 670/10 NON SUBMISSION
NOT RECOMMENDED: denosumab (Prolia®) is not recommended for use within NHS Scotland.
Indication under review: bone loss associated with hormone ablation in men with prostate
cancer at increased risk of fractures. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use with in NHS Scotland.
NOT RECOMMENDED
denosumab 120 mg solution for injectio n
(Xgeva®)
Amgen
October 2012
NICE MTA 265 supersedes SMC Report No. 752/11
denosumab(Xgeva®)is recommended as an option for preventing skeletal-related events
(pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in a d u lts with bone metastases from breast cancer and from solid tumours other than prostate if:
• bisphosphonates would otherwise be prescribed, and
• the manufacturer provides denosumab with the discount agreed in the patient acce ss scheme.
Included in the LJF, for Specialist Use
only, for the indication in question. Application was for breast cancer patients
only.
April 2013
denosumab (Xgeva®) 120mg solution for
injection Amgen Ltd
07.12.15
SMC Report No. 1119/15 NON SUBMISSION
NOT RECOMMENDED: denosumab (Xgeva®) is not recommended for use within NHS
Scotland. Indication under review:Adults and skeletally mature adolescents with giant cell tumour of bone
that is unresectable or where surgical resection is likely to result in severe morbidity The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
denosumab (Xgeva)®) 120mg solution for
injection Amgen Ltd
13.08.18
SMC Report No. 2110 NON SUBMISSION
NOT RECOMMENDED: denosumab (Xgeva®) is not recommended for use within NHSScotland.
Indication under review: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with haematological malignancies
involving bone. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
dexamethasone 2mg and 4mg
soluble tablets
Local formulary process
Inflammation, various.
The 2mg and 4mg soluble tablets are more cost effective than the non-soluble tablets a n d th e 4mg tablet may reduce the tablet burden in patients receiving large dexamethasone doses.
Soluble tablets are also advantageous for patients with swallowing difficulties.
Routinely available in line with local
guidance. Included in the LJF.
August 2017
dexamethasone 40mg tablets (Neofordex
®)
Aspire Pharma Ltd
12.03.18 SMC Report No. 1322/18
NON SUBMISSION
NOT RECOMMENDED: dexamethasone (Neofordex®) is not recommended for use within NHS
Scotland.
Indication under review: In adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
dexrazoxane (Cardioxane®)
Novartis Pharmaceuticals UK Ltd
12.11.07 SMC Report No. 419/07
NON SUBMISSION
NOT RECOMMENDED: dexrazoxane (Cardioxane®) is not recommended for use within NHS
Scotland for the prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic cancer patients after previous anthracycline
containing treatment. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
dexrazoxane 20mg/mL, for infusion (Savene
®)
TopoTarget A/S
13.10.08 SMC Report No. 361/07
RESUBMISSION
NOT RECOMMENDED: dexrazoxane (Savene®) is not recommended for use within NHS
Scotland for the treatment of anthracycline extravasation. Data from non-comparative, open-label phase II/III studies indicate that administration of dexrazoxane is associated with a relatively low rate of surgery and adverse sequelae follo win g
extravasation of anthracyclines. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance b y
SMC and in addition the justification of the treatment’s cost in relation to its health benefit s wa s not sufficient.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
dinutuximab beta 4.5mg/mL concent ra te
for solution for infusion (Qarziba®)
Eusa Pharma
12.11.18
SMC Report No 2105 Patient Access Scheme
Following a full submission assessed under the ultra-orphan process, dinutuximab beta
(Qarziba®) is accepted for use within NHSScotland.
Indication under review: for the treatment of high-risk neuroblastoma in patients aged 12 months
and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as
patients with history of relapsed or refractory neuroblastoma, with or without residua l d ise a se . Prior to the treatment of relapsed neuroblastoma, any actively progressing disea se sh o u ld b e
stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a
complete response after first line therapy, dinutuximab beta should be combined with interleukin-2.
Comparisons with historical controls indicate that dinutuximab beta plus isotretinoin with and without aldesleukin (interleukin-2) improved event-free survival and overall survival in p a t ie n ts
undergoing first-line treatment for high-risk neuroblastoma and improved overall survival in patients with relapsed neuroblastoma. In patients with relapsed or refractory neuroblastoma
dinutuximab beta in combination with isotretinoin and aldesleukin was associated with tu mo u r responses.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dinutuximab beta. This advice is contingent upon the continuing
availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Routinelyavailable in line with national
guidance. Included on the Additional List , for Specialist Use only.
December 2018
docetaxel (Taxotere) Aventis
09.05.03
SMC Report No. 42/03
docetaxel, in combination with cisplatin, is an effective treatment option for the first line treatment of unresectable, locally advanced or metastatic (stage III/IV) non -small cell lung
cancer (NSCLC). In common with the other drugs recommended by Quality Improvement Scotland (QIS) fo r th is
condition, benefit has only been proven in patients with good performance status. Est ima te d cost per quality adjusted life year (QALY) gained is relatively high. Docetaxel should be initiated
by respiratory physicians/oncologists experienced in the treatment of NSCLC.
Included in Formulary.
Taxotere brand has been discontinued. In NHS Lothian generic docetaxel is used for
this indication.
June 2019
docetaxel (Taxotere®) injection
concentrate
Sanofi-Aventis UK
13.11.06 SMC Report No. 333/06
NON SUBMISSION
NOT RECOMMENDED: docetaxel (Taxotere®) injection concentrate in combination with
cisplatin and 5-fluorouracil is not recommended for use within NHS Scotland for the treatment of
patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
docetaxel 20 and 80mg concentrate a n d
solvent for solution for infusion (Taxotere
®)
Sanofi-Aventis
07.05.07 SMC Report No. 369/07
docetaxel (Taxotere®) is accepted for restricted use within NHS Scotland for the induction
treatment of patients with unresectable locally advanced squamous cell carcinoma of th e h e a d and neck in combination with cisplatin and 5-fluorouracil. It is restricted to patients in whom
induction chemotherapy is appropriate. The docetaxel-containing induction regimen was associated with improved progression-free and
overall survival, compared with cisplatin and 5-fluorouracil alone, in patients with good performance status.
Added to the Additional List, for Specialist
Use only.
Taxotere brand has been discontinued. In NHS Lothian generic docetaxel is used for
this indication.
July 2007
June 2019
09 September 2020
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31/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
docetaxel 20mg, 80mg concentrate and
solvent for solution for infusion, single dose vials (Taxotere
®)
Sanofi-Aventis
10.10.05 SMC Report No. 201/05
docetaxel (Taxotere®) is accepted for use within NHS Scotland in combination with doxorub ic in
and cyclophosphamide for the adjuvant treatment of operable, node-positive breast cancer. Docetaxel in combination with doxorubicin and cyclophosphamide was associated with a
significant improvement in disease free survival at 5 years when compared with one of the standard treatment regimens. However, this benefit is associated with an increased risk of
toxicity. Docetaxel has demonstrated cost effectiveness in comparison to standard t re a tme n t regimen used in NHS Scotland.
Added to the Formulary, for Specialist Use
only.
Taxotere brand has been discontinued. In NHS Lothian generic docetaxel is used for
this indication.
November 2005
June 2019
docetaxel concentrate and solvent for
solution for infusion, single dose vials (Taxotere
®)
Sanofi-Aventis
June 2006 NICE MTA 101 supersedes SMC Report
No. 209/05
NICE MTA 101 Docetaxel for the treatment of hormone-refractory metastatic prostate cancer.
Docetaxel is recommended, within its licensed indications, as a treatment option fo r me n with hormone-refractory metastatic prostate cancer only if their Karnofsky performance-status sco re
is 60% or more. It is recommended that treatment with docetaxel should be stopped: •at the completion of planned treatment of up to 10 cycles, or
•if severe adverse events occur, or •in the presence of progression of disease as evidenced by clinical or laboratory crite ria , o r b y
imaging studies. Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after
completion of the planned course of chemotherapy.
Added to the LJF as first choice, for
Specialist Use only.
Taxotere brand has been discontinued. In NHS Lothian generic docetaxel is used for
this indication.
January 2007
June 2019
docetaxel 20 and 80mg concentrate a n d solvent for solution for infusion
(Taxotere®)
Sanofi-aventis
07.07.08
SMC Report No. 481/08
docetaxel (Taxotere®) is accepted for restricted use within NHS Scotland for the induction
treatment of patients with resectable locally advanced squamous cell carcinoma of the head and
neck in combination with cisplatin and 5-fluorouracil. It is restricted to patients in whom induction chemotherapy is appropriate. In the pivo ta l stu d y,
which included patients with technically resectable disease, the docetaxel-containing in d uct io n regimen was associated with improved overall survival compared with cisplatin and 5 -
fluorouracil alone. SMC has previously issued advice for patients with unresectable disease and this now exte n ds
the advice to patients with resectable disease.
Added to the Additional List, Specialist Use only.
Taxotere brand has been discontinued. In
NHS Lothian generic docetaxel is used for this indication.
May 2009
June 2019
docetaxel (Taxotere®) 20 mg/1mL and 80
mg/4mL and 160 mg/8mL concentrate for solution for infusion
Sanofi Aventis
08.11.10 SMC Report No. 659/10
NON SUBMISSION
NOT RECOMMENDED: docetaxel (Taxotere®) in combination with doxorubicin and
cyclophosphamide is not recommended for use within NHS Scotland. Indication under review: adjuvant treatment of patients with operable node-negative breast
cancer. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result SMC cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
docetaxel
Local formulary process
Treatment in patients with newly diagnosed (within 3 months of starting LHRH analogue or antagonist therapy) metastatic or locally advanced
(TanyN1M0 or T3-4N0M0) prostate cancer with a performance status of 0 -1 and no contraindication to chemotherapy (e.g. marrow failure).
Added on the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
Specialist Use only.
In NHS Lothian generic docetaxel is u se d for this indication.
September 2015
June 2019
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
docetaxel, oxaliplatin, folinic acid, 5-
fluorouracil (FLOT)
Local Formulary process
Peri-operative chemotherapy for oesophago-gastric adenocarcinoma.
Included on the Additional List for
Specialist Use Only.
docetaxel, oxaliplatin, folinic acid, 5-fluorouracil (FLOT) for peri-operative
chemotherapy for oesophago-gastric adenocarcinoma has been classified RED
under the ADTC “Policy for the use of unlicensed (and off-label use) Medicines in
NHS Lothian.
July 2019
durvalumab 50mg/mL concentrate for
solution for infusion (Imfinzi®)
AstraZeneca
10.06.19 SMC Report No. 2156
Patient Access Scheme
durvalumab (Imfinzi®) is accepted for use within NHSScotland.
Indication under review: as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 [programme d ce ll
death ligand 1] on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.
Durvalumab, compared with placebo, improved progression-free survival and overall surviva l in adults who have locally advanced unresectable NSCLC with PD-L1 expressed on ≥1% of
tumour cells and disease that has not progressed following platinum-based chemoradiation therapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of durvalumab. This advice is contingent upon the continuing availa bil it y
of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
July 2019
edoxabantosilate 15mg, 30mg, 60mg
film-coated tablets (Lixiana®) Daiichi Sankyo UK Limited
09.10.15
SMC Report No. 1090/15
edoxaban (Lixiana®) is accepted for use within NHS Scotland.
Indication under review: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults in malignant disease.
One phase III study showed non-inferiority of edoxaban versus a vitamin K antagonist for venous thromboembolism recurrence in patients who had received at least five days tre a tme nt
with low molecular weight heparin or unfractionated heparin. Edoxaban was also associated with a significant reduction in the risk of major and clinically relevant non-major bleeding (compo site
endpoint).
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
January 2019
elotuzumab (Empliciti®) 300mg and
400mg powder for concentrate for solution for infusion
Bristol Myers Squibb Pharmaceutical Limited
08.08.16
SMC Report No. 1183/16 NON SUBMISSION
NOT RECOMMENDED: elotuzumab (Empliciti®) is not recommended for use within NHS
Scotland for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone in adult patients who have received at least one prior therapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
eltrombopag (Revolade®) film-coated
tablets 25mg and 50mg Novartis UK Ltd
16.01.17
SMC Report No. 1206/17 PRODUCT UPDATE
ABBREVIATED SUBMISSION Patient Access Scheme
eltrombopag (Revolade®) is accepted for restricted use within NHS Scotland for chronic immune
(idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year to 17 years who are refracto ry to other treatments (e.g. corticosteroids, immunoglobulins).
SMC restriction: use in patients with severe symptomatic ITP or a high risk of bleeding. Eltrombopag has previously been accepted for restricted use in adult patients with chronic
immune (idiopathic) thrombocytopenic purpura. The license has been extended to include children from 1 year.
SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves th e cost-effectiveness of eltrombopag. This advice is contingent upon the continuing availa bil it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
January 2017
encorafenib 50mg and 75mg hard capsules (Braftovi
®)
Pierre Fabre Ltd
08.07.19 SMC Report No. 2145
NOT RECOMMENDED: encorafenib (Braftovi®)is not recommended for use within
NHSScotland.
Indication under review: In combination with binimetinib for the treatment of adult patien ts with unresectable or metastatic melanoma with a BRAF V600 mutation.
Progression-free survival was significantly longer in the encorafenib plus binimetinib group compared with BRAF inhibitor monotherapy in a phase III study of patients with unresectable o r
metastatic BRAF V600 melanoma. The submitting company did not present a sufficiently robust economic analysis to gain
acceptance by SMC. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
encorafenib 50mg and 75mg hard
capsules (Braftovi®)
Pierre Fabre Ltd
10.02.20 SMC Report No. 2238
RESUBMISSION Patient Access Scheme
Following a resubmission assessed under the end of life and orphan medicine process
encorafenib (Braftovi®) is accepted for use within NHSScotland
Indication under review: In combination with binimetinib for the treatment of adult patie nts with
unresectable or metastatic melanoma with a BRAF V600 mutation. Progression-free survival was significantly longer in the encorafenib plus binimetinib group
compared with BRAF inhibitor monotherapy in a phase III study of patients with unresectable o r metastatic BRAF V600 melanoma.
This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was b a se d, o r
PAS/ list prices that are equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List for Specialist Use only.
July 2020
enzalutamide 40mg soft capsules (Xtandi
®)
Astellas Pharma Ltd
11.11.13 SMC Report No. 911/13
Patient Access Scheme
enzalutamide (Xtandi®) is accepted for use within NHS Scotland for the treatment of ad ult me n
with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on
or after docetaxel therapy. In one randomised, double-blind, phase III clinical study, enzalutamide significantly in cre a sed
overall survival compared with placebo. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of enzalutamide. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or
lower.
Includedon the Additional List, for Specialist Use only, for the indication in
question.
December 2013
09 September 2020
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34/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
enzalutamide, 40mg soft capsules
(Xtandi®)
Astellas Pharma Ltd
07.03.16
SMC Report No. 1066/15 INDEPENDENT REVIEW PANEL
Patient Access Scheme
enzalutamide (Xtandi®) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom chemotherapy is not yet clinically indicated. In a randomised, double-blind phase III study of adult men with chemothera py n a ive mCRPC
treatment with enzalutamide was associated with a statistically significant extended overall survival and radiographic progression free survival compared to placebo.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost-effectiveness of enzalutamide. This advice is contingent upon the continuing availabilit y o f
the patient access scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, Specialist
Use only, for the indication in question.
April 2016
enzalutamide 40mg soft capsules (Xtandi
®)
Astellas Pharma Ltd
07.10.19 SMC Report No. 2195
NOT RECOMMENDED: following a full submission considered under the orphan equivalent process, enzalutamide (Xtandi
®) is not recommended for use within NHSScotland.
Indication under review: The treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
In a phase III study in men with high-risk non-metastatic CRPC enzalutamide was superior to placebo for metastasis-free survival. High-risk was defined as prostate specific antigen (PSA)
doubling time ≤10 months and PSA ≥2 nanograms/mL. Both groups received on -going androgen-deprivation therapy or had undergone bilateral orchiectomy. Overall survival data a re
immature. The submitting company’s justification of the treatment’s cost in relation to its health benefits
was not sufficient and in addition the company did not present a sufficiently ro b u st e co no mic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
epirubicin (Pharmorubicin®), cisplatin
(Platinex®) and capecitabine (Xeloda
®)
(ECX)
Pharmacia, Bristol-Myers Squibb, Roche
Local formulary process
Peri-operative treatment of operable gastric and type 3 oesophagogastric junctional
adenocarcinomas.
Added to the LJF as first choice treatme n t
for peri-operative treatment of operable gastric and type 3 oesophagogastric
junctional adenocarcinomas, Specialist Use only.
September 2007
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
35/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
eribulin (mesilate) 0.44mg/mLsolution for
injection (Halaven®)
Eisai Ltd
07.03.16
SMC Report No. 1065/15 (Supersedes SMC Report No. 726/11)
RESUBMISSION Patient Access Scheme
eribulin (Halaven®) is accepted for restricted use within NHS Scotland.
Indication under review: for the treatment of adult patients with locally advanced or me ta sta t ic breast cancer who have progressed after at least one chemotherapeutic regimen for adva n ced
disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
SMC restriction: for use in patients with locallyadvanced or metastatic breast cancer wh o h a ve progressive disease after at least two prior chemotherapeutic regimens for advan ced d ise ase
which includes capecitabine if indicated. In a randomised, phase III, open-label study, median overall survival was extended by 2.5
months in patients treated with eribulin compared with the comparator, treatment of physicia n ’s choice, which included a range of single agent chemotherapy treatments. In th e su b g ro up o f
patients previously treated with capecitabine the extension to median overall surviva l wa s 2 .9 months.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost-effectiveness of eribulin. This advice is contingent upon the continuing availa b il it y o f th e
PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, for
Specialist Use only, for the indication in question.
July 2016
eribulin 0.44mg/mL solution for injection (Halaven
®)
Eisai Ltd
09.09.19 SMC Report No. 2231
NON SUBMISSION
NOT RECOMMENDED: in the absence of a submission from the holder of the marketing authorisation eribulin (Halaven
®) is not recommended for use within NHSScotland for the
treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic d isease.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
erlotinib (Tarceva®)
Roche Pharmaceuticals
09.07.07 SMC Report No. 382/07
NON SUBMISSION
NOT RECOMMENDED: erlotinib (Tarceva®) in combination with gemcitabine is not
recommended for use within NHS Scotland for the treatment of patients with metastatic pancreatic cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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36/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
erlotinib, 100 and 150mg film-coated
tablets (Tarceva®)
Roche
December 2015
NICE MTA 374 supersedes SMC Report No. 220/05
Patient Access Scheme
NICE MTA374 Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed
after prior chemotherapy Erlotinib is recommended as an option for treating locally advanced or metastatic non-small-ce ll
lung cancer that has progressed in people who have had non-targeted chemotherapy be cau se of delayed confirmation that their tumour is epidermal growth factor receptor tyrosine kinase
(EGFR-TK) mutation-positive, only if the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 258.
Erlotinib is recommended as an option for treating locally advanced or metastatic non-small-ce ll lung cancer that has progressed after non-targeted chemotherapy in people with tumours of
unknown EGFR-TK mutation status, only if:
• the result of an EGFR-TK mutation diagnostic test is unobtainable because of an inadequate tissue sample or poor-quality DNA and
• the treating clinician considers that the tumour is very likely to be EGFR-TK mutatio n -positive and
• the person’s disease responds to the first 2 cycles of treatment with erlotinib and
• the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 258.
Erlotinib is not recommended for treating locally advanced or metastatic non-small-cell lung
cancer that has progressed after non-targeted chemotherapy in people with tu mo u rs th a t a re EGFR-TK mutation-negative.
Gefitinib is not recommended for treating locally advanced or metastatic non-small-cell lung cancer that has progressed after non-targeted chemotherapy in people with tu mo u rs th a t a re
EGFR-TK mutation-positive.
Added to the Additional List, for Specialist
Use only.
September 2006
erlotinib, 25, 100 and 150mg film-co a te d
tablets (Tarceva®)
Roche
17.01.11
SMC Report No. 664/10
NOT RECOMMENDED: erlotinib (Tarceva®) is not recommended for use within NHS Scotland.
Indication under review: as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard
platinum-based first-line chemotherapy. Erlotinib maintenance treatment provided a statistically significant increase in progressio n f re e
survival and overall survival in patients treated with standard first-line platinum-based chemotherapy, both in the whole study population and in a post hoc analysis in p a t ie n ts with
stable disease. In the whole study population the changes in these outcomes were consid e re d to be of modest size.
The manufacturer’s justification of the treatment’s cost in relation to its health benefit s wa s n o t sufficient to gain acceptance by SMC.
NOT RECOMMENDED
erlotinib 25, 100 and 150mg film-coated
tablets (Tarceva®)
Roche Products Ltd
16.01.12
SMC Report No. 749/11 Patient Access Scheme
erlotinib (Tarceva®) is accepted for use within NHS Scotland for first-line treatment of patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epiderma l g ro wth factor receptor (EGFR) activating mutations.
In patients with advanced or metastatic NSCLC with EGFR mutations, erlotinib was associa te d with significantly improved progression-free survival compared with platinum-based doublet
chemotherapy regimens. There are no mature overall survival data. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of erlotinib. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland.
Added to the Additional List, for Specialist
Use only.
March 2012
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
etanercept (Enbrel®)
Local formulary process
Immunosuppressant therapy for islet cell transplant.
Routunely available in line with regional
guidance. Included on the Additional L ist , for Specialist Use only
Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
March 2019
everolimus 2.5mg, 5mg and 10mg tablets
(Afinitor®)
Novartis Pharmaceuticals UK Limited
10.11.14
SMC Report No. 595/10 RESUBMISSION
everolimus (Afinitor®) is accepted for use within NHS Scotland for the treatment of patients with
advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
Everolimus, in conjunction with best supportive care (BSC), increased median progression-f re e survival (PFS) by three months compared with placebo plus BSC in heavily pre-treated patien ts
with metastatic renal cell carcinoma.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2014
everolimus (Votubia®) 2.5mg and 5mg
tablets Novartis Pharmaceuticals UK Ltd
09.04.12
SMC Report No. 787/12 NONSUBMISSION
NOT RECOMMENDED: everolimus (Votubia®) is not recommended for use within NHS
Scotland for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic
intervention but are not amenable to surgery. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
everolimus, 5mg, 10mg tablets (Afinitor®)
Novartis Pharmaceuticals UK Limited
July 2017
NICE MTA 449 supersedes SMC Report No. 777/12
Patient Access Scheme
everolimus (Afinitor®) is accepted for use within NHS Scotland for the Treatment of unresectable
or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin
(pNET) in adults with progressive disease. Everolimus was superior to placebo in prolonging progression-free survival in adults with
progressive, advanced pNET who were receiving best supportive care. NICE MTA 449Everolimus and sunitinib for treating unresectable or metastatic neuroendocrin e
tumours in people with progressive disease. Everolimus and sunitinib are recommended, within their marketing authorisations, as options for
treating well- or moderately-differentiated unresectable or metastatic neuroendocrin e tu mo u rs (NETs) of pancreatic origin in adults with progressive disease.
Everolimus is recommended, within its marketing authorisation, as an option for treating well-differentiated (grade 1 or grade 2) non-functional unresectable or metastatic NETs of
gastrointestinal or lung origin in adults with progressive disease.
Includedon the Additional List, for Specialist Use only.
August 2017
everolimus (Votubia®) 10mg tablets
Novartis Pharmaceuticals Ltd
10.06.13
SMC Report No. 884/13 NON SUBMISSION
NOT RECOMMENDED: everolimus (Votubia®) is not recommended for use within NHS
Scotland for the treatment of adult patients with renal angiomyolipoma associated with tuberous
sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do n o t re q u ire
immediate surgery. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
everolimus 2.5mg, 5mg and 10mg tablets
(Afinitor®)
Novartis Pharmaceuticals UK Limited
11.04.16
SMC Report No. 872/13 2
nd RESUBMISSION
everolimus (Afinitor®) is accepted for use within NHS Scotland.
Indication under review: For the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without
symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
The addition of everolimus to exemestane treatment significantly increased progression free survival compared with exemestane alone in postmenopausal women with disease progression
following a non-steroidal aromatase inhibitor. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of everolimus. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, for
Specialist Use only, for the indication in question.
July 2016
everolimus (Certican®) 0.25mg, 0.5mg
and 0.75mg tablets Novartis Pharmaceuticals UK Ltd
09.11.15
SMC Report No. 1117/15 NON SUBMISSION
NOT RECOMMENDED: everolimus (Certican®) is not recommended for use within NHS
Scotland. Indication under review:Prophylaxis of organ rejection in adult patients at low to moderate
immunological risk receiving a cardiac transplant Prophylaxis of organ rejection in patients receiving a hepatic transplant
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
everolimus 2.5mg, 5mg and 10mg tablets
(Afinitor®)
Novartis Pharmaceuticals UK Ltd
July 2017
NICE MTA 449 supersedes SMC Report No. 1215/17
Patient Access Scheme
NICE MTA 449Everolimus and sunitinib for treating unresectable or metastatic neuroendocrin e
tumours in people with progressive disease. Everolimus and sunitinib are recommended, within their marketing authorisations, as options for
treating well- or moderately-differentiated unresectable or metastatic neuroendocrin e tu mo u rs (NETs) of pancreatic origin in adults with progressive disease.
Everolimus is recommended, within its marketing authorisation, as an option for treating well-differentiated (grade 1 or grade 2) non-functional unresectable or metastatic NETs of
gastrointestinal or lung origin in adults with progressive disease.
Routinely available in line with national
guidance. Included on the Additional L ist , Specialist Use only, for the indication in
question.
Augist 2017
everolimus 0.25mg, 0.5mg and 0.75mg
tablets (Certican®)
Novartis Pharmaceuticals UK Ltd
13.11.17
SMC Report No. 1288/17 NON SUBMISSION
NOT RECOMMENDED: everolimus (Certican®) is not recommended for use within NHS
Scotland. Indication under review: Prophylaxis of organ rejection in adult patients at low to moderate
immunological risk receiving an allogenic renal transplant. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
exemestane 25mg tablets (Aromasin®)
Pfizer Limited
07.11.05 SMC Report No. 210/05
exemestane (Aromasin®) is accepted for restricted use within NHS Scotland for the adjuvant
treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 - 3 years of initial adjuvant tamoxifen therapy.
Exemestane has shown benefit in terms of disease-free survival when given as an alternative to tamoxifen after initial adjuvant treatment with tamoxifen for 2 - 3 years. It offers an alternative to
tamoxifen after initial adjuvant treatment with tamoxifen for 2 - 3 years and has a different adverse effects profile. Treatment with exemestane is restricted to initiation by a breast ca n ce r
specialist.
Added to the LJF as a prescribing note.
August 2010
09 September 2020
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39/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
febuxostat 120mg film-coated tablet
(Adenuric®)
A. MenariniFarmaceuticaInternazionale
SRL
13.06.16 SMC Report No. 1153/16
febuxostat film-coated tablet (Adenuric®) is accepted for restricted use within NHS Scotla n d fo r
the prevention and treatment of hyperuricaemia in adult patients undergoing chemothera p y fo r haematologic malignancies at intermediate to high risk of Tumour Lysis Syndrome (TLS).
SMC restriction: prevention of hyperuricaemia in adult patients at intermediate risk of TLS in
whom allopurinol is either unsuitable or contraindicated, such as:
• Those intolerant of allopurinol
• Those in whom allopurinol is contraindicated, e.g. patients with renal impairment
In a phase III, randomised, double-blind study in adults with haematologic malignancies at
intermediate to high risk of TLS, febuxostat was significantly superior to a xanthine oxidase inhibitor at reducing serum uric acid levels.
Not included on the LJF, because
clinicians have not responded to an invitation to apply for formulary inclusion
for this medicine.
July 2016
fludarabine, 10mg tablet and 50mg for
injection or infusion (Fludara®)
Schering Health Care Ltd
13.11.06
SMC Report No. 176/05
fludarabine phosphate (Fludara®) is accepted for restricted use within NHS Scotland for the
treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone ma rro w reserves. First line treatment should only be initiated in patients with advanced disease, Rai
stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has d ise a se related symptoms or evidence of progressive disease.
Fludarabine phosphate has been associated with higher response rates than ch lo ra mb u cil in clinical trials. No overall survival advantage over other therapies has been demonstrated.
Fludarabine is restricted to use by specialists in haemato-oncology.
Added to the Additional List, for Specialist
Use only.
July 2009
FOLFIRINOX combination chemotherapy (Folic acid, 5-Fluorouracil, Irinotecan,
Oxaliplatin) Various
Local formulary process
For use in palliative chemotherapy for inoperable pancreatic adenocarcinoma in good performance status patients.
Added to the Additional List, for Specialist Use only.
December 2011
5-FU, irinotectan, oxaliplatin (modified
Folfirinox regimen)
Local formulary process
As adjuvant treatment following potentially curative resection of pancreatic cancer. Routinely available in line with local
guidance, Included on the Additiona l L ist for Specialist Use only.
CategorisedRED under the ADTC “Policy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian. Included
on the Additional List for Specialist Use only.
July 2019
fosaprepitant, 115mg powder for solutio n for infusion (Ivemend
®)
Merck Sharp & Dohme Limited
13.10.08 SMC Report No. 506/08
fosaprepitant (Ivemend®) is accepted for restricted use within NHS Scotland for the prevention of
acute and delayed nausea and vomiting associated with highly emetogenic cisplatin -based
cancer chemotherapy. Fosaprepitant is marginally more expensive than aprepitant. It is restricted to use in patients fo r
whom aprepitant is indicated but the oral formulation is not appropriate. Prescribing sh o u ld b e initiated by hospital based specialists only.
Fosaprepitant is also licensed for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. As the manufacturer’s submission related only to
its use with highly emetogenic cancer chemotherapy, SMC cannot recommend its use in this setting.
Added to the Additional List, for Specialist Use only.
July 2009
Withdrawn from the UK market, February 2011
09 September 2020
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40/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
fosaprepitantdimeglumine 150 mg
powder for solution for infusion (IVEmend
®)
MSD Ltd
07.03.11 SMC Report No. 678/11
PRODUCT UPDATE ABBREVIATED SUBMISSION
fosaprepitantdimeglumine (IVEmend 150mg®) is accepted for use within NHS Scotland.
Indication under review: Prevention of acute and delayed nausea and vomiting associate d with highly emetogenic cisplatin based cancer chemotherapy in adults.
IVEmend 150 mg is given as part of a combination therapy. Fosaprepitant 150mg is not recommended for the prevention of nausea and vomiting associated
with moderately emetogenic cancer chemotherapy in adults, as SMC has previously not recommended both fosaprepitant iv and aprepitant capsules for this indication.
Added to the Additional List, for Specialist
Use only.
March 2011
fosaprepitant 150mg powder for solu t io n
for infusion (Ivemend®)
Merck Sharp & Dohme
12.11.18
SMC Report No. 2108 PRODUCT UPDATE
ABBREVIATED SUBMISSION
fosaprepitant (Ivemend 150mg®) is accepted for use within NHSScotland.
Indication under review: prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in paediatric patients aged 6 months to 17 years.
Fosaprepitant is given as part of a combination therapy. SMC has previously accepted fosaprepitant as part of combination therapy for the prevention o f
acute and delayed nausea and vomiting associated with highly emetogenic cisplatin -based chemotherapy in adults (678/11).
SMC has previously accepted aprepitant for use as part of combination therapy for the prevention of nausea and vomiting associated with moderately and highly emetog en ic ca n ce r
chemotherapy in children, toddlers and infants from the age of six months to 17 years (1252 /1 7 and 1241/17 respectively). Intravenous fosaprepitant is a pro-drug of oral aprepitant and it offers
an alternative with limited budget impact.
Routinely available in line with national
guidance. Included on the Additional List, for Specialist Use only.
November 2018
fulvestrant 250mg solution for injection (Faslodex
®)
AstraZeneca UK Limited
11.12.17 SMC Report No. 1294/17
NON SUBMISSION
NOT RECOMMENDED: fulvestrant (Faslodex®) is not recommended for use within NHS
Scotland.
Indication under review: Treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine
therapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
fulvestrant 250mg solution for injection (Faslodex
®)
AstraZeneca UK Limited
08.02.16 SMC Report No. 114/04
RESUBMISSION Patient Access Scheme
fulvestrant (Faslodex®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of postmenopausal women with oestro g en re ce p to r
positive, locally advanced or metastatic breast cancer for disease relapse on or afte r a d ju va nt anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.
In a phase III randomised double blind study, fulvestrant 500mg increased progression free survival and overall survival compared to fulvestrant 250mg.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fulvestrant. This advice is contingent upon the continuing availability o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting
Included on the Additional List, Specia list Use only, for the indication in question.
October 2016
09 September 2020
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41/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
gefitinib 250mg film-coated tablets
(Iressa®)
AstraZeneca UK Ltd
07.12.15
SMC Report No: 615/10 2
nd RESUBMISSION
Patient AccessScheme
gefitinib (Iressa®) is accepted for restricted use within NHS Scotland.
Indication under review: the treatment of adult patients with locally advanced or metastatic n o n-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor
tyrosine kinase (EGFR-TK). SMC restriction: in patients with previously untreated locally advanced or metastatic NSCLC with
activating EGFR-TK mutations i.e. as a first-line therapy. In patients with EGFR mutation-positive, advanced NSCLC, randomised controlled studies
demonstrated an improvement in the progression-free survival and tumour respon se ra te s fo r those treated with gefitinib compared with platinum-doublet chemotherapy. There was no overall
survival benefit demonstrated. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost-effectiveness of gefitinib. This advice is contingent upon the continuing availabil it y o f th e patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Not included on the LJF, because
clinicians have not responded to an invitation to apply for formulary inclusion
for this medicine.
March 2016
gemcitabine (Gemzar®)
Eli Lilly & Co Ltd
Local formulary process
Biliary tract cancer.
Added to the Additional List, for Specialist
Use only. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
September 2005
gemcitabine 200mg and 1g powder for
solution for infusion (Gemzar®)
Eli Lilly and Company Ltd
11.12.06
SMC Report No. 154/05 RESUBMISSION
gemcitabine (Gemzar®), in combination with paclitaxel, is accepted for restricted use within NHS
Scotland for the treatment of patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an
anthracycline unless clinically contraindicated. Gemcitabine in combination with paclitaxel modestly improves outcomes, compared to paclitaxel
monotherapy, in those previously treated with an anthracycline. For this indication gemcitabine is restricted to use by oncologists specialising in the treatment of
breast cancer.
Added to the Additional List, for Specialist
Use only.
December 2007
gemcitabine (Gemzar®)
Local formulary process
In combination with dexamethasone and cisplatin for relapsed / refractory lymphoma.
Added to the Additional List, for Specialist
Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
May 2014
gemcitabine in combination with carboplatin
April 2016
NICE MTA 389
NOT RECOMMENDED: NICE 389 Topotecan, pegylated liposomal doxorubicin hydrochlorid e , paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Gemcitabine in combination with carboplatin is not recommended within its marketing authorisation for treating the first recurrence of platinum-sensitive ovarian cancer. The Appraisal
Committee was unable to make recommendations on the use of these technologies for treat in g platinum-sensitive ovarian cancer beyond the first recurrence.
NOT RECOMMENDED
gemcitabine powder for infusion and
capecitabine tablets
Local formulary process
Adjuvant treatment following potentially curative resection of pancreatic cancer. Routinely available in line with local or
regional guidance. Included on the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
July 2017
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
gemtuzumabozogamicin 5mg powder fo r
concentrate for solution for infusion (Mylotarg
®)
Pfizer Ltd
08.10.18 SMC Report No. 2089
Following a full submission assessed under the end of life and orphan medicine process
gemtuzumab ozogamicin (Mylotarg®) is accepted for restricted use within NHSScotland for
combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years
and above with previously untreated, de novo CD33-positive acute myeloid leuka e mia (AML ), except acute promyelocytic leukaemia (APL).
SMC restriction: use in patients with a favourable, intermediate or unknown cytogenetic profile. In an open-label, phase III study of adults with AML, the addition of gemtuzumab ozogamicin to
standard intensive chemotherapy was associated with significant improvement in event -free survival compared with standard intensive chemotherapy alone. Events included failure to
achieve remission with induction therapy, relapse of disease, or death. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
December 2018
gilteritinib 40mg film-coated tablets
(Xospata®)
Astellas Pharma Ltd
07.09.20
SMC Report No. 2252 Patient Access Scheme
Following a full submission assessed under the end of life and orphan medicine process
gilteritinib (Xospata®) is accepted for use within NHSScotland.
Indication under review: as monotherapy for the treatment of adult patients who have relapsed
or refractory acute myeloid leukaemia with a FLT3 mutation. In an open-label, phase III study, gilteritinib improved overall survival compared with salvage
chemotherapy in patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based,
or a PAS/ list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Formulary classification not yet decided –
waiting for information from clinician.
granisetron 3.1mg / 24 hours transdermal
patch (Sancuso®)
ProStrakan Ltd
07.10.13
SMC Report No. 895/13 PRODUCT UPDATE
ABBREVIATED SUBMISSION
granisetron 3.1mg / 24 hours transdermal patch (Sancuso®) is accepted for use within NHS
Scotland in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where o ra l
anti-emetic administration is complicated by factors making swallowing difficult. Granisetron 3.1mg / 24 hours transdermal patch is slightly more expensive than the oral
formulation. It provides an alternative option in patients who have difficulty swallowing oral medication.
Included on the Additional List, Specia list
Use only, for the indication in question.
October 2013
histamine dihydrochloride, 500
microgram/0.5mL, vial (Ceplene®)
Meda Pharmaceuticals Ltd
17.01.11
SMC Report No. 666/10
NOT RECOMMENDED: histamine dihydrochloride (Ceplene®) is not recommended for use
within NHS Scotland. Indication under review: maintenance therapy for adult patients with acute myeloid leukaemia in
first remission concomitantly treated with interleukin-2. The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60 years.
In a randomised open-label study, histamine plus interleukin-2 was superior to no treatment fo r the endpoint of leukaemia free survival (LFS) in a sub-group of patients in first complete
remission. In post hoc analysis of patients in first complete remission and aged less than 60 years, LFS rates at 36 months were 50% versus 30%.
Overall the manufacturer did not present a sufficiently robust clinical or economic ca se to g a in acceptance by SMC.
NOT RECOMMENDED
histidine - tryptophan - ketoglutarate
(HTK) (Custodial®)
Kohler Medical Ltd
Local formulary process
(1) Non heart-beating kidney - liver donors (NHBD)
(2) Live donor liver transplantation (LDLT)
Added to the Additional List, for Specialist
Use only.
May 2006
09 September 2020
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43/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
histrelin acetate, 50mg subcutaneous
implant (Vantas®)
Orion Pharma (UK) Ltd
10.08.09
SMC Report No. 557/09
histrelin (Vantas®) subcutaneous implant is accepted for restricted use within NHS Scotlan d fo r
palliative treatment of advanced prostate cancer. Histrelin is restricted to use in patients with an anticipated life expectancy of at least one year in
whom annual administration will offer advantages. In a single-arm study, histrelin provided effective suppression of testosterone levels in p a t ie n ts
with advanced prostate cancer. It requires less frequent administration than othe r lu te in is i n g hormone releasing hormone (LHRH) agonists. Other LHRH agonists are available at a lower
acquisition cost.
‘Not preferred’ in Lothian as suitable
alternatives exist.
January 2010
hydroxycarbamide (Siklos®)
Nordic Pharma UK
12.10.09 SMC Report No. 582/09
NON SUBMISSION
NOT RECOMMENDED: hydroxycarbamide (Siklos®) is not recommended for use within NHS
Scotland for the prevention of recurrent painful vaso-occlusive crises including acute chest
syndrome in paediatric and adult patients suffering from symptomatic Sickle Cell Syndrome. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland
NOT RECOMMENDED
hydroxycarbamide (Xromi®)
100mg/mLoral solution
Nova Laboratories Limited
10.08.20 SMC Report No.2271
PRODUCT UPDATE ABBREVIATED SUBMISSION
hydroxycarbamide oral solution (Xromi®) is accepted for restricted use within NHSScotland.
Indication under review: for the prevention of vaso-occlusive complications of Sickle Cell
Disease in patients over 2 years of age. SMC restriction: children who are too young to be able to swallow capsules / tablets and adults
and adolescents who have difficulty in swallowing solid oral dosage forms. The availability of hydroxycarbamide oral solution (Xromi
®) provides a licensed alternative to
unlicensed liquid preparations.
Routinely available in line with national guidance. Included on the Additional List ,
for Specialist Use only. All prescribing an d supply is via the specialist paediatric
haematology service.
August 2020
ibandronic acid (Bondronat®)
Roche
11.10.04
SMC Report No. 123/04
ibandronic acid is accepted for use within NHS Scotland for the prevention of ske le tal e ve n ts (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with
breast cancer and bone metastases. It reduces the rate of skeletal events consisting of a composite of vertebral fractures,
pathological non-vertebral fractures and the need for radiotherapy or surgery to deal with b o n e complications. It can be given both by the oral or intravenous route.
Added to the Formulary as first choice bisphosphonate, on the advice of an
oncologist/ haematologist, for the prevention of skeletal related events in
patients with breast cancer.
February 2005
ibritumomab tiuxetan (Zevalin®)
Schering Health Care Ltd
09.07.07 SMC Report No. 171/05
RESUBMISSION
NOT RECOMMENDED: ibritumomab tiuxetan (Zevalin®) is not recommended for use within
NHS Scotland for the preparation of a radiopharmaceutical incorporating Yttrium 90 [90
Y] for th e treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-
Hodgkin's lymphoma (NHL). The manufacturer did not present a sufficiently robust economic analysis to gain acceptance b y
SMC.
NOT RECOMMENDED
ibritumomab tiuxetan 1.6mg/mL (Zevalin
®)
Bayer plc
11.08.08 SMC Report No. 449/08
NON SUBMISSION
NOT RECOMMENDED: ibritumomab tiuxetan (Zevalin) is not recommended for use within NHS Scotland as consolidation therapy after remission induction in previously untreated patients with
follicular lymphoma. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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44/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ibrutinib 140mg hard capsule (Imbruvica®)
Janssen-Cilag Ltd.
08.08.16 SMC Report No. 1150/16
Patient Access Scheme
ibrutinib (Imbruvica®) is accepted for use within NHS Scotland for the treatment of adult patients
with relapsed or refractory mantle cell lymphoma (MCL). In a randomised, open-label, phase III study ibrutinib significantly prolonged progression-free
survival, the primary endpoint, compared to a chemotherapy treatment, in patients with relapsed or refractory MCL.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib. This advice is contingent upon the continuing availability of
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
November 2016
ibrutinib 140mg hard capsules
(Imbruvica®)
Janssen-Cilag Ltd.
10.04.17
SMC Report No. 1151/16 RESUBMISSION
Patient Access Scheme
Following a resubmission assessed under the end of life and orphan medicine process:
ibrutinib (Imbruvica®) is accepted for restricted use within NHS Scotland.
Indication under review: the treatment of adult patients with chronic lymphocytic leukaemia
(CLL) who have received at least one prior therapy. SMC restriction: patients with relapsed/refractory CLL and for whom fludarabine-based regimens
are inappropriate. In an open-label, phase III study, ibrutinib significantly increased progression-free survival
compared with an anti-CD20 antibody in patients with relapsed or refractory CLL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of ibrutinib. This advice is contingent upon the continuing ava ila bil it y o f the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account o f
views from a Patient and Clinician Engagement (PACE) meeting. This resubmission relates to use as a single agent for the treatment of adult patien ts with CL L
who have received at least one prior therapy. SMC published advice in August 2016 that ibrutinib was accepted for restricted use as a single agent for patients with 17p deletion or TP53
mutation who are unsuitable for chemo-immunotherapy (SMC 1151/16).
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
July 2017
ibrutinib (Imbruvica®) 140mg hard
capsules
Janssen-Cilag Ltd
12.06.17 SMC Report No. 1258/17
NON SUBMISSION
NOT RECOMMENDED: ibrutinib (Imbruvica®) is not recommended for use within NHS Scotland.
Indication under review: In combination with bendamustine and rituximab for the t re a tme n t o f
adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
ibrutinib 140mg hard capsules
(Imbruvica®)
Janssen-Cilag Ltd
13.11.17
SMC Report No. 1289/17 NON SUBMISSION
NOT RECOMMENDED: ibrutinib (Imbruvica®) is not recommended for use within NHS Scotland.
Indication under review: As a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (who do not have 17p deletion or TP53 mutation).
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
ibrutinib 140mg hard capsules and
140mg, 280mg, 420mg and 560mg film-coated tablets (Imbruvica
®)
Janssen-Cilag Ltd
11.11.19 SMC Report No. 2244
NON SUBMISSION
NOT RECOMMENDED: ibrutinib (Imbruvica®) is not recommended for use within NHSScotland.
Indication under review: In combination with obinutuzumab for the treatment of a d ult p a t ie nts with previously untreated chronic lymphocytic leukaemia.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
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45/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ibrutinib 140mg hard capsules and
140mg, 280mg, 420mg and 560mg film-coated tablets (Imbruvica
®)
Janssen-Cilag Ltd
11.11.19 SMC Report No. 2245
NON SUBMISSION
NOT RECOMMENDED: ibrutinib (Imbruvica®) is not recommended for use within NHSScotland.
Indication under review: As a single agent for the treatment of adult patients with Waldenström’smacroglobulinaemia who have received at least one prior therapy, or in first l in e
treatment for patients unsuitable for chemo-immunotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
idelalisib 100mg and 150mg tablets (Zydelig
®)
Gilead Sciences Ltd.
09.03.15 SMC Report No. 1026/15
Patient Access Scheme
idelalisib (Zydelig®) is accepted for restricted for use within NHS Scotland in combination with
rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
• who have received at least one prior therapy, or • as first line treatment in the presence of 17p deletion or TP53 mutation in patients
unsuitable for chemo-immunotherapy. SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and treatment
naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo -immunotherapy.
Idelalisib in combination with an anti-CD20 antibody significantly improves progression free survival compared with an anti-CD20 antibody alone in patients with relapsed CLL. The
treatment effect across subgroups with 17p deletion and/or TP53 mutation was consiste n t with that of the total study population.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib. It is contingent upon the continuing availability of the patie n t
access scheme in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, Specia list Use only.
September 2015
idelalisib, 100mg and 150mg film-coated tablets (Zydelig
®)
Gilead Sciences Ltd.
11.05.15 SMC Report No. 1039/15
Patient Access Scheme
idelalisib (Zydelig®) is accepted for use within NHS Scotland.
Indication under review: Monotherapy for the treatment of adult patients with follicular lymphoma
(FL) that is refractory to two prior lines of treatment. Idelalisib demonstrated clinical activity, measured by overall response rate, in a p h a se I I n o n -
comparative study. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of idelalisib and is contingent upon the continuing availability of th e PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the Additional List, Specialist Use only, for the indication in question.
December 2015
idelalisib (Zydelig®) 100mg, 150mg film-
coated tablets
Gilead Sciences Ltd
12.12.16 SMC Report No. 1212/16
NON SUBMISSION
NOT RECOMMENDED: idelalisib (Zydelig®) is not recommended for use within NHS Scotland in
combination with ofatumumab for the treatment of adult patients with chronic lymphocytic
leukaemia: • who have received at least one prior therapy, or
• first line treatment in the presence of 17p deletion or TP53 mutation in patients who are no t eligible for any other therapies.
The holder of the marketing authorisation has not made a submission to SMC regardin g this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib (Glivec) Novartis
April 2012
NICE MTA 251 supersedes SMC Report No. 01/02 and SMC Report No. 26/02
NICE MTA 251 advised that standard-dose imatinib (400mg per day for patients in chronic
phase) is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive chronic myeloid leukaemia (CML).
The Scottish Medicines Consortium (SMC) has previously accepted imatinib and nilotinib for the treatment of adult patients with newly diagnosed Philadelphia-chromosome-positive CML in th e
chronic phase. NICE MTA 251 was withdrawn in December 2016 but the NICE MTA 251 advice for imatinib
remains valid in NHSScotland.
Approved for use - added to the Additional
List.
January 2003
09 September 2020
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46/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
imatinib (Glivec) Novartis
09.08.03
SMC Report No. 08/02
imatinib (Glivec) is recommended for restricted use within the NHS in Scotland, under the supervision of an oncologist for patients with Kit-positive gastrointestinal stromal tumours
(GIST).
Approved for use - added to the Additional
List.
imatinib (Glivec®)
Novartis Pharmaceuticals UK Ltd
10.12.07 SMC Report No. 426/07
NON SUBMISSION
NOT RECOMMENDED:imatinib (Glivec®) is not recommended for use within NHS Scotla n d fo r
the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) as monotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib (Glivec®)
Novartis Pharmaceuticals UK Ltd
10.12.07
SMC Report No. 427/07 NON SUBMISSION
NOT RECOMMENDED:imatinib (Glivec®) is not recommended for use within NHS Scotla n d fo r
the treatment of adult patients with newly diagnosed Philadelphia chromosome posit ive a cu te
lymphoblastic leukaemia (PH + ALL) in combination with chemotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib (Glivec®)
Novartis Pharmaceuticals UK Ltd
10.12.07 SMC Report No. 428/07
NON SUBMISSION
NOT RECOMMENDED:imatinib (Glivec®) is not recommended for use within NHS Scotla n d fo r
the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib (Glivec®)
Novartis Pharmaceuticals UK Ltd
10.12.07
SMC Report No. 429/07 NON SUBMISSION
NOT RECOMMENDED:imatinib (Glivec®) is not recommended for use within NHS Scotla n d fo r
the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chron ic
eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib (Glivec®)
Novartis Pharmaceuticals UK Ltd
10.12.07
SMC Report No. 430/07 NON SUBMISSION
NOT RECOMMENDED:imatinib (Glivec®) is not recommended for use within NHS Scotla n d fo r
the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) a n d
adult patients with recurrent and/or metastatic DFSP who are not e ligible for surgery. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imatinib 100mg and 400mg film-coated
tablets (Glivec®)
Novartis Pharmaceuticals UK Ltd
07.12.09
SMC Report No. 584/09 RESUBMISSION
imatinib (Glivec®) is accepted for restricted use within NHS Scotland.
Indication under review: adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). Patients who
have a low or very low risk of recurrence should not receive adjuvant treatment. SMC restriction: Imatinib is restricted to use in patients at high risk of recurrence following
complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria). Imatinib, given for a period of one year, significantly improved the estimated one year
recurrence-free survival compared with placebo and was associated with an increase of 16.4 months in median time to recurrence in patients at high risk of relapse following resection.
The economic case was demonstrated for a one-year adjuvant treatment duration only.
Added to the Additional List, for Specialist
Use only.
April 2011
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
47/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
imatinib 100mg and 400mg film-coated
tablets (Glivec®)
Novartis Pharmaceuticals UK Ltd
09.04.12
SMC Report No. 584/09 2
nd RESUBMISSION
imatinib (Glivec®) is accepted for restricted use within NHS Scotland.
Indication under review: adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). Patients who
have a low or very low risk of recurrence should not receive adjuvant treatment. SMC restriction: Imatinib is restricted to use in patients at high risk of recurrence following
complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria). Adjuvant imatinib therapy given for a period of three years compared to one year, sig n if ica n tly
improved the recurrence free survival in adult patients at significant risk of relapse following resection of GIST.
The clinical and cost-effectiveness of three years adjuvant imatinib treatment was demonstrated.
Includedon the Additional List, Specialist
Use only, for the indication in question.
See SMC advice above. Same SMC Report Number – this advice relates to a n
extension in treatment length to 3 years.
July 2012
imatinib 100mg and 400mg film-coated tablets (Glivec
®)
Novartis Pharmaceuticals UK Ltd
January 2012 NICE MTA 241
NOT RECOMMENDED: NICE MTA 241 Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (CML) (part review of NICE technology
appraisal guidance 70), and dasatinib and nilotinib for people with CML for whom treatment with imatinib has failed because of intolerance states that high-dose imatinib is not recommended for
the treatment of chronic, accelerated or blast-crisis phase Philadelphia-chromosome-positive CML that is resistant to standard-dose imatinib.
NOT RECOMMENDED
imatinib 100mg and 400mg film-coated
tablets(Glivec®)
Novartis Pharmaceuticals UK Ltd
07.10.13
SMC Report No. 923/13 NON SUBMISSION
NOT RECOMMENDED: matinib (Glivec®) is not recommended for use within NHS Scotlan d fo r
the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
imiquimod 5% cream (Aldara®)
3M Health Care
09.05.05
SMC Report No. 167/05
imiquimod 5% (Aldara) is accepted for restricted use within NHS Scotland for the topical treatment of small superficial Basal Cell Carcinoma in adult patients in whom standard treatment with surgery or cryotherapy is contraindicated.
Its use should be supervised by specialists in dermatology. At 12 weeks post treatment the composite clearance rates in the randomised con tro lle d t ria ls
were between 73-77% and initial clearance rates in the open label studies we re b e twe e n 9 0 -94%. There is only limited follow-up data beyond 12 months.
Added to the LJF as a prescribing note.
September 2005
inotuzumabozogamicin 1mg powder for
concentrate for solution for infusion (BESPONSA
®)
04.05.18
SMC Report No. 1328/18 Patient Access Scheme
Following a full submission assessed under the ultra-orphan and end of life medicine process, i
inotuzumabozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland.
Indication under review: as monotherapy for the treatment of adults with relapsed or refractory
CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive relapsed or refractory B cell precursor ALL should have failed
treatment with at least one tyrosine kinase inhibitor. SMC restriction: in patients for whom the intent is to proceed to stem cell transplantation.
A phase III open label randomised controlled study demonstrated improvements in re missio n rates and overall survival for the patient population under review when treated with
inotuzumabozogamicin compared with standard chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of inotuzumabozogamicin. This advice is contingent upon the contin u ing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
October 2018
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
48/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ipilimumab 5mg/mL concentrate for
solution for infusion (Yervoy®)
Bristol-Myers Squibb
08.04.13
SMC Report No. 779/12 RESUBMISSION
Patient Access Scheme
ipilimumab (Yervoy®) is accepted for use within NHS Scotland for the treatment of advanced
(unresectable or metastatic) melanoma in adults who have received prior therapy. Ipilimumab demonstrated a survival benefit over an investigational glycoprotein100 peptide
vaccine in previously treated patients with advanced melanoma. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of ipilumumab. This SMC advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower.
Included on the Additional List, Specia list
Use only, for the indication in question.
June 2013
ipilimumab 5mg/mL concentrate for solution for infusion (Yervoy
®)
Bristol-Myers Squibb Pharmaceuticals Ltd
10.11.14 SMC Report No. 997/14
Patient Access Scheme
ipilimumab (Yervoy®) is accepted for use within NHS Scotland for the treatment of advanced
(unresectable or metastatic) melanoma in adults (first-line use).
In a phase III, randomised study median overall survival was extended by 2.1 months in patients treated with ipilimumab plus dacarbazine (an unlicensed dose regimen) compared with
dacarbazine alone. Efficacy data for the licensed dose of ipilimumab are limited to two retrospective single-arm observational studies where median overall survival was 11.5 to 1 4 .3
months. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost-effectiveness of Ipilimumab. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the Additional List, for Specialist Use only, for the indication in
question.
December 2014
ipilimumab 5mg/mL concentrate for
solution for infusion (Yervoy®)
Bristol-Myers Squibb Pharmaceuticals UK
08.10.18
SMC Report No. 2094 PRODUCT UPDATE
ABBREVIATED SUBMISSION Patient Access Scheme
ipilimumab (Yervoy®) is accepted for use within NHSScotlandasmonotherapyfor the treatment of
advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older. SMC has previously accepted ipilimumab for the treatment of advanced (unresectable or
metastatic) melanoma in previously untreated adult patients (SMC 997/14) and in a d u lts wh o have received prior therapy (SMC 779/12).
Ipilimumab was accepted for use in previously untreated patients (SMC 997/14) following a submission under the end of life and orphan process.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ipilimumab. This SMC advice is contingent upon the continuing
availability of the patient access scheme or a list price that is equivalent or lower.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
November 2018
ixazomib 2.3mg, 3mg and 4mg hard
capsules(Ninlaro®)
Takeda UK Ltd
09.07.18
SMC Report No. 2099 NON SUBMISSION
NOT RECOMMENDED: ixazomib (Ninlaro®) is not recommended for use within NHS Scotland.
Indication under review:in combination with lenalidomide and dexamethasone for the treatme nt of adult patients with multiple myeloma who have received at least one prior therapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
lanadelumab 300mg solution for injection
(Takhzyro®)
Shire, part of Takeda UK Ltd
09.12.19
SMC Report No. 2206 Patient Access Scheme
lanadelumab (Takhzyro®) is accepted for restricted use within NHSScotland.
Indication under review: For the routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
SMC restriction: patients with HAE type I or II, who would otherwise be considered for long-term prophylaxis treatment with C1-esterase inhibitor.
In a phase III study in patients with HAE, lanadelumab reduced the rate of angioedema atta cks compared with placebo.
This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based,
or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time or there is a local
preference for alternative medicines.
January 2020
09 September 2020
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49/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
lanreotide (Somatuline® LA)
Ipsen Ltd
11.12.06 SMC Report No. 231/06
NON SUBMISSION
NOT RECOMMENDED:lanreotide (Somatuline® LA) is not recommended for use within NHS
Scotland for the treatment of thyrotrophic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
lanreotide(Somatuline®Autogel)
Local formulary process
Management of neuroendocrine tumours. Included on the LJF, as first choice, for the indication in question.
Routinely available in line with local
guidance. Included in the LJF, Specialist Initiation only.
March 2016
As per LJF
March 2019
lapatinib, 250mg film-coated tablets
(Tyverb®)
GlaxoSmithKline
13.07.10
SMC Report No. 526/09 RESUBMISSION
NOT RECOMMENDED:lapatinib (Tyverb®) is not recommended for use within NHS Scotland.
Indication under review: in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have
progressive disease following prior therapy including anthracyclines and taxanes a n d th e ra py with trastuzumab in the metastatic setting.
In a randomised open-label study the median time to progression for lapatinib plus capecitabin e was significantly longer than for capecitabine monotherapy. There was no statistically significant
difference in overall survival. Compared with capecitabine monotherapy, the manufacturer’s justification of the treatment’s
cost in relation to its health benefits was not sufficient to gain acceptance by SMC. Th e re wa s also uncertainty about the comparative effectiveness and cost-effectiveness compared to
unlicensed use of trastuzumab and capecitabine in patients with metastatic disease confined to the central nervous system, itself a treatment of unproven cost-effectiveness.
NOT RECOMMENDED
lapatinib (Tyverb®) 250 mg film-coated
tablets
GlaxoSmithKline
June 2012 NICE MTA 257 supersedes SMC Report
No. 768/12
NOT RECOMMENDED: NICE MTA 257 states that lapatinib in combination with an aroma ta se inhibitor is not recommended for first-line treatment in postmenopausal women with meta sta t ic
hormone-receptor-positive breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2).
NOT RECOMMENDED
lapatinib (Tyverb®) 250 mg film-coated
tablets
GlaxoSmithKline
11.11.13 SMC Report No. 925/13
NON SUBMISSION
NOT RECOMMENDED: lapatinib (Tyverb®) is not recommended for use within NHS Scotland
for the treatment of adult patients with breast cancer, whose tumours overexpress HER2
(ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with
chemotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
50/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
lenalidomide, 7.5mg, 10mg, 15mg and
25mg hard capsules (Revlimid®)
Celgene Limited
07.04.14
SMC Report No. 441/08 2
nd RESUBMISSION
lenalidomide (Revlimid®) is accepted for restricted use within NHS Scotland in combination with
dexamethasone, for the treatment of multiple myeloma in adult patients who have re ce ive d a t least one prior therapy. (This resubmission relates to patients who have received only one p rio r
therapy). SMC restriction: to use at first relapse in patients who have received prior therapy with
bortezomib in whom thalidomide has not been tolerated or is contraindicated. Lenalidomide plus dexamethasone significantly increased the time to progression compared
with dexamethasone alone in multiple myeloma patients who had been treated with at least on e prior therapy.
SMC has previously accepted lenalidomide for use in patients who have received a t le a st two prior lines of therapy i.e. at second relapse. This advice now extends its use to patients a t f irst
relapse who received bortezomib as their one prior therapy.
For use in patients who have received at
least two prior lines of therapy. Added to the Additional List, for Specialist Use only.
For patients who have received only one
prior therapy. Not included on the LJF, pending protocol.
September 2010
July 2014
lenalidomide, 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg
capsules(Revlimid®)
Celgene Europe Limited
07.12.15
SMC Report No. 1096/15
lenalidomide (Revlimid®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adult patients with previously untreated multiple mye lo ma
who are not eligible for transplant. SMC restriction: for use in patients unsuitable for thalidomide-containing regimens.
Continuous lenalidomide plus low-dose dexamethasone, compared with melphalan, prednisolone plus thalidomide, significantly improved progression-free survival in treatment-
naive patients with newly diagnosed multiple myeloma who were not eligible for transplant. Overall survival data are immature, but interim analyses suggest a survival benefit for
lenalidomide plus low-dose dexamethasone compared with melphalan, prednisolone plus thalidomide.
This submission focuses on lenalidomide in combination with dexamethasone. Lenalidomid e is also licensed for use in combination with melphalan and prednisolone for the treatment of a d ult
patients with previously untreated multiple myeloma who are not eligible for transplant. The submitting company did not provide evidence for SMC assessment therefore SMC cannot
recommend this combination for use in this treatment setting. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, Specialist Use only, for the indication in question.
April 2016
lenalidomide (Revlimid®) 2.5mg, 5mg,
7.5mg, 10mg, 15mg, 20mg and 25mg
hard capsules Celgene Ltd
07.11.16
SMC Report No. 1211/16 NON SUBMISSION
NOT RECOMMENDED: lenalidomide (Revlimid®) is not recommended for use within NHS
Scotland for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
lenalidomide 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg hard capsules
(Revlimid®)
Celgene Ltd
08.10.18
SMC Report No.2125 NON SUBMISSION
NOT RECOMMENDED:lenalidomide (Revlimid®) is not recommended for use within
NHSScotland as monotherapy for the maintenance treatment of adult patients with newly
diagnosed multiple myeloma who have undergone autologous stem cell transplantation. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
51/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
lenalidomide 2.5mg, 5mg, 7.5mg, 10mg,
15mg, 20mg and 25mg hard capsules (Revlimid
®)
Celgene Ltd
12.08.19
SMC Report No. 2217 NON SUBMISSION
NOT RECOMMENDED:lenalidomide (Revlimid®) is not recommended for use within
NHSScotland. Indication under review: as combination therapy with bortezomib and dexameth aso ne fo r th e
treatment of adult patients with previously untreated multiple myeloma who are not e lig ib le fo r transplant.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Note :
SMC advice 1096/15 is still valid.
NOT RECOMMENDED
lenvatinib 4mg and 10mg hard capsules
(Lenvima®)
Eisai Ltd.
10.10.16
SMC Report No. 1179/16 Patient Access Scheme
lenvatinib (Lenvima®) is accepted for use within NHS Scotland for the treatment of adult patients
with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle ce ll) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Lenvatinib, compared with placebo, significantly improved progression free survival in adults with RAI-refractory DTC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of lenvatinib. This advice is contingent upon the continuing availability of
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
November 2016
lenvatinib 4mg hard capsules
(Lenvima®)
Eisai Ltd
08.04.19
SMC Report No. 2138 Patient Access Scheme
lenvatinib (Lenvima®) is accepted for use within NHSScotland as monotherapy for the treatment
of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.
In a phase III study in patients with unresectable hepatocellular carcinoma who had not received treatment for advanced disease, lenvatinib was non-inferior to another multikinase inhib ito r fo r
overall survival. SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves th e
cost effectiveness of lenvatinib and is contingent upon the continuing availability of th e PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
July 2019
lenvatinib 4mg and 10mg hard capsules (Kisplyx
®)
Eisai Ltd
11.11.19 SMC Report No. 2199
Patient Access Scheme
lenvatinib (Kisplyx®) is accepted for use within NHSScotland.
Indication under review: in combination with everolimus for the treatment of adult patie nts with
advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy
In a phase II study, the addition of lenvatinib to everolimus significantly improved pro g ressio n -free survival in patients with advanced renal cell carcinoma who had received one previous
VEGF-targeted therapy. This SMC advice takes account of the benefit of Patient Access Schemes (PAS) th a t imp ro ve
the cost effectiveness of lenvatinib and everolimus. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional L ist
for Specialist Use only.
August 2020
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
letrozole 2.5mg tablets (Femara®)
Novartis Pharmaceuticals (UK) Ltd
07.03.05 SMC Report No. 152/05
letrozole (Femara®) is accepted for restricted use within NHS Scotland for the treatment of
invasive early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy.
Treatment should continue for 3 years or until tumour relapse, whichever occurs first. Following 5 years of adjuvant tamoxifen therapy the risk of recurrence (in ipsilateral breast, n e w
tumour in contralateral breast or distance metastases) occurs at an aggregate rate of 2 - 3% p e r year. The use of letrozole as extended adjuvant treatment resulted in a 43% lower risk of
recurrence compared with placebo. However, a significant difference for overall survival, defined as time to death from any cause, was seen in lymph-node positive patients only.
Clinicians and patients should consider the residual risk of recurrence, individual preferences and the risks and benefits of treatment.
Letrozole is restricted to initiation to breast cancer specialists.
Added to the Formulary as a prescribing
note.
August 2005
letrozole 2.5mg tablets (Femara®)
Novartis Pharmaceuticals UK Ltd
08.05.06
SMC Report No. 251/06
letrozole (Femara) is accepted for restricted use within NHS Scotland for the adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast
cancer. Letrozole has shown benefit over standard anti-oestrogen therapy in terms of disease-free
survival, although a pre-planned sub-group analysis showed a statistically significant benef ic ia l effect in node-positive but not node-negative patients. It offers an alternative to existing
treatment and has a different range of adverse effects. Another aromatase inhibitor is available for the same indication at a lower cost.
Treatment with letrozole should be initiated by a breast cancer specialist.
Added to the LJF as first choice for patients at risk of early recurrence or with
a contraindication to tamoxifen. Letrozole also first choice for extended adjuvant
treatment after 5 years treatment with tamoxifen.
August 2010
letrozole 2.5mg tablets
Local formulary process
For epithelial ovarian cancer. Added to the Additional List, for Specialist initiation.
Categorised AMBER under the ADTC
‘Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
December 2016
levofloxacin (Tavanic®)
Hoechst Marion Roussel
Local formulary process
Antibiotic prophylaxis for neutropenic sepsis in lung cancer patients undergoing chemotherapy
only.
Not preferred as suitable alternatives exist.
December 2006
lipegfilgrastim, 6mg, solution for inject io n (Lonquex
®)
Teva Pharma BV
07.04.14 SMC Report No. 908/13
lipegfilgrastim (Lonquex®) is accepted for restricted use within NHS Scotland for reduction in the
duration of neutropenia and the incidence of febrile neutropenia in adult patien ts t re a te d with
cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
SMC restriction: where a long-acting granulocyte-colony-stimulating factor is appropriate. In a randomised, double-blind study, in adults with breast cancer given myelosuppressive
chemotherapy associated with a high risk of febrile neutropenia, lipegfilgrastim was co mp a re d with another long-acting granulocyte colony-stimulating factor when used as primary prophylaxis
against febrile neutropenia. The study found lipegfilgrastim was non-inferior to the co mp a ra to r preparation in terms of the mean duration of severe neutropenia in the first chemotherapy cycle.
Included on the Additional List, Specia lis t Use only.
March 2016
liposomal cytarabine 50mg suspension for injection (DepoCyte
®)
Napp Pharmaceuticals
13.08.07 SMC Report No. 164/05
RESUBMISSION
NOT RECOMMENDED: liposomal cytarabine suspension (DepoCyte®) is not recommended fo r
use within NHS Scotland for the intrathecal treatment of lymphomatous meningitis. There is limited clinical evidence to support a claim of superior efficacy for liposomal cytara b in e over existing therapy. Effects on symptom improvement and quality of life were not well defined.
The manufacturer did not present a sufficiently robust economic analysis and its justifica t io n o f the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by
SMC.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
liposomal daunorubicin/cytarabine
44mg/100mg powder for concentrate for solution for infusion (Vyxeos
®)
Jazz Pharmaceuticals UK Ltd
11.03.19 SMC Report No. 2130
daunorubicin/cytarabine (Vyxeos®) is accepted for use within NHSScotland.
Indication under review: The treatment of adults with newly diagnosed, therapy -re la ted a cu te myeloid leukaemia (AML) or AML with myelodysplasia-related changes.In a randomised p ha se
III study, in adults (aged 60 to 75 years) with high risk AML, liposomal daunorubicin/cyta rab in e improved overall survival when compared with a standard of care regimen.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of liposomal daunorubicin/cytarabine. This advice is contingent upon th e
continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
July 2019
liposomal irinotecan hydrochloride trihydrate (as irinotecan sucrosofate salt),
5mg/mL concentrate for solution for infusion (Onivyde
®)
Shire
13.03.17 SMC Report No. 1217/17
NOT RECOMMENDED: Following a full submission assessed under the orphan and end of l ife process, liposomal irinotecan (Onivyde
®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of metastatic adenocarcinoma of the pancreas, in combination with fluorouracil (5-FU) and leucovorin (folinic acid), in adult patients who have
progressed following gemcitabine based therapy. The addition of liposomal irinotecan to 5-FU/folinic acid, compared with 5-FU/folinic acid a lo n e ,
significantly improved overall survival and progression free survival in patients with metastatic adenocarcinoma of the pancreas who had progressed after gemcitabine-based therapy.
The submitting company’s justification of the treatment’s costs in relation to its health b e n e fit s was not sufficient and in addition did not present a sufficiently robust clinical or economic case to
gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
lorlatinib 25mg and 100mg film-coated tablets (Lorviqua
®)
Pfizer Limited
09.03.20
SMC Report No. 2239 Patient Access Scheme
Following a full submission assessed under the end of life process, lorlatinib (Lorviqua®) is
accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and
future reassessment. Indication under review: as monotherapy for the treatment of adult patients with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose dise a se has progressed after:
alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI
In the relevant subgroup of a non-comparative phase I/II study of previously-treated patients with ALK-positive advanced NSCLC, lorlatinib was associated with an objective response rate of
approximately 40%. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional L ist
for Specialist Use only.
August 2020
lutetium (177
Lu) oxodotreotide
370MBq/mL solution for infusion (Lutathera
®)
Advanced Accelerator Applications
08.06.18 SMC Report No. 1337/18
Following a full submission assessed under the orphan medicine process, lutetium (177
Lu)
oxodotreotide (Lutathera®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of unresectable or metastatic, progressive, well
differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
In an open-label, phase III study, lutetium (177
Lu) oxodotreotide significantly improved progression-free survival compared with a high dose somatostatin analogue in patients with
progressive midgut neuroendocrine tumours. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time.
There is ongoing work to access this
medicine through national centres
August 2018
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
mercaptopurine 20mg/mL oral
suspension (Xaluprine®)
Nova Laboratories Limited
13.08.12
SMC Report No. 798/12 PRODUCT UPDATE
ABBREVIATED SUBMISSION
mercaptopurine 20mg/mL oral suspension (Xaluprine®) is accepted for use within NHS Scotland
for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. Mercaptopurine dosing is governed by cautiously monitoring haematotoxicity. The oral
suspension and tablet formulations are not bioequivalent in terms of peak plasma concentrations and therefore careful haematological monitoring of the patient is advised on switching
formulations. Mercaptopurine oral suspension is more expensive than the tablet formulation.
Included on the Additional List for the
indication in question, where an oral suspension is required.
August 2012
methotrexate 2mg/mL oral solution
Local formulary process
As treatment of acute lymphoblastic leukaemia and inflammatory arthritis. Included on the LJF
• For acute lymphoblastic
leukaemia: Additional List.
• For inflammatory arthritis: as first choice, Specialist Initiation.
March 2016
methyl aminolevulinate cream (Metvix) Galderma
0.11.03
SMC Report No. 51/03 RESUBMISSION
methyl aminolevulinate cream (Metvix) is accepted for restricted use within NHS Sco t la n d fo r the treatment of basal cell carcinoma in those patients in whom standard treatment with surgery
or cryotherapy is contraindicated. Its use should be restricted to specialist dermatologists and to superficial lesions where
penetration is most effective.
Added to the Additional List.
October 2005
midostaurin 25mg soft capsules
(Rydapt®)
Novartis Pharmaceuticals UK Limited
04.05.18
SMC Report No 1330/18 Patient Access Scheme
Following a full submission assessed under the ultra-orphan and end of life medicine p ro ce ss,
midostaurin (Rydapt®) is accepted for use within NHS Scotland.
Indication under review: In combination with standard daunorubicin and cytarabine induction and
high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly
diagnosed acute myeloid leukaemia (AML) who are FMS-like tyrosine kinase 3 (FLT3) mutation-positive.
In a randomised, double-blind, phase III study of adults (aged <60 years) with FLT3 mutation-positive AML, the addition of midostaurin to standard intensive chemotherapy regime n
resulted in improved overall survival when compared with addition of placebo.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
December 2018
midostaurin 25mg soft capsules (Rydapt
®)
Novartis Pharmaceuticals UK Ltd
09.07.18 SMC Report No. 2100
NON SUBMISSION
NOT RECOMMENDED: midostaurin (Rydapt®) is not recommended for use within NHS
Scotland.
Indication under review:as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or
mast cell leukaemia. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
mifamurtide, 4mg powder for suspensio n for infusion (Mepact
®)
Takeda UK and Ireland Ltd
08.08.11 SMC Report No. 621/10
RESUBMISSION Patient Access Scheme
mifamurtide (Mepact) is accepted for use within NHS Scotland. Indication under review: in combination with post-operative multi-agent chemotherapy for the
treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults. Safety and effica cy h a ve b e e n
assessed in studies of patients 2 to 30 years of age at initial diagnosis. Mifamurtide has been shown to increase overall survival compared with multi-agent
chemotherapy alone in patients aged up to 30 years with newly-diagnosed resectable osteosarcoma.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of mifamurtide. This SMC advice is contingent upon the continuing
availability of the PAS in NHS Scotland.
Added to the Additional List, for Specialist Use only.
September 2011
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
mitotane 500mg tablets (Lysodren®)
Laboratoire HRA Pharma
11.12.06 SMC Report No. 328/06
NOT RECOMMENDED:mitotane (Lysodren®) is not recommended for use within NHS Scotla n d
for the symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of mitotane on non-functional adrenal cortical carcin o ma is n o t
established. Mitotane relieves the symptoms of advanced adrenal cortical carcinoma, but there is insufficien t
evidence to support an increase in survival. The economic case has not been demonstrated. Mitotane should be used only within the context of clinical trials.
NOT RECOMMENDED
mycophenolate mofetil (CellCept ®)
Roche
Local formulary process
Management of steroid-dependent nephrotic syndrome in paediatric patients.
Added to the Additional List and
prescribed in accordance with Shared Care Protocol.
Categorised AMBER for paediatrics
under the ADTC ‘Policy for the use of unlicensed (and off-label use) Medicines in
NHS Lothian’.
April 2012
mycophenolic acid (as mycophenolate sodium), 180mg and 360mg film-coated
gastro-resistant tablets (Myfortic®)
Novartis Pharmaceuticals UK Limited
07.02.05
SMC Report No. 144/04
mycophenolate sodium (Myfortic®) is accepted for use within NHS Scotland for the proph yla xis
of acute transplant rejection in adult patients receiving allogenic renal transplants in combination
with ciclosporin and corticosteroids. It is restricted to use by transplant specialists as part of an immunosuppressive regimen.
Added to the Additional List. Suitable for shared care.
March 2012
necitumumab (Portrazza®) 800mg
concentrate for solution for infusion Eli Lilly and Company Limited
08.08.16
SMC Report No. 1184/16 NON SUBMISSION
NOT RECOMMENDED:necitumumab (Portrazza®) is not recommended for use within NHS
Scotland in combination with gemcitabine and cisplatin chemotherapy for the treatment of ad u lt patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)
expressing squamous non-small cell lung cancer who have not received prior chemotherapy fo r this condition.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
nelarabine, 5mg/mL solution for infusion
(Atriance®)
GlaxoSmithKline UK
07.04.08
SMC Report No. 454/08
nelarabine (Atriance®) is accepted for restricted use within NHS Scotland for the treatment of
patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymp h o ma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at le a st
two chemotherapy regimens. It is restricted to patients in whom nelarabine is being used as a treatment to bridge to allogeneic
stem cell transplant and restricted to use by specialists in haemato-oncology. It is not cost-effective when used for palliation.
Added to the Additional List, Specialist
Use only.
November 2009
neratinib (Nerlynx®) 40mg film-coated
tablets Pierre Fabre Limited
10.08.20
SMC Report No. 2251 Patient Access Scheme
neratinib (Nerlynx®) is accepted for use within NHSScotland.
Indication under review:forthe extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed
adjuvant trastuzumab-based therapy less than one year ago. In the relevant subgroup of a phase III study neratinib, given less than one year after adjuvant
trastuzumab-based therapy, improved invasive disease-free survival in patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer compared with
placebo. This advice applies only in the context of an approved NHSScotland Patient Access Scheme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Formulary classification not yet decide d –
waiting for information from clinician
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
netupitant/palonosetron 300mg/0.5mg,
hard capsule (Akynzeo®)
Chugai Pharma UK Limited
11.01.16
SMC Report No. 1109/15 Patient Access Scheme
netupitant/palonosetron (Akynzeo®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately
emetogenic cancer chemotherapy. SMC restriction: prevention of acute and delayed nausea and vomiting associated with highly
emetogenic cisplatin-based cancer chemotherapy. In patients receiving a first course of highly emetogenic cisplatin-based chemotherapy, treatment
with netupitant/palonosetron plus dexamethasone resulted in a significantly higher proportion of patients achieving no emesis and no breakthrough medication compared with palonosetron plus
dexamethasone. This advice takes account of the benefits of Patient Access Scheme (PAS) that improves the
cost-effectiveness of netupitant/palonosetron. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or
lower.
Included on the Additional List, for
Specialist Use only, for the indication in question.
July 2016
nilotinib, 200mg capsules (Tasigna®)
Novartis Pharmaceuticals UK Ltd
January 2012
NICE MTA 241 supersedes SMC Report No. 440/08
Patient Access Scheme
NICE MTA 241 states that nilotinib is recommended for the treatment of chronic or accele ra ted phase Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) in adultswhose CML
is resistant to treatment with standard-dose imatinib, or who have imatinib intolerance, and if the manufacturer makes nilotinib available with the discount agreed as part of the p a t ie nt a cce ss
scheme.
Added to the Additional List, for Specialist Use only.
March 2009
nilotinib 150mg and 200mg hard capsules (Tasigna
®)
Novartis Pharmaceuticals UK Ltd
12.03.18 SMC Report No. 1325/18
NON SUBMISSION
NOT RECOMMENDED: nilotinib (Tasigna®) is not recommended for use within NHS Scotland. Indication under review:
• paediatric patients with newly diagnosed Philadelphia chromosome positive ch ro nic myelogenous leukaemia (CML) in the chronic phase
• paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
nilotinib 150mg hard capsules (Tasigna®)
Novartis Pharmaceuticals UK Ltd
April 2012
NICE MTA 251 supersedes SMC Report No. 709/11
Patient Access Scheme
NICE MTA 251 advised that nilotinib is recommended as an option for the first-line treatment o f adults with chronic phase Philadelphia-chromosome-positive CML if the manufacturer makes
nilotinib available with the discount agreed as part of the patient access scheme (PAS). NICE MTA 251 was withdrawn in December 2016 but the NICE MTA 251 advice for nilotinib
remains valid in NHSScotland.
Added to the Additional List, for Specialist Use only.
November 2011
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
nintedanib 100mg and 150mg soft
capsules (Vargatef®)
Boehringer Ingelheim International GmbH
13.04.15
SMC Report No. 1027/15 Patient Access Scheme
nintedanib (Vargatef®) is accepted for use within NHS Scotland in combination with docetaxel for
the treatment of adult patients with locally advanced, metastatic or locally recurre n t n o n -sma ll cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
Addition of nintedanib to second-line treatment of stage IIIb/IV NSCLC with docetaxel significantly increased overall survival in the subgroup patients with adenocarcinoma tumour
histology. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost effectiveness of nintedanib and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
July 2015
niraparib tosylate monohydrate 100mg
hard capsules (Zejula®)
Tesaro UK Limited
13.08.18
SMC Report No 1341/18 Patient Access Scheme
Following a full submission assessed under the end of life and orphan medicine process,
niraparib tosylate monohydrate (Zejula®) is accepted for restricted use within NHS Scotland.
Indication under review: As monotherapy for the maintenance treatment of adult p a t ien ts with
platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
SMC restriction: to patients who do not have a germline BRCA mutation. Niraparib was assessed in a double blind, randomised, placebo controlled phase III study of
patients with high grade serous, recurrent, platinum-sensitive ovarian, fallopian tube or p rima ry peritoneal cancer in which there had been an objective response to the most recen t p la tin u m-
based chemotherapy regimen. Niraparib maintenance was associated with a significantly improved progression free survival when compared with placebo.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of niraparib. This advice is contingent upon the continuing availa bil it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not routinely available as local
implementation plans are being developed or the ADTC is waiting for further advice
from local clinical experts – decision expected by 19 December 2018.
November 2018
nivolumab 40mg/4mL and 100mg/10mL
vials of concentrate for solution for infusion (Opdivo
®)
Bristol-Myers Squibb Pharmaceuticals Ltd.
11.07.16
SMC Report No. 1144/16 Patient Access Scheme
nivolumab (Opdivo®) is accepted for use within NHS Scotland for the treatment of locally
advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Nivolumab, compared with a standard second-line chemotherapy, significantly increased overall survival in patients with locally advanced or metastatic squamous NSCLC who had received
previous therapy including platinum-based doublet chemotherapy. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability o f
the PAS in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, Specia list
Use only, for the indication in question.
October 2016
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
nivolumab, 10mg/mL, concentrate for
solution for infusion (Opdivo®)
Bristol-Myers Squibb Pharmaceuticals Ltd
08.08.16
SMC Report No. 1120/16 RESUBMISSION
Patient Access Scheme
nivolumab (Opdivo®) is accepted for restricted use within NHS Scotland as monotherapy for th e
treatment of advanced (unresectable or metastatic) melanoma in adults. SMC restriction: patients previously untreated with ipilimumab.
In a phase III randomised double-blind study, treatment with nivolumab extended overall survival compared with a palliative chemotherapy in patients with previously untreated advanced
melanoma without a BRAF mutation. In an ongoing open label phase III study, tre a tmen t with nivolumab, at the time of primary analysis, extended overall response rate, compared with
investigator’s choice of chemotherapy in patients with advanced melanoma previously t re a te d with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) treatment or an anti-CTL A-4
treatment and a BRAF inhibitor. The base-case economic analysis submitted by the company assumed that patients were
treated for a maximum of two years. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not included on the LJF because the NHS
Lothian decision is that the medicine does not represent sufficient added benefit to
other comparator medicines to treat the condition in question.
October 2016
nivolumab, 10mg/mL, concentrate for solution for infusion (Opdivo
®)
Bristol-Myers Squibb Pharmaceutical Limited
10.10.16
SMC Report No. 1180/16 Patient Access Scheme
nivolumab (Opdivo®) is accepted for restricted use within NHS Scotland for the treatment of
locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior
chemotherapy in adults. SMC restriction: treatment with nivolumab is subject to a two-year clinical stopping rule.
Nivolumab, compared with a standard, second-line chemotherapy, significantly increased overall survival in patients with locally advanced or metastatic non-squamous NSCLC who had received
previous therapy including platinum-based doublet chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability o f the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meet ing.
Routinely available in line with national guidance. Included on the Additional L ist ,
Specialist Use only, for the indication in question.
January 2017
nivolumab 10mg/mL concentrate for solution for infusion (Opdivo
®)
Bristol-Myers Squibb Pharmaceutical Limited
07.11.16
SMC Report No. 1187/16 Patient Access Scheme
nivolumab (Opdivo®)
is accepted for restricted use within NHS Scotland in combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults.
SMC restriction: for the first-line treatment of advanced melanoma In a randomised, double-blind, phase III study of adults with previously untreated advanced
melanoma nivolumab in combination with ipilimumab was associated with a clinically imp o rta n t and statistically significant improvement in progression-free survival when compared with a
single-agent immunotherapy. Overall survival data are immature. The base-case economic analysis submitted by the company assumed that responding patients
were treated for a maximum of 18 months. SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves th e
cost effectiveness of nivolumab and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional L ist ,
Specialist Use only, for the indication in question.
January 2017
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
nivolumab, 10mg/mL, concentrate for
solution for infusion (Opdivo®)
Bristol-Myers Squibb Pharmaceutical
Limited
12.06.17 SMC Report No. 1188/16
RESUBMISSION
Following a resubmission assessed under the end of life and orphan medicine process
nivolumab (Opdivo®) is accepted for use within NHS Scotland.
Indication under review: As monotherapy for the treatment of advanced renal cell carcinoma
after prior therapy in adults. Nivolumab, compared with a mammalian target of rapamycin (mTOR) inhibitor, significantly
increased overall survival in patients with advanced or metastatic renal cell carcinoma who h a d received one or two previous regimens of anti-angiogenic therapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
August 2017
nivolumab 10mg/mL concentrate for
solution for infusion (Opdivo®)
Bristol-Myers Squibb Pharmaceutical
Limited
10.07.17 SMC Report No. 1240/17
Patient Access Scheme
Following a full submission assessed under the end of life and ultra-orphan process
nivolumab (Opdivo®) is accepted for use within NHS Scotland.
Indication under review: the treatment of adult patients with relapsed or refractory classical
Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
In an open-label, single-arm study, a clinically meaningful objective response rate was achieved in patients with relapsed or refractory cHL treated with nivolumab.
SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves th e cost effectiveness of nivolumab and is contingent upon the continuing availability of the PAS in
NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
April 2018
nivolumab, 10mg/mL concentrate for solution for infusion (Opdivo
®)
Bristol-Myers Squibb Pharmaceutical Limited
11.09.17
SMC Report No 1261/17 Patient Access Scheme
Following a full submission assessed under the end of life and ultra-orphan medicine process, nivolumab (Opdivo
®) is accepted for restricted use within NHS Scotland.
Indication under review: As monotherapy, for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.
SMC restriction: treatment with nivolumab is subject to a two year clinical stopping rule. A phase III randomised study demonstrated significantly improved overall survival in patients
receiving nivolumab compared with investigator choice of treatment (taxane, folic acid antagonist or epidermal growth factor receptor monoclonal antibody) in adults with SCCHN wh o
had progressed within six months after platinum-based therapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability o f the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional L ist ,
for Specialist Use only.
May 2018
nivolumab 10mg/mL concentrate for
solution for infusion (Opdivo®)
Bristol-Myers Squibb Pharmaceuticals Ltd
15.01.18
SMC Report No. 1285/18
NOT RECOMMENDED: nivolumabas monotherapy is indicated for the treatment of locally
advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
In a single arm, phase II study of patients with metastatic, or surgically unresectable, uro th elia l carcinoma with progressive disease on or after platinum based chemotherapy, tre a tme n t with
nivolumab resulted in an objective response in 20% of patients. The submitting company did not present a sufficiently robust economic and clinical a n a lysis to
gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
nivolumab 10mg/mL concentrate for
solution for infusion (Opdivo®)
Bristol-Myers Squibb Pharmaceuticals
Limited
09.11.2018 SMC Report No. 2112
Patient Access Scheme
nivolumab (Opdivo®) is accepted for use within NHSScotland.
Indication under review: As monotherapy for the adjuvant treatment of adults with me la n o ma with involvement of lymph nodes or metastatic disease who have undergone complete
resection. Adjuvant treatment with nivolumab improved recurrence free survival compared with another
immunotherapy in adults with melanoma with involvement of lymph nodes or metastatic disease who had undergone complete resection.
SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of nivolumab and is contingent upon the continuing availability of this PAS in
NHSScotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
January 2019
nivolumab 10mg/mL concentrate for solution for infusion (Opdivo
®)
Bristol-Myers Squibb Pharmaceuticals Limited
10.06.19
SMC Report No. 2153 Patient Access Scheme
nivolumab (Opdivo®) is accepted for use within NHSScotland.
Indication under review: in combination with ipilimumab for the first-line treatment of adult
patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). Overall survival was significantly longer in the nivolumab plus ipilimumab group compared with a
multiple receptor tyrosine kinase inhibitor in a phase III study in treatment naïve p a tie n ts with intermediate/poor-risk advanced RCC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab in combination with ipilimumab.
Not routinely available as local implementation plans are being developed
or the ADTC is waiting for further advice from local clinical experts – decision
expected by 18 December 2019.
November 2019
obinutuzumab 1,000mg concentrate for
solution for infusion (Gazyvaro®)
Roche Products Limited
08.12.14
SMC Report No. 1008/14
obinutuzumab (Gazyvaro®) is accepted for use within NHS Scotland in combination with
chlorambucil, obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitab le
for full dose fludarabine based therapy. The combination of obinutuzumab plus chlorambucil produced a statistically and clinically
significant increase in progression free survival compared with an alkylating agent alo n e o r a n alkylating agent/antibody combination, in older patients with previously untreated CLL wh o h a d
substantial comorbidities.
Included on the Additional List, for
Specialist Use only, for the indication in question.
January 2015
obinutuzumab 1,000mg concentrate for
solution for infusion (Gazyvaro®)
Roche Products Ltd.
13.03.17
SMC Report No. 1219/17 Patient Access Scheme
obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance is
indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituxima b -co n ta in in g
regimen.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
May 2017
obinutuzumab, 1,000mg, concentrate fo r solution for infusion (Gazyvaro
®)
Roche Products Limited
15.01.18 SMC Report No. 1286/18
NOT RECOMMENDED: obinutuzumab in combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of
patients with previously untreated advanced follicular lymphoma. In a phase III study, obinutuzumab decreased the risk of disease progressio n co mp a red with
another monoclonal antibody in a subgroup of patients with previously untreated advanced follicular lymphoma.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently ro b u st e co no mic
analysis to gain acceptance by SMC.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
obinutuzumab, 1,000mg, concentrate fo r
solution for infusion (Gazyvaro®)
Roche Products Limited
10.09.18
SMC Report No. 2015 REBSUBMISSION
NOT RECOMMENDED: obinutuzumab (Gazyvaro®) is not recommended for use within
NHSScotland. Indication under review:obinutuzumab in combination with chemotherapy, followed by
obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.
In a phase III study, obinutuzumab decreased the risk of disease progressio n co mp a red with another monoclonal antibody in a subgroup of patients with previously untreated advanced
follicular lymphoma. The submitting company did not present a sufficiently robust economic analysis to gain
acceptance by SMC.
NOT RECOMMENDED
ofatumumab, 100mg concentrate for solution for infusion (Arzerra
®)
GlaxoSmithKline
09.08.10 SMC Report No. 626/10
NOT RECOMMENDED: ofatumumab (Arzerra®) is not recommended for use within NHS
Scotland. Indication under review: the treatment of chronic lymphocytic leukaemia (CLL) in pat ie n ts wh o are refractory to fludarabine and alemtuzumab.
Interim analysis of a non-randomised, single-arm small study in a subgroup of patients refractory to fludarabine and alemtuzumab found that ofatumumab produced a response rate of 58%.
The manufacturer’s justification of the treatment’s cost in relation to its health benefit s w a s n o t sufficient to gain acceptance by SMC and in addition the manufacturer did not present a
sufficiently robust economic analysis.
NOT RECOMMENDED
ofatumumab 100mg and 1,000mg concentrate for solution for infusion
(Arzerra®)
Novartis
11.05.15
SMC Report No. 1037/15 Patient Access Scheme
ofatumumab (Arzerra®) is accepted for restricted use within NHS Scotland.
Indication under review: ofatumumab in combination with chlorambucil or bendamustine is
indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) who h a ve n o t received prior therapy and who are not eligible for fludarabine-based therapy.
SMC restriction: for use in patients who would not be considered for bendamustine therapy a n d who would receive chlorambucil-based therapy.
The combination of ofatumumab plus chlorambucil produced a statistically and clinically significant increase in progression free survival compared with an alkylating agent alone in older
patients with previously untreated CLL who had co-morbidities. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of ofatumumab and it is contingent upon the continuing availability of th e PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Not included because clinicians do not support the formulary inclusion.
July 2015
ofatumumab (Arzerra®) 100mg & 1000mg
concentrate for solution for infusion
Novartis Pharmaceuticals UK Ltd
10.04.17 SMC Report No. 1237/17
NON SUBMISSION
NOT RECOMMENDED: In the absence of a submission from the holder of the marketing authorisation, ofatumumab (Arzerra
®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of adult patients with relapsed CLL in combination with fludarabine and cyclosphosphamide.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
olaparib, 50mg, hard capsules
(Lynparza®)
AstraZeneca UK
07.11.16
SMC Report No. 1047/15 RESUBMISSION
Patient Access Scheme
olaparib (Lynparza®) is accepted for use within NHS Scotland as monotherapy for the
maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Olaparib was assessed in a phase II randomised, placebo-controlled study of patients with hig h grade serous, recurrent, platinum-sensitive ovarian, fallopian-tube or primary peritoneal ca n ce r
in which there had been an objective response to the most recent platinum-based chemotherapy regimen. In a pre-planned analysis of the sub-group of patients with BRCA mutatio n , o la p arib
was associated with a significantly improved progression-free survival compared with p la ce b o . An interim analysis of overall survival in the BRCA mutation sub-group (70% maturity)
demonstrated a benefit of more than four months for olaparib over placebo. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of olaparib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , Specialist Use only, for the indication in
question.
January 2017
olaparib, 100mg and 150mg, film-coated
tablets (Lynparza®)
AstraZeneca UK
09.12.19
SMC Report No. 2209 Patient Access Scheme
olaparib (Lynparza®) is accepted for use within NHSScotland.
Indication under review: for the maintenance treatment of adult patients with adva n ced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian,
fallopian tube or primary peritoneal cancer who are in response (complete or partial) fo llo win g completion of first-line platinum-based chemotherapy.
In a phase III study, olaparib prolonged progression-free survival compared with placebo. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
March 2020
ondansetron 4mg, 8mg orodispersible films (Setofilm
®)
Norgine
11.11.13 SMC Report No.912/13
PRODUCT UPDATE ABBREVIATED SUBMISSION
ondansetron orodispersible films (Setofilm®) are accepted for restricted use within NHS Scotland
for the use:
In adults:
• Prophylaxis of acute nausea and vomiting induced by moderately emetogenic chemotherapy.
• Prophylaxis and treatment of delayed nausea and vomiting induced by moderately to h ig h ly emetogenic chemotherapy.
• Prophylaxis and treatment of acute and delayed nausea and vomiting induced by highly emetogenic radiotherapy.
• Prophylaxis and treatment of post-operative nausea and vomiting (PONV). In paediatric populations:
• Management of chemotherapy-induced nausea and vomiting in children aged ≥6 months.
• Prophylaxis and treatment of post-operative nausea and vomiting (PONV) in children aged ≥4 years.
SMC restriction: ondansetron orodispersible films are restricted to use in patients with an
enhanced risk of aspiration or who experience difficulties in swallowing. Generic preparations of ondansetron are available at a lower cost than the proprietary products.
Included on the Additional List, for the indication in question.
November 2013
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
osimertinib 40mg and 80mg film-coated
tablets (Tagrisso®)
AstraZeneca UK Limited
13.02.17
SMC Report No.1214/17 Patient Access Scheme
osimertinib (Tagrisso®) is accepted for restricted use within NHS Scotland for the treatment of
adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).
SMC Restriction: in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor.
Osimertinib was associated with an overall response rate of 66% in the pooled analysis o f two phase II single-arm studies of patients with EGFR T790M advanced NSCLC who had re ce ive d
previous treatment with an EGFR tyrosine kinase inhibitor. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of osimertinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , Specialist Use only, for the indication in
question.
April 2017
osimertinib 40mg and 80mg film-coated tablets (Tagrisso
®)
AstraZeneca UK Limited
09.09.19 SMC Report No.2171
NOT RECOMMENDED: osimertinib (Tagrisso®) is not recommended for use within
NHSScotland as monotherapy for the first-line treatment of adult patients with locally adva n ce d
or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Osimertinib, compared with two other EGFR tyrosine kinase inhibitors, improved progression -free survival in adults with locally advanced or metastatic NSCLC with activating EGFR
mutations. The submitting company did not present a sufficiently robust economic analysis to gain
acceptance by SMC.
NOT RECOMMENDED
oxaliplatin 50mg, 100mg powder for intravenous infusion (Eloxatin
®)
Sanofi-aventis
07.11.05 SMC Report No. 211/05
oxaliplatin (Eloxatin®) is accepted for use within NHS Scotland, in combination with fluoro u ra cil
and folinic acid, for the adjuvant treatment of stage III (Dukes’ C) colon cancer a f te r co mp le te
resection of the primary tumour. Addition of oxaliplatin to a standard regimen of fluorouracil and folinic acid increase d d ise a se -
free survival in patients who had undergone complete resection of stage III (Dukes’ C) colon cancer. An economic evaluation demonstrated that this is a cost effective treatment op tio n fo r
these patients. Treatment with oxaliplatin (Eloxatin®) should be under the supervision of an
oncologist.
Added to the Additional List, for Specialist Use only.
November 2005
oxaliplatin (Eloxitan®)
Sanofi Aventis
Local formulary process
Oesophagogastric cancer Added to the Additional List. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
May 2006
oxaliplatin (Eloxitan®)
Sanofi Aventis
Local formulary process
Treatment of metastatic or locally advanced inoperable oesophagogastric carcinoma (in combination with epirubicin and capecitabine (EOX))
Added to the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
March 2009
oxaliplatin, 5-fluorouracil and folinic acid
Local formulary process
Second-line combination chemotherapy regimen for patients with pancreatic
cancer who have progressed after first–line gemcitabine-based chemotherapy and are of very good performance status.
Added to the Additional List, for Specialist
Use only. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
July 2013
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
oxycodone (OxyNorm®)
Napp Pharmaceuticals
11.10.04 SMC Report No. 125/04
oxycodone (OxyNorm®) injection is accepted for restricted use within NHS Scotland only for th e
treatment of moderate to severe pain in patients with cancer. Use of this drug should be restricted to patients who have difficulty in tolerating morphine or
diamorphine therapy. Limited data indicate that it provides analgesia similar to parenteral morphine at similar doses. However, there are no comparative data with diamorphine, the
opioid recommended by Scottish Intercollegiate Guidelines Network (SIGN) for patients with cancer who require parenteral opioids. Oxycodone is more expensive than diamorphine and the
economic case for this product replacing the other products has not been clearly demonstrated. Other indications for this medicine, treatment of moderate to severe post-operative pain and
severe pain requiring the use of strong opioid, have yet to be considered by the Scottish Medicines Consortium. Advice on these indications will be made after the relevant submission s
have been made by the licence holder.
Added to the Formulary for palliative care.
To be initiated by Specialists in patients unable to tolerate morphine or
diamorphine therapy.
November 2004
oxycodone hydrochloride 50mg/mL solution for injection or infusion
(OxyNorm®)
Napp Pharmaceuticals Limited
08.11.10
SMC Report No. 648/10
oxycodone hydrochloride 50mg/ml injection (OxyNorm®) is accepted for restricted use within
NHS Scotland.
Indication under review: treatment of moderate to severe pain in patients with cancer SMC restriction: patients who have difficulty in tolerating morphine or diamorphine therap y a n d
who require a high dose of oxycodone delivered via syringe pump which necessitates the d a ily preparation of an additional syringe pump if oxycodone 10mg/mL is used.
No new clinical or pharmacokinetic evidence has been presented for this higher strength formulation. Comparative evidence of analgesia achieved with parenteral administration is
extrapolated from the lower strength 10mg/mL oxycodone formulation compared with morph in e 10mg/mL.
The economic case was made only for patients in a hospice or community setting who require a high dose of oxycodone which necessitates the daily preparation of an additional syringe pump.
Care should be taken to minimise any risk of administration error with the introduction of this increased strength formulation.
Oxycodone 50mg/mL is also licensed for the treatment of moderate to severe post -operative pain and severe pain requiring the use of strong opioid. The manufacturer’s submission related
only to use in moderate to severe pain in patients with cancer therefore SMC cannot recommend the use of oxycodone 50mg/mL injection in the treatment of non-cancer pain.
‘Not preferred’ in Lothian as suitable alternatives exist.
August 2011
paclitaxel (Abraxane®)
AbraxisBioScience Limited
12.04.10 SMC Report No. 556/09
paclitaxel albumin (Abraxane®) is accepted for restricted use within NHS Scotland.
Licensed indication under review: the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing
therapy is not indicated. SMC restriction: Use is restricted to patients who would otherwise receive docetaxel or 3 -weekly
solvent-based paclitaxel as second-line treatment for metastatic breast cancer. In one study the overall response rate for paclitaxel albumin was significantly superior to solvent-
based paclitaxel in a subgroup analysis of patients who had previously rece ive d o n e o r mo re lines of therapy for metastatic disease.
The health economic case was only demonstrated for a subset of the licensed indication wh ich is the basis for the SMC restriction.
Note that paclitaxel albumin may have substantially different pharmacological properties compared to other formulations of paclitaxel and is licensed for use in a 3-weekly dosage
schedule.
Added to the Additional List, for Specialist
Use only. September 2010
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
paclitaxel albumin (Abraxane®)
Celgene Ltd.
08.06.15 SMC Report No. 1071/15
NON SUBMISSION
NOT RECOMMENDED: paclitaxel albumin (Abraxane®) is not recommended for use within NHS
Scotland. Indication under review: in combination with carboplatin for the first-line treatment of non-small
cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
paclitaxel formulated as albumin bound
nanoparticles 5mg/mL powder for suspension for infusion (Abraxane
®)
Celgene Ltd.
09.02.15 SMC Report No. 968/14
RESUBMISSION
paclitaxel albumin (Abraxane®) is accepted for use within NHS Scotland in combination with
gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma o f th e pancreas.
In a randomised, phase III, open-label study paclitaxel albumin plus gemcitabine treatment improved median overall survival by 1.8 months compared with gemcitabine alone.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
April 2015
paclitaxel
April 2016 NICE MTA 389
NICE MTA 389 Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Paclitaxel in combination with platinum or as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer.
Routinely available in line with national guidance. Included on the Additional L ist ,
for Specialist Use only.
March 2017
palbociclib 75mg, 100mg and 125mg
hard capsules (Ibrance®)
Pfizer Limited.
11.12.17 SMC Report No. 1276/17
Patient Access Scheme
palbociclib (Ibrance®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of hormone receptor (HR)-positive, human epidermal gro wth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy.
In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
SMC restriction: in combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer.
In an open label phase II study and a double-blind, placebo-controlled phase III study, palbociclib in combination with letrozole increased progression-free survival when compared
with letrozole alone in patients with oestrogen receptor-positive, HER2-negative advanced breast cancer.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of palbociclib. This advice is contingent upon the continuing availability o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
July 2018
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
palbociclib 75mg, 100mg and 125mg
hard capsules (Ibrance®)
Pfizer Limited.
08.07.19
SMC Report No. 2149 Patient Access Scheme
palbociclib (Ibrance®) is accepted for use within NHSScotland.
Indication under review: for the treatment of hormone receptor (HR)-positive, human epide rma l growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteiniz in g hormone-releasing hormone (LHRH) agonist.
This submission relates to use in combination with fulvestrant in women who have received prior endocrine therapy.
In a phase III study palbociclib plus fulvestrant, compared with fulvestrant, prolonged progression-free survival in women with HR-positive HER2-negative locally advanced or
metastatic breast cancer who had received prior endocrine therapy. This SMC advice takes account of the benefits of Patient Access Schemes (PAS) that imp ro ve
the cost-effectiveness of palbociclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
SMC has previously accepted palbociclib for restricted use in combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic
breast cancer (SMC 1276/17). This advice remains valid.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
November 2019
palifermin (Kepivance®)
Amgen Ltd
08.05.06 SMC Report No. 272/06
NON SUBMISSION
NOT RECOMMENDED: palifermin (Kepivance®) is not recommended for use within NHS
Scotland for the treatment of oral mucositis in bone marrow transplantation. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
palonosetron 250micrograms solution fo r injection (Aloxi
®)
Cambridge Laboratories
07.11.05 SMC Report No. 208/05
palonosetron (Aloxi®) is accepted for use within NHS Scotland for the prevention of acute
nausea and vomiting associated with highly emetogenic cancer chemotherapy and the
prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
It is as effective as other 5HT3 antagonists in preventing emesis when given as a single intravenous injection following highly emetogenic chemotherapy (HEC) in the acute pha se a n d
moderately emetogenic chemotherapy (MEC) in the acute and delayed phases post-chemotherapy.
Added to the Additional List, for Specialist Use only.
July 2008
palonosetron 500microgram soft capsules
(Aloxi®)
Sinclair IS Pharma
11.02.13
SMC Report No. 838/13 PRODUCT UPDATE
ABBREVIATED SUBMISSION
palonosetron soft capsules (Aloxi®) is accepted for use within NHS Scotland for p re ve n t io n o f
nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. At recommended licensed doses the soft capsule formulation has been shown to b e clin ica lly
non-inferior to the intravenous formulation and is cost neutral. SMC has previously accepted palonosetron intravenous injection for the prevention o f n a u se a
and vomiting associated with moderately emetogenic cancer chemotherapy.
Includedon the Additional List for the
indication in question.
January 2013
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
palonosetron, 250 micrograms solution
for injection (Aloxi®)
Chugai Pharma UK Limited
10.08.15
SMC Report No. 1073/15 PRODUCT UPDATE
ABBREVIATED SUBMISSION
palonosetron (Aloxi®) is accepted for use within NHS Scotland.
Indication under review: prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with
moderately emetogenic cancer chemotherapy, in paediatric patients 1 month of age and older. A phase III double blind study demonstrated non-inferiority of palonosetron to another 5-HT3
antagonist in paediatric patients.
Included on the Additional List, Specia list
Use only.
September 2015
panitumumab 20mg/mL concentrate for solution for infusion (Vectibix)
Amgen Ltd
January 2012 NICE MTA 242 supersedes SMC Report
No. 486/08
NOT RECOMMENDED: NICE MTA 242 Panitumumab monotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line
chemotherapy.
NOT RECOMMENDED
panitumumab (Vectibix®) 20 mg/mL
concentrate for solution for infusion
Amgen Ltd
April 2017 NICE MTA 439 supersedes SMC Report
No. 769/12 Patient Access Scheme
NICE MTA 439 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer. Panitumumab is recommended, within its marketing authorisation, as an option for
previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with: FOLFOX, or FOLFIRI.
Not routinely available as local clinical experts do not wish to add the medicine to
the formulary at this time or there is a local preference for alternative medicines.
May 2017
panitumumab (Vectibix®)
Amgen Ltd
April 2017
NICE MTA 439 supersedes SMC Report No. 1082/15
Patient Access Scheme
NICE MTA 439 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer. Panitumumab is recommended, within its marketing authorisation, as an option for
previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with: FOLFOX, orFOLFIRI.
SMC or NICE MTA 439 Recommendations
1.1 Cetuximab is recommended, within its marketing authorisation, as an option for p re vio u sly untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic
colorectal cancer in adults in combination with: • 5 fluorouracil, folinic acid and oxaliplatin (FOLFOX) or
• 5 fluorouracil, folinic acid and irinotecan (FOLFIRI). 1.2 Panitumumab is recommended, within its marketing authorisation, as an option for
previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with: • FOLFOX or
• FOLFIRI. 1.3 The drugs are recommended only when the companies provide them with the discount
agreed in the patient access scheme (for panitumumab) or commercial access agree me n t (fo r cetuximab).
Routinely available in line with local guidance. Included on the Additional L ist ,
for Specialist Use only.
July 2020
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
panobinostat, 10mg, 15mg and 20mg
hard capsules (Farydak®)
Novartis Europharm Limited
08.02.16
SMC Report No. 1122/16 Patient Access Scheme
panobinostat (Farydak®) is accepted for use within NHS Scotland.
Indication under review: In combination with bortezomib and dexamethasone, for the treatme n t of adult patients with relapsed and/or refractory multiple myeloma who have rece ive d a t le a st
two prior regimens including bortezomib and an immunomodulatory agent. In patients with relapsed or relapsed and refractory multiple myeloma, panobinostat in
combination with bortezomib plus dexamethasone was associated with a significant b e n ef it in progression-free survival (PFS) compared with bortezomib plus dexamethasone. The treatme n t
effect of the panobinostat containing regimen on PFS was greater in the subgroup of p a t ie n ts’ representative of the licensed indication.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of panobinostat. This advice is contingent upon the continuing availabilit y
of the PAS in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, for
Specialist Use only, for the indication in question.
July 2016
pasireotide (as pamoate), 20mg, 40mg 60mg powder and solvent for suspension
for injection (Signifor®)
Novartis Pharmaceuticals UK Ltd.
07.09.15
SMC Report No. 1048/15
pasireotide (as pamoate) (Signifor®) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with acromegaly for whom surgery is not an
option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Pasireotide administered every four weeks was significantly superior to an active control group (comprising other somatostatin analogues administered monthly) for the primary endpoint of
biochemical control, in patients with inadequately controlled acromegaly following treatment with a somatostatin analogue for at least six months.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the LJF as a prescribing n o te for the indication in question.
October 2015
pazopanib 200mg, 400mg film-coated
tablets (Votrient®)
GlaxoSmithKline UK
07.03.11
SMC Report No. 676/11
pazopanib (Votrient®) is accepted for restricted use within NHS Scotland.
Indication under review: First-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
SMC restriction: use is restricted to the first-line treatment of advanced RCC. Pazopanib was superior to placebo for the primary endpoint, progression f ree survival, in the
whole population and the treatment naïve and cytokine pre-treated sub-groups. An indirect comparison demonstrated that pazopanib had similar efficacy to the main comparator.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pazopanib. This SMC advice is contingent upon the continuing
availability of the Patient Access Scheme in NHS Scotland.
Added to the Additional List, for Specialist
Use only.
September 2011
pazopanib 200mg, 400mg film-coated
tablets (Votrient®)
GlaxoSmithKline UK
10.12.12
SMC Report No. 820/12
NOT RECOMMENDED: pazopanib (Votrient®) is not recommended for use within NHS Scotland
for the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12
months after (neo) adjuvant therapy. Efficacy and safety has only been established in ce rta in STS histological tumour subtypes.
In a pivotal study, pazopanib significantly improved progression-free survival compared with placebo in adult patients with selective subtypes of advanced STS. However there was no
significant improvement in overall survival. The submitting company's justification of the treatment's cost in relation to its health benefits
was not sufficient to gain acceptance by SMC, and in addition the submitt ing compan y d id n o t present a sufficiently robust economic analysis to gain acceptance by SMC.
NOT RECOMMENDED
PCV – procarbazine 50mg capsules,
lomustine (CCNU) “medac” 40mg capsules and vincristine sulphate 1mg/mL
injection vials / pre-filled infusion
Local formulary process
Adjuvant treatment for patients with grade II glioma following radiotherapy.
Routinely available in line with local
guidance. Included on the Additional L ist , for Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
April 2017
09 September 2020
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69/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pegaspargase (Oncaspar®) 750U/mL
solution for injection/infusion Baxalta
07.11.16
SMC Report No. 1197/16 PRODUCT UPDATE
ABBREVIATED SUBMISSION
pegaspargase (Oncaspar®) is accepted for use within NHS Scotland as a component of
antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Pegaspargase (Oncaspar®) has been used in NHS Scotland as an unlicensed medicine fo r th e
treatment of ALL in children and adults; it has now been granted a product licence.
Included on the LJF as first choice,
Specialist Use only, for the indication in question.
November 2016
pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx
®) in
combination with carboplatin Janssen-Cilag
April 2016
NICE MTA 389
NICE (Multiple) Technology Appraisal Guidance No 389 ‘Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian
cancer’. Pegylated liposomal doxorubicin hydrochloride (PLDH) as monotherapy is recommended within
its marketing authorisation as an option for treating recurrent ovarian cancer. PLDH in combination with platinum is recommended as an option for treating recurrent ovarian
cancer. The Appraisal Committee was unable to make recommendations on the use of these
technologies for treating platinum-sensitive ovarian cancer beyond the first recurrence. The recommendations replace the recommendations in NICE MTA 91 relating to the use of
paclitaxel, pegylated liposomal doxorubicin hydrochloride and topotecan for second -line or subsequent treatment of advanced ovarian cancer.
Routinely available in line with national guidance. Included on the Additional L ist ,
for Specialist Use only, for the indication in question.
January 2017
pegylated liposomal doxorubicin
(Caelyx®)
Schering-Plough Ltd
09.01.04
SMC Report No. 84/03
NOT RECOMMENDED: This pegylated liposomal formulation of doxorubicin hydrochloride is
now licensed as monotherapy for the treatment of metastatic breast cancer where th e re is a n increased cardiac risk. An inconclusive study has suggested that it was not inferior to
conventional doxorubicin in terms of progression-free survival. It was less cardiotoxic than conventional doxorubicin, but was associated with other troublesome adverse events,
particularly palmar-plantar erythrodysesthesia. The product is significantly more expensive than the standard preparation and its cost effectiveness in managing metastatic breast ca n cer h a s
not been addressed by the company in their submission.
NOT RECOMMENDED
pegylated liposomal doxorubicin, 2mg/mL
concentrate for solution for infusion (Caelyx
®)
Schering Plough
13.07.09 SMC Report No. 503/08
RESUBMISSION
NOT RECOMMENDED: pegylated liposomal doxorubicin (Caelyx®) is not recommended for use
within NHS Scotland in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already
undergone or are unsuitable for bone marrow transplant. Results from an interim analysis showed that pegylated liposomal doxorubicin plus bortezo mib
significantly increased the time to disease progression compared to bortezomib mon o the ra py. At the time of the interim analysis only 31% of patients in the combination arm had reached th e
primary endpoint. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance b y
SMC.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pembrolizumab 50mg powder for
concentrate for solution for infusion (Keytruda
®)
Merck Sharp and Dohme Ltd
09.11.15 SMC Report No. 1086/15
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for use within NHS Scotland as monotherapy for the
treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously untreated with ipilimumab.
In a phase III randomised open-label study, treatment with pembrolizumab (at unlicensed doses) extended median progression free survival and overall survival compared with other immune
therapy in patients with advanced melanoma previously untreated with ipilimumab. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or
lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting. SMC has also assessed pembrolizumab as monotherapy for the treatment of advanced
(unresectable or metastatic) melanoma in adults previously treated with ipilimumab and has advised that it is not recommended for use within NHS Scotland in this setting (SMC
No.1087/15).
Included on the Additional List, Specialist
Use only, for the indication in question.
April 2016
pembrolizumab 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp and Dohme Ltd
12.12.16
SMC Report No. 1087/15 RESUBMISSION
NOT RECOMMENDED: pembrolizumab (Keytruda®) is not recommended for use within NHS
Scotland as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma
in adults. This submission relates to use in adults previously treated with ipilimumab. In a phase II randomised study, pembrolizumab improved progression free survival co mp a re d
with chemotherapy in patients with advanced melanoma previously treated with ipilimumab and, if BRAF V600 mutant-positive, a BRAF or MEK inhibitor.
The submitting company did not present a sufficiently robust economic analysis and in addit io n its justification of the treatment’s cost in relation to its health benefits was not sufficien t to g a in
acceptance by SMC. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
pembrolizumab 50mg powder for
concentrate for solution for infusion (Keytruda
®)
Merck Sharp and Dohme Ltd
16.01.17 SMC Report No. 1204/17
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland for the treatment
of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one p rio r
chemotherapy regimen. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
Pembrolizumab, compared with a standard taxane monotherapy, significantly improved o ve ra ll survival in adults with advanced NSCLC tumours that express PD-L1 and have progressed after
platinum-doublet chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Not routinely available as local clinical
experts do not wish to add the medicine to the formulary at this time or there is a local
preference for alternative medicines.
March 2017
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
71/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pembrolizumab 50mg powder for
concentrate for solution for infusion and 25mg/mL concentrate for solution for
infusion (Keytruda®)
Merck Sharp and Dohme Ltd
07.08.17
SMC Report No. 1239/17 Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.
Indication under review: As monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express
programmed death ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase
(ALK) positive tumour mutations. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
In a randomised, open-label, phase III study, treatment with pembrolizumab provided an additional 4.3 months of progression free survival compared to standard of care.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician
Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
December 2019
pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for
concentrate for solution for infusion (Keytruda®)
Merck Sharp and Dohme Ltd
12.02.18 SMC Report No. 1291/18
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.
Indication under review: as monotherapy for the treatment of locally advanced or metastatic
urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
In a phase III study of patients with measurable urothelial carcinoma with progressive d ise a se on or after platinum based chemotherapy, treatment with pembrolizumab was associated with a
statistically significant improvement in overall survival when compared with investigator’s choice of single agent chemotherapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional List ,
for Specialist Use only.
May 2018
pembrolizumab (Keytruda®) 50mg
powder for concentrate for solution for infusion and 25mg/mL concentrate for
solution for infusion Merck Sharp and Dohme Ltd
12.03.18
SMC Report No. 1296/18
pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.
Indication under review: As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and
brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
In a phase II study, pembrolizumab was associated with a clinically meaningful overall response rate in adults with classical Hodgkin lymphoma who had failed autologous stem cell tra n sp la n t
and brentuximab vedotin, or who were transplant-ineligible and had failed brentuximab vedotin. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting
Not routinely available as local experts d o
not wish to add the medicine to the formulary at this time.
April 2018
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp & Dohme Limited
10.09.18
SMC ReportNo. 1339/18
NOT RECOMMENDED: Following a full submission considered under the end of life and orphan
equivalent process, pembrolizumab (Keytruda®) is not recommended for use within NHS
Scotland.
Indication under review: as monotherapy, for the treatment of locally advanced or metastat ic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and
whose tumours express PD-L1 with a combined positive score (CPS)≥10. In an open-label, non-comparative phase II study of adults with advanced / metastatic urothelia l
cancer who had no previous treatment for advanced / metastatic disease and who were ineligible for first-line cisplatin-based therapy, treatment with pembrolizumab was associated
with an objective response in 47% of patients with strongly positive PD-L1 expression (CPS≥10). The submitting company’s justification of the treatment’s cost in relation to its health benefits
was not sufficient and in addition the company did not present a sufficiently robust clin ica l a n d economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp & Dohme Limited
10.12.18
SMC Report No. 2143 NON SUBMISSION
NOT RECOMMENDED: In the absence of a submission from the holder of the marketing
authorisation pembrolizumab (Keytruda®) is not recommended for use within NHSScotland.
Indication under review: As monotherapy for the treatment of recurrent or metastatic head and
neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp & Dohme UK Ltd
13.05.19
SMC Report No. 2144
Following a full submission considered under the orphan equivalent process
pembrolizumab (Keytruda®) is accepted for use within NHSScotland.
Indication under review: As monotherapy for the adjuvant treatment of adults with Stage III
melanoma and lymph node involvement who have undergone complete resection. Recurrence-free survival was significantly longer in the pembrolizumab group compared with
placebo in a phase III study of adult patients with completely resected, stage III melanoma with lymph node involvement.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing
availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting .
Not routinely available as local clinical
experts do not wish to add the medicine at this time or there is a local preference fo r
alternative medicines.
July 2019
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
73/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp & Dohme UK Ltd
09.09.19
SMC Report No. 2187 Patient Access Scheme
Following a full submission assessed under the end of life medicine process, pembrolizumab
(Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: In combination with carboplatin and either paclitaxel or nab-paclita xel,
for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults. SMC restriction: in combination with carboplatin and paclitaxel in patients whose tumours
express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), o r in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizuma b is
subject to a two-year clinical stopping rule. Pembrolizumab in combination with platinum based doublet chemotherapy was associated with
a progression-free survival and overall survival benefit over platinum based doublet chemotherapy in patients with treatment naïve metastatic squamous NSCLC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing
availability of the PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only.
November 2019
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck Sharp & Dohme UK Ltd
07.10.19
SMC Report No. 2207 RESUBMISSION
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: in combination with pemetrexed and platinum chemothe ra py, fo r th e first-line treatment of metastatic non-squamous non-small cell lung carcinoma (NSCLC) in adults
whose tumours have no EGFR or ALK positive mutations. SMC restriction: in patients whose tumours express programmed death ligand 1 (PD-L1) with a
<50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.
The addition of pembrolizumab to pemetrexed and platinum chemotherapy significantly improved progression-free survival and overall survival in patients with metastatic non-
squamous NSCLC with no EGFR or ALK mutations. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only..
December 2019
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck, Sharpe and Dohme Limited
07.09.20 SMC Report No. 2247
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma in adults.
SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. In an open-label, phase III study, first-line treatment with pembrolizumab plus axitinib
significantly improved progression-free and overall survival in adults with advanced renal cell carcinoma compared with a vascular endothelial growth factor (VEGF)-targeting tyrosine-kinase
inhibitor (TKI). This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS)
arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Formulary classification not yet decided –
waiting for information from clinician.
09 September 2020
Produced by the Medicines Management Team, NHS Lothian - email [email protected]
74/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pembrolizumab 25mg/mL concentrate for
solution for infusion and 50mg powder for concentrate for solution for infusion
(Keytruda®)
Merck, Sharpe and Dohme Limited
07.09.20 SMC Report No. 2257
Patient Access Scheme
pembrolizumab (Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: as monotherapy or in combination with platinum and fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck
squamous cell carcinoma (HNSCC) in adults whose tumours express programmed cell death ligand-1 (PD-L1) with a combined positive score (CPS)≥1.
SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. Overall survival was longer in patients who received pembrolizumab as monotherapy or in
combination with chemotherapy compared with a monoclonal antibody plus chemotherapy in a phase III study in patients with untreated, locally incurable, recurrent or metastatic HNSCC with
PD-L1 CPS≥1. This advice applies only in the context of an approved NHSScotland Patient Access Scheme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Formulary classification not yet decided –
waiting for information from clinician.
pemetrexed (Alimta®)
Eli Lilly and Company Limited
08.05.06
SMC Report No. 268/06 NON SUBMISSION
NOT RECOMMENDED: pemetrexed (Alimta®) is not recommended for use within NHS Scotland
as monotherapy for the treatment of patients with locally advanced or metastatic non-small ce ll
lung cancer after prior chemotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
pemetrexed, 500mg vial of powder for
solution for intravenous infusion (Alimta®)
Eli Lilly and Company Limited
08.09.08
SMC Report No. 342/07 2
ND RESUBMISSION
pemetrexed (Alimta®) is accepted for restricted use within NHS Scotland for monotherapy for the
second-line treatment of patients with locally advanced or metastatic non-small cell lung can ce r (NSCLC) other than predominantly squamous cell histology.
It is restricted to use in patients with good performance status who would otherwise be e lig ib le for treatment with docetaxel.
In a retrospective unplanned sub-group analysis of a study comparing pemetrexed with anothe r agent used in the second line treatment of NSCLC, treatment with pemetrexed re su lte d in a n
additional median survival of 1.3 months in patients with a non-squamous histology.
Added to the Additional List, for Specialist
Use only.
July 2009
pemetrexed, 100mg, 500mg powder for
concentrate for solution for infusion (Alimta
®)
Eli Lilly and Company Limited
08.02.10 SMC Report No. 531/09
2nd
RESUBMISSION
pemetrexed (Alimta®) is accepted for restricted use within NHS Scotland in combination with
cisplatin for the first line treatment of patients with locally advanced or metastatic non-small ce ll lung cancer (NSCLC) other than predominantly squamous cell histology.
It is restricted to patients in whom histology has been confirmed as adenocarcinoma or large cell carcinoma.
In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin with another platinum-based combination regimen, treatment with pemetrexed plus cisplatin re su lte d in a n
improvement in median survival in patients with a non-squamous (adenocarcinoma p lu s la rg e cell carcinoma) histology.
Add to the Additional List, for Specialist
Use only as first-line treatment
July 2010
pemetrexed 500mg infusion (Alimta®)
Eli Lilly
05.08.05 SMC Report No. 192/05
pemetrexed (Alimta) in combination with cisplatin is accepted for restricted use within NHS Scotland for the treatment of chemotherapy-naïve patients with stage III/IV unresectable
malignant pleural mesothelioma. Pemetrexed in combination with cisplatin prolonged survival compared with cisplatin alone in
patients with unresectable malignant pleural mesothelioma. Pemetrexed is the first licensed agent for the treatment of malignant pleural mesothelioma.
Pemetrexed is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. SMC has not yet receive d a
submission for this indication and therefore cannot currently recommend its use.
Added to the Additional List, for Specialist
Use only.
August 2005
09 September 2020
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75/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pemetrexed, 100mg, 500mg powder for
concentrate for solution for infusion (Alimta
®)
Eli Lilly
11.10.10 SMC Report No. 642/10
NOT RECOMMENDED: pemetrexed (Alimta®) is not recommended for use within NHS
Scotland. Indication under review: monotherapy for the maintenance treatment of locally advanced or
metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platin um -b a se d
chemotherapy. First-line treatment should be a platinum doublet with gemcitabine, paclitaxel o r docetaxel.
In a sub-group analysis of patients with non-squamous NSCLC, progression free su rviva l a n d overall survival (secondary endpoint) were significantly longer for pemetrexed plus best
supportive care (BSC) compared to placebo plus BSC. However, the manufacturer did not present a sufficiently robust economic case and their
justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
NOT RECOMMENDED
pemetrexed, 100mg & 500mg, powder for
concentrate for solution for infusion (Alimta
®)
Eli Lilly and Company Limited
08.12.14 SMC Report No. 770/12
pemetrexed (Alimta®) is accepted for use within NHS Scotland as monotherapy for the
maintenance treatment of locally advanced or metastatic non-small cell lung cancer oth e r th a n predominantly squamous cell histology in patients whose disease has not progressed
immediately following platinum-based chemotherapy. In patients with locally advanced or metastatic non-squamous non-small cell lung cancer,
maintenance treatment with pemetrexed, following completion of first -line platinum-based chemotherapy, was associated with prolonged overall survival and progression -free survival
when compared with placebo. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Included on the Additional List, for
Specialist Use only, for the indication in question.
January 2015
pertuzumab 30mg/mL concentrate for solution for infusion (Perjeta
®)
Roche Products Limited
07.12.18
SMC Report No. 2120 3
rd RESUBMISSION
Following a third resubmission assessed under the orphan equivalent process, pertuzumab (Perjeta
®) is accepted for use within NHSScotland.
Indication under review: In combination with trastuzumab and docetaxel, in adult pa tie n ts with HER2 positive metastatic or locally recurrent unresectable breast cancer, who have not received
previous anti HER2 therapy or chemotherapy for their metastatic d isease. Addition of pertuzumab to current first-line treatment, trastuzumab plus docetaxel, signif ica nt ly
increased progression-free and overall survival for women with HER2-positive metastatic or locally recurrent unresectable breast cancer.
This SMC advice takes account of the benefit of Patient Access Schemes (PAS) that imp ro ve s the cost effectiveness of pertuzumab and trastuzumab IV (Herceptin®). This advice is
contingent upon the continuing availability of these PAS in NHSScotland or list price s th a t a re equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Added to the Additional List fo r
Specialist Use only.
April 2019
pertuzumab 420mg concentrate for solution for infusion (Perjeta
®)
Roche Products Limited
09.11.18
SMC Report No. 2119 2
nd RESUBMISSION
Following a second resubmission assessed under the orphan medicine process, p e rtuzu ma b (Perjeta
®) is accepted for use within NHSScotland.
Indication under review: for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammato ry, o r
early stage breast cancer at high risk of recurrence. In a phase II study conducted in women with locally advanced, inflammatory, or early HER2 -
positive breast cancer, in the neoadjuvant setting, the addition of pertuzumab to t ra stu zuma b plus chemotherapy resulted in a significantly higher proportion of patients achieving pathological
complete response in the breast. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance.Included on the Additional L ist ,
for Specialist Use only, for the indication in question.
January 2019
09 September 2020
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76/97
Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
pertuzumab 420mg concentrate for
solution for infusion (Perjeta®)
Roche Products Ltd
07.10.19 SMC Report No. 2197
NOT RECOMMENDED:following a full submission considered under the orphan equivalent
process, pertuzumab (Perjeta®) is not recommended for use within NHSScotland.
Indication under review: for use in combination with trastuzumab and chemotherapy in the
adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
The addition of pertuzumab to trastuzumab and chemotherapy improved invasive disease-f re e survival in patients with HER2-positive early breast cancer at high risk of recurrence. Overall
survival data are immature. The submitting company did not present a sufficiently robust clinical or economic analysis to
gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
NOT RECOMMENDED
pertuzumab 420mg concentrate for solution for infusion (Perjeta
®)
Roche Products Limited
07.09.20
SMC Report No. 2284 3
rd RESUBMISSION
Patient Access Scheme
Following a resubmission assessed under the orphan medicine process pertuzumab (Perjeta
®) is accepted for restricted use within NHSScotland.
Indication under review: for use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of
recurrence. SMC restriction: for use in patients with lymph node-positive disease.
The addition of pertuzumab to trastuzumab and chemotherapy improved invasive disease-free survival in patients with HER2-positive early breast cancer at high risk of recurrence.
This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or
PAS/ list prices that are equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Formulary classification not yet decided – waiting for information from clinician.
pixantrone (Pixuvri®) 29 mg power for
concentrate for solution for infusion
CTI Life Sciences Ltd
07.02.16 SMC Report No. 1138/16
NON SUBMISSION
NOT RECOMMENDED: pixantrone (Pixuvri®) is not recommended for use within NHS Scotland.
Indication under review:As monotherapy for the treatment of adult patients with multiply relapsed
or refractory aggressive Non Hodgkin B-cell Lymphomas. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
plerixafor, 20mg/ml solution for injection
(Mozobil®)
Genzyme Therapeutics Ltd.
18.01.10
SMC Report No. 594/09
plerixafor (Mozobil®) is accepted for use within NHS Scotland in combination with G-CSF to
enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma who se
cells mobilise poorly. Significantly more patients treated with plerixafor than with placebo achieved their target
collection of CD 34+ cells required for autologous stem cell transplantation with subsequent sustained engraftment.
Added to the Additional List, for Specialist
Use only.
August 2010
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
plerixafor 20mg/mL solution for injection
(Mozobil®)
Sanofi Aventis
10.02.20
SMC Report No. 2249 PRODUCT UPDATE
ABBREVIATED SUBMISSION
plerixafor (Mozobil®) is accepted for use within NHSScotland.
Indication under review: in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and
subsequent autologous transplantation in children aged 1 year to <18 years with lymp h o ma o r solid malignant tumours, either:
- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilisation with G-CSF (with or without chemotherapy) is expected to be insufficie n t
with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells.
SMC has previously accepted plerixafor for use in adults, in combination with G-CSF to enhance
mobilisation of haematopoietic stem cells to the peripheral blood for collection and subse qu e nt autologous transplantation in patients with lymphoma and multiple myeloma whose cells
mobilise poorly (SMC No. 594/09).
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
March 2020
polatuzumab vedotin 140mg powder for concentrate for solution for infusion
(Polivy®)
Roche Products Ltd
07.09.20 SMC Report No. 2282
Patient Access Scheme
polatuzumab vedotin (Polivy®) is accepted for use within NHSScotland on an interim basis
subject to ongoing evaluation and future reassessment.
Indication under review: in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates
for haematopoietic stem cell transplant. In a phase Ib/II study polatuzumabvedotin in combination with bendamustine and rituximab
significantly increased complete response rate compared to bendamustine and rituximab alone. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Formulary classification not yet decided – waiting for information from clinician.
pomalidomide 1mg, 2mg, 3mg and 4mg
hard capsules (Imnovid®)
Celgene Ltd
08.12.14
SMC Report No. 972/14 RESUBMISSION
Patient Access Scheme
pomalidomide (Imnovid®) is accepted for use within NHS Scotland in combination with
dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomid e a n d
bortezomib, and have demonstrated disease progression on the last therapy. Pomalidomide plus dexamethasone significantly increased progression-free survival comp a re d
with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost-effectiveness of pomalidomide. This advice is contingent upon the continuing availability o f
the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, for
Specialist Use only, for the indication in question.
January 2015
pomalidomide 1mg, 2mg, 3mg and 4mg
hard capsules (Imnovid®)
Celgene Ltd
12.08.19
SMC Report No. 2219 NON SUBMISSION
NOT RECOMMENDED: pomalidomide (Imnovid®)is not recommended for use within NHS
Scotland. Indication under review:In combination with bortezomib and dexamethasone for the treatment of
adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ponatinib 15mg, 45mg film-coated tablets
(Iclusig®)
ARIAD pharmaceuticals, Inc.
13.04.15
SMC Report No.1032/15
ponatinib (Iclusig®) is accepted for use within NHS Scotland for adult patients with chronic
phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent
treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Or adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who
are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
A non-comparative phase II study of ponatinib was conducted with primary outcomes of major cytogenetic response in patients with baseline chronic phase CML and major haematologic
response in patients with baseline accelerated or blast phase CML or Ph+ALL. Ponatinib demonstrated efficacy in heavily pre-treated CML and Ph+ALL patients who had received
dasatinib/nilotinib as second line or further line tyrosine kinase inhibitor therapy or who had the T315I mutation.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, Specia list
Use only, for the indication in question.
July 2015
posaconazole 100mg gastro-resistant
tablets (Noxafil®)
MSD Limited
13.10.14
SMC Report No.999/14 PRODUCT UPDATE
ABBREVIATED SUBMISSION
posaconazole tablets (Noxafil®) is accepted for restricted use within NHS Scotland in the
treatment of the following fungal infections in adults:
• Invasive aspergillosis in patients with disease that is refractory to amphotericin B or
itraconazole or in patients who are intolerant of these medicinal products;
• Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
• Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
• Coccidioidomycosis in patients with disease that is refractory to amphotericin B,
itraconazole or fluconazole or in patients who are intolerant of these medicinal products. for prophylaxis of invasive fungal infections in the following patients:
• Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
• Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high -dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
SMC restriction: to patients in whom there is a specific risk of Aspergillus infection or where fluconazole or itraconazole are not tolerated on the advice of local microbiologists or specialists
in infectious diseases. Posaconazole plasma concentrations are generally higher following administration of
posaconazole tablets than posaconazole oral suspension. The tablet and oral susp e nsio n a re therefore not to be used interchangeably. While the tablets are cost saving when admin istere d
for treatment they are significantly more expensive than the oral suspension when administere d for prophylaxis.
Included on the LJF, for Specialist Use
only, for use in immunocompromised patients for prophylaxis of invasive fun g a l
infections.
October 2014
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
rabbit anti-human thymocyte
immunoglobulin, 25mg powder for solution for infusion (Thymoglobuline
®)
Genzyme Therapeutics Ltd
11.08.08 SMC Report No. 489/08
NOT RECOMMENDED:rabbit anti-human thymocyte immunoglobulin, 25mg powder forsolutio n
for infusion (Thymoglobuline®) is not recommended for use within NHS Scotland for preve n t io n
of graft rejection in renal transplantation. Compared with an alternative agent for induction of immunosuppression it was associated with a lower rate of acute rejection but this did not translate into improved patient or graft survival within
the 12-month study period. The manufacturer has not presented a sufficiently robust econo mic analysis to gain acceptance by SMC.
Rabbit anti-human thymocyte immunoglobulin is also licensed for the treatment of steroid resistant graft rejection in renal transplantation and for the prevention of graft rejection in h e a rt
transplantation. The manufacturer’s submission related only to the prevention of graft reject io n in renal transplantation. SMC cannot recommend the use of rabbit anti-human thymocyte
immunoglobulin for these additional indications.
NOT RECOMMENDED
radium-223 dichloride 1000kBq/mL solution for injection (Xofigo
®)
Bayer Pharma AG
12.10.15 SMC Report No. 1077/15
Patient Access Scheme
radium-223 dichloride (Xofigo®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of adults with castration-resistant prostate cancer,
symptomatic bone metastases and no known visceral metastases. In a randomised phase III study of adult men with castration-resistant prostate cancer with
symptomatic bone metastases and no known visceral metastases, treatment with ra d iu m -2 2 3 dichloride was associated with a significant improvement in overall survival compared to
placebo. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost-effectiveness of radium-223 dichloride. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or
lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Includedon the Additional List, for Specialist Use only, for the indication in
question.
December 2015
ramucirumab (Cyrmaza®) 10 mg/mL
concentrate for solution for infusion
Eli Lilly and Company Limited
09.05.16 SMC Report No. 1156/16
NON SUBMISSION
NOT RECOMMENDED: ramucirumab (Cyramza®) is not recommended for use within NHS
Scotland.
Indication under review: in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) for the treatment of adult patients with metastatic colorectal cancer with disease progression o n
or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
ramucirumab (Cyrmaza®) 10 mg/mL
concentrate for solution for infusion Eli Lilly and Company Limited
13.06.16
SMC Report No. 1165/16 NON SUBMISSION
NOT RECOMMENDED: ramucirumab (Cyramza®) is not recommended for use within NHS
Scotland in combination with docetaxel for the treatment of adult patients with locally adva n ce d or metastatic non-small cell lung cancer with disease progression after platinum-based
chemotherapy. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ramucirumab (Cyramza®) 10 mg/mL
concentrate for solution for infusion Eli Lilly and Company Limited
11.07.16
SMC Report No. 1176/16 NON SUBMISSION
NOT RECOMMENDED: ramucirumab (Cyramza®) is not recommended for use within NHS
Scotland. Indications under review:
• In combination with paclitaxel for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progre ssio n a f ter prior platinum and fluoropyrimidine chemotherapy
• As monotherapy for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior
platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate
The holder of the marketing authorisation has not made a submission to SMC regarding this product in these indications. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
ramucirumab (Cyramza®) 10 mg/mL
concentrate for solution for infusion Eli Lilly and Company Limited
11.11.19
SMC Report No. 2246 NON SUBMISSION
NOT RECOMMENDED: ramucirumab (Cyramza®) is not recommended for use within
NHSScotland. Indication under review: As monotherapy for the treatment of adult patients with a d va nce d o r
unresectable hepatocellular carcinoma who have a serum alpha fetoprotein of ≥ 400 ng/mL an d who have been previously treated with sorafenib.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
recombinant E.coli asparaginase 10,000
units powder for concentrate for solution for infusion (Spectrila
®)
medac Pharma LLP
09.04.18 SMC Report No. 1319/18
PRODUCT UPDATE ABBREVIATED SUBMISSION
asparaginase (Spectrila®) is accepted for use within NHS Scotland.
Indication under review: as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Asparaginase produced in E. coli cells has been used in NHS Scotland as an unlicensed medicine as part of treatment of ALL in children and adults; asparaginase (Spectrila
®) provides a
licensed alternative.
Routinely available in line with national
guidance. Included on the Additional List, for Specialist Use only.
April 2018
regorafenib 40mg film-coated tablet
(Stivarga®)
Bayer plc
13.04.15
SMC Report No. 1031/15 Patient Access Scheme
regorafenib (Stivarga®) is accepted for use within NHS Scotland as treatment of adult p a t ien ts
with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progresse d o n o r are intolerant to prior treatment with imatinib and sunitinib.
In a study of patients with metastatic or unresectable GIST who had prior treatment with imatinib and sunitinib, treatment with regorafenib prolonged the median progression free survival b y 3 .9
months when compared with placebo. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost-effectiveness of regorafenib and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Includedon the Additional List, Specialist
Use only, for the indication in question.
May 2015
regorafenib (Stivarga®) 40mg film-coated
tablets
Bayer Plc
09.11.15 SMC Report No. 1118/15
NON SUBMISSION
NOT RECOMMENDED: regorafenib (Stivarga®) is not recommended for use within NHS
Scotland.
Indication under review:Adult patients with metastatic colorectal cancer (CRC) who h a ve b e e n previously treated with, or are not considered candidates for, available therapies
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
regorafenib (Stivarga®) 40mg film-coated
tablets Bayer plc
07.05.18
SMC Report No. 1316/18 Patient Access Scheme
Following a full submission assessed under the end of life process, regorafenib (Stivarga®) is
accepted for use within NHS Scotland. Indication under review: as monotherapy for the treatment of adult patients with hepato cellu la r
carcinoma who have been previously treated with sorafenib. In a randomised, double-blind, phase III study in patients with hepatocellular ca n ce r th a t h ad
progressed on sorafenib treatment, regorafenib significantly improved overall survival compared with placebo on a background of best supportive care.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of regorafenib. This advice is contingent upon the continuing availability of
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only.
August 2018
ribociclib 200mg film-coated tablets
(Kisqali®)
Novartis Pharmaceuticals UK Ltd
12.03.18
SMC Report No. 1295/18 Patient Access Scheme
ribociclib (Kisqali®) is accepted for use within NHS Scotland.
Indication under review: In combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth fa cto r
receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial endocrine-based therapy.
A phase III double-blind, randomised controlled study demonstrated that ribociclib plus an aromatase inhibitor significantly improved progression-free survival compared with aromatase
inhibitor monotherapy in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer who had not previously received systemic therapy for
advanced disease. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of ribociclib. This advice is contingent upon the continuing availa bil it y o f the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
July 2018
ribociclib 200mg film-coated tablets (Kisqali
®)
Novartis Pharmaceuticals UK Ltd
11.11.19 SMC Report No. 2198
Patient Access Scheme
ribociclib (Kisqali®) is accepted for restricted use within NHSScotland.
Indication under review: for the treatment of women with hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant* as initial endocrine-based therapy, o r in wo me n
who have received prior endocrine therapy. SMC restriction: women who have relapsed on or within 12 months of completing (neo) adjuvant
endocrine therapy, or those who have progressed on first-line endocrine-based therapy for advanced breast cancer.
Ribociclib in combination with fulvestrant significantly increased progression-free survival
compared with endocrine monotherapy in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer.
This SMC advice takes account of the benefit of Patient Access Schemes (PAS) th a t imp ro ve the cost effectiveness of ribociclib and fulvestrant. This advice is contingent upon the continuing
availability of these PAS in NHSScotland or list prices that are equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
* For SMC advice relating to the use of ribociclib in combination with an aromatase in h ib ito r in this setting, please refer to SMC 1295/18
Not routinely available as local clinical experts do not wish to add the medicine to
the formulary at this time or there is a local preference for alternative medicines.
December 2019
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
rituximab (MabThera) Roche
07.03.03
SMC Report No. 33/03
rituximab(MabThera) is recommended for use by oncologists or haematologists in Scotland who have expertise in treating lymphoma. It should be administered in a hospital enviro n men t
where full resuscitation facilities are available.
Added to the Formulary as a prescribing
note, for Specialist Use only.
September 2004
rituximab (MabThera®)
Roche
13.12.04 SMC Report No. 135/04
rituximab(MabThera®) is accepted for use within NHS Scotland for the treatment of p re vio u sly
untreated patients with stage III-IV follicular lymphoma in combination with cyclophosp ha mid e , vincristine and prednisolone (CVP) chemotherapy.
Rituximab is for use only by oncologists or haematologists who have expertise in treating lymphoma. It should be administered in a hospital environment where full resuscitation facilities
are available. Limited results show that rituximab plus CVP significantly increased th e t ime to treatment failure compared with CVP alone.
Added to the Formulary as a prescribing
note, for Specialist Use only.
March 2005
rituximab 10mg/mL concentrate for
infusion (MabThera®)
Roche
11.12.06
SMC Report No. 330/06
rituximab (MabThera®) is accepted for restricted use within NHS Scotland as maintenance
therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without rituximab.
In a phase lll, randomised, open-label study, rituximab maintenance treatment significantly increased the median progression-free survival from 15 months in the observation arm to 52
months in the rituximab arm with an increase in overall survival at three years. This pro lo n g e d survival requires to be confirmed in longer term follow up.
Rituximab is restricted for use only by oncologists or haematologists who have expertise in treating lymphoma.
Added to the Additional List, for Specialist
Use only.
May 2007
rituximab, 100mg and 500mg concentrate
for solution for infusion (MabThera®)
Roche
January 2012
NICE MTA 243 supersedes SMC Report No. 493/08
NICE MTA 243 Rituximab for the first-line treatment of stage III–IV follicular lymphoma (review
of NICE technology appraisal guidance 110) states that rituximab, in combination with:
• cyclophosphamide, vincristine and prednisolone (CVP)
• cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)
• mitoxantrone, chlorambucil and prednisolone (MCP)
• cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-α (CHVPi), or chlorambucil
is recommended as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated people.
Added to the Additional List, for Specialist
Use only.
March 2011
rituximab, 100mg and 500mg concentrate
for solution for infusion (MabThera®)
Roche
08.06.09
SMC Report No. 540/09
rituximab (MabThera®) is accepted for restricted use within NHS Scotland for first-line treatme n t
of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide.
Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression free survival than fludarabine and cyclophosphamide alone. The patient populat io n
in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status o f 0 or 1 and was a younger population than that generally seen in practice. Evidence in pa t ie n ts
over 70 years of age is limited. Rituximab is restricted to use by specialists in haematology and haemato-oncology.
Added to the Additional List, for Specialist
Use only.
December 2009
rituximab, 100mg and 500mg concentrate
for solution for infusion (MabThera®)
Roche
18.01.10
SMC Report No. 591/09
rituximab (MabThera®) is accepted for restricted use within NHS Scotland.
Licensed indication under review: for the treatment of patients with previously u n t re ate d a n d relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression-free survival than fludarabine and cyclophosphamide alone. The patient population
in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status o f 0 or 1 and was a younger population than that generally seen in clinical practice. Evid e n ce in
patients over 70 years of age is limited. Restriction: Rituximab is restricted to use by specialists in haematology and haemato-oncology.
Added to the Additional List, Specialist
Use only.
April 2011
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
rituximab, 100mg in 10mL, 500mg in
50mL, concentrate for solution for infusion (MabThera
®)
Roche Products Limited
07.02.11 SMC Report No. 675/11
rituximab (MabThera®) is accepted for restricted use within NHS Scotland.
Indication under review: Rituximab maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
SMC restriction: for maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy.
Rituximab significantly increased progression free survival following a response to induction therapy in patients with previously untreated follicular lymphoma compared with observation
alone. Longer follow up is required to establish benefit in overall survival.
Added to the Additional List, for Specialist
Use only.
March 2011
rituximab (Mabthera®)
Roche
Local formulary process
In combination with bendamustine for first-line treatment of chronic lymphocytic leukaemia. Added to the Additional List, for Specialist Use only.
April 2014
rituximab 1400mg solution for
subcutaneous injection (Mabthera®)
Roche Products Limited
07.07.14
SMC Report No. 975/14 Patient Access Scheme
rituximab subcutaneous injection (Mabthera®) is accepted for restricted use within NHS Scotland
for non-Hodgkin’s lymphoma (NHL) in adults: - previously untreated patients with stage III-IV follicular lymphoma in combination with
chemotherapy; - maintenance therapy is indicated for the treatment of follicular lymphoma patients respo nd ing
to induction therapy; - treatment of patients with CD20 positive diffuse large B cell - non-Hodgkin's lymphoma in
combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
SMC restriction: Subcutaneous rituximab is accepted for use in line with previous SMC a d vice for intravenous rituximab i.e. accepted within licensed indication as above except in the
maintenance setting, where use is restricted to patients who have responded to induction therapy with rituximab plus chemotherapy.
In two pharmacokinetic-based clinical bridging studies, rituximab subcutaneous injection was shown to be non inferior to rituximab intravenous infusion for trough concentration and area
under the concentration time curve. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of rituximab subcutaneous injection. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is
equivalent or lower.
Included on the Additional List, Specia list
Use only, for the indication in question.
October 2014
rituximab with dose adjusted EPOCH
(R-DA-EPOCH)
Local formulary process
Treatment of primary mediastinal B-cell lymphoma.
Routinely available in line with local or
regional guidance.Included on the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Policy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
November 2018
rituximab, methotrexate, cytarabine and
thiotepa (MATRIX)
Local formulary process
Treatment of central nervous system lymphoma. Routinely available in line with local or
regional guidance. Included on the Additional List, for Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
April 2017
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
rolapitant (Varuby®) 90mg tablets
Tesaro UK Ltd
04.08.17 SMC Report No. 1266/17
Patient Access Scheme
rolapitant (Varuby®) is accepted for restricted use within NHS Scotland.
Indication under review: Prevention of delayed nausea and vomiting associated with highly a n d moderately emetogenic cancer chemotherapy in adults. Rolapitant is given as part of
combination therapy. SMC restriction: as a first-line option in adults undergoing highly emetogenic chemotherapy
(HEC). In phase III studies of patients scheduled to receive highly or moderately emetogenic
chemotherapy,a greater proportion of patients treated with rolapitant-based combination therapy achieved acomplete response (defined as no emesis or use of rescue medication) in the
delayed phase (>24to 120 hours after initiation of chemotherapy) of cycle one co mp a re d with combination therapy alone.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves thecost-effectiveness of rolapitant. This advice is contingent upon the continuing availa b il it y o f
the PASin NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national
guidance. Included on the Additional L ist , for Specialist Use only
July 2018
rucaparib 200mg, 250mg and 300mg film-coated tablets (Rubraca
®)
Clovis Oncology UK Ltd
12.08.19 SMC Report No. 2221
NON SUBMISSION
NOT RECOMMENDED: rucaparib (Rubraca®)is not recommended for use within NHS Scotland.
Indication under review: as monotherapy treatment of adult patients with platinum sensitive,
relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior l in e s
of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
The holder of the marketing authorisation has not made a submission to SMC regard ing this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
rucaparib 200mg, 250mg, 300mg
film-coated tablets (Rubraca®)
Clovis Oncology UK Ltd
09.03.20 SMC Report No. 2224
Patient Access Scheme
Following a full submission assessed under the end of life and orphan medicine process,
rucaparib (Rubraca®) is accepted for restricted use within NHSScotland.
Indication under review: As monotherapy for the maintenance treatment of adult p a t ien ts with
platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary p e rito n e a l cancer who are in response (complete or partial) to platinum-based chemotherapy.
SMC restriction: to patients who do not have a BRCA mutation Rucaparib significantly improved progression free survival compared with placebo in a phase I I I
study in patients with platinum-sensitive serous or endometrioid ovarian, primary perito n e a l o r fallopian tube carcinoma who had received at least two previous platinum based chemothera py
regimens. This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only.
August 2020
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
ruxolitinib (Jakavi®) 5mg, 15mg and 20mg
Tablets Novartis Pharmaceuticals UK Ltd
09.03.15
SMC Report No. 867/13 Patient Access Scheme
ruxolitinib (Jakavi®) 5mg, 15mg and 20mg Tablets is accepted for use within NHS Scot la n d a s
thetreatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera
myelofibrosis or post essential thrombocythaemia myelofibrosis. In patients with myelofibrosis, a significantly greater proportion of patients achieved a spleen
response (reduction in spleen volume of at least 35% from baseline) at 48 weeks when tre a ted with ruxolitinib compared with best available therapy. Ruxolitinib was also associated with a
greater proportion of patients reporting a clinically significant reduction in myelofibrosis-re la te d symptoms when compared with placebo.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e cost effectiveness of ruxolitinib. It is contingent upon the continuing availabilit y o f th e Pa t ie n t
Access Scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
April 2015
ruxolitinib phosphate (Jakavi®) 5mg,
10mg, 15mg and 20mg tablets
Novartis Pharmaceuticals UK Ltd
09.12.19 SMC Report No. 2213
Patient Access Scheme
ruxolitinib phosphate (Jakavi®) is accepted for use within NHSScotland.
Indication under review: The treatment of adult patients with polycythaemia vera who are
resistant to or intolerant of hydroxyurea (hydroxycarbamide). Ruxolitinib was superior to best available therapy in two phase III studies in patients with
polycythaemia vera who were resistant to or intolerant of hydroxycarbamide, with or without splenomegaly.
This advice applies only in the context of an approved NHSScotland Patient Acce ss Sch eme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based,
or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional L ist
for Specialist Use only.
July 2020
sorafenib 200mg tablets (Nexavar®)
Bayer Plc
13.11.06 SMC Report No. 321/06
NOT RECOMMENDED: sorafenib (Nexavar®) is not recommended for use within NHS Scotlan d
for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alfa or interleukin-2 based therapy or are considered unsuitable for such therapy.
Sorafenib has been compared with best supportive care and has been shown to increase progression-free survival, though the impact on overall survival is uncertain. The cost
effectiveness of sorafenib has not been demonstrated.
NOT RECOMMENDED
sorafenib 200mg film-coated tablets
(Nexavar®)
Bayer Plc.
13.07.15
SMC Report No. 1055/15 Patient Access Scheme
sorafenib (Nexavar®)is accepted for use within NHS Scotland.
Indication under review: treatment of patients with progressive, locally advanced or metasta t ic, differentiated thyroid carcinoma, refractory to radioactive iodine.
Treatment with sorafenib demonstrated a significant, clinically relevant five-month improveme n t in median progression free survival compared with placebo in patients with progressive, lo ca lly
advanced or metastatic, differentiated thyroid carcinoma, refractory to radioact ive iodine. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of sorafenib. This advice is contingent upon the continuing availabil it y o f the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, for
Specialist Use only.
September 2015
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
sorafenib 200mg film-coated tablets
(Nexavar®)
Bayer plc
11.01.16
SMC Report No. 482/08 2
nd RESUBMISSION
Patient Access Scheme
sorafenib (Nexavar®) is accepted for restricted use within NHS Scotland.
Indication under review: the treatment of hepatocellular carcinoma. SMC restriction: in patients with advanced hepatocellular carcinoma who have failed or are
unsuitable for surgical or loco-regional therapies. In a phase III study in patients with advanced hepatocellular carcinoma, sorafenib was supe rio r
to placebo in terms of overall survival, but not for time to symptomatic progression. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improve s th e
cost-effectiveness of sorafenib. This advice is contingent upon the continuing availability o f th e PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Included on the Additional List, Specialist
Use only, for the indication in question.
April 2016
sunitinib 12.5mg, 25mg, 50mg capsules
(Sutent®)
Pfizer Ltd
March 2009
NICE MTA 169 supersedes SMC Report No. 384/07
sunitinib (Sutent®) is recommended as a first-line treatment option for people with advanced
and/or metastatic renal cell carcinoma who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Added to the Additional List, for Specialist
Use only.
July 2010
sunitinib 50mg capsule (Sutent®)
Pfizer
09.11.09 SMC Report No. 275/06
RESUBMISSION Patient Access Scheme
sunitinib (Sutent®) is accepted for use within NHS Scotland for the treatment of unresectable
and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance.
Sunitinib compared with placebo delayed tumour progression by approximately five months. Treatment with sunitinib should not be continued if there is evidence of unacceptable toxicity
or progression of disease. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of sunitinib. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Added to the Additional List, for Specialist
Use only.
July 2010
sunitinib 50mg capsule (Sutent®)
Pfizer
12.02.07
SMC Report No. 343/07
NOT RECOMMENDED: sunitinib (Sutent®) is not recommended for use within NHS Scotland for
the treatment of advanced and/or metastatic renal cell carcinoma after failure of interferon -alpha
or interleukin-2 therapy. In uncontrolled trials, sunitinib has been associated with tumour responses in patients who have
metastatic renal cell cancer. However, the economic case has not been demonstrated.
NOT RECOMMENDED
sunitinib 12.5mg, 25mg, 37.5mg, 50mg hard capsules (Sutent
®)
Pfizer Limited
July 2017 NICE MTA 449 supersedes SMC Report
No. 698/11 Patient Access Scheme
NICE MTA 449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Everolimus and sunitinib are recommended, within their marketing authorisations, as options for treating well- or moderately-differentiated unresectable or metastatic neuroendocrine tumours
(NETs) of pancreatic origin in adults with progressive disease.
Added to the Additional List, for Specialist use only.
August 2017
tacrolimus, 5mg/mL concentrate for
infusion and 0.5mg, 1mg, 5mg hard capsules (Prograf
®)
Astellas Pharma Ltd
12.02.07 SMC Report No. 346/07
tacrolimus (Prograf®) is accepted for restricted use within NHS Scotland for the prophylaxis of
transplant rejection in heart allograft recipients. It has shown comparable efficacy to ciclosporin-based regimens in prevention of acute rejection.
It is restricted to use in patients where ciclosporin is not suitable.
Added to the Additional List, if initiate d b y
specialists working in Heart Transplantation.
Shared care for use in kidney and liver
transplants.
December 2008
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
tacrolimus 0.5mg, 1mg, 5mg prolonged-
release capsule (Advagraf®)
Astellas Pharma
10.09.07
SMC Report No. 402/07 PRODUCT UPDATE
ABBREVIATED SUBMISSION
tacrolimus (Advagraf®) is accepted for use within NHS Scotland for prophylaxis of transplant
rejection in adult kidney or liver allograft recipients and treatment of allograft rejection re sista n t to treatment with other immunosuppressive medicinal products in adult patients.
It is suitable for use by patients for whom tacrolimus is an appropriate choice of immunosuppressive therapy. It has similar costs per equivalent dose to the tacrolimus
immediate release capsule.
New formulation of a drug already included
in the Formulary.
October 2007
tacrolimus granules for oral suspension (Modigraf
®)
Astellas Pharma Ltd
13.12.10 SMC Report No. 657/10
PRODUCT UPDATE ABBREVIATED SUBMISSION
tacrolimus granules for Oral Suspension (Modigraf®) are accepted for restricted use within NHS
Scotland.
Indication under review: • Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft
recipients. • Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal
products in adult and paediatric patients. SMC restriction: for use in patients for whom tacrolimus is an appropriate choice of
immunosuppressive therapy and where small changes (less than 0.5mg) in dosing incre me n ts are required (e.g. in paediatric patients) or seriously ill patients who are unable to swallow
tacrolimus capsules. Modigraf
® granules for oral suspension offer 18% greater bioavailability than immediate relea se
capsules and may have different bioavailability compared to other unlicensed tacrolimus suspensions in use in the past. Careful monitoring and possible dosage chang es a re n e e d ed
when introducing treatment with Modigraf®.
Tacrolimus granules for oral suspension are significantly more expensive than the capsule
formulation.
Added to the Additional List, for use on the advice of a transplant specialist.
March 2011
tacrolimus (as monohydrate) 0.75mg, 1mg and 4mg prolonged- release tablets
(Envarsus®)
Chiesi Ltd
13.04.15
SMC Report No.1041/15 PRODUCT UPDATE
ABBREVIATED SUBMISSION
tacrolimus (Envarsus®) prolonged release-tablets are accepted for use within NHS Scotla n d a s
prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of
allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Tacrolimus (Envarsus®) is suitable for use by patients for whom tacrolimus is an appropriate
choice of immunosuppressive therapy. It has increased bioavailability compared with other
tacrolimus preparations. Tacrolimus (Envarsus®) has demonstrated non-inferiority to a
tacrolimus immediate-release capsule and has a similar cost per equivalent dose.
Not included on the LJF because clinicians do not support the formulary inclusion.
April 2015
tacrolimus (Adoport®)
Local formulary process
Immunosuppression - for new patients who require immediate release tacrolimus.
Routinely available in line with local or
regional guidance. Included on the LJF a s a first choice, for Specialist Initiation.
April 2018
tegafur/gimeracil/oteracil 15mg/4.35mg/ 11.8mg and 20mg/5.8mg/15.8mg hard
capsules (Teysuno®)
Nordic Pharma Ltd.
10.09.12
SMC Report No. 802/12
tegafur/gimeracil/oteracil (Teysuno®) is accepted for restricted use within NHS Scotla n d a n d is
indicated in adults for the treatment of advanced gastric cancer when given in combination with
cisplatin. SMC restriction: tegafur/gimeracil/oteracil is restricted to use in patients with advance d g a st ric
cancer who are unsuitable for an anthracycline, fluorouracil and platinum triplet first -line regimen.
In a multicentre, randomised, open-label clinical study in adult patients with ad va nce d g a st ric cancer, tegafur/gimeracil/oteracil in combination with cisplatin was non-inferior to an intravenous
fluoropyrimidine plus cisplatin with respect to overall survival.
Not included on the LJF because clinicians do not support the formulary inclusion.
October 2012
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
telotristat ethyl 250mg film-coated tablets
(Xermelo®)
Ipsen Limited
04.05.18 SMC Report No. 1327/18
Patient Access Scheme
telotristat ethyl (Xermelo®) is accepted for restricted use within NHS Scotland.
Indication under review: Treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue therapy in adults inadequately controlled by somatostatin analogue
therapy. SMC restriction: patients with CS diarrhoea who experience an average of four or m o re b o we l
motions per day, despite receiving somatostatin analogue therapy. A phase III double-blind randomised study showed that telotristat ethyl produced a stat ist ica lly
significant greater reduction in the number of daily bowel motions in patients with carcinoid syndrome on stable dose somatostatin analogue therapy compared with placebo.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of telotristat ethyl. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additiona l L ist for Specialist Use only.
August 2018
talimogenelaherparepvec (Imlygic®) 10
6
and 108 plaque forming units (PFU)/mL
solution for injection
Amgen Ltd
08.05.17 SMC Report No. 1248/17
NON SUBMISSION
NOT RECOMMENDED: In the absence of a submission from the holder of the marketing
authorisation, talimogenelaherparepvec (Imlygic®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of adults with unresectable melanoma that is re g io n a lly o r distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral
disease. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHSScotland.
NOT RECOMMENDED
temoporfin (Foscan®)
Biolitec Pharma
10.05.04
SMC Report No. 96/04
NOT RECOMMENDED: temoporfin (Foscan®) is not recommended for use within NHS Scotland
for the palliative treatment of patients with advanced head and neck squamous cell ca rcin o ma
failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. It is the first photosensitising drug licensed in the UK for use in photodynamic therapy (PDT) fo r
the treatment of these patients. Its effect in terms of tumour mass reduction and improvement in quality of life were small and were only observed in patients with lesions less than 10mm d e e p ,
which were fully illuminated with activating light. The quality of life benefits resulting from palliation, particularly in this subgroup, were marginal and the economic case for its use over
other palliative treatments was not made.
NOT RECOMMENDED
temozolomide 5, 20, 100 and 250mg
capsules (Temodal®)
Schering Plough UK Ltd
11.12.06
SMC Report No. 244/06 RESUBMISSION
temozolomide (Temodal®) is accepted for restricted use within NHS Scotland for the tre a tme n t
of newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy treatment.
In a three-year follow up of the pivotal phase lll study, a significant survival benefit was seen over placebo in patients with good performance status and favourable prognostic markers.
Temozolamide is restricted to patients who have had a partial or complete macroscopic resection of their tumour and with World Health Organisation (WHO) performance status 0 or 1.
Added to the LJF as first choice ad ju va n t
treatment in patients with grade IV GBM. For Specialist Use only.
Routinely available in line with local or
regional guidance. Included on the Additional List, for Specialist Use only.
April 2007
As per LJF
July 2019
temozolomide 5, 20, 100 and 250mg
capsules
Local formulary process
Concurrent with intermediate course radiotherapy and adjuvant for patients with newly
diagnosed glioblastoma.
Routinely available in line with local or
regional guidance. Included on the Additional List, for Specialist Use only.
July 2017
temozolomide 5, 20, 100 and 250mg capsules
Local formulary process
Adjuvant treatment following radiotherapy for patients with grade III glioma without 1p19q co-deletion.
Routinely available in line with local or regional guidance. Included on the
Additional List, for Specialist Use only, Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian’.
August 2017
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
temsirolimus (Torisel®)
Wyeth Pharmaceuticals
12.04.10 SMC Report No. 617/10
NON SUBMISSION
NOT RECOMMENDED:temsirolimus (Torisel®) is not recommended for use within NHS
Scotland. Licensed indication under review: the treatment of adult patients with relapsed and/or refracto ry
mantle cell lymphoma [MCL]. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
thalidomide, 50mg hard capsule (Thalidomide Pharmion
®)
Celgene Ltd
12.01.09 SMC Report No. 525/08
thalidomide (Thalidomide Pharmion®) is accepted for use within NHS Scotland in co mb in a t io n
with melphalan and prednisone, as first line treatment of patients with untreated multiple
myeloma, aged 65 years or over or ineligible for high dose chemotherapy. Thalidomide is prescribed and dispensed according to the Thalidomide Pharmion Pregnancy
Prevention Programme. In the pivotal trial in patients aged 65 to 75 years, at 51.5 months median follow-up, the additio n
of thalidomide to melphalan and prednisone gave an overall survival advantage of 18.4 months.
Added to the Additional List, for Specialist Use only.
July 2009
thiopenta and carmustine
Local formulary process
Treatment of central nervous system lymphoma. Routinely available in line with or regio n a l guidance. Included on the Additional L ist ,
for Specialist Use only. Categorised RED under the ADTC ‘Po licy
for the use of unlicensed (and off-label use) Medicines in NHS Lothian.
April 2018
thiotepa 15mg and 100mg powder for concentrate for solution for infusion
(Tepadina®)
AdienneS.r.l.
09.07.12
SMC Report No. 790/12
NOT RECOMMENDED: thiotepa (Tepadina®) is not recommended for use within NHS Scotla n d
in combination with other chemotherapy medicinal products:
1) with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in
adult and paediatric patients; 2) when high dose chemotherapy with HPCT support is appropriate for the treatment of solid
tumours in adult and paediatric patients. Two uncontrolled, non-randomised studies including patients with advanced non-Hodgkin’s
lymphoma or Hodgkin’s disease have reported data for non -relapse mortality and overall survival.
The submitting company did not present sufficiently robust clinical and economic analyses to gain acceptance by SMC.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
tisagenlecleucel 1.2 x 106 – 6 x 108 cells
dispersion for infusion (Kymriah®)
Novartis Pharmaceuticals UK Ltd
11.02.19
SMC Report No. 2129 Patient Access Scheme
tisagenlecleucel (Kymriah®) is accepted for use within NHSScotland.
Indication under review: treatment of paediatric and young adult patients up to 25 years o f a g e with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in
second or later relapse. Tisagenlecleucel was associated with an overall remission rate of 81% within thre e mo n th s o f
treatment in a single-arm, open-label, phase II study in paediatric and young adult patients with CD19+ relapsed or refractory B-cell ALL.
SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of tisagenlecleucel and is contingent upon the continuing availabil it y o f th is
PAS in NHSScotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Routinely available in line with national
guidance. Included on the Additional L ist for Specialist Use only..
December 2019
tisagenlecleucel 1.2 x 106 to 6 x 10
8 cells
dispersion for infusion (Kymriah®)
Novartis Pharmaceutical UK Ltd
09.09.19 SMC Report No. 2200
RESUBMISSION Patient Access Scheme
Following a resubmission under the end of life and ultra-orphan medicine process, tisagenlecleucel (Kymriah
®) is accepted for use within NHSScotland.
Indication under review:for adult patients with relapsed or refractory diffuse large B -cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Tisagenlecleucel was associated with an overall response rate of 53% in a single -arm, open-label, phase II study in patients with relapsed or refractory DLBCL.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tisagenleceucel. This advice is contingent upon the continuing
availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Routinely available in line with national guidance. Included on the Additional L ist
for Specialist Use only..
December 2019
tivozanib 890 micrograms and 1,340 micrograms hard capsules, (Fotivda
®)
Eusa Pharma Limited
08.06.18 SMC Report No. 1335/18
Patient Access Scheme
tivozanib (Fotivda®) is accepted for restricted use within NHSScotland.
Indication under review: the first-line treatment of adult patients with advanced renal cell
carcinoma and for adult patients who are vascular endothelial growth factor receptor and mammalian target of rapamycin pathway inhibitor-naïve following disease progression after on e
prior treatment with cytokine therapy for advanced renal cell carcinoma (RCC). SMC restriction: to first-line treatment of advanced RCC.
In a phase III, open-label, randomised, controlled study tivozanib increased progression free survival when compared with a multi-kinase inhibitor in patients with advanced RCC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tivozanib. This advice is contingent upon the continuing availab il it y o f
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national guidance. Included on the Additional List ,
for Specialist Use only.
January 2019
topotecan 1mg, 4mg powder for concentrate for solution for infusion
(Hycamtin®)
GlaxoSmithKline
07.05.07
SMC Report No. 366/07
NOT RECOMMENDED: topotecan (Hycamtin®) is not recommended for use within NHS
Scotland for the treatment of patients with relapsed small cell lung cancer (SCLC) for wh o m re -
treatment with the first-line regimen is not considered appropriate. In a trial comparing oral topotecan plus active symptom control (ASC) to ASC alone the
difference in median survival was 12 weeks, in favour of the oral topotecan plus ASC group. Topotecan is not available as an oral formulation in the UK, however, in one trial the re sp o n se
rate and median survival duration were similar for oral and IV topotecan groups. The treatment’s cost in relation to its health benefits was not sufficient to gain a cce pta nce b y
SMC.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
topotecan 1mg, 4mg powder for
concentrate for solution for infusion (Hycamtin
®)
GlaxoSmithKline
10.12.07 SMC Report No. 421/07
topotecan (Hycamtin®) is accepted for restricted use within NHS Scotland in combination with
cisplatin for patients with carcinoma of the cervix recurrent after radiotherapy and fo r p a t ie nts with stage IVB disease. It is restricted to patients who are cisplatin-naïve.
In an open-label study, overall and progression-free survival were significantly longer for cisplatin plus topotecan compared with cisplatin alone. Haematological adverse e ven ts we re
more common in the cisplatin plus topotecan group. The economic submission d e mo n st rate d that topotecan plus cisplatin was cost effective compared to cisplatin alone in cisplatin -naïve
patients. However, the manufacturer’s justification of the treatment’s cost in relation to its health benefit was not sufficient to gain acceptance by SMC for use in patients with previous exposu re
to cisplatin.
Added to the Formulary. November 2008
topotecan (Hycamtin®)
GlaxoSmithKline
Local formulary process
Treatment for new patients presenting with metastatic (stage IVb) cervical carcinoma or patients with recurrence of cervical carcinoma outside the radiation field and with cisplatin free interval of
more than 3 months.
Not preferred. November 2008
topotecan 0.25mg, 1mg hard capsules
(Hycamtin®)
GlaxoSmithKline
14.04.09
SMC Report No. 545/09
topotecan capsules (Hycamtin®) are accepted for restricted use within NHS Scotland as
monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCL C) fo r whom re-treatment with the first-line regimen is not considered appropriate.
The efficacy of topotecan capsules relative to standard IV chemotherapy is unknown. Topotecan capsules are restricted to use in patients for whom standard intravenous chemotherapy is
inappropriate and who would otherwise receive best supportive care. In one study, oral topotecan plus best supportive care (BSC) was superior to BSC alone fo r th e
primary endpoint of median survival.
Added to the Additional List, for Specialist
Use only.
July 2009
topotecan (Hycamtin®)
Merck Pharmaceuticals
April 2016 NICE MTA 389 supersedes previous FC
advice
NOT RECOMMENDED: NICE MTA 389 Topotecan, pegylated liposomal doxorubicin
hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer Topotecan is not recommended within its marketing authorisation for treating the first recurrence
of platinum-sensitive ovarian cancer. The Appraisal Committee was unable to make recommendations on the use of these technologies for treating platinum-sensitive ovarian
cancer beyond the first recurrence.
NOT RECOMMENDED
trabectedin 0.25mg and 1mg powde r fo r concentrate for solution for infusion
(Yondelis®)
Immedica
09.12.19
SMC Report No. 2210 RESUBMISSION
NOT RECOMMENDED: trabectedin (Yondelis®) is not recommended for use within NHS
Scotland.
Indication under review: treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. E f f ica cy
data are based mainly on liposarcoma and leiomyosarcoma patients. Trabectedin, compared with an alkylating chemotherapy, increased progression-free survival but
not overall survival in patients with advanced liposarcoma or leiomyosarcoma who had previously been treated with an anthracycline-based chemotherapy.
The submitting company did not present a sufficiently robust clinical and economic an a lysis to gain acceptance by SMC.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
trabectedin (Yondelis®)
Pharma Mar SA Ltd
April 2016
NICE MTA 389 supersedes SMC Report No. 634/10
NOT RECOMMENDED:NICE MTA 389 Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Trabectedin in combination with PLDH is not recommended within its marketing authorisation for treating the first recurrence of platinum-sensitive ovarian cancer. The Appraisal Committee was
unable to make recommendations on the use of these technologies for treating platinum-sensitive ovarian cancer beyond the first recurrence.
NOT RECOMMENDED
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
trametinib 0.5mg and 2mg film-coated
tablets (Mekinist®)
Novartis Pharmaceuticals UK Ltd
12.09.16
SMC Report No. 1161/16 Patient Access Scheme
trametinib (Mekinist®) is accepted for restricted use within NHS Scotland in combination with
dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
SMC restriction: to first-line treatment. In two phase III studies, trametinib in combination with dabrafenib improved progression -free
survival and overall survival compared with BRAF inhibitor monotherapy for the first -line treatment of unresectable or metastatic melanoma with BRAF V600 mutation in adults.
This advice takes account of the benefits of Patient Access Schemes (PAS) th a t imp ro ve th e cost-effectiveness of trametinib and dabrafenib. This advice is contingent upon the co n t in uin g
availability of these patient access schemes in NHS Scotland or list prices that are equivalent o r lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Trametinib is also licensed as monotherapy. As the company submission related only to
combination therapy, SMC cannot recommend use as monotherapy.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
December 2016
trametinib 0.5mg, 2mg film-coated tablets (Mekinist
®)
Novartis Pharmaceuticals UK Limited
10.07.17 SMC Report No. 1264/17
NON SUBMISSION
NOT RECOMMENDED: In combination with dabrafenib for the treatment of adult patie nts with advanced non-small cell lung cancer with a BRAF V600 mutation.
NOT RECOMMENDED
trastuzumab (Herceptin®)
Roche Pharmaceuticals
NICE MTA 257 supersedes SMC Report
No. 386/07
NOT RECOMMENDED:NICE MTA 257 states that trastuzumab in combination with an aromatase inhibitor is not recommended for first-line treatment in postmenopausal wome n with
metastatic hormone-receptor-positive breast cancer that overexpresses HER2.
NOT RECOMMENDED
trastuzumab 150mg vial (Herceptin®)
Roche
09.06.06 SMC Report No. 278/06
trastuzumab (Herceptin®) is accepted for restricted use within NHS Scotland for the treatment of
patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadju va nt or adjuvant) and radiotherapy (if applicable).
In the pivotal trial, the addition of one year of 3-weekly trastuzumab after adjuvant chemotherapy significantly increased disease-free survival compared with that in the observation gro u p . Th e
trial excluded patients with a range of cardiovascular conditions and trastuzumab treatme n t fo r early breast cancer is not recommended in such patients. In patients treated with trastu zu ma b
for early breast cancer, monitoring of cardiac function is required before treatment, every th re e months during treatment and for up to two years after treatment has stopped.
Trastuzumab in this indication is restricted to use by breast cancer specialists.
Added to LJF as first choice for use in
patients with HER2 positive early breast cancer following surgery, chemotherapy
and radiotherapy (if applicable). For Specialist Use only.
April 2007
trastuzumab, 150mg powder for concentrate for solution for infusion
(Herceptin®)
Roche Products Ltd.
12.10.15
SMC Report No. 623/10 2
nd RESUBMISSION
trastuzumab (Herceptin®) is accepted for restricted use within NHS Scotland.
Indication under review: in combination with capecitabine or fluorouracil and cisplatin for the
treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or g a st ro -oesophageal junction who have not received prior anti-cancer treatment for their metastatic
disease. It is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, a s
determined by an accurate and validated assay. SMC restriction: for use in patients whose tumours have HER2 overexpression defined by
immunohistochemistry (IHC) 3+ (“HER2 high expresser”). The addition of trastuzumab to doublet chemotherapy improved overall and progression -free
survival and tumour response. This advice takes account of the views from a Patient and Clinician Engagement (PACE)
meeting.
Includedon the Additional List, for Specialist Use only, for the indication in
question.
December 2015
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
trastuzumab, 600mg/5mL solution for
injection (Herceptin®)
Roche Products Ltd
13.01.14
SMC Report No. 928/13
trastuzumab (Herceptin®) is accepted for restricted use within NHS Scotland for the treatment of
adult patients with HER2 positive metastatic breast cancer (MBC) and early breast cancer (EBC) in a range of settings.
Trastuzumab should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an
accurate and validated assay. SMC restriction: Subcutaneous trastuzumab injection is accepted for use in line with p re vio u s
SMC advice for intravenous trastuzumab (this excludes its use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive
MBC, not previously treated with trastuzumab). In a phase III randomised, open-label clinical study in patients with HER2-positive early b re a st
cancer, subcutaneous trastuzumab was non-inferior to intravenous trastuzumab for the co-primary pharmacokinetic and efficacy endpoints of serum trough concentration (C trough) at pre-
dose cycle 8 before surgery and pathological complete response.
Includedon the Additional List, for
Specialist Use only, for the indication in question.
April 2014
trastuzumab emtansine, 100mg and 160mg, powder for concentrate for
solution for infusion (Kadcyla®)
Roche Products Ltd.
10.04.17
SMC Report No. 990/14 RESUBMISSION
Patient Access Scheme
As a single agent, for the treatment of adult patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously
received trastuzumab and a taxane, separately or in combination. Patients should have either:
• Received prior therapy for locally advanced or metastatic disease, or
• Developed disease recurrence during or within six months of completing adjuvant therapy.
Routinely available in line with national guidance. Included on the Additional L ist ,
for Specialist Use only.
May 2017
trastuzumab (Herzuma®)
Local formulary process
As a replacement for the existing trastuzumab brand, Herceptin, where IV trastuzumab is indicated and approved.
Routinely available in line with national guidance. Included on the Additional L ist ,
for Specialist Use only.
March 2019
trifluridine/tipiracil (as hydrochloride),
15mg/6.14mg and 20mg/8.19mg film-coated tablets (Lonsurf
®)
Servier Laboratories Limited
13.02.17 SMC Report No. 1221/17
Patient Access Scheme
trifluridine/tipiracil (Lonsurf®) is accepted for use within NHS Scotland for the treatment of a d u lt
patients with metastatic colorectal cancer (CRC) who have been previously treated with, o r a re not considered candidates for, available therapies including fluoropyrimidine-, oxalip la tin - a n d
irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.
Treatment with trifluridine/tipiracil was associated with an improvement in overall surviva l wh e n compared with best supportive care in patients who had received, or were intolerant of, first an d
second-line therapies for metastatic CRC. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of trifluridine/tipiracil. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional L ist , Specialist Use only, for the indication in
question.
April 2017
triptorelin acetate (Decapeptyl®
SR 11.25mg)
Ipsen Ltd
12.07.04 SMC Report No. 109/04
PRODUCT UPDATE ABBREVIATED SUBMISSION
triptorelin acetate (Decapeptyl® SR 11.25mg) is accepted for use within NHS Scot la n d fo r th e
treatment of advanced prostate cancer in patients for whom the use of triptorelin is appro p ria te
and who would benefit from reduced frequency of administration compared with Decapeptyl®
SR 3mg (every 3 months vs every 28 days).
Added to the Formulary as first choice gonadorelin analogue for advanced
prostate cancer instead of goserelin or leuprorelin.
Routinely available in line with national
guidance. Included in the LJF, for Specialist Initiation.
May 2005
As per LJF
July 2019
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
triptorelin 3.75mg (Gonapeptyl Depot®)
Ferring Pharmaceuticals Ltd
08.05.06 SMC Report No. 269/06
NON SUBMISSION
NOT RECOMMENDED:Gonapeptyl Depot® is not recommended for use within NHS Scotland
for the treatment of advanced, hormone-dependent prostate carcinoma. The holder of the marketing authorisation has not made a submission to SMC regarding this
product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
triptorelin (Decapeptyl SR®) 22.5mg
powder and solvent for suspension for
injection Ipsen Ltd
13.06.11
SMC Report No. 705/11 PRODUCT UPDATE
ABBREVIATED SUBMISSION
triptorelin pamoate 22.5mg (Decapeptyl SR®) is accepted for use within NHS Scotland.
• Treatment of patients with locally advanced, non-metastatic prostate cancer, as an
alternative to surgical castration.
• Treatment of metastatic prostate cancer. This new preparation of triptorelin allows 6-monthly administration (as triptorelin pamoate in a
22.5mg dose). Triptorelin 11.25mg (as acetate) is administered every 3 months and has previously been accepted by SMC. Bioequivalence of the pamoate and acetate salts ha s b e en
demonstrated and the new preparation is cost neutral. Note: The indication for triptorelin 11.25mg formulation was reworded in 2007 to achieve
consistency Europe-wide and now reads as per the indication for triptorelin 22.5mg.
Added to the Formulary, as a new formulation of a product already included.
May 2011
triptorelin sustained–release 3mg powder for suspension for injection
(Decapeptyl SR®)
Ipsen Ltd
07.10.19
SMC Report No. 2186 Patient Access Scheme
triptorelin (Decapeptyl SR®) is accepted for use within NHSScotland.
Indication under review: As adjuvant treatment in combination with tamoxifen or an a ro ma ta se
inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurre n ce who are confirmed as premenopausal after completion of chemotherapy.
In premenopausal women with early breast cancer at high risk of recurrence, ovarian suppression (provided by triptorelin, oophorectomy or radiation ablation) plus an aromatase
inhibitor increased disease free survival compared to ovarian suppression plus tamoxifen. In the same patient population, ovarian suppression plus tamoxifen increased disease -free survival
compared with tamoxifen alone. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of triptorelin. This advice is contingent upon the continuing availabil it y o f the PAS in NHSScotland or a list price that is equivalent or lower.
Not routinely available as local clinical experts do not wish to add the medicine to
the formulary at this time or there is a local preference for alternative medicines.
November 2019
vandetanib (Caprelsa®) 100 mg / 300mg
film coated tablets AstraZeneca UK Limited
11.06.12
SMC Report No. 797/12 NON SUBMISSION
NOT RECOMMENDED: vandetanib (Caprelsa®) is not recommended for use within NHS
Scotland for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
vemurafenib 240mg film-coated tablet (Zelboraf
®)
Roche Products Ltd.
09.12.13 SMC Report No. 792/12
RESUBMISSION Patient Access Scheme
vemurafenib (Zelboraf®) is accepted for restricted use within NHS Scotland as monotherapy fo r
the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic
melanoma. SMC restriction: for use in the first-line treatment of BRAF V600 mutation-positive unresectab le
or metastatic melanoma. Vemurafenib significantly increases overall survival and progression-free survival compared with
a current standard chemotherapy for patients with previously untreated unresectable stage I I IC or stage IV melanoma with V600 BRAF mutation.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of vemurafenib. This SMC advice is contingent upon the
continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
Included on the Additional List, for Specialist Use only, for the indication in
question.
February 2014
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
venetoclax 10mg, 50mg and 100mg
film-coated tablets (Venclyxto®)
AbbVie Ltd
07.08.17
SMC Report No. 1249/17 Patient Access Scheme
Following a full submission assessed under the end of life and orphan medicine process,
venetoclax (Venclyxto®) is accepted for use within NHS Scotland.
Indication under review: As monotherapy for the treatment of chronic lymphocytic leukaemia
(CLL):
• in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
In phase II, non-comparative studies of patients with relapsed / refractory CLL, tre a tme n t with venetoclax was associated with clinically meaningful overall response rates.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of venetoclax. This advice is contingent upon the continuing availability of
the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List , for Specialist Use only.
April 2018
venetoclax 10mg, 50mg and 100mg
film-coated tablets (Venclyxto®)
AbbVie Ltd
12.08.19
SMC Report No. 2166 Patient Access Scheme
Following a full submission considered under the orphan equivalent process, venetoclax
(Venclyxto®) is accepted for usein combination with rituximab for the treatment of adult patie nts
with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Progression-free survival was significantly longer in the venetoclax plus rituximab group compared with chemoimmunotherapy in a phase III study of patients with relapsed or refracto ry
CLL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of venetoclax. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Routinely available in line with national
guidance. Included on the Additional List
for Specialist Use only.
July 2020
vinflunine ditartrate 25mg/mL
concentrate for solution for infusion (Javlor
®)
Pierre Fabre Ltd
13.07.15
SMC Report No. 686/11 RESUBMISSION
NOT RECOMMENDED: vinflunine (Javlor®) is not recommended for use within NHS Scotland.
Indication under review: monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-
containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Vinflunine plus best supportive care was associated with improved survival when compared with best supportive care alone in the second-line treatment of advanced or metastatic tra n sit io na l
cell carcinoma of the urothelial tract in patients with good performance status. The submitting company did not present a sufficiently robust economic analysis and in additio n
their justification of the treatment’s cost in relation to its benefits was not sufficient to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
NOT RECOMMENDED
vinorelbine 20 and 30mg capsules
(Navelbine® Oral)
Pierre Fabre Ltd
13.06.05
SMC Report No. 179/05
vinorelbine capsule (NavelbineOral) is accepted for restricted use within NHS Scotland for th e
first line treatment of stage lll or lV non-small-cell lung cancer. It is restricted to use by specialist oncologists as an alternative to the intravenous formulation of
vinorelbine. It is more expensive than the intravenous formulation of vinorelbine. However, it s use may allow changes to service delivery that have individual patient or organisational
benefits.
‘Not preferred’ in Lothian.
July 2007
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
vinorelbine 20mg and 30mg capsule
(Navelbine®)
Pierre Fabre Ltd
13.08.07
SMC Report No. 324/06 PRODUCT UPDATE
ABBREVIATED SUBMISSION
vinorelbine (Navelbine®) is accepted for restricted use within NHS Scotland for treatment of
advanced breast cancer stage III and IV relapsing after, or refractory to, an anthracycline -containing regimen.
It is restricted to use by specialist oncologists as an alternative to the intravenous formulation o f vinorelbine where vinorelbine is considered to be appropriate. It is more expensive than the
intravenous formulation of vinorelbine. However, its use may allow changes to service d e live ry that have individual patient or organisational benefits.
Added to the Additional List, for Specialist
Use only.
July 2008
vismodegib (Erivedge®) 150 mg hard
capsules
Roche Products Ltd
07.10.13 SMC Report No. 924/13
NON SUBMISSION
NOT RECOMMENDED: vismodegib (Erivdege®) is not recommended for use within NHS
Scotland for the treatment of adult patients with:
• symptomatic metastatic basal cell carcinoma • locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
NOT RECOMMENDED
Zarzio filgrastim 300mcg and 480mcg pre-filled syringes
Local formulary process
For primary or secondary prophylaxis of neutropenia; treatment of profound neutropenia associated with sepsis and mobilisation of autologous stem cells for transplants.
Routinely available in line with local or regional guidance. Included in the LJF, fo r
Specialist Initiation.
May 2017
zoledronic acid (Zometa) Novartis Europharm Ltd
12.05.03 SMC Report No. 29/02
RESUBMISSION
zoledronic acid (Zometa) should be restricted to prescribing by oncologists for patients with breast cancer and multiple myeloma. It provides an alternative to other bisphosphonates licensed for prevention of ske le ta l re la te d
events. It may offer some minor advantages in terms of administration. At a local level the decision will rest on weighing up the additional cost against other options available for improving
the delivery of oncology services. Zoledronic acid has a broader range of indications than other bisphosphonates available
and has shown some efficacy in patients with prostate cancer and NSCLC and other solid tumours. The quality of the economic evidence provided is insufficient to demonstrate that
the use of this product for these indications is cost effective. The licence holder has indicated their decision to appeal.
‘Not Preferred’ in Lothian. A submission has not been made to FC regarding this
product for this indication.
zoledronic acid (Zometa)
Novartis Europharm Ltd
12.01.04 SMC Report No. 29/02
INDEPENDENT REVIEW PANEL ASSESSMENT
NOT RECOMMENDED:zoledronic acid (Zometa) is not recommended for use within NHS
Scotland for the prevention of skeletal related events (SREs) in patients with advanced prostate cancer involving bone.
Although zoledronic acid demonstrated a reduction in SREs compared with placebo in these patients, the absolute reduction was small and the study requires caution in acce p t in g th is a s
sufficient evidence to introduce zoledronic acid into standard practice for the treatment of patients with metastatic prostate cancer. An economic case was submitted by the manufacturer
but its quality was not judged to be sufficient to support a recommendation that the drug is co st effective relative to standard practice in Scotland for this particular indication.
NOT RECOMMENDED
zoledronic acid (Zometa®)
Novartis
Local formulary process
For tumour induced hypercalcaemia.
Added to the Formulary as first choice.
Routinely available in line with local or
regional guidance. Included in the LJF, fo r Specialist Use only.
April 2010
09 September 2020
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Product
Manufacturer
Date SMC/NICE Recommendation Report number
Condition being treated
For more details see www.scottishmedicines.org.uk
NHS Lothian decision
Date of NHS Lothian
decision
zoledronic acid (Zerlinda®) 4mg/100mL
solution for infusion pre-filled bag Actavis
Local formulary process
Adjuvant use in women at high risk of recurrence to reduce the rate of
breast cancer recurrence in bone. High risk patients are:
• breast cancer patients (irrespective of whehter they have had chemotherapy)
• who are post-menopausal and deemed by local protocol to be high risk: i.e. ER
low/negative, or ER 4-8 with one or more of the following features – HER2 positive or Grade 3 or
T3/4 or node positive.
• pre-menopausel patients in the same risk category who warrant ovarian suppression.
Included on the Additional List, for
Specialist Use only.
Categorised RED under the ADTC ‘Po licy for the use of unlicensed (and off-label
use) Medicines in NHS Lothian’.
October 2016
zoledronic acid (Zerlinda®) 4mg/100mL
solution for infusion
Actavis
Local formulary process
Prevention of skeletal related events in patients with skeletal metastases from solid tumours excluding breast and prostate cancer.
Routinely available in line with local or regional guidance. Included on the
Additional List, for Specialist Use only.
August 2017