APC Annual Report 2012-13 - North Of Tyne Area Prescribing

Produced by S Turner, Professional Secretary for North of Tyne Area Prescribing Committee. April 2013 Page 1 of 26

Executive Summary The North of Tyne Area Prescribing Committee (APC) has continued its work of facilitating medicine related clinical decision making across the North of Tyne area during 2012-13 despite this being a year of great uncertainty for many of its member organisations. 32 new products were considered by the committee. 29 products were considered for an extension of approved uses or formulations. Approx 74% of reviews resulted in approval. The rest were either rejected or deferred. 23 decisions made by the North East Cancer Drugs Approval Group (NECDAG) were

ratified. 10 decisions made by the North East Treatment Advisory Group (NETAG) were ratified. 1 decision made by the North of England Specialised Commissioning Group (NESCG)

was ratified. 23 NICE Technology Appraisals were noted and the recommendations made within

them reflected in the North of Tyne Formulary. 23 miscellaneous decisions relating to the use of drugs across the area were taken. The North of Tyne Formulary was updated regularly and made available on the APC’s

website for public scrutiny along with minutes of meetings and decision summaries. The committee continued to look at NICE and SMC decisions as well as reviewing newly

licensed drugs and formulations. A number of shared care guidelines and information leaflets for primary care were

developed by the Committee’s Shared Care subgroup. The QIPP subgroup, which leads on a specific work stream of medicines optimisation

across the health economy, continued to work on improving quality and generating savings relating to prescribing.

The committee now needs to secure an appropriate level of engagement and ownership from its new member organisations in order to continue this work. This will be particularly challenging given the level of change and uncertainty associated with commissioning in the new NHS landscape.

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ANNUAL REPORT April 2012 to March 2013

Background The APC was established in January 2007 with the aim of facilitating a cross-organisational approach to medicines management, clinical decision making and related commissioning issues that affect primary care, acute hospitals, mental health, learning disabilities and social care. The work has been as relevant as ever despite member organisations changing during this period. Furthermore there has been an increasing focus on medicines usage as well as medicines policy, particularly through the work of the APC’s subgroups. As the NHS reforms develop it is essential that commissioners and clinicians continue to make population and individual patient funding decisions in a manner that is robust, rational and defensible. Funding decisions about medicines and treatments need to be made based on consideration of the best available evidence. The commitments in the NHS Constitution reinforce the need for clinical commissioning groups (CCGs) to have in place robust arrangements for their local decision-making groups and an established APC is one of the key mechanisms used to help make local decisions about medicines for their patient populations. The NHS constitution (March 2013) states that:

“You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you. You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.”

Sir David Nicholson wrote to PCT Chief Executives and CCG Leads in August 2012 requiring that all NHS organisations ensure that drugs approved within a NICE Technology Appraisal are included in local medicines formularies and these formularies should be published online and be patient and stakeholder accessible. The APC facilitates this process for its members. Keith Ridge, the DH Chief Pharmaceutical Officer also urged PCTs and CCGs to review their local formulary processes in order to ensure they are fit for purpose. The NICE Medicines and Prescribing Centre has recognised the importance of local decision making bodies by publishing Good Practice Guidance relating to Developing and Updating Local Formularies in December 2012. The APC has reviewed its processes, terms of reference and membership in light of this and is fully compliant with these requirements. This report has been compiled to inform participating organisations of the Committee’s activities for the 12 months up to the end of March 2013. The report includes the outcomes of new drug requests, membership details, attendance figures and other relevant/significant developments, areas of interest and involvement. The challenge for 2013/14 will be to continue the excellent work of the APC at a time of significant change to member organisations, NHS architecture and, perhaps most significantly, the new arrangements for commissioning of medicines that are taking shape as part of NHS reform.


Membership & Terms of Reference The Area Prescribing Committee (APC) served the following participating organisations during the year:

Newcastle Primary Care Trust (NPCT)

Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH)

North Tyneside Primary Care Trust (NTPCT)

Northumberland Care Trust (NCT)

Northumberland, Tyne and Wear NHS Foundation Trust (NTWT)

Northumbria Healthcare NHS Foundation Trust (NHCT)

NHS Northumberland Clinical Commissioning Group (NHS NCCG)*

NHS North Tyneside Clinical Commissioning Group (NHS NTCCG)*

NHS Newcastle North and East Clinical Commissioning Group (NHS NNECCG)*

NHS Newcastle West Clinical Commissioning Group (NHS NWCCG)* *Note – The CCGs were running in shadow form during 2012-13 until their full statutory responsibility took effect on 1/4/2013. Membership of the committee reflects a wide variety of professional, clinical, educational, management, commissioning and organisational backgrounds. Clearly membership will change as a result of the impact of NHS reforms but significant effort has been put into ensuring this is appropriate to ensure a successful transfer of responsibilities in 2013/4. Committee Officers The following is a list of officers to the committee during 2012-13 and its main sub groups/committees:

APC – Chair David Campbell

APC – Vice Chair 1 Simon Thomas

APC – Vice Chair 2 Rosie England

APC – Vice Chair 3 Hilary Wynne

APC – Professional Secretary Susan Turner

Formulary sub-committee – Chair Simon Thomas

Formulary sub-committee – Vice Chair 1 Alexander Dyker

Formulary sub-committee – Vice Chair 2 Zahra Irannejad

Formulary sub-committee – Professional Secretary

Matthew Lowery

Shared Care Group – Chair Hilary Wynne

Shared Care Group – Vice Chair Helen Seymour

Shared Care Group – Professional Secretary

QIPP Group – Chair Martin Wright

QIPP Group – Vice Chair Rosie England

Attendance figures Between April 2012 and March 2013 there have been 6 meetings of the APC. The table below describes the attendance figures for members of the Committee.

Name Job Title Organisation Attendance

Arpita Bhattacharya (from Sept 2012)

Consultant Community Paediatrician NHCT 4

Mark Burdon Community Pharmacist /prison service representative

0

David Campbell Chief Pharmacist/Clinical Director for Medicines Management (Chair)

NHCT 6

Ian Campbell Assistant Director of Pharmacy NUTH 5

Lindsay Caulfield Deputising for Zahra Irannejad NHS NoT 2

Sarah Chandler Formulary Pharmacist NHCT 6

Helen Coundon GP representative NHS NT CCG 4

Sue Dickinson Director of Pharmacy RDTC 5

Tim Donaldson Trust Chief Pharmacist/Associate Director of Medicines Management

NTWT 5

Alexander Dyker Consultant Physician NUTH 4

Rosie England Associate Director of Medicines Management

NHS NoT 5

Paul Fieldhouse Deputising for Sue Dickinson RDTC 1

Sue Gordon Executive Director of Public Health NHS NoT 4

Matt Grove Consultant Rheumatologist, NTGH NHCT 4

Zahra Irannejad Head of Prescribing (provider) NHS NoT 3

Janet Kelly Nurse Clinical Manager NHCT 4

Matthew Lowery Formulary and Audit Pharmacist NUTH 5

Peter McEvedy GP representative NHS NCCG 5

Tamsin Oswald (from July 2012)

Consultant Microbiologist NHCT 4

John Ross (from November 2012)

Patient Representative 2

Wendy Ross (from January 2013)

GP representative NHS NNECCG 1

Helen Seymour Deputising for Rosie England NHS NoT 1

Simon Thomas Consultant Clinical Pharmacologist NUTH/RDTC 4

Susan Turner

Medicines management advisor (professional secretary)

NHS NoT 6

Neil Watson Clinical Director of Pharmacy and Medicines Management

NUTH 6

Steve Williamson Consultant Pharmacist in Cancer services NECN 5

Hilary Wynne Consultant Physician NUTH NUTH 4

Glossary for organisations not listed on page 3

NECN North of England Cancer Network NETAG North of England Treatment Advisory Group NHS NoT NHS North of Tyne RDTC Regional Drugs and Therapeutics Centre


Sub groups and committees Various sub groups/committees exist to carry out specific programmes of work for the main committee. These include:

- Formulary Sub-Committee – This considers new product applications and leads the development of the shared formulary. Recommendations to approve defer or reject applications, with summaries of evidence, are presented to the APC.

- Shared Care Group – This looks at the development of Shared Care Guidelines and

associated issues. - Antimicrobial Chemotherapy Sub-group – This looks at sharing good practice with

regard to antimicrobial chemotherapy as well as developing, reviewing and maintaining Primary Care Antibiotic guidelines.

Medicines Management QIPP Sub-group – This sub-group is responsible for the relevant Quality, Improvement, Productivity and Prevention (QIPP) work-stream across the North of Tyne area. It is evolving to also consider the wider medicines optimisation agenda.

Committee’s activities/achievements During the period from April 2012 to March 2013 the committee carried out the following key activities:

Formulary - Work continued on the ongoing development and maintenance of the North of Tyne

Formulary. All NICE TAGs are now automatically incorporated into the formulary within 90 days of publication.

New drug applications - Applications to have new drugs or formulations added to the formulary continued to

be a large part of the committee’s work. New products were considered by the committee and products were considered for an extension of approved uses or formulations.

- All formulary decisions are made on the basis of a detailed review of the available evidence of efficacy, safety and cost effectiveness.

- Details of these applications and the committee’s decisions are noted in appendix 1.

Communication - The committee continued to publish details of its meetings and decisions, the North

of Tyne Formulary, finalised Shared Care Guidelines and information leaflets for primary care and other statements and guidelines for both healthcare professionals and members of the public on its website: www.northoftyneapc.nhs.uk.

Shared Care - Progress on developing shared care guidelines has occasionally been delayed by

issues relating to the funding of medications and/or associated changes in locations of care. The movement of funds from original providers to new providers of care has

http://www.northoftyneapc.nhs.uk/

proved challenging and has sometimes delayed implementation. Representation on the group has changed during the year as emerging organisations become involved.

- Despite the above challenges the following Shared Care Guidelines were developed or updated:

Cinacalcet in Primary Hyperparathyroidism – January 2013

Melatonin in children and young people – March 2013

Dronedarone - August 2012

Erythropoietin – October 2012 - 8 information leaflets were developed or updated to provide information to primary

care professionals on drugs classified as BLUE under the ‘traffic light’ system. These were:

Guidelines and statements - Guidelines to aid prescribing decisions were produced in the following areas:

Newly licensed drugs and formulations - At each meeting the committee continued to review a list of drugs and formulations

which had been newly licensed since the previous meeting. This included any formulary drug which had received a license for a new indication.

NICE and SMC - The committee regularly looked at both NICE appraisals/guidance and SMC

decisions to ensure that its own decisions and work plans are robust. NICE TAG recommendations are endorsed by the committee within 90 days of publication.

Formulary compliance - Work continued on assessing compliance with the North of Tyne Formulary across

primary and secondary care.

NECDAG - The Cancer Network approved a number of drugs for prescribing, including some

from the interim Cancer Drugs Fund (CDF), and these decisions were endorsed by the APC.

NETAG - The North of England Treatment Advisory Group approved a number of drugs for

prescribing and these decisions were endorsed by the APC.

http://www.northoftyneapc.nhs.uk/files/2013/03/Cinacalcet-in-Primary-Hyperparathyroidism-January-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2013/03/Melatonin-in-children-and-young-people-March-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2012/08/Dronedarone-August-2012.doc

http://www.northoftyneapc.nhs.uk/files/2013/03/Erythropoietin-October-2012.pdf

http://www.northoftyneapc.nhs.uk/files/2013/03/Acetylcholinesterase-Inhibitors-March-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2013/03/Agomelatine-January-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2013/03/Denosumab-January-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2012/10/Exenatide-information-for-primary-care-Sept-2012.doc

http://www.northoftyneapc.nhs.uk/files/2012/11/Melatonin-Information-for-Primary-Care-Final-Nov-2012.doc

http://www.northoftyneapc.nhs.uk/files/2013/03/Memantine-March-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2012/09/Nebulised-Gentamicin-Information-for-Primary-Care-Updated-sept-2012.pdf

http://www.northoftyneapc.nhs.uk/files/2012/10/Tacrolimus-Ointment-Information-for-Primary-Care-Sept-2012.doc

http://www.northoftyneapc.nhs.uk/files/2012/12/Comparison-of-New-Oral-Anticoagulants-with-Warfarin-Approved-Dec-2012.doc

http://www.northoftyneapc.nhs.uk/files/2012/12/Oral-anticoagulants.pdf

http://www.northoftyneapc.nhs.uk/files/2013/01/Guidelines-for-the-treatment-of-scalp-psoriasisFinal0113.pdf

http://www.northoftyneapc.nhs.uk/files/2013/04/Blood-Glucose-monitoringGuideline-March-2013.pdf

http://www.northoftyneapc.nhs.uk/files/2012/08/Primary-Care-Guidelines-for-the-management-of-InfectionAugust12FINAL.doc


Summary The APC continues to provide an excellent forum to bring together medicines related clinical and commissioning decision making across the North of Tyne health economy. It has had excellent primary and secondary care representation, has been well attended and delivers a significant work programme and system of governance associated with medicines use for all of the organisations involved. Recommendation The Boards of member organisations are requested to note the details of this report.

APPENDIX 1 Summary of APC Decisions April 12 to March 13 Classification of products:

R = ‘RED’ drugs for hospital use only

A = ‘AMBER’ drugs suitable for use under Shared Care arrangements

B = ‘BLUE’ drugs initiated in secondary care where an information sheet for GPs is

recommended

T = drugs used in Tertiary Care only.

Product Decision + date of decision Comments / notes Approved Refused Deferred

1) Requests Reconsidered or Deferred from 2010 - 2011

Ozurdex® dexamethasone ocular implant for uveitis

R

8/05/12

Decision: Approved for uveitis only in accordance with the defined treatment protocol from the North East Retinal Group.

2) New Requests

Aclidinium bromide

08/01/13

Decision: Refused The evidence for improved efficacy compared with tiotropium was lacking.

Adapalene 0.1%, benzoyl peroxide 2.5% gel (Epiduo®)

11/09/12

Decision: Refused as the first line topical therapy (primarily in place of the topical antibiotic therapies) for acne vulgaris.

Anidulafungin for the treatment of invasive candidiasis in adult non neutropenic patients.

R

10/07/12

Decision: Approved. The committee requested clarification to be sought on whether it was necessary to retain Micafungin on the Formulary to treat resistant cases.

Argatroban

R

11/09/12

Decision: Approved for the treatment of heparin-induced thrombocytopenia type II who require parenteral anticoagulation.

Biotin sur

R

11/09/12

Decision: Approved for the treatment of multiple carboxylase deficiency. It should be initiated only by a specialist.

Viscous budesonide u for the treatment of eosinophilic oesophagitis.

R

10/07/12

Decision: Approved.



Ceftaroline

R

12/03/13

Decision: Approved as an alternative to Daptomycin or linezolid in patients with bacteraemia/cSSSI only on the advice of a microbiologist.

Citrasate

R

10/07/12

Decision: Approved for use in place of standard dialysate formulations for patients where anticoagulation is problematic or contraindicated.

Sodium Hyaluronate 0.4% eye drops (Clinitas®)

11/09/12

Decision: Approved for the treatment of Keraconjunctiva sicca, post refractive surgery and corneal healing disorders.

Artificial Tears SDU will be removed from the Formulary.

Eculizumab – paediatric heart transplantation

12/03/13

See notes

Decision: The request for eculizumab in the prevention of AMR in paediatric heart transplantation should be referred to the Local Area Team of The NHS Commissioning Board.

Enalapril- Postnatal hypertension

8/05/12

Decision: Enalapril was added to the NoT formulary for use in breastfeeding mothers only. Mothers will be converted to ramipril when no longer breastfeeding.

R

8/05/12

Decision: Eviplera was approved for use in patients who cannot tolerate Atripla (emtricitabine + efavirenz + tenofovir disoproxil).

Rilpivirine was approved for patients who, due to renal impairment, require reduced doses that are not able to be accommodated by the fixed combination product.


Fidaxomicin (Dificlir®)

R

11/09/12

Decision: Approved for third line use in the treatment of C. difficile.

Fluenz®

13/11/12

Decision: Approvedfor use in line with DoH guidance.

Fluticasone & Formoterol (Flutiform®)

12/03/13

Decision: Approved for maintenance treatment of asthma in line with licensed indications.

Glycopyrronium bromide

08/01/13

Decision: Approved as a second line option for the maintenance treatment of COPD.

Hyalofemme®

13/11/12

Decision: Approved for the relief of symptoms of atrophic vaginitis in women who have had treatment for gynaecological malignancy (radiotherapy) and where topical estriol is not a treatment option.

8/05/12

Decision – Refused

Infratini Peptisorb®

08/01/13

Decision: Approved for patients that require a higher calorie feed, subject to use in line with the treatment algorithm and an audit of use being undertaken at 6 months.

Lidocaine 4%, adrenaline 0.1% & tetracaine 0.5% (LAT® gel) u

R

10/07/12

Decision: Approved subject to the development of an algorithm which will ensure that LAT will not be used in children under 15kg without appropriate dose adjustment.

Mannitol (Osmohale®)

R

08/01/13

Decision: Approved The request for mannitol was approved for diagnostic use when conducting spirometry and bronchial provocation testing as an alternative to methacholine.

8/05/12

Decision: Refused.



Primasol 4mmol/l potassium®

11/09/12

Decision: Deferred. The request was deferred pending the receipt of information from the applicant regarding the possibility of using Phoxilium . The application is to be discussed by the Dialysis Fluids Group before coming back to the APC for final approval.

Primsocitrate 18/0 & PrimsOcal B22

R

10/07/12

Decision: Approved for regional anticoagulation using citrate in continuous renal replacement therapies (CRRT).

ProZero® protein free milk replacement

11/09/12

Decision: Approved for children with metabolic diseases.

Regadenoson

R

10/07/12

Decision: Approved for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress;

for patients with COPD and asthma where dobutamine is indicated;

for obese patients who require several vials of adenosine.

Sodium Hyaluronate (1.6%) / Sodium Chondroitin Sulphate (2%) (Ialuril®)

R

11/09/12

Decision: Approved as a second line treatment of Interstitial cystitis in patients who have failed on Cystistat

Steriflex 165 Potassium chloride 0.3% (20mmol); sodium chloride 0.9%; and glucose 5% 500ml

R

08/01/13

Decision: Approved: for the management of diabetic ketoacidosis in line with current guidelines from the British Society of Paediatric Endocrinology and Diabetes.


Tafluprost

13/11/12

Decision: Approved subject to initiation by specialists only and should be used third line after preservative containing latanoprost and preservative free timolol. The ophthalmologists must clearly document that signs and symptoms of preservative intolerance/allergy have been demonstrated in their patient prior to initiation & use should be audited in 12 months.

3) New Formulations & Extensions to Use

Acetic acid 5% - endoscopy

R

11/09/12

Decision: Approved for endoscopy.

AdCal D caplets

8/05/12

Decision: The formulary subcommittee have asked for additional information relating to dosing and compliance before a decision can be made.

Alendronic acid solution

12/03/13

Decision: Refused.

Anakinra – severe acute gout

R

8/05/12

Decision: Approved for the treatment of severe gout in patients who have not responded to other treatment and for patients with pseudogout who have failed to respond to conventional treatment or unable to tolerate conventional treatment.

Botulinum Toxin A – Paediatrics u

R

13/11/12 See Notes

Decision: Anal fissures – Approved. There must be documented informed consent from patients/carers. Bladder dysfunction – Deferred until data can be provided on treatment outcomes for patients in whom this treatment has already been tried and the provision of a clear treatment pathway.



Cefixime

R

12/03/13

Decision: Approved for the prevention of irinotecan related diarrhoea.

Cinacalcet – Primary hyperparathyroidism

A

13/11/12

Decision: Approved for use in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated based on serum calcium levels, symptoms and end- organ damage, but in whom parathyroidectomy is either not clinically appropriate or is contraindicated. Approval is subject to the production of an agreed Shared Care Protocol documenting the strict parameters for use and clearly documenting the reason as to why surgery is not an appropriate treatment option for the particular patient.

Cinacalcet – Secondary hyperparathyroidism in ESRD change of status from red to amber.

13/11/12

Decision : Deferred pending further information

Clopidogrel suspension 75mg/ml

R

12/03/13

Decision: Approved for hospital use in children on Berlin Heart Devices.

Colesevelam (Cholestagel®)

11/09/12

Decision: Approved for second line use after colestyramine for the treatment of bile acid malabsorption that results in diarrhoea. This is often seen in patients with small bowel, Crohn’s disease and post-cholecystectomy.

Usage should be reviewed after 6 months.

Denosumab u

B

08/01/13

Decision: Approved for use in men with osteoporosis who are not able to tolerate bisphosphonates or strontium ranelate.


Dovobet gel

10/07/12

Decision: Approved

A supporting leaflet that will aid prescribers with the intended position in therapy compared with other available products, how use can be kept to within the licensed duration(s) and how often treatment would be expected to be repeated will be made available.

Sublingual/buccal fentanyl

R

08/01/13

Decision: Approved Abstral was approved for restricted use in patients who experience incident pain during radiotherapy:

on positioning for treatment

or who experience pain flare during the course of radiotherapy treatment.

The Palliative Care Team must ensure that the monitoring as outlined in the request is adhered to.

Forceval soluble

12/03/13

Decision: Approved for short term use in patients who are unable to swallow Forceval capsules.

Gastrografin

8/05/12

Decision: Approved

Meningitis ACWY conjugate vaccine

8/05/12

Decision: Approved as per DoH Green Book advice.

8/05/12

Decision: Octasa should not be approved as it is considerably more expensive than Mesren and the rebate scheme to equalise the price with Mesren in primary care would be difficult to administer.

Decision subsequently reversed on discontinuation of Mesren.

Mexiletine – Myotonic dystrophy u

13/11/12

Decision: Refused



Intranasal midazolamfor use prior to cannulation for adult patients with special needs receiving dental treatment under IV sedation

R

10/07/12

Decision: The request was approved. Intranasal midazolam will be classified as a red drug. In addition it was stated that this use should be added to the Dental Hospital’s risk register.

Nystatin pessariessu

R

11/09/12

Decision: Approved as a second line treatment. Prescribing will be restricted to the GUM clinics. .

Pancreatin (Creon Micro®)

11/09/12

Decision: Approved for the treatment of pancreatic exocrine insufficiency in CF babies.

Plenadren (MR Hydrocortisone)

12/03/13

Decision: Refused.

Pregabalin – General anxiety disorder

10/07/12

Decision: Approved in line with NICE Guidance for General Anxiety Disorder.

Tadalafil 2.5mg -5mg daily – post radical prostatectomy

Decision: Deferred Application subsequently withdrawn.

Thalidomide - angiodysplasia u

R

12/03/13

Decision: Approved.

TOBI Podhaler

R

8/05/12 &10/7/13

Decision: Approved. for second line use after Colomycin subject to cost neutrality with the competing product. This decision will be reviewed if the market changes significantly.

Trichloroacetic acid 50%

13/11/12

Decision: Refused.

Ulipristal 5mg tablets

R

8/01/13

Decision: Approved for the shrinking of uterine fibroids and cessation of bleeding before surgery. Use is restricted to 3 months prior to surgery.


Warfarin suspension 1mg/ml

12/03/13

Decision: Deferred The committee has asked for data to be provided that the current practice of crushing warfarin tablets leads to paediatric patients being out range for longer than is acceptable.

4) Products Considered by NECDAG

Abiraterone acetate (Zytiga®)

R

08/01/13 & 12/03/13 See notes

Decision: Approved in line with NECDAG recommendations.

Rejected from Standard NHS Funding

Approved from Cancer Drug Fund

Note this approval is subject to ongoing review of priorities and along with all CDF approvals will be reviewed for 2013/14.:

Arsenic Trioxide for relapsed or refractory acute promyelocytic leukaemia (APL).

R

08/01/13

Decision - Approved in line with NECDAG decision of 28.11.12 For implementation at specialist Haematology Units Only

Bevacizumab (Avastin®) in combination with irinotecan for the treatment of Low Grade Gliomas in paediatric patients

R

08/01/13 See notes

Decision:


Approved from Cancer Drug Fund for the treatment of Low Grade Gliomas in paediatric patients that are resistant to standard therapies. To be used pre radiotherapy (Unlicensed indication)

(Note existing patients who have already received radiotherapy may receive treatment, for new patients treatment must be used prior to radiotherapy.)

Cetuximab (Erbitux) for Metastatic Colorectal Cancer (CRC)

R

10/07/12

Decision - Approved in line with NECDAG recommendations from the Interim Cancer Drug Fund (ICDF)

Clofarabine (Evoltra®)

R

13/11/12

Decision: Rejected from Standard NHS Funding Decision - Approved in line with NECDAG recommendations from the Interim Cancer Drug Fund (ICDF)



Denosumab in selected patients with advanced breast or prostate cancer with bone metastases

R

8/05/12


Denosumab for the prevention of skeletal-related events in adults with bone metastases from prostate cancer

R

8/01/13

Decision: Approved for CDF funding in line with NECDAG recommendations.

Everolimus (Afinitor®)

R

13/11/12

See notes

Decision - Approved in line with NECDAG recommendations:


Approved from Cancer Drug Fund (subject to ongoing review) for

the treatment of hormone receptor-positive HER2 -ve advanced breast cancer, in combination with exemestane, in postmenopausal women with symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Everolimus (Afinitor®)

R

13/11/12

See notes

Decision - Approved in line with NECDAG recommendations:


Approved from Cancer Drug Fund for the treatment of patients with unresectable or metastatic advanced pancreatic neuroendocrine tumours (PNETs), whose disease has progressed on or after treatment with VEGF targeted therapy, as a 2nd line treatment option after somastostatin analogue therapy with the condition unable to give Sunitinib in succession. A national audit must be undertaken within 12 months.


Fulvestrant (Faslodex) in 3rd or later line metastatic breast cancer

R

10/07/12

See notes

Cancer Drug Fund Decision

Approved from Cancer Drug Fund on 30th May 2012 for a limited period to allow audit data from existing patients to be collated and reported to NECDAG in September. The decision will be reviewed in light of the audit data.

Gemcitabine 1000mg/m²

R

13/11/12


Glucarpidase (Varoxase®) (Unlicensed) for the treatment of toxic plasma methotrexate concentrations

R

08/01/13

See notes

Decision: Approved for NHS funding subject to discussion with local commissioners and in line with NECDAG recommendations.

Rejected for CDF funding

PEG Asparginase 1000IU/m2 for 6 doses

R

13/11/12

Decision: Approved in line with NECDAG recommendations for ALL.

Rituximab in combination with bendamustine

R

13/11/12

Approved in line with NECDAG recommendations for the use in combination with Bendamustine for patients with either first line or relapsed Low Grade Non Hodgkins Lymphoma.

Approved from NHS funding

Rituximab in combination with bendamustine

13/11/12

Refused in line with NECDAG recommendations for the use in combination with Bendamustine for patients with either first line or relapsed High Grade Non Hodgkins Lymphoma.

Rituximab (Mabthera®) with Bendamustine (BR regimem)

R

13/11/12

Approved in line with NECDAG recommendations for use in combination with Bendamustine for patients with CLL not fit for FCR chemotherapy or for patients who relapse within 2 years of FCR chemotherapy and not fit for alemtuzumab (Campath®)



Rituximab + salvage chemotherapy

R

13/11/12

Approved in line with NECDAG recommendations for patients relapsing > 12 months post 1st line therapy with R-CHOP

Rituximab – 375mg/m2 weekly for up to four doses

R

13/11/12

Approved in line with NECDAG recommendations for rising EBV viral copy numbers in patients after allogenic bone marrow transplant to pre-empt development of Post Transplant Lymphoproliferative disorders (PTLD)(An unlicensed indication )

Rituximab 375mg/ m2 for 6 cycles in combination with a standard NHL induction regimen. (Frequency variable depending on regimen e.g. CVP / DECC/MACOP-B)

R

08/01/13

Decision - Approved in line with NECDAG recommendations

Rituximab – 375mg/m2 every 2 weeks, for 6 doses (unlicensed indication ) for the treatment of patients with hairy Cell Leukaemia (HCL) or Hairy cell Leukaemia varian (HCL-v) who:

Relapse early after purine analogue therapy (< 2 years post treatment)

Are refractory to purine analogues.

R

08/01/13

Decision - Approved in line with NECDAG recommendations.

To be implemented following agreement from the Haematology NSSG

SIRT (Selective internal radiation therapy) in colorectal liver metastasis

R

10/07/12

Decision - NECDAG agreed to fund a maximum of 20 patients per year from the Cancer Drug Fund for SIRT who meet specific criteria.

Sorafenib in thyroid cancer

R

10/07/12

Decision - Approved in line with NECDAG recommendations from the Interim Cancer Drug Fund (ICDF) (subject to ongoing review)


Vemurafenib for 1st line treatment of inoperable or metastatic BRAF V600 mutation +ve melanoma

R

8/05/12

Decision - Approved in line with NECDAG recommendations.

5) Products considered by NETAG

Aflibercept (Eylea®) for neovascular age-related macular degeneration

R

12/03/13

See notes

Decision - Approved in line with the NETAG recommendation.

Anti-thymocyte globulin for first-line treatment of adult aplastic anaemia

12/03/13

Decision - Approved in line with the NETAG recommendation.

Bevacizumab (Avastin®) for diabetic macular oedema

12/09/12

Decision - Refused in line with the NETAG recommendation

Bevacizumab (Avastin®) for hereditary haemorrhagic telangiectasia

08/01/13

Decision - Refused in line with the NETAG recommendation

Collagenase(Xiapex®) for Dupuytren’s contracture – appeal

R

8/05/12

Decision - Approved in line with NETAG recommendations

Fampridine (Fampyra®) in multiple sclerosis

R

8/05/12

Decision - Refused in line with the NETAG recommendation that the use of Fampridine (Fampyra®) in multiple sclerosis should not be approved.

Paliperidone depot injection (Xeplion®) for schizophrenia – appeal

8/05/12

Decision - Refused in line with the NETAG recommendation. The group noted uncertainty regarding clinical efficacy and was not satisfied that cost-effectiveness had been adequately demonstrated.



Pasireotide (Signifor®) for Cushing’s disease

12/09/12

Decision - Refused in line with the NETAG recommendation. The NHS North East Treatment Advisory Group

Perampanel (Fycompa®) for focal epilepsy

08/01/13

Decision: Approved in line with the NETAG recommendation.

Ulipristal (ellaOne®) for post-coital contraception: Updated appraisal

12/03/13

See notes

Decision: Endorsement of The NHS North East Treatment Advisory Group decision not to change its previous recommendation following an updated appraisal of ulipristal ellaOne®) for post-coital contraception.

6) Products considered by NESCG and decisions endorsed by APC

Ivacaftor (Kalydeco) for cystic fibrosis

08/01/13

Decision: Approved in line

with the Specialised Commissioning Groups (SCGs) in England decision.

7) Appeals against earlier decisions by the APC

Nevirapine MR (Viramune®) prolonged - release)

8/05/12

At the meeting of 13/3/12 the application to have Nevirapine MR (Viramune®) prolonged - release) included in the formulary was rejected.

An appeal was heard in May 2012.

Decision: The original decision was upheld.

8) Products considered by NICE

TA247 – Tocilizumab (rapid review TA198)

8/05/12

The formulary will reflect the recommendations in the NICE TA

TA248 – Diabetes (type 2) exenatide (prolonged release)

8/05/12


TA252 – Hepatitis C (Genotype 1) - Telaprevir

10/07/12


TA253 – Hepatitis C (Genotype 1) - Boceprevir

10/07/12


TA254 – Multiple Sclerosis (relapsing – remitting) - Fingolimod

10/07/12


TA255 – Prostate Cancer - Cabazitaxel

10/07/12


TA256 – Atrial Fibrillation (Stroke Prevention) - Rivaroxaban

10/07/12


TA257 – Breast cancer (metastatic hormone-receptor) - Lapatinib and Trastuzumab (with aromatase inhibitor)

10/07/12


TA258 – Lung cancer (non small cell, EGFR-TK mutation positive) - Erlotinib (1st line)

10/07/12


TA260 - Migraine (chronic) - Botulinum toxin type A

10/07/12


TA259 – Prostate cancer (metastatic, castration resistant) – Abiraterone (following cytoxic therapy)

10/07/12



TA261 Venous thromboembolism (treatment and long term secondary prevention) - rivaroxaban

12/09/12


TA263 Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer

12/09/12

Refused from mainstream funding in line with NICE but approved for use under the Interim Cancer drugs fund.

TA264 – Stroke (acute, ischaemic) - Alteplase

13/11/12

Approved in line with NICE TAG

TA265- Bone metastases from solid tumours - Denosumab

13/11/12


TA266: Cystic fibrosis – Mannitol dry powder for inhalation – Bronchitol

08/01/13


TA 267: Chronic Heart Failure - Ivabradine

08/01/13

Approved in line with NICE TAG. The previous restriction on the North of Tyne approval will be relaxed to match the NICE TAG.

TA268: Melanoma (stage III or IV) - ipilimumab

08/01/13

Approved in line with NICE TAG.

TA269: Melanoma (BRAF V600 mutation positive, unresectable metastatic) - vemurafenib

08/01/13


TA271: Diabetic macular oedema - fluocinolone acetonide intravitreal implant

12/03/13


TA272 : Urothelial tract carcinoma (transitional cell, advanced, metastatic) – vinflunine

12/03/13


TA 274: Macular oedema ( diabetic) – ranibizumab

12/03/13


TA275: Stroke and systemic embolism (prevention, non-valvular atrial fibrillation) - apixaban

12/03/13


9) Miscellaneous decisions by the APC

Atorvastatin chewable

8/05/12

Decision: Approved first line ahead of simvastatin suspension where solid dosage forms cannot be used.

Clonidine IV – use in critical care

8/05/12

Decision: Approval extended to include adult ITU patients for delirium and agitation, often around extubation.

Clopidogrel 300mg tablets

8/05/12 See Notes

Decision: Clopidogrel 300mg tablets should be removed from the Formulary.

Colecalciferol 20,000iu

10/7/12

Decision: Bio Vitamin D3 20,000iu (unlicensed) will be added to the Formulary alongside Dekristol. This will be reviewed on confirmation of the availability of a licensed 10,000 unit product.

Dabigatran – use in cardioversion

8/05/12

Decision: The APC accept that the use of dabigatran prior to cardioversion is in line with NICE approval and endorses its use in these circumstances if the patient’s cardiologist recommends this.

Darunavir 800mg tablets

12/03/13

Decision: Approved


Dornase alfa - traffic light status from red to blue

12/03/13

Decision: Approved

Etravirine 200mg tablets

13/11/12

Etravine 100mg tablets are currently included in the formulary. Etravine 200mg tablets are cost equivalent and are therefore to be added to the formulary.

Glyceryl Trinitrate 0.2% ointment

08/01/13

To be removed from the formulary.

Interferon 20mcg (Rebidose®)

10/7/12

See notes

Decision: Approved for use only when the cartridges and prefilled syringes are unsuitable.

Levetiracetam

08/01/13

Decision: Approved The Formulary first and alternative choices for the different epilepsies will be updated in line with NICE CG137

Metformin – polycystic ovaries

12/09/12

Decision: Approved for the treatment of polycystic ovaries.

Melatonin oral liquid

12/09/12

Decision: Approved. The Formulary will be updated to recommend use of the solution in preference to suspension.

Mesalazine 400mg MR (Octasa 400mg MR)

08/01/13

Decision: Approved Octasa 400mg MR will be added to formulary in place of Mesren.

Methylene Blue

13/11/12

Decision: Aggutenent will be added to the formulary in addition to Proveblue.

Nicorette 15mg inhalator

8/05/12

Decision: The committee asked for a full review of the nicotine products that are currently included in the Formulary. This was subsequently undertaken and the agreed changes reflected in the formulary.

Octaplas® and Octaplas LG®

13/11/12

Decision: Octaplas and Octaplas LG should be added to the Formulary

Rimexolone 10/7/12 See notes

The traffic light status of Rimexolone has been reviewed and has been changed from Red, Hospital Use only. to specialist initiation.

Rufinamide suspension

10/7/12

Decision: Approved for use as a 2nd or 3rd line treatment in patients with Lennox-Gastaut syndrome and related encephalopathies in patients who are unable to tolerate the tablets (paediatrics).

Sitagliptin and Saxagliptin

Decision: Sitagliptin will be added to the formulary in place of saxagliptin.

Topiramate

10/7/12

Decision: Approved The Formulary will be updated to reflect the recommendation in NICE CG150 - a treatment option for migraine.

Tretinoin gel (Retin A)

12/03/13

Discontinued by the manufacturer. Adapalene is being used instead of isotretinoin. Decision: Approved

Vagifem 25 microgram vaginal tablets

13/11/12

Vagifem 25 microgram tablets have been discontinued as the manufacturer has confirmed that studies have shown that the lower strength is equally efficacious. Decision: Vagifem 10 microgram tablets will be added to the Formulary as a replacement.

Documents

APC Annual Report 2012-13 - North Of Tyne Area Prescribing