INDIVIDUAL FUNDING REQUEST

ANNUAL REPORT

2016/17

Document Reference Information

Status Final Draft to CCGs

Authors / Lead June Farquharson, Associate Director - IFR Service

Co Authors Dr Lily Wong, GP Medical Advisor

Chakshu Sharma, Senior IFR Business Development Manager

Beverley Braithwaite, IFR Operations Manager

Alison Kay – Prescribing Team

Owner June Farquharson, Associate Director - IFR Service

Directorate Quality & Safety

Target Audience All Clinical Commissioning Group Chairs, Managing

Directors and Chief Operating Officers

All CCG Stakeholders

Table of Contents

Item Name Page

Foreword & Executive Summary 1

IFR – Background and Scope 2

1. IFR Outcomes 16/17 1.1 Key Performance Indicator(KPI) Update

1.2 IFR Application Outcomes by CCG

1.3 IFR Outcomes – Clinical Triage

1.4 IFR Outcomes by Expenditure

1.5 IFR Outcomes by Source of Referral

1.6 Top 10 approved IFRs for Prescribing drugs in 16/17

1.7 IFR Urgent applications

3 to 14

2. IFR Appeals

15

3. IFR Signposting - Applications Out of Scope of IFR Policy o NCAs with outcome by CCGs

17

4. IFR Governance 4.1 Patient Engagement & communication

4.2 Freedom of Information Requests

4.3 IFR Stakeholder Feedback from IFR Applicants

19

5. Update from Policy development Group(PDG)

22

6. Conclusions and Recommendations

23

Page | 1

Foreword & Executive Summary

Clinical Commissioning Groups responsible for local commissioning decisions, have a duty under the NHS Constitution to provide the best value for taxpayers money and the most effective, fair and sustainable use of finite resources. One of the key values that underpin the NHS Constitution is that patients have the right to expect local decisions on funding of drugs and other treatments to be made by local Clinical Commissioning Groups (CCGs) rationally following proper consideration of the evidence. As part of this, CCG’s must have a system in place to enable exceptional case reviews. To support the drive for equality locally, the 8 NWL CCGs continue to have one Individual Funding Request service in place across North West London to facilitate decisions for funding requests for treatments outside policy. Although run centrally, local CCGs are pivotal in the IFR decision making, with IFR panels chaired by a CCG Chief Operating Officer/Managing Director on a rotational basis. Aligned to the Individual Funding Requests decision making, the 8 CCGs also have one Policy Development Group that ensures that decisions that should be made on a population basis are reviewed against the latest evidence base. This Annual Report covers all the IFR applications received in the 2016/17 financial year and

their outcomes. The outcomes include when IFRs that are received are diverted to more

appropriately commissioned pathways and also where there are patterns of IFR’s identified,

how they are flagged up for consideration as policy.

For 2016/17 the NWL IFR service continues with delegated authority from the 8 CCG’s

within NW London to process and make decisions (as part of their Standing Financial

Instructions) for IFR applications up to the value of £20k per case for Central London, West

London, Ealing, Hammersmith and Fulham, and Hounslow CCGs and £50k for Brent,

Harrow and Hillingdon CCGs

One of the key challenges for the panel in 2016/17 was ensuring equity of care for North

West London patients. The North West London CCG IFR Panel cannot NOT make a

decision to fund a patient where by so doing a precedent would be set that establishes new

policy (for example, in situations where the patient is not, in fact, exceptional, but

representative of a group of patients). The report key highlights include:

In 2016/17, a total of 460 IFRs were received of which 98 (21%) were approved, 327

(71%) declined by the IFR Panel or rejected by Clinical Triage, 6% (27 IFRs) discharged

by Clinical triage and 2% (8 IFRs) were withdrawn by the Applicant. This represented a

decrease by 28% in comparison to 2015/16

The role of IFR Clinical Triage and the NWL Policy Development Group has been crucial

in 2016/17 to ensure that only those cases where a sufficient basis is presented results

in a review and decision by an IFR panel and cohorts of IFR cases identified post-

decision are referred to the Policy Development Group for consideration.

The % of Appeal applications post IFR panel decision continues to remain low and for

2016/17 represented 6% of the overall cases declined at panel.

North West London CCGs spent a total of £1,658,284 on treatments that funding was

approved via the IFR route.

Page | 2

IFR Background and Scope

An Individual Funding Request (IFR) is a request made by a clinician for a treatment or intervention that is not routinely funded by the NHS. These cases are therefore considered on a case by case basis for funding on the basis of clinical exceptionality. North West London Clinical Commissioning Groups work collaboratively and have one IFR panel process across the 8 CCGs. The scope of the service includes the screening (clinical Triage), the preparation and the co-ordination of outcomes for all cases received. The screening of cases is a key part of the IFR process, as this determines whether a case has sufficient information for consideration by an IFR panel on the basis of exceptionality. The IFR Panel comprises of a Chair (CCG Chief Operating Office/Managing Director), Lay Person, Public Health Consultant and a GP advisor and is supported by members of the IFR team. The IFR Panel makes decision based on the NWL CCG Decision Making Framework. (Published online: http://www.hounslowccg.nhs.uk/news-and-publications/publications.aspx?n=2432) As per the NWL Clinical Commissioning Groups IFR Operational Policy, there can be no exhaustive definition of the conditions which are likely to come within the definition of a clinically exceptional individual case. The word “exception” means “a person, thing or case to which the general rule is not applicable” However, to meet the definition of ‘exceptional clinical circumstances’ there must be some unusual or unique clinical factor about the patient that suggests that they are:

Significantly different clinically to the group of patients with the condition in question and at the same stage of progression of the condition. (I.e. compared with the same age, sex, disease specific cohort of patients). An example would be an exceptionally indolent or other ’variant’ of the illness or host factors such as an unusual genetic make-up that will make them exceptionally responsive to treatment.

AND

Likely to gain significantly more clinical benefit from the intervention than might be

expected from the average patients with the same clinical condition. An example will

be where a treatment is likely to be more clinically effective as well as cost effective

on an individual patient.

However, the fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for an exemption.

If a patient's clinical condition matches the 'accepted indications' for a treatment that

is not funded, their circumstances are not, by definition, exceptional.

It should be noted that social value judgments are rarely relevant to the consideration

of exceptional status.

The NWL CCG’s IFR Panel will NOT make a decision to fund a patient where by so doing a

precedent would be set that establishes new policy (for example, in situations where the

patient is not, in fact, exceptional, but representative of a group of patients). In such cases,

if the IFR Panel feels strong evidence has been provided in support of a particular health

technology (treatment or intervention); it would make a recommendation to North West

London Collaboration of CCG’s Policy Development Group.

Page | 3

SECTION 1 - IFR Outcomes

Standard Application Process Timeline IFR received,

administrative triage and

acknowledgment sent

Case

Logged

IFR Clinical

Triage

Case worked

up for IFR

Panel

IFR

Panel

Minutes agreed and

decision letters sent

Day1-3 28 Working days from receipt of all

information 5 Working Days

1.1 Key Quality/Performance Indicators (KPI) (IFR Service)

This section reports on the IFR Service internal Key Performance Indicators. This is one of

the indicators that demonstrate how the service is running. The IFR service has a number of

internal quality targets regarding the processing and outcomes of applications received.

Table 1 below shows a breakdown of the KPI’s the target and achievement. It also makes a

comparison against the KPI delivery report in 2015/16. The table reports that for 2016/17 all

service KPI’s continue to be met.

Table1 – IFR Internal Key Performance Indicators 2016/17

Key Performance Indicator Target 15/16 16/17

IFR applications logged and acknowledged within three working days of receipt

90% 99% 99%

Incomplete applications returned to the requesting clinician within three working days

100% 100% 100%

Applications outside the scope of IFR Policy returned to the requesting clinician within three working days

90% 100% 99%

Non urgent IFR requests (from clinicians) that are completed within 28 days from the date all information received from applicant

90% 100% 99%

Urgent requests with decision within 3 working days of receipt

90% 100% 100%

1.2 IFR Application Outcomes by CCG

Tables 2 and 3 below provide a breakdown of the IFRs received by CCG within 2016/17

with their outcomes. Key highlights are:

In 2016/17, a total of 460 IFRs were received of which 21% were approved, 71%

declined by the IFR Panel or rejected by Clinical Triage, 6% discharged by Clinical triage

and 2% were withdrawn by the Applicant.

Page | 4

The highest level in terms of the IFRs received and per weighted population (100,000)

was for Ealing CCG but the lowest level of weighted applications for NHS Central

London CCG.

IFRs received within 2016/17 decreased by 28% in comparison to 2015/16. In 2015/16

the highest numbers of applications received were for Ealing, Brent and Hounslow and

this trend has continued into 2016/17. IFR applications have decreased due to continual

clinician engagement and education regarding clinical exceptionality which has aided the

understanding of the nature of IFR submissions.

The overall approval rate for IFRs dropped by 7% in 2016/17 in comparison to 2015/16.

Overall 21% IFRs were approved in 16/17 in comparison to 28% approved in 15/16 by

IFR Panel and Clinical Triage Panel.

Table 2 average per weighted capitation for received IFRs by CCG

CCG Name IFRs Received

CCG Population

IFRs per 100,000 population

Ealing CCG 116 281242 41

Brent CCG 68 397262 17

Hounslow CCG 59 282535 21

Hillingdon CCG 56 227089 25

West London CCG 51 193977 26

Harrow CCG 46 200012 23

Central London CCG 35 339904 10

Hammersmith & Fulham CCG 29 219030 13

Table 3 IFRs received per CCG with decision outcomes

CG Name Approved Declined Discharged Withdrawn

Grand Total

Ealing CCG 29 75 9 3 116

Brent CCG 13 50 4 1 68

Hounslow CCG 13 41 4 1 59

Hillingdon CCG 13 41 2 56

West London CCG 5 43 2 1 51

Harrow CCG 14 30 2 46

Central London CCG 7 24 3 1 35

Hammersmith & Fulham CCG 4 23 1 1 29

Grand Total 98 327 27 8 460

Key:

The case outcomes are defined as:

Approved – refers to the funding applications agreed by the IFR Panel or the Clinical Triage

Panel

Declined – refers to the funding applications that are not agreed by the IFR Panel and Triage

Panel. This could be because of various reasons such as :

a. Case for clinical exceptionality is not made

b. Case for rarity is not made

c. Insufficient evidence on clinical effectiveness and cost effectiveness of the requested

treatment etc.

Page | 5

Discharged – refers to the funding applications that are reviewed and closed by IFR Clinical

Triage Panel due to non-receipt of the information requested from the applicant. IFR team

sends three reminders to the applicant and provides 28 working days to submit this

information. If information is not received within the set timeframe, these cases are closed

and IFR team provides detailed information to the applicant stating why this case is closed

and that they are unable to process the request in absence of the requested information.

Applicant is notified that they can resubmit the case any time along with the additional

information requested by the Triage Panel.

Withdrawn – refers to the cases that are withdrawn/ requested to be closed by the applicant

1.3 IFR Outcomes- Clinical Triage

All Individual Funding Requests (IFR’s) are processed in line with the North West London

CCG’s IFR Operational Policy. As part of the process, all cases are reviewed by the IFR

Clinical Triage Panel which has representation from a GP Medical Advisor, Public Health

Consultant, IFR Knowledge Manager, Medicines Management Advisor and administrative

support.

For a case to be accepted as an IFR for consideration by the panel; there needs to be clear

grounds for consideration of clinical exceptionality. The IFR Clinical Triage Panel screens all

application to determine whether there has been sufficient information put forward for

consideration by the IFR Panel. The IFR Clinical Triage Panel will communicate with

referrers if additional information or clarification is required prior to the IFR being reviewed by

the IFR Panel.

The IFR Clinical Triage Panel also have delegated authority (from the IFR panel) to make

decisions for cases where an extension is required to an original approval made by an IFR

panel or if the application is within the scope of an existing policy and requires validation.

From an internal governance perspective, the IFR Clinical Triage Panel decisions are

periodically reviewed by internal audit to ensure that the outcomes of triage are within the

remit of the delegated authority.

For 2016/17 key highlights include:

With a new IT IFR system now in place, the triage team have been able to screen

and manage IFR applications with greater consistency, particularly in identifying

cohorts of applications.

Clinical triage reviewed 477 case in 2016/17 of which 90 IFR cases have were taken

to the IFR Panel, this was primarily due to applications lacking sufficient detail on

clinical exceptionality for the panel to consider the full aspects of the case or cohorts

were identified.

The Clinical Triage process however allows applicants the opportunity to relook at

the evidence submitted in the initial application, by further building a comprehensive

case if rejected on the grounds of insufficient exceptionality.

The clinical triage team also assists the Policy Development Group in identifying

possible service developments, through the number of consistent applications for

specific interventions policies can developed to inform commissioning decisions.

Page | 6

Clinical triage provides clarity for requests which sit outside the remit of IFR which

have an alternative funding pathway, e.g. non-contracted activity.

Further Highlights on outcomes of clinical triage include:

61 IFR cases with an associated value of £232,454 were approved,

274 applications with a value of £808,961 were rejected by the Clinical Triage panel

on the basis that there was insufficient information provided by the applicant for

consideration by the IFR Panel. NB: of these 274 applications, 17 IFRs were

resubmitted to the IFR Panel of which 5 were approved and 12 were declined by the

IFR Panel.

27 applications with a value of £74,561 were discharged due to non-receipt of the

information requested by the Triage Panel.

NB: it is important to note that the option to resubmit an IFR is always open. An IFR can be

resubmitted when new clinical evidence becomes available. For the IFRs rejected by the

Clinical Triage Panel, applicants are entitled to request a full Panel review in case they don’t

agree with the Triage Panel’s decision.

1.4 IFR Outcomes by Expenditure

Table 4 below provides a further breakdown of IFRs received per CCG with decision

outcomes, and associated indicative cost. Key highlights are:

460 IFRs were received in 2016/17 in comparison to 640 received in 2015/16.

Of 460 IFRs received in 2016/17, 90 IFRs (i.e. 20%) were considered by the IFR

Panel; of which 37 were approved with indicative cost of £262,569.

Through delegated authority from IFR Panel / CCGs, 79% (i.e. 362) cases were

considered and outcomes processed by the IFR Clinical Triage Panel as it has the

delegated authority form CCGs and IFR Panel to :

o Review and approve cases that require an extension of an existing approval.

The Clinical Triage Panel will validate that the outcome measures agreed by the

IFR Panel have been met.

o Make decision on cases that are outside the IFR remit and already have an

existing policy with clear r criteria that the applicant may be unaware of.

o Pre-screen all the all the applications to ensure there are sufficient grounds for

clinical exceptionality & sufficient evidence to warrant a review by the IFR Panel

o Request further clinical information form Applicant to ensure Panel has sufficient

information available to make decision on a case.

Page | 7

Table 4 – IFR Summary by Outcome & Expenditure in 2016/17

Decision Forum & CCG Name

Approved Declined Discharged Withdrawn Total IFRs Total Cost IFRs Cost IFRs Cost IFRs Cost IFRs Cost

Clinical Triage Panel 61 £232,454 274 £808,961 27 £74,561 362 £1,115,975

Ealing CCG 16 £69,721 65 £166,779 9 £26,579

90 £263,079

Brent CCG 8 £25,362 45 £161,149 4 £17,895

57 £204,406

Hillingdon CCG 7 £32,380 33 £110,250 2 £3,967

42 £146,597

Hounslow CCG 10 £43,313 32 £90,727 4 £7,900

46 £141,940

Harrow CCG 10 £31,315 26 £87,758 2 £6,500

38 £125,572

West London CCG 3 £9,500 35 £80,149 2 £4,500

40 £94,149

Central London CCG 5 £13,364 23 £72,343 3 £5,220

31 £90,927

Hammersmith & Fulham CCG 2 £7,500 15 £39,806 1 £2,000

18 £49,306

IFR Panel 37 £263,569 53 £223,209 90 £486,778

Ealing CCG 13 £96,939 10 £23,444

23 £120,383

Hounslow CCG 3 £35,605 9 £73,728

12 £109,333

Harrow CCG 4 £70,760 4 £18,115

8 £88,875

Brent CCG 5 £15,482 5 £34,164

10 £49,646

Hillingdon CCG 6 £31,756 8 £17,820

14 £49,576

West London CCG 2 £4,500 8 £28,206

10 £32,706

Hammersmith & Fulham CCG 2 £5,112 8 £26,232

10 £31,344

Central London CCG 2 £3,414 1 £1,500

3 £4,914

Applicant 8 £55,531 8 £55,531

Ealing CCG

3 £28,241 3 £28,241

Brent CCG

1 £22,176 1 £22,176

Hammersmith & Fulham CCG

1 £2,000 1 £2,000

Hounslow CCG

1 £1,900 1 £1,900

Central London CCG

1 £1,214 1 £1,214

West London CCG

1 £0 1 £0

Grand Total 98 £496,023 327 £1,032,170 27 £74,561 8 £55,531 460 £1,658,284

Page | 8

1.5 IFR Outcomes by Source of Referral

As the basis of funding decisions for IFRs are determined by clinical exceptionality,

North West London CCG’s will only accept IFRs that are referred by a clinician.

Table 5 below provides a breakdown of IFR’s received by referral route and their

outcomes. Key highlights are:

Overall of the 460 referrals received there were more referrals received from General

Practice (55%) than secondary care (44%). A similar trend was noticed in 15/16

where 304 (48%) IFRs were received from the General practitioners and 336(52%)

from secondary care hospital Trusts.

The highest number GP referrals received were from Ealing (67 applications),

West London CCG (37 applications) and Hounslow CCG (34)

The lowest number of applications received by GP were from Harrow CCG (17)

The overall proportion of IFR applicants received from GP’s approved was 33%

(Panel and Triage)

The overall proportion of IFR applicants received from GP’s and were declined were

59% (Panel and Triage)

In terms of IFR’s received from secondary care, there was a total of 203 applications

received, of which 67 were approved and 121 were declined.

Table 5: top 10 GP Referrals with decision outcomes by procedure

Treatment Name

Approved Declined Discharged by Clinical

Triage Panel

Withdrawn by

Applicant Grand Total

Clinical Triage Panel

IFR Panel

Clinical Triage Panel

IFR Panel

In Vitro Fertilisation 1 1 18 3 1 1 25

Gynaecomastia Reduction 1 19 1 3 24 Re-fashioning of scars and keloids 4 14 3 2 23

Pinnaplasty 12 2 2 16

Breast Augmentation 10 2 1 13

Breast Reduction 2 8 1 1 12

Abdominoplasty 1 9

10

Female Labial Reduction 1 1 7 1 10

Liposuction 7 2 9 Hair depletion in Hirsutism (use of laser) 8 8

Page | 9

Tables 6&7 below shows the top ten IFR’s receive and approved by procedure. This

highlights that:

The majority of top 10 non-drug cases were for procedures that are deemed as

cosmetic in nature under the Current North West London Planned Procedures with a

Threshold (PPwT) policy. North West London CCG’s have a policy not to fund

procedures that are deemed as cosmetic in nature. Of the total 200 applications in

the top 10 received 145 fell into the cosmetic procedure category.

The highest number of IFR requests received for procedure type cases deemed as

cosmetic were for refashioning of scar tissue. Broadly exceptionality sited for this

cases include functional issues and psychological impact.

The second highest IFR requests received for cosmetic type interventions were for

Gynaecomastia (enlargement of male breast tissue).

However, the highest non-cosmetic procedure request received in the top 10 was for

IVF. North West London CCG’s continue to have a policy in place to offer 1 (NHS

funded) cycle of IVF to women under the age of 40. Further analysis of the IVF

requests showed that they were predominantly request for second cycles and for a

first cycle where the woman is over the age of 40.

The second highest non-cosmetic procedure cases received were for an abdominal

wall mesh currently outside mesh’s within the commissioned pathway. This

abdominal wall mesh has subsequently been highlighted and policy development

area and reviewed by the North West London Policy Development Group. A further

update of this is provided in the policy development section of this report.

Page | 10

Table 6– IFR Summary by Procedure (Top 10 IFRs received in 2016/17)

Treatment Name

Approved Declined Discharged Withdrawn Total IFRs Total Cost IFRs Cost IFRs Cost IFRs Cost IFRs Cost

Re-fashioning of scars and keloids 7 £9,956 29 £46,950 2 £4,500 38 £61,406

In Vitro Fertilisation 2 £8,105 25 £90,638 1 £3,000 1 £3,000 29 £104,743

Gynaecomastia Reduction 2 £6,000 23 £55,941 4 £7,800 29 £69,741

Pinnaplasty 2 £3,974 17 £31,256 4 £7,499 23 £42,729

Breast Augmentation 18 £49,297 1 £3,000 19 £52,297 Abdominal Wall repair using Biological Mesh 2 £16,428 14 £110,016 16 £126,444

Female Labial Reduction 2 £3,300 12 £20,600 14 £23,900

Breast Reduction 2 £3,000 9 £27,000 1 £1,900 12 £31,900

Penile Implants 10 £58,800

10 £58,800

Liposuction 10 £30,400 10 £30,400

Table 7 – Top 10 approved IFRs for Non- Drugs (2016/17)

Treatment Name

Approved Declined Discharged Total IFRs

Total Cost IFRs Cost IFRs Cost IFRs Cost

Penile Implants 10 £58,800

10 £58,800

Re-fashioning of scars and keloids 7 £9,956 29 £46,950 2 £4,500 38 £61,406

Embryo Cryopreservation 4 £9,396

1 £2,000 5 £11,396

Oocyte Cryopreservation 4 £8,789 3 £11,658 7 £20,447

Light therapy and Laser therapy for Aesthetic 4 £5,400 5 £12,800 9 £18,200

Facet Joint Injections 4 £5,000

4 £5,000

Continuous Glucose Monitoring Sensor (CGMS) 3 £5,402 2 £6,715 5 £12,117

Blepharoplasty 3 £6,041 1 £1,249 4 £7,290

Dermatology Procedure (removal of benign skin lesions) 2 £2,000 3 £2,300 5 £4,300

Female Labial Reduction 2 £3,300 12 £20,600 14 £23,900

Page | 11

1.6 Top 10 Approved IFRs for Prescribing Drugs in 16/17

This section provides a breakdown of IFR applications received in 2016/17 for the use of high

cost drugs outside their current licensing and/or commissioning arrangements. These IFR’s are

often for cases that are rare and therefore the evidence base is limited, which provides its own

challenges for panel in their decision making.

An illustration of this is for off-label use of high cost drugs in very rare and potentially life

threatening haematological disorders (whereby as the condition is so rare the evidence to

support treatment is limited to a few case reports or case series of low quality). Alternatively,

cases received can be for drugs which have a UK marketing authorisation for a particular

indication, however NICE have either not recommended the drug, or have specified a criteria

which the patient in question does not meet. Other reasons could be that NICE are in the

process of publishing guidance or have not published guidance as the cohort of patients is so

small for use of the drug in that indication (i.e. of low priority for NICE).

Table 8 below provides a summary of all high cost drug related IFR applications received in

2016/17, of which 28 (38%) out of 73 were approved.

Key highlights include:

One of the most common types of IFRs received in 2016/17 was for ophthalmic conditions.

11 out of 17 ophthalmic requests were for bevacizumab (also the second most requested

drug funding request) in various conditions. Bevacizumab is a vascular endothelial growth

factor inhibitor (anti-VEGF anti vascular endothelial growth factor)) licensed for use in

cancer. For use in various eye conditions, anti-VEGFs work by blocking the growth of

abnormal blood vessels in the back of the eye. These abnormal blood vessels can leak

affecting vision or cause vision loss. Although it is not licensed for the treatment of

ophthalmological conditions, it is often used off label as it is similar to ranibizumab, another

anti-VEGF agent which does have a license for some ophthalmological conditions but has a

higher cost than bevacizumab. There has been much debate in the medical press about

suitability of using an off-label medicine, when a licensed preparation is available, on cost-

effectiveness grounds. The requesting hospital and its host commissioner have been

informed that a business case is the most appropriate method of seeking funding for

unlicensed use of bevacizumab in this cohort of ophthalmologic patients rather than via the

individual funding request route.

43 out of 73 (59%) IFR applications received were for drugs which are classed as

“biologics” e.g. adalimumab, infliximab, secukinumab etc. These drugs target/inhibit various

immune processes in the body. Therefore, they are often used to treat an array of

autoimmune conditions (within licence and off-label) given their mode of action. IFRs for

biologics were predominantly applied for treating a variety of autoimmune related conditions

in gastroenterology (19/73 cases), rheumatology (16/73 cases) and dermatology (8/73

cases).

Of importance, a number of IFRs (13 out of 19 cases) were received for dose escalation of

biologics to treat gastroenterological conditions - Crohn’s disease and Ulcerative colitis.

Page | 12

This has been flagged up for review by the PDG in 2016/17, whereby funding requests for

these cohorts are either outside of NICE recommendations or are off-label.

The other group of 16 biologic funding requests for rheumatology consisted of 10 patients

with rheumatoid arthritis and 6 patients with psoriatic arthritis. The majority of requests in

rheumatoid arthritis were for patients who had received and had loss of/no response to

three previous biologics and therefore required a fourth. Sequential use after this number of

biologics has limited evidence base however. Policy development has been identified and

recommended for this cohort of patients. For use in psoriatic arthritis, funding requests

were made for various different reasons including continuation despite initiation outside of

NICE criteria (in patients started overseas) or for various licensed treatments with no NICE

guidance available at that time.

In dermatology, 7 of the 8 funding requests were for third or fourth line use of biologics in

psoriasis. Whereby sequential use after this number of biologics has limited evidence base.

Policy development had been identified and a business case to support use was submitted

by a tertiary care centre in NWL in Q4 2015/16. In March 2016, the NWL Collaboration

Board approved this business case for routine commissioning of biologics in this cohort in

the tertiary care setting. Therefore the majority of these funding requests received were

reviewed according to the locally agreed policy or required referral/advice to a tertiary care

centre.

Page | 13

Table 8 – IFRs received for drugs 2016/17

Drug Name

Approved by Declined by Discharged*

by Withdrawn by

Total IFRs

Total Cost

Clinical Triage Panel IFR Panel

Clinical Triage Panel IFR Panel

Clinical Triage Panel Applicant

IFRs Cost IFRs Cost IFRs Cost IFRs Cost IFRs Cost IFRs Cost

Adalimumab 3 £28,190 5 £89,054 3 £19,727 1 £8,580 12 £145,550 Bevacizumab 11 £27,461 11 £27,461 Infliximab 1 £11,000 3 £26,630 3 £15,840 2 £3,120 9 £56,590 Secukinumab 3 £23,899 1 £8,242 4 £32,141 Vedolizumab 2 £40,050 1 £18,450 1 £21,600 4 £80,100 Abatacept 1 £4,062 2 £6,636 3 £10,698 Certolizumab 2 £11,440 1 £8,580 3 £20,020 Ozurdex 3 £4,164 3 £4,164 Tocilizumab 1 £11,182 1 £9,318 2 £20,500 Deferasirox 1 £16,320 1 £16,320 2 £32,640 Rituximab 1 £6,708 1 £5,000 2 £11,708 Insulin pump therapy 1 £2,800 1 £3,000 2 £5,800 Sodium oxybate 2 £12,096 2 £12,096 Eltrombopag 1 £19,958 1 £22,176 2 £42,134 Ustekinumab 1 £12,885 1 £2,147 2 £15,032 Ranibizumab 1 £2,490 1 £3,641 2 £6,131 Etanercept 1 £8,580 1 £5,280 2 £13,860 Trichloroacetic acid 1 £1,500 1 £1,500 Aflibercept 1 £1,200 1 £1,200 Siltuximab 1 £15,944 1 £15,944 Stiripentol 1 £9,324 1 £9,324 Octreotide 1 £2,398 1 £2,398 Apremilast 1 £6,625 1 £6,625

Grand Total 11 £87,826 17 £217,804 31 £147,024 8 £60,156 2 £10,389 4 £50,417 73 £573,616 * Discharged – deadline breached for referrer’s response to query sent from the IFR team

Page | 14

1.7 IFR Urgent Applications

Urgent Application Process Timeline

An urgent request is one which requires urgent consideration and a decision because the patient faces a substantial risk of death or significant harm if a decision is not made before the next scheduled meeting of the IFR panel. Urgent IFR applications are processed and reviewed by virtual IFR Panel (against the same

decision making framework used by full IFR Panel) but within 3 working days following

acceptance and clinical validation of the urgency.

Only one urgent IFR was received within year 2016/17 that accounted for less than 1% of

the total applications received within this period. In terms of the KPI target, a decision was

made for this urgent application within 3 working days from the date of receipt. This was a

reduction in comparison with 2015/16 where 4 cases were received.

Urgent

request

received

Clinical

reasons

for

urgency

confirmed

Urgent

process

initiated

IFR Clinical

Triage Review

Virtual IFR

Panel

alerted

Case worked up

for IFR Panel

Virtual

IFR

Panel

Applicant

informed

of

decision

1-2 Working Days Day 1 of Urgent Process Days 2-

3 Day 3

Page | 15

Section 2 IFR Appeals

Appeal Application Process Timeline

IFR Appeal received,

administrative triage and

acknowledgment sent

Case Logged &

Applicant/Patient

engaged

IFR

Clinical

Triage

Review

Appeal

Panel Chair

Review &

Decision

Appeal

Panel

Minutes agreed and

decision letters sent

Day1-3 30 days 5 Working Days

The IFR Appeals process provides a process for applicants and patients to appeal against a

decision made by an IFR panel. The appeal process is independent of the IFR panel and

appeal panels are chaired by a Lay Member of a CCG Governing Body. The Appeal panel

focuses on whether the original panel followed due process as opposed to re-looking at the

case on the basis of clinical exceptionality. If it is deemed as part of the Appeal that the

panel did not take into account sufficiently the evidence then the appeal panel can make a

recommendation that the original case is reviewed by another IFR panel. For the Appeal

hearing, when warranted. There is a separate GP, public health and lay representation and

a CCG Director or a deputy. The decision of an IFR panel can be appealed on the grounds

of:

a) Illegality: The refusal of the request was not an option that could lawfully have been taken by the IFR panel

b) Procedural Impropriety: There were substantial and/or serious procedural errors in the way in which the IFR process was conducted

c) Irrationality: The decision to refuse funding for the requested treatment was a

decision which no reasonable IFR panel could have reached on the evidence before the panel.

As the appeals process includes the opportunity for patients to present part of the appeal

case, it is imperative that the process is clearly explained to the patient including the

members of the panel and their roles. Patients are encouraged to ensure they are

supported throughout the process which includes a dedicated IFR Service patient phone

line.

Once an Appeal is received, an Appeal Chair is assigned for the whole process, including

making a decision on whether there are sufficient grounds for an appeal based on the

grounds of the appeal and the reviewing of the supporting evidence presented at the original

IFR panel. The role of the Appeal Chair is different from an IFR Panel Chair in that they look

at whether process was followed rather than reviewing the individual circumstances.

Appeals that are based on new clinical evidence however go back to a separate IFR panel

as this is the designated forum to review clinical evidence.

Table 9 below shows a summary of the IFR Appeals received in year 2016/17 along with

their outcomes. The key highlights were:

Page | 16

In comparison to 2015/16, the IFR Service received 1% less appeals within 2016/17 as a

total of IFR cases declined by an IFR panel. In 15/16, a total of 7 Appeals representing 7%

of the 101 IFRs declined by the IFR Panel were received. However, in 2016/17 there were

3 appeals received representing 6% of the 53 IFR cases declined by the IFR Panel.

Of the three Appeals received in 2016/17;

One appeal based on “irrationality” was considered by the Appeal Panel. Upon reviewing

the decision making procedure and outcome, the Appeal Panel agreed that the decision

making procedure and the decision made by the IFR Panel were appropriate and

rationale based on the evidence that had been made available to it. Appeal Panel agreed

that the IFR panel had reviewed this case based on their remit to look at the cases on

the basis of clinical exceptionality and had objectively reviewed this evidence against

current NWL policy, and that it had made its decision in accordance with the IFR Panel

terms of reference. Based on the above review, whilst sympathetic, the Appeal Panel

agreed to not uphold this appeal and did not make a recommendation for the IFR Panel

to reconsider this case.

Two appeals were considered and rejected by the Appeal Chair on the basis that the

Appeal did not include sufficient basis to warrant an appeal hearing based on irrationality

or procedural impropriety, therefore the decisions of the original IFR Panels were upheld

as being a rational and reasonable decision.

Table 9 - Appeals received in 16/17 with CCG and outcome details

Appeal Detail

Central London CCG

Hillingdon CCG

Hounslow CCG

Grand Total

Appeal Considered & Declined by the Appeal Panel 1 1

Complementary and Alternative Therapies

Appeal Rejected by the Appeal Chair

2

IVF 1 Light therapy and Laser therapy for

Aesthetic

1

Grand Total 1 1 1 3

Page | 17

Section 3 - IFR Sign posting - Applications Out of

Scope of IFR Policy

As part of the IFR process, a number of referrals are received for requests that sit outside

the scope of the IFR service. These are predominantly for cases that are for standard

commissioned interventions but at providers where no contractual agreement are in place

and are therefore deemed as Non-Contracted Activity (NCA), or in some instances, for

mental health interventions which are also outside the scope of the current IFR service and

of which CCG’s make funding decisions locally.

The IFR team process these on behalf of the CCGs to ensure there is a central logging and

tracking system in place. Centralised logging also enables the CCGs to identify patterns of

referrals that can be used to negotiate with providers for inclusion in contracts and existing

pathways.

A key area of note was that across the CCG’s there were 11 applications received for

referrals to chronic fatigue services outside of the standard contract that is held for the 8

CCGs with one main provider. For most of these requests patient choice was the rationale.

Table 10 below provides a summary of the applications received that are outside the current

scope of the IFR.

Table 10 – Out of Scope Applications (NCA Requests) by CCG

CCG Name & NCA Request Approved Declined Discharged Grand Total

NHS HARROW CCG 12 1 1 14

Functional Electrical Stimulation 4

4

Chronic Fatigue Services 1

1 2

TheraBite Jaw Motion Rehabilitation System (Device) 1

1

Laser Treatment for Hidradenitis Suppurativa 1

1

Liposuction for Lymphoedema 1

1

Neurophysiotherapy 1

1

Standing Frame 1

1

Hysterectomy 1 1 CDT, Manual Lymphatic Drainage, Kinesio-tex taping for

multi-layer lymphoedema 1

1

Implantable Functional Electrical stimulation 1

1

NHS WEST LONDON CCG 6 1 7

Chronic Fatigue Services 4

1 5

Speech and Language Therapy 1

1

Functional Electrical Stimulation 1

1

NHS HOUNSLOW CCG 5 1 6

Orbital Prosthesis for Retinoblastoma 1

1

Prosthetic Right Lower Limb 1

1

Post-operative specialised rehabilitation 1

1 Laryngeal Botulinum Toxin Injection with

Electromyography (EMG) 1

1

Hydrotherapy 1 1

Liposuction for Lymphoedema 1

1

Page | 18

CCG Name & NCA Request Approved Declined Discharged Grand Total

NHS CENTRAL LONDON (WESTMINSTER) CCG 3 3 6

Chronic Fatigue Services 2 2

Pain Management 1

1

Total laparoscopic hysterectomy and bilateral salpingo-oophorectomy 1 1

Communication Aid 1

1

Hallux Valgus Correction 1

1

NHS EALING CCG 6 6

Chronic Fatigue Services 2

2

Post-op Physiotherapy 1

1

Functional Electrical Stimulation 1

1

Botox injections to reduce muscle spasticity 1

1

Custom made Hinged Ankle Dynamic AFO 1

1

NHS HILLINGDON CCG 1 1 2

Hearing Aid 1 1

Functional Electrical Stimulation 1

1

NHS BRENT CCG 2 2

Standing Frame 1

1

Communication Aid 1

1

NHS HAMMERSMITH AND FULHAM CCG 2 2

Functional Electrical Stimulation 1

1

Communication Aid 1

1

Grand Total 37 6 2 45

Page | 19

SECTION 4 – IFR GOVERNANCE

There are a number of support tools in place to ensure that the IFR service is accessible and

transparent in terms of its governance structure to all stakeholders.

Published Communication

IFR and PPwT policies along with the forms are published online on eight CCG websites for

GPs, clinicians and patients in order to provide information and guidance regarding IFR

process, Appeal Process, PPwT process and work of Policy Development group:

IFR Operations Policy provides details with regards to the IFR process and Appeal

process

IFR Forms (urgent and routine IFRs) for clinical applicants

IFR Decision making framework used by the IFR Panel

PPwT policies provide the access criteria and evidence base.

PPwT forms published in all versions used by GP surgeries in NWL e.g. EMIS Web,

VISION and SystmOne.

Position statements published on the CCG websites providing updated status for

business cases / policies reviewed by the Policy development Group.

4.1 Patient Engagement and Communication:

Patient helpline - A dedicated telephone helpline is in place for patients to contact the IFR

team for any process related queries. Patients can email their queries using the generic IFR

email address. Contact details are published online on CCG websites and are included on

the patient leaflet.

Patient leaflet has been published online on all 8 CCG websites and is shared on demand

to help patients understand the IFR and PPwT process. This document provides guidance

on how NWL CCGs make decision about treatments which may not be normally available

through the NHS i.e. IFRs. Patient leaflets are circulated to all NWL providers and GP

surgeries to ensure these are available for the patients.

Complaints process is in place for patients to report any issues they may have experienced

during processing of their funding request. To maintain confidentiality and transparency,

complaints are handled by the CCG Complaints team.

In terms of formal patient complaints, Table 11 shows the number of patient complaints (15)

received by the CCG’s regarding the IFR process for 2016/17. Patient complaints were

either sent directly by the patient or a representative (including local MP) on behalf of the

patient to the CCG complaints team. All the complaints followed the NHS Complaints

procedure and are responded to within those NHS Complaints Procedure timescales via the

CCGs Complaints Teams.

The total number of complaints regarding the NWL CCGs IFR service (including current

policies) was 15 for 2016/17. The key theme for complaints is IVF and cosmetic procedures

which year on year remains the same. In responding to these complaints the IFR team can

identify gaps in our engagement with stakeholders. The IFR service uses the feedback from

patients to update information leaflets along with our policies on an annual basis.

Page | 20

Table 11 IFR Complaints received in 2016/17

CCG & Complaint Subject No. of Complaints

Hillingdon CCG 3

IVF

Cosmetic

Laser Hair Removal

Harrow CCG 3

IVF (2) Biologic Mesh

Central CCG 1

Scar Revision

Ealing CCG 1

IVF

Brent CCG 1

IVF

Hounslow CCG 3

Cosmetic

West London CCG 3

Cryo Therapy Breast Reduction IVF

Grand Total 15

4.2 Freedom of Information Requests

The NWL Communication Team also receive a number of FOI requests that relate to IFR

procedures that are not routinely commissioned by North West London CCG’s and only

available via the IFR route or requesting details on current policy.

Table12 FOI’s Received 2016/17 All NWL CCGs

Subject Query Total

IVF The FOI requests were related to the number of IFR IVF applications for requests outside of the current policy.

6

Complementary Therapy These inquiries are based on funding of complementary therapy, including homeopathy and hypnotherapy

3

Continuous Glucose Monitoring (CGM)

NWL CCGs did not have a CGM policy throughout 2016/17, the current policy was launched in November 2016

3

Bariatric Tier 3 Services Provision of weight management programmes 3

Low Value Procedures Restrictions on procedures and the thresholds 2

Orthopaedic Knee and hip procedures 2

Various procedures Including drug, cosmetic and specialist treatments

7

Total FOIs received in 2016/17 26

Page | 21

4.3 IFR Stakeholder Feedback from IFR Applicants

IFR Applicants (clinicians) are also periodically surveyed to gain feedback in order to monitor

the quality of the service. Applicants have been randomly selected using hospital clinicians,

general practitioners, and clinical co-ordinators and are sent to applicants who have cases

approved and declined, in order to achieve a balanced perspective.

Applicants were asked to comment on their experience of the service using a sliding scale of

0 to 10 (where 10 is good) on all aspects of the process, including completing the

application, and pre and post panel communication.

Table 13 below provides a summary analysis of the ten responses received. This showed

that there are some areas, particularly around the appeals process that would need to be

further analysed and identify any appropriate improvement areas. The data represents the

total percentage scored by each applicant for each question.

Table 13 Summary of Responses IFR Applicants

Page | 22

Section 5 – Update from Policy Development Group

(PDG)

The NWL CCG Policy Development Group (PDG) continues to meet quarterly to review

business cases for new policies, including those where there are cohorts of IFR applications

received. These can be in the form of an internal review by the IFR team or a business

case received from a particular provider trust. The PDG is a clinically led forum that review

proposals based on the clinical evidence presented, both in terms of clinical and cost

effectiveness. Any policy areas that are approved following PDG recommendations are

then presented and considered for final approval by the NWL Collaboration of Clinical

Commissioning Groups following discussion locally at each CCG. The CCG Collaboration

reviews the recommendations in the wider context of CCG priorities and affordability. For

2016/17 below provides a summary on two key areas relating to IFR cohorts.

Continuous Glucose Monitoring for Type 1 Diabetes:

The IFR team received a number of IFR requests for continuous glucose monitoring (CGM)

devices for Type 1 diabetic patients. A CGM device allows patients to have better control of

their glucose levels, and reduces the risks of potentially serious consequences of

hypoglycaemic episodes. The IFR team recognised this intervention as a service

development and convened a meeting with consultant diabetiologists to discuss the

evidence base and potential clinical criteria that could be adopted across NWL. It was

recognised that there would be approximately 50 patients at high risk of recurrent

hypoglycaemic episodes in NWL per year who would benefit from a CGM device.

On the 26th April 2016, the PDG were presented with the outputs of the meeting and a case

for change. The PDG approved the service development as they were satisfied that CGM

devices would be both a clinical and cost effective intervention for a selected group of

patients at risk of severe hypoglycaemic episodes.

Biological Mesh for abdominal procedures

Over the past few years, a number of IFR requests for the use of biological mesh in complex

abdominal wall repairs had been received from LNWH. The trust was asked to submit a

business case for this intervention, given that the intervention requested was intended for a

definable cohort of patients rather than send applications via the IFR panel.

The trust presented a business case to the Policy Development Group on the 14th of March

2017. The trust presented a proposal to use biological mesh (at a cost of around £8000

each) for approximately 40 to 50 patients per annum, for patients with contaminated

abdominal wall defects. The trust felt that using biological mesh in this group of patients

rather than the standard synthetic mesh reduced complication rates requiring further

surgery. The published evidence base was reviewed by the PDG group. The PDG identified

that there is very little published data supporting the effectiveness of this particular

intervention, and noted that the proposal was based on level 5 evidence i.e. expert clinical

opinion rather than robust randomised controlled trials (level 1 evidence). The PDG also

noted that there was also a significant lack of evidence supporting cost effectiveness.

The PDG declined the policy based on this rationale, and advised the trust that they would

re-look at this business case should they wish to provide further supporting evidence.

Page | 23

Section 6 – Conclusion & Recommendations

Conclusion This report has provided a summary of the outcomes of the IFR decision making across

North West London CCG’s in 2016/17. It has shown that there continues to be a decrease

in cases going to panel, predominantly due to the number of cohorts identified by clinical

triage screening. The report has shown it is imperative that where there is a cohort of

patients identified this should be reviewed through the appropriate commissioning routes

either via contracting or in some instances the North West London Policy Development

group. This ensures equity of access for service provision across North West London.

The report has shown that there has been an increase in IFR’s received from general

practice.

The report has shown that the number of appeals continues to be low in comparison to the

number of overall that go to IFR panel and are declined.

The report has highlighted there are a number of applications received for the use of non-

PBR drugs outside the current licenced indication for use. An example provided of this was

the use of Bevacizumab licenced for use to treat cancer) but requested for its unlicensed use

for ophthalmology conditions. As the service is run across the 8 NWL CCG’s there has been

the ability to highlight this as a cohort and this has been flagged up for review by the NWL

Policy Development Group, although the IFR route will still be available for any clinical

exceptionality cases.

Recommendations:

CCG’s Committees are asked to:

Note the content of the report and identify any further analysis that is required

Identify any further stakeholder engagement particular around cascading the content

of the report to the wider clinical commissioning community.