Paper 11

Cover Sheet: Governing Body

Date Wednesday, 28th January 2015

Presenter & Organisation

June Farquharson and Chakshu Sharma

Author June Farquharson, Associate Director – IFR Service Chakshu Sharma, IFR Business Development Manager

Responsible Director Andrew Burgess, Director of Contracts, Performance and Procurement

Clinical Lead Dr. Lily Wong

Confidential No

The Executive Management is asked to:

To note and discuss the content of the report and highlight any further analysis required by CCG in any key area of IFR

Summary of purpose and scope of report

The purpose of this this report is to provide Ealing CCG with a summary on outcomes of the Individual Funding Request (IFRs) applications received within year 2013/14 (April 2013 to March 2014). The report provides analysis with regard to patterns of referral, both individually for Ealing CCG, as well as benchmarking these with the other CCGs in North West London. This report also provides:

• Key qualitative aspects of the IFR decision making and identifies any areas of risk in terms of delivery and mitigation actions taken where relevant.

• Detail on the Appeal Applications received • Stakeholder feedback including patients, Panel members and applicants • Update on clinically led Policy development group • Update on applications received that are out of scope of IFR

Finally where appropriate the report provides recommendations for the CCG Boards/Governing Body to consider in changes to the current governance arrangements.

Title of paper Individual Funding Request (IFR) Annual Report 13/14

Quality & Safety/ Patient Engagement/ Impact on patient services:

The IFR service uses both structured and ad hoc feedback to adjust the internal system and processes.

As the IFR team is not normally communicating directly with patients due to the clinical nature of the requests, no formal methodology is currently in place to gain patient feedback. However, two main indicators are used as a measure of patient satisfaction – the IFR Appeal Process and Patient Complaints.

Details included on page 14 and 15 of the annual report.

Financial and resource implications

No resource implications for this period The Quality Committee is asked to note and discuss the expenditure to date.

Equality / Human Rights / Privacy impact analysis

The North West London Collaboration of Clinical Commissioning Groups (NWL CCGs) have a duty to take into account the need to reduce health inequalities in the access of health services and the health outcomes achieved as defined in the Health and Social Care Act 2012. NWL CCGs are therefore committed to ensuring equality of access and non-discrimination irrespective of age, gender, disability (including learning disability), gender re-assignment, marriage and civil partnership, race, religion or belief, sexual orientation and sex (gender). This is also in line with the Equality Act 2010. NWL CCGs have one Individual Funding Request system in place across North West London to support decisions in instances described above. This approach ensures consistency in decision making across NWL. Although run centrally, local CCGs are pivotal in the decision making, as IFR panels are chaired by a CCG Chief Operating Officer/Managing Director and the Appeal Panel Chaired by a Lay Member from the Governing Body. This Annual Report covers the work of the NWL CCGs’ IFR Service from April 2013 to March 2014. The report provides detail on IFR outcomes but it also highlights how the wealth of data currently available, can inform wider decision making for CCGs particularly around areas for policy development.

Risk

N/A

Supporting documents

None

Governance and reporting (list committees, groups, or other bodies that have discussed the paper)

Committee name Date discussed Outcome

Name DD/MM/YYYY

Application

Governance

Panel Outcomes

Stakeholder

Policy Development

INDIVIDUAL FUNDING REQUEST

ANNUAL REPORT

2013/14

Document Reference Information Version V5

Status Draft

Author/Lead June Farquharson, Associate Director - IFR Service Chakshu Sharma, Senior IFR Business Development Manager

Owner June Farquharson

Directorate Contracting and Performance

Date Issued 1st December 2014

Target Audience All Clinical Commissioning Group Chairs, Managing Directors and Chief Operating Officers All CCG Stakeholders

Table of Contents

Foreword 1

Section 1 - Executive Summary 2

Section 2 - IFR Background and Scope 3

Section 3 - IFR Outcomes 3.1 IFR Standard Applications Outcomes 3.2 IFR Summary of Applications by Intervention

3.2.1 Procedures and Interventions (Non-Drug) 3.2.2 Analysis by Applications (Drugs)

3.3 Summary of Applications by expenditure 3.4 IFR Urgent Applications

4

Section 4 - IFR Appeals Process 4.1 Appeal Applications 2013/14

11

Section 5 - IFR Panel 12

Section 6 - IFR Signposting - Applications out of scope of IFR 12

Section 7 - IFR Outcomes Policy Development 14

Section 8 - IFR Stakeholders 8.1 IFR Stakeholder Feedback – Patient 8.2 IFR Stakeholder Feedback – Panel Members

14

Section 9 - IFR Internal Governance 9.1 IFR Audit 9.2 IFR Panel Training

16

Section 10 – Conclusion and Recommendations 17

Foreword The NHS Constitution (March 2013) provides a clear statement that patients have the right “to drugs and treatments that have been recommended by the National Institute for Health and Clinical Excellence (NICE) for use in the NHS”.1 The relevant health body is obliged to fund specified NICE recommendations. Patients also have the right to expect local decisions on funding of other drugs and treatments outside of policy (whether national or local) to be made rationally following proper consideration of the evidence. This is to ensure that:

• There is no outright blanket ban for interventions or treatments • Must be sensitive to individual circumstances and take account of those

circumstances in any decisions • A system is in place to enable exceptional case reviews • Must have robust policies in place which can support clear and defensible

decisions on whether access to services will or will not be possible. The North West London Collaboration of Clinical Commissioning Groups (NWL CCGs) have a duty to take into account the need to reduce health inequalities in the access of health services and the health outcomes achieved as defined in the Health and Social Care Act 2012. NWL CCGs are therefore committed to ensuring equality of access and non-discrimination irrespective of age, gender, disability (including learning disability), gender re-assignment, marriage and civil partnership, race, religion or belief, sexual orientation and sex (gender). This is also in line with the Equality Act 2010. NWL CCGs have one Individual Funding Request system in place across North West London to support decisions in instances described above. This approach ensures consistency in decision making across NWL. Although run centrally, local CCGs are pivotal in the decision making, as IFR panels are chaired by a CCG Chief Operating Officer/Managing Director and the Appeal Panel Chaired by a Lay Member from the Governing Body. This Annual Report covers the work of the NWL CCGs’ IFR Service from April 2013 to March 2014. The report provides detail on IFR outcomes but it also highlights how the wealth of data currently available, can inform wider decision making for CCGs particularly around areas for policy development.

1 NICE (the National Institute for Health and Care Excellence) is an independent organisation producing guidance on drugs and treatments. ‘Recommended for use by NICE’ refers to a type of NICE recommendation set out in legislation. The relevant health body is obliged to fund specified NICE recommendations from a date no longer than three months from the publication of the recommendation unless, in certain limited circumstances, a longer period is specified

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Section 1 Executive Summary North West London Collaboration of Clinical Commissioning Groups has one integrated system for the management of Individual Funding Requests (IFR) both in terms of processing and decision making. In summary this reduces inequity in decision making for exceptional cases (outside policy) and also provides real time data that can be used to identify gaps in service provision and therefore potential policy development This Annual Report covers the period of the 1st April 2013 to 31st March 2014. The report covers both quantitative information, such as the number of applications received and their outcomes broken down by CCG and Provider, as well as more qualitative data, such as basis of exceptionality. The report includes additional information about the IFR referrals received outside of the current scope and areas of policy development. In terms of outcomes, the report looks at the 770 IFR applications received in 2013/14 and their outcomes, and in summary this shows:

• Of the 770 applications received 349 (45%) went to panel, of which 288 (18%) were approved with an overall expenditure of £928,515 across the collaboration.

• The highest level in terms of applications received per weighted population (100,000) was for Ealing CCG (49) and the lowest level of weighted applications for Brent (and Hammersmith& Fulham CCG’s (26).

• The largest area in terms of applications approved and expenditure was attributed to

drugs and in some instances where there are cohorts identified these have been signalled as areas for potential policy development.

• In terms of non-drug cases, the top 3 requests that were approved were for hip

replacement, acupuncture, and abdominal wall repair.

• The report also shows that of the IFR applications received, 454 were for Planned Procedures with a Threshold Policy type cases in instances where patients did not meet policy threshold and clinicians put forward an IFR based on clinical exceptionality.

The report also highlights that commissioning intelligence gathered through the real time IFR database has resulted in a more proactive approach to identifying patterns of IFR applications for the same indications and as a response the establishment of the NWL CCG Policy Development Group (PDG). The PDG looks at whether there is a business case for additional local policies to be implemented and therefore limit any risk to consistency in decision making.

The report looks at the internal governance infrastructure, including the changes to the IFR panel membership to ensure that the CCGs are pivotal in the decision making.

The report also measures patient satisfaction, by using the appeals process and patient complaints regarding the service as a proxy. This showed that 12 appeal cases (2% of the overall applications received) were received and 3 went to an appeal panel which represented 1% of cases that were declined by the IFR Panel. Of the appeal cases heard, one case had a recommendation of being reviewed back at an IFR panel.

Finally the report concludes that based on the stakeholder feedback and responsive internal governance that there are significant benefits for running one single IFR System across North West London.

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Section 2

IFR Background and Scope The IFR service has 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 Inner London CCGs) and £50k for outer London CCGs). The benefits of having one system across North West London include:

• One single processing, panel and decision making framework across North West London

• Ability to identify patterns of referrals and therefore areas that are not deemed as exceptional

• Real time data collection that can be used to inform areas of potential service/policy development

• Consistency in decision making with one clear governance framework

All applications received are reviewed on a weekly basis by the IFR Clinical Triage Panel who identify whether there are grounds for clinical exceptionality for consideration by an IFR panel. Clinical triage review identifies whether there are further points of clarification or additional information needed to strengthen the case. Individual Funding Requests (IFRs) are for treatments that are not normally funded by the NHS, or are only funded in certain exceptional circumstances that are reviewed on a case by case basis. Such cases, involving patients with unusual or unique clinical factors, are considered by a panel set up to specifically review IFR’s. The panel comprises of a Chair (CCG Chief Operating Office/Managing Director), Lay Person, Public Health Consultant and Clinical Advisor (GP) and is supported by members of the IFR team. The panel makes decision based on the NWL CCG Decision Making Framework (see summary app1).

As per the NWL Clinical Commissioning Groups 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 patient with the condition. An example will be where a treatment is likely to be more clinically effective as well as cost effective on an individual patient.

• The 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).

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• 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 the Service development group to consider the health technology within its planned priority setting and service development process.

Section 3 - 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 Days 5 Working Days

3.1 IFR Standard Applications Outcomes All IFR applications are both administratively and clinically triaged. The administrative triage is to ensure that the minimum dataset has been received to process the application and to validate that the patient is registered within North West London. Clinical Triage is a sub-committee of the IFR panel that validates cases to ensure that there are:

a) Grounds for exceptionality b) Communicate with the applicant for further clarification of key points, and c) Communicate with the applicant for additional information that would support the

case. Tables 1 and 2 below shows an overall summary of IFR applications received for 2013/14 and their outcomes. Key highlights include:

• Of the 770 applications received 349 (45%) went to panel, of which 288 (18%) were approved.

• The highest level in terms of applications received and per weighted population (100,000) was from Ealing CCG (49) and the lowest level of weighted applications from Brent and Hammersmith and Fulham CCG’s (26).

• The largest area in terms of applications approved and associated expenditure

pertain to drugs cases such as infliximab for ulcerative colitis / Crohn’s disease and rituximab for rheumatic diseases. These have been highlighted as areas for policy development.

• Of the IFR non-drug applications received, 454 were for procedures that are covered

by a Planned Procedure with Threshold (PPwT) policy, but in instances where patients did not meet policy threshold and clinicians put forward an IFR based on clinical exceptionality. Further analysis shows that a high number of these were for Acupuncture, IVF, Refashioning of Scars and Keloids, Laser Surgery, Gynaecomastia Reduction, Breast Reduction and Breast Augmentation.

• 133 of PPwT related cases presented to panel were declined due to no clear clinical exceptionality demonstrated that would warrant a deviation from existing policy.

• 48 (6%) of applications were discharged at the triage stage. This is where there the

clinical triage team have requested additional information/points of clarification to strengthen an IFR case and despite follow-up have had no response.

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• Applicants are therefore advised that the case has been withdrawn and they can re-submit when the additional information becomes available.

• In response to the cohorts identified there has been an establishment of a NWL CCG-wide policy development group, with a remit of reviewing new policy and service developments, as well as making recommendations to change and review thresholds within existing policies. More detail on the function of the policy development group is described later in this report.

Table1

CCG Name Approved Declined Discharged Withdrawn Grand Total

NHS Brent CCG 50 32 5 3 90 NHS Central London (Westminster) CCG 21 39 3 1 64 NHS Ealing CCG 62 117 8 7 194 NHS Hammersmith & Fulham CCG 16 27 8 1 52 NHS Harrow CCG 52 35 3 1 91 NHS Hillingdon CCG 33 65 5 3 106

NHS Hounslow CCG 31 59 6 5 101 NHS West London CCG (K&C & QPP) 24 35 10 3 72

Grand Total 289 409 48 24 770

Table 2

CCG Name Applications

Received Applications Per

100,000 Population

NHS Brent CCG 90 26

NHS Central London (Westminster) CCG 64 33

NHS Ealing CCG 194 49

NHS Hammersmith & Fulham CCG 52 26

NHS Harrow CCG 91 40

NHS Hillingdon CCG 106 38

NHS Hounslow CCG 101 36

NHS West London CCG (K&C & QPP) 72 33

Grand Total 770 *36 *average per weighted population

3.2 IFR Summary of Applications by Intervention 3.2.1 Procedures and Interventions (Non-Drug) Table 3 IFR Requests by Intervention (Non Drug)

Table 3 below provides a summary of the top ten non- drug IFR applications received, their outcomes and further analysis. This demonstrates that:

• The highest non-drug cases were for acupuncture. The majority of acupuncture IFR forms were received from the pain clinic at Imperial College Health Care Trust.

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• IFR forms are assessed against the NWL complementary therapies acupuncture policy and for cost effectiveness. An evidence review of the current acupuncture policy was undertaken and the findings were presented to the CCG Collaboration for consideration and more recently this has gone to each CCG Governing Body. The recommendations put forward by the evidence review include narrowing the access criteria to chronic low-back and tension-type headaches, and to only commission acupuncture as part of a wider MSK pathway, rather than a stand-alone service, as this would be more cost-effective. This has been agreed and where acupuncture is being provided as a standalone service in an acute trust, notice for decommissioning has been given (Imperial). The IFR team have also met with MSK leads to ensure there is alignment to local provision and identify any potential gaps as an impact.

• The table also shows a high number of IVF applications in year 13/14 where patients were out of the scope of the IVF policy due to the following:

o Requesting second or third cycle after failure of the first cycles funded by the NHS

o IVF cycle for women over the age of 40 o For couples where one of the partners have living children (including adopted

children) from previous or current relationships. o IVF with donor sperm o IVF using a surrogate mother

The volume of IVF referrals could coincide with the updated NICE guidelines CG156 published in February 2013, which in summary re-iterated the recommendations of offering women up to 3 cycles and made a new recommendation to increase the age range for some women to offer 1 cycle up to the age of 42. The updated guidelines were discussed at all 8 Governing Bodies and it was agreed to keep the existing policy in place, in the context of the wider local commissioning priorities across NWL.

• Analysis also shows a number of applications (collectively) for a cosmetic related procedure such as gynaecomastia reduction, breast augmentation and refashioning of scars and keloids etc. The main reason for exceptionality cited was the psychological impact on the patient’s well-being due their discontent with their body image. North West London CCG’s have an overarching policy on the funding of cosmetic treatment which is through the IFR route. Psychological distress is taken into account in each application presented at panel but if it is part of an identifiable cohort this is not deemed as exceptional.

Finally, although not within the main scope of this report, trend comparison undertaken for Months 1 to 6 of 2014/15 shows a continued trend with the highest applications being from acupuncture, breast augmentation, reduction and refashioning of scars and keloids.

Table 3 – IFR Applications (non-drug) by Intervention

Intervention Name Approved Declined Discharged Withdrawn Grand Total

Acupuncture 47 10 2

59

Refashioning of Scars and Keloids 1 33 9 1 44

IVF 3 34

37

Gynaecomastia Reduction 1 26 4

31

6

Intervention Name Approved Declined Discharged Withdrawn Grand Total

Laser Treatment 1 28

29

Breast Augmentation 1 24 2

27

Double Balloon Enteroscopy (DBE) 24

24

Breast Reduction 7 9 4 2 22

Blepharoplasty 9 6 4

19

Pinnaplasty 9 3 2 1 15

Grand Total 103 173 27 4 307

3.2.2 Analysis by Applications (Drugs)

Table 4 below shows the top ten applications for drugs received and their outcomes. This demonstrates:

• The two highest drug request and subsequent approvals were for infliximab and rituximab

• The majority of infliximab requests have been for gastro-intestinal diseases - Crohn's

and ulcerative colitis. The high numbers are likely to reflect: o The ambiguity in NICE guidance for continuation of dose escalated biologics

in Crohn's disease. o Clinicians attempting to keep patients with ulcerative colitis out of hospital by

using infliximab before NICE criteria is met N.B. NICE assumes that people will need admission for 72 hours to receive IV antibiotics for an acute exacerbation

o Maintaining control of ulcerative colitis by continuing infliximab beyond three induction doses recommended by NICE

• Rituximab is licensed in the UK for use in non-Hodgkin's lymphoma, chronic lymphocytic

leukaemia, rheumatoid arthritis and granulomatosis. o The majority of IFRs for rituximab are for rheumatoid arthritis outside of NICE

and/or license e.g. for use without methotrexate which is outside of license but has some evidence

Its mode of action also means that it is has been requested for a number of autoimmune conditions e.g. autoimmune haemolytic anaemia and pemphigus.

Table 4 IFR Requests by Intervention (Drugs) 2013/14

Drug Name Approved Declined Discharged Withdrawn Grand Total

Infliximab 33 18 1 1 53

Rituximab 31 3

1 35

Bevacizumab (Avastin) 6 17

5 28

Adalimumab 16 7

2 25

Ustekinumab 8 2

1 11

Etanercept 7 1

8

Tocilizumab 4 3

7

Certolizumab 6

6

Ranibizumab (Lucentis) 5

5

Abatacept 2 2

4

Grand Total 118 53 1 10 182

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3.3 Summary of Applications by expenditure Figure 1 below provides a summary of IFR procedures approved by expenditure in 2013/14. These shows:

• The top two areas of expenditure are related to applications for drug therapies - infliximab and adalimumab. The majority of these applications were for inflammatory bowel disease – i.e. Crohn’s disease and ulcerative colitis for indications outside of NICE guidance. For example, requests for the continuation of infliximab for ulcerative colitis where there is high risk of recurrence or active disease. Requests for adalimumab were for a wider set of indications and, other than Crohn’s, included psoriasis, rheumatoid arthritis and ankolysing spondylitis.

• The top two areas of expenditure in non-drug applications were for acupuncture that were mainly received from Imperial College Hospital Healthcare NHS Trust and Double Balloon Enteroscopy (DBE) that are undertaken at St Mark’s. In light of the high volume of applications, a business case was requested in order to facilitate routine commissioning of the service, and subsequently submitted by St Mark’s to the Policy Development Group.

3.4 IFR Urgent Applications Urgent Application Process Timeline

Urgent IFR applications are processed and reviewed by virtual panel (against the same decision making framework) within 3 working days following acceptance and clinical validation of the urgency or the next available IFR panel if scheduled within 3 working days. In 2013/14, there were far fewer urgent applications received than under the previous NWL-wide Primary Care Trust system. The main reason being that areas such as cancer drug commissioning was transferred to NHS England which manages its own IFR system. For 2013/14, 11 clinically urgent cases that were processed accounted for 3% of the total IFR applications that went to the standard panel. All 11 urgent applications were considered via urgent Virtual IFR Panel within 3 working days. All 11 were approved with the following outcomes: Three applications for ‘Double Balloon Enteroscopy’ were approved by the IFR Clinical Triage Panel within 3 working from the date of receipt as Triage Panel has the delegated authority form the IFR Panel to review and agree these cases. Urgent Virtual IFR Panel: Funding requests for following drugs and procedures were reviewed and approved by the urgent IFR Panel within 3 working days form the date of receipt:

Urgent request receive

d

Clinical reasons for

urgency confirmed

Urgent process initiated

Knowledge Manager assigned

case

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

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• Rituximab as a treatment for Pemphigus Foliaceus • Romiplostim as a treatment for EVANS Syndrome (Autoimmune haemolytic anaemia

& Immune thrombocytopenic purpura) • Infliximab as a treatment for Hidradenitis Suppuritiva • Certolizumab as a treatment for Rheumatoid Arthritis • Embryo Cryopreservation for cancer patient • Oocyte Cryopreservation for cancer patient

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Figure 1

£0

£50,000

£100,000

£150,000

£200,000

£250,000

£300,000

£350,000

£400,000

£450,000 £423,341

£181,338 £142,619

£80,190 £75,065 £68,601 £52,374 £50,400 £36,750 £35,000

Cost - Top 10 IFR Procedures Approved - 2013/14

cost

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Section 4 - IFR Appeals Process

IFR Appeal Process Appeal Application Process Timeline

IFR Appeal received, administrative triage and

acknowledgment sent

Case Logged

IFR Clinical Triage Review

Director of Service Review and Appeal Panel Chair

Appeal Panel

Minutes agreed and decision letters sent

Day1-3 30 days 5 Working Days

The IFR Appeals process allows applicants and patients (in some instances) to appeal against a decision made by an IFR panel. The appeal process must be independent of the IFR process and are chaired by a Lay Member of a CCG Governing Body. There is separate clinical, public health and lay representation and a CCG Director or deputy. Whereas the basis of decision making for an IFR case focuses on clinical exceptionality, appeal cases are considered in light of decision making process. The decision of an IFR panel can be appealed on the grounds of:

• Illegality: The Refusal of the request was not an option that could lawfully have been taken by the IFR panel

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

• 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.

• New evidence: additional evidence is provided which amounts to a material difference to the case originally submitted.

Once an appeal is received, an Appeal Chair is assigned and will make the decision on whether there are sufficient grounds for an appeal based on the evidence. Appeals that are based on new evidence however go back to a separate IFR panel as this is the designated forum to review clinical evidence. 4.1 Appeal Applications 2013/14 Table5 IFR Appeal Applications

Appeals Information

2013 to 2014

% (where applicable)

Appeals received in 2013/2014 12 6%

Appeals approved by Appeal Chair & case resubmitted to the IFR Panel 3 25%

Appeals rejected by Appeal Chair 6 50%

Appeals considered by Appeal Panel 3 25%

Appeals declined by Appeal Panel 2 67%

Appeals Upheld by Appeal Panel & case resubmitted to IFR Panel 1 33%

Appeals withdrawn by Appellant 0 0%

Appeal cases taken back to IFR Panel and approved 1 25% Appeal cases taken back to IFR Panel and Declined with no further appeal received 3 75%

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Table 5 above provides a summary of IFR appeals received for 2013/14 and their outcomes. The key highlights were:

• Of the total appeals received 8 (67%) were as a result of the IFR’s received for Planned Procedures with a Threshold that went to an IFR panel and were declined.

• This represented 6% of the overall 133 PPwT-related IFR cases that were declined by the IFR Panel.

• 4 were related to IVF cases where patient was over the age of 40 and therefore outside the scope of the current NWL CCG policy.

• 50% of the cases received were rejected by the appeal chair as having insufficient grounds for appeal

• 3 appeal cases went back to a standard IFR panel for review of new evidence

submitted

• 3 cases were reviewed by an Appeal panel and of the 3 cases, in one instance, the panel decided to take the case back to an IFR panel for re-consideration. In summary this case involved a cancer patient who had embryos frozen prior to cancer treatment before aged 39 and requested funding re-implantation at 42. As this affected a cohort of patients, this was not deemed by the original IFR panel as exceptional. However, the appeal was based on the age criteria and after receiving legal advice in terms of the evidence on re-implantation being based on the age of the embryo and not the patient, this was re-submitted back to IFR panel for consideration. The IFR panel agreed that declining to fund this patient’s treatment on age alone would be in breach of the Equality Act 2013 and therefore approved the case. The case was therefore subsequently approved. Based on this decision, it was also recognized that this would have wider implications in terms of policy and the policy on cryopreservation has subsequently been reviewed by the NWL CCG Policy Development Group and recommendations approved at the NWL CCG Collaborative. In particular the policy now has guidance on re-implantation for post-cancer patients being separate from current IVF criteria. This was made in the context that the evidence is based on the age of the women’s egg, not the ability for the women to have a successful pregnancy and subsequent birth. This decision would be made by the individual clinician managing the case.

Section 5 - IFR Panel A pivotal part of the IFR process is the IFR panel. Panels are held weekly and are made up of a Chair (CCG Managing Director/Chief Operating Officer, Lay Person, GP/Clinical Advisor, Public Health and IFR Team support. The Chair of the panel ensures that each case is considered on its own merit and the decision is in keeping with the principles of the IFR Decision Making. The role of the lay representative is to provide insight from a non-commissioning clinical perspective based on the supporting evidence. There is also clinical representation on the panels to provide additional guidance and support particularly in terms of the evidence presented. Section 6 - IFR Signposting - Applications out of scope of IFR As part of the IFR process, a number of referrals are received for requests that sit outside the scope of the IFR service, which is built around the concept of exceptionality. These are

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predominantly for cases that are for standard commissioned interventions but at providers where no contractual agreement is in place and are therefore deemed as Non-Contracted Activity, or in some instances, for mental health interventions which are also outside the scope of the current IFR service. The IFR team process these on behalf of the CCG to ensure there is a central logging and tracking system in place. However, as it is outside the current IFR delegated decision making responsibility, CCGs make the funding decisions locally. Table 6 provides a summary of the applications received that are outside the current scope of the IFR. Using the same approach as IFR, the data gathered has been used to identify areas that are deemed potential areas of service development. An illustration of this was that the IFR Service for this reporting period received a number of referrals from Central North West London Mental Health Trust for a sleep disorder service or the following conditions: Although Mental Health IFRs falls outside the remit of the current service scope, the IFR team have been validating these referrals through IFR clinical triage. As this appeared to be an established service and therefore deemed to be for a recognised cohort of patients, the Provider has been asked for a formal service development proposal, as this service had not been commissioned by the NWL CCG’s.

Table 6 – NCA Requests by CCG and Intervention

CCG Name Q1 Q2 Q3 Q4 Grand Total

Brent CCG 3

1 2 6 Communication Aid 2

1 1 4

Electric Standing Frame 1

1 Orthotic Dynamic Glove

1 1

Ealing CCG 4 1 5 2 12 Chronic Fatigue Syndrome Services

1 1

Communication Aid

1 4 1 6 Laser Hair Removal for transgender patient 2

2

Manual Lymphatic Drainage and Hydrotherapy 1

1 Neuro-rehab Physiotherapy 1

1

Second skin Dynamic Postural Splint

1

1 Hammersmith and Fulham CCG 8

1

9

Art Therapy 1

1 Chronic Fatigue Syndrome Services 4

4

Manual Lymphatic Drainage 2

2 Mobile Arm Support

1

1

Specialist service for mood disorder 1

1 Harrow CCG 3

1

4

Treatment from TVN/ Leg Ulcer Clinic 1

1 Lycra Sleeve 1

1

Physiotherapy 1

1 Silicone Ankle Foot Orthoses (SAFO)

1

1

Hillingdon CCG 5

1 6 Electric Standing Frame 1

1

Intrathecal pump 1

1 Knee Blocks 1

1

Physiotherapy 1

1 Stance control knee ankle foot orthoses

1 1

Traumatic Stress clinic 1

1 Hounslow CCG 2

2

Laser Hair Removal for transgender patient 1

1 Vocational Rehabilitation 1

1

NHS Central London (Westminster) CCG 4

1 2 7 Chronic Fatigue Syndrome Services 2

1 1 4

Neuro-rehabilitation 1

1 2 Sleep Clinic for ADHD 1

1

West London (K&C & QPP) CCG 6

1 7

13

CCG Name Q1 Q2 Q3 Q4 Grand Total

Chronic Fatigue Syndrome Services 1

1 Manual Lymphatic Drainage 1

1

Mental Health Assessment 1

1 Neuro-rehabilitation 1

1 2

Psychiatric Support 1

1 Sleep Clinic for ADHD 1

1

Grand Total 35 1 9 8 53

Section 7 - IFR Outcomes Policy Development During the course of the year, the key benefit of having a NWL-wide IFR Service has been the ability to use real time commissioning data to identify patterns of applications from particular providers and ensure that providers are required to establish new or uncommmissioned services only through a formal route, by submitting a business case. In some instances, where the requests come from a number of providers, then the IFR team will signal an internal review. It has been recognised there was no local forum across NWL for the appraisal of proposals for new treatments and devices that are not routinely funded, nor for reviews of existing policies requiring an updated in light of new developments. The IFR Team has therefore worked with CCGs in North West London to set up a clinically-led Policy Development Group to reduce inconsistencies in service provision across North West London. Aligning with local needs, the development of this Group has helped facilitate decision making for local commissioners. The Group puts clinicians from multiple settings, commissioners and patient representatives together at the heart of the decision making process to achieve best-practice evidence-based commissioning by appraising new business cases and policies in a systematic way. As well as cohorts of IFR’s the PDG reviews funding requests that:

• Fall outside the range of commissioned services including those identified as cohorts of IFRs

• Business cases from provider trusts submitted as part of the annual contracting round.

• Have been recommended as a policy outside the NWL Sector

Section 8 - IFR Stakeholders

8.1 IFR Stakeholder Feedback – Patient

The IFR service uses both structured and ad hoc feedback to adjust the internal system and processes.

As the IFR team is not normally communicating directly with patients due to the clinical nature of the requests, no formal methodology is currently in place to gain patient feedback. However, two main indicators are used as a measure of patient satisfaction – the IFR Appeal Process and Patient Complaints.

The IFR Appeal process provides an independent platform for appealing an original IFR decision. This can be instigated by the patient, preferably with clinical endorsement. As part of the NWL IFR Service Appeals Terms of Reference, patients are given an opportunity to come and present to the IFR Appeal Panel the impact from patient perspective. Of the 12 Appeals cases held, 1 patient has made a presentation at panel. In 2013/14, the IFR Service received 2% of appeals as a percentage of the total applications received and 6% as a percentage of the total applications that were declined at IFR Panel.

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In terms of formal patient complaints, Table 7 shows the number of patient complaints received by the CCG’s regarding the IFR process for 2013/14. Patient complaints were either received directly from the patient or from the patient representative (including local MP) on behalf of the patient. Of the 21 complaints, the highest number related to the current parameters of the IVF policy (age or number of cycles offered). Table 7 – IFR Decision Patient Complaints by Intervention Intervention Number of Complaints

Acupuncture 2 IVF 5 Homeopathy 2 Breast augmentation (including PIP implant replacements) 3 Sleep apnoea 1 CHART Radiotherapy 1 Sperm donation 1 Mental health 1 Knee replacement 3 Hip replacement 1 Drugs 1 Total 21

8.2 IFR Stakeholder Feedback – Panel Members Panel members are asked periodically for feedback on their perspective of the IFR process, including pre-panel and post panel communication and support. Key highlights from the most recent IFR panel member survey showed that:

• The Service had an overall good process • Panel members however felt that they would like more analysis of the available

published evidence and an explanation of medical terminology • Better interaction of virtual panels, that are used for urgent cases particularly

discussion and outcomes • A more structured review of the cases in light of the aspects outlined in the NWL IFR

decision making framework

As a result of the feedback received an updated Decision Making Framework Quick Guide has been developed for use by Panel Members during panel.

8.3 IFR Stakeholder Feedback – Applicants IFR Applicants 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 have been asked to comment on their experience of the service using a scale of 1-10 on all aspects of the process, including completing the application, and pre and post panel communication. Table 8 provides a summary of the questions asked and the scores (1-10). Key commentary feedback that the team will use to adjust internal processes as appropriate also included:

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• The IFR Form itself being too lengthy to complete • More information regarding process i.e. who makes the decision • More regular updates on tracking of cases i.e. date for panel etc.

Table 8 – Summary of Responses IFR Applicants

Questions

Average score - agreed

Average Score - declined

Average score - all samples

How would you describe your experience of the application process in general? 7.1 4.9 5.9

Do you think you were kept sufficiently informed at all stages of the process? 7.1 6.4 6.8

Did you know who to contact if you had a query? 7.3 7.0 7.1

Were any queries answered in a satisfactory and timely way? 8.0 7.1 7.5

Were you informed when your patient’s case was being presented at panel? 6.3 6.8 6.6

Post Panel Questions:

Did you feel you were given sufficient information regarding the decision? 7.3 6.7 6.9

Did you feel the Appeals Process was clear? 6.5 6.5 6.5

OVERALL SCORE 7.1 6.5 6.7

Section 9 - IFR Internal Governance 9.1 IFR Audit The IFR process is continuously monitored and updated to ensure a robust system is in place to support the IFR panel decision making. Key areas of note are: An internal audit was undertaken which reviewed 25 randomly selected case files and undertook an end-to-end review. Some of the key recommendations from the audit that have since been implemented were:

• There is a need to ensure that the decision making framework was more visible during panel discussions and as a basis for the minutes

• Making sure that approval letters contain as much detail and are of the same standard as the decline letters so applicants can see the basis of the decisions made, as well as avoiding any potential legal challenge in future cases.

• More emphasis should be placed on the necessity to make effective use of NHS resources, especially in relation to cosmetic requests

• Have a more definitive timeline for closing cases within the different stages of the IFR process

• Create a GP Commissioning Guidance information sheet to support general practitioners completing IFR forms.

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9.2 IFR Panel Training Periodically panel (both IFR and Appeal Panel) members are brought together for mandatory training. This provides an opportunity for panel members to be updated /refreshed on the decision making framework and test the theory with a series of case studies.

Section 10 – Conclusion and Recommendations

This report has provided an overview of the IFR Service in the first year of operation under North West London Collaboration of CCGs. It has described the adjustments that have been made to the panel membership to ensure that CCGs are pivotal in IFR decision making. It has provided a summary in terms of the outcome of applications received and some additional commentary on the governance processes that support the decision making. The report has highlighted that by providing real time commissioning intelligence, patterns of referrals were starting to emerge for use of some drugs, for the same indications. In response to this, a proposal went to the 8 NWL CCG’s for the establishment of a NWL-wide Policy Development Group (PDG), which was agreed. The PDG now provides a single process for reviewing new service developments policies or reviewing existing policies where new evidence has emerged. This provides CCGs with consistency in decision making by ensuring that decision making is equitable and population-based where appropriate.

The report has also highlighted that the IFR service receive a number of referrals that are outside of the current scope in terms of clinical exceptionality and are for standard treatments where no formal commissioning arrangements are in place or are for mental health provision (currently outside the existing service scope). Where these have been received by the IFR team, there has been an agreement with the CCGs for the team to administratively process these, and for each CCG to make the decision at a local level. This however could lead to inconsistency in decision making and there is an on-going discussion to look at centralising this process and using one decision making framework across NWL. However there needs to be recognition that these cases are not based on clinical exceptionality but, are actually more of a financial and commissioning decision.

The report reviewed how stakeholder feedback is used to adjust and improve internal processes. In terms of patient feedback, the team have used the IFR Appeals received and patient complaints as a measure to review patient satisfaction. The report showed that the level of appeals represented 2% of overall applications received and 6% of overall numbers of cases that declined. In response to the number of appeals that the Appeal Chair has identified has no basis, the team have reviewed the information provided post decision to applications and as a result more detailed decision letters are now being sent out. This not only provides the detailed decision to the appellant, but it also sets out the evidence and the different aspects considered by the panel.

A dedicated section looked at stakeholder feedback both from IFR panel members and applicants, and established that both groups were generally happy with the process. However, there were some key themes in terms of feedback on the process, including communication during Virtual panel reviews and updates on the tracking of cases for applicants.

To conclude, the different aspects considered in this report have confirmed that there is a robust system in place for IFR decision making, which is continuously monitored and adjusted to ensure that patients have the best outcomes using the latest evidence and equitable decision-making across North West London.

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