Part: Public Summary Sheet: Governing Body · The Governing body is asked to: To sign off the Individual Requests Operational policy. Summary of purpose and scope of report ... The

Part: Public Paper 10

Summary Sheet: Governing Body Date Wednesday 28th January 2015

Presenter & Organisation

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

Author June Farquharson, Associate Director – IFR Service Chakshu Sharma, IFR Business Development Manager, IFR Team Beverley Braithwaite, Operations Manager , IFR Team

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

Clinical Lead Dr. Lily Wong

Confidential No

The Governing body is asked to:

To sign off the Individual Requests Operational policy.

Summary of purpose and scope of report

The North West London Collaboration of Clinical Commissioning Groups (CCGs) have one Individual Funding Request system in place across North West London to support decisions for individual funding requests. The process is run by the CCG’s IFR Team and the decision making panel includes membership of the eight Clinical Commissioning Groups. This document sets out the NWL CCG’s IFR Policy for assessing, processing and decision making for all IFRs requests received for NWL CCG patients. These requests are clinically driven and are usually made by clinicians in provider organisations or GPs. The processes through which IFR requests are considered are set out in this document. This document should be read in conjunction with the ethical framework and IFR decision making framework. (Appendix 5 & 6) The Policy is required in order to demonstrate that: i) The eight CCGs policy for the management of IFRs is compliant with national guidance; ii) The IFR process conforms to sector-wide, London-wide and national policy iii) A consistent process for assessment and decision-making is applied to each request received in line

with the ‘clinical exceptionality’ criteria included within the policy. This overarching policy documents the process of how decisions are made relating to Individual Funding

Title of paper Individual Funding Request Operations Policy

Requests. It builds on the existing NHS NWL CSU policy and has been updated to reflect the new organisational structures. The IFR Panel and Appeal panel membership and arrangements have also been updated to reflect the new organisational structures. This is within a legal context of the role of 8 NWL CCGs and the role of NHS England. Amendments to the Policy:

Item no

Page No. Item name Details of amendments

1.3 5 IFR Scope This section is elaborated to provide clear details on the scope of the IFR Operations policy. This section will help the applicants to decide if the IFR route is suitable for their funding request.

1.4 6 to 8 Out of Scope of IFR / Policy Exclusions

IFR route is not suitable for various types of funding requests. This section includes the list of those categories and provide explanation as to why IFR route is not suitable for these requests

1.5 8 to 15 Patient Group Definitions / Guidance notes from NHS England IFR Policy

This section provides patient group definitions and detailed information on clinical exceptionality, Rarity and the concept of cohort of similar patients.

2.5 18 to 20 Pre Panel screening for IFRs • Clinical Triage

Screening

In comparison to the previous policy, this section includes more detailed explanation on functions and remit of the IFR Clinical Triage Panel

5. 26 to 28 IFR Appeal Process This section is elaborated to provide detailed information on Appeal process. It outlines clearly : • Scenarios where appeal is available or not

available as an option for the applicant and patient.

• Role, membership and accountability of the Appeal Panel

• Patient’s information and participation 6.1 29 Patient consent This section provides information on the

significance and importance of the patient consent.

8 31 Appendix 1 - Revised IFR form

• Includes a new section on patient’s consent • IFR form has been updated with a few new

questions and removal of a few previous sections due to the fact that NHS England has taken over various request categories such as bariatric surgery, cancer treatments etc.

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

A common IFR policy across 8 NWL CCGs will help to improve the quality and safety of the treatment and care provided to the patients, as it will ensure faster and more consistent access to evidence-based treatments via IFR system and also improving patient experience. 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 There has been no direct public involvement in the development of this policy but in order to make it clear and transparent; detailed definitions of clinical exceptionality, cohorts and rarity are included within the policy. It also provides a clear detailed explanation on: scope of IFR, IFR standard operating model, IFR Panel operation and management, IFR resubmission and IFR Appeal Panel process.

Financial and resource implications

The IFR policy seeks to help mitigate financial risks in relation to inappropriate funding of treatments; ensuring decisions are made on clinical best practice.

Equality / Human Rights / Privacy impact analysis

North West London Collaboration of Clinical Commissioning Groups including NHS Central London CCG, West London CCG, Hammersmith and Fulham CCG, Hounslow CCG, Ealing CCG, Brent CCG, Harrow CCG and Hillingdon 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. The 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. The IFR policy ensures a consistent approach to funding requests for all patients across 8 North West London CCGs

Risk

Risk that the patient is not at the centre of the decision made is mitigated by the IFR Policy

Supporting documents

- IFR Operational Policy - Appendix 1 - IFR Form - Appendix 2 - Urgent IFR Form

- Appendix 3 - IFR Appeal Form - Appendix 4 - IFR Summary Sheet Template - Appendix 5 - NWL CCGs Ethical Framework for decision making - Appendix 6 - IFR Decision Making Framework - Appendix 7 - NWL CCG Individual Funding Request Panel Terms of Reference - Appendix 8 - NWL CCG IFR Appeal Panel Terms of Reference

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

Committee name Date discussed Outcome

Name DD/MM/YYYY

INDIVIDUAL FUNDING REQUEST SUBMISSION FORM 2014 / 2015

For review of an exception to a policy The use of a standard submission form for IFRs ensures that the same level of relevant information is provided by every clinician for every IFR, regardless of the nature of the patients’ condition or the type of intervention requested. For all IFR applications the following sections are generic and must be completed: Parts 1, 2, 3, 4, 5, 9, 10, 11 and 12

• Drug requests - Part 6 must also be completed • Device interventions - Part 7 must be completed • PPwT procedures requiring IFR - Part 8 must be completed

Guidance notes for completing this form can be found at the back of this form Please complete this form electronically and email to [email protected]. Incomplete or handwritten forms will be returned to the applicant without processing.

Part 1 - PATIENT CONSENT

I confirm that this Individual Funding Request (IFR) has been discussed in full with the patient. The patient is aware that they are consenting for the Individual Funding Request Team to access confidential clinical and patient identifiable information held by clinical staff involved in their care about them as a patient to enable full consideration of this funding request YES / NO [Please indicate] Date: Note for GPs & Clinicians Please note that the patient identifiable information will not be shared with any other organisation. To ensure confidentiality, patient’s details e.g. NHS number will be removed and a unique identifier number will be assigned to all forms before these are reviewed by the clinical Triage and IFR Panel. This information will only be used to answer queries from the applicant and GP surgery staff regarding this application. On occasion, if necessary, IFR team may use this information to contact patient’s clinician or GP in order to obtain clinical information required to process this funding request. IFR team will retain this information in a secure environment to facilitate billing and monthly challenges only. GPs and clinicians are requested to record patients consent within patient’s individual health records.

Please note that if this form contains patient identifiable information, we are unable to accept this form without patient’s consent.

IS THE CASE CLINICALLY URGENT? IF SO AN URGENT IFR FORM MUST ALSO BE SUBMITTED ALONGSIDE THIS APPLICATION. This can be found here:

NWL_IFR_urgent_request_form_-_2014-2 Alternatively, the Urgent form can be downloaded from our website, http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx

Page 1 of 8 NHS NWL CCGs IFR form 2014-2015

mailto:[email protected]

http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx

Anonymity – Please ensure that, apart from Part 1 - question 2, the patient is not referred to by name or initials within the application form. PART 2: DETAILS OF CLINICIAN SUBMITTING REQUEST AND PATIENT

1. Details of

the clinician/ applicant submitting the request

Name: Designation: NHS Trust, GP Consortium

Correspondence Address:

Email: Tel:

2. Patient details

Patient Initials: NHS Number: Hospital Number Date of Birth: Registered GP Name:

Registered GP Practice:

CCG Name Consultant:

PART 3: TREATMENT PROVIDER DETAILS 3. Which

organisation will be providing the treatment requested?

NHS Trust NHS GP Private Sector Other (Specify name) Name of Provider:

Address of the Provider:

Provider Postcode:

PART 4: DIAGNOSIS AND PATIENT’S CURRENT CONDITION 4. Patient

diagnosis (for which intervention is requested)

Medical Condition:

Relevant Past Medical History:

Allergies:

PART 5: INTERVENTION REQUESTED: 5. Details of

intervention (for which

Name of Intervention:


funding is requested)

Type of Intervention:

Drug Procedure Device Other (Please ensure all relevant sections of this form are completed with regards to type of intervention )

Planned Duration of Intervention

Anticipated Start Date:

Anticipated Cost (inc VAT) with breakdown

Are there any offset costs? If yes, describe type and value of offset costs

YES/NO(Delete as appropriate)

6. Is requested intervention part of a clinical trial?

If yes, give details (e.g. name of trail, is it an MRC/National trial?)


If request is for a drug, is this funded through a clinical trial?

YES/NO/NA(Delete as appropriate)

7. Is the requested intervention a continuation of existing treatment funded via another route?

If yes, give details of existing funding arrangement and why ceased


PART 6: COMPLETE FOR DRUG INTERVENTIONS REQUESTS ONLY 8. Full name of drug:

9. Name of manufacturer: 10. Planned dose and frequency:

11. Route of administration

12. If the intervention forms part

of a regimen please document in full (e.g. Drug X as part of regimen Y (consisting of drug V, drug W, drug X and drug Z)

13. Drug licensed for requested indication in the UK? (Refer to pharmacy is required)


14. Has the Trust Drugs and Therapeutics Committee of equivalent Committee approved the requested intervention for use?

YES/NO(Delete as appropriate) If no, has the Committee Chair or Chief Pharmacist approved?: YES/NO / NA(Delete as appropriate)

Name and contact details of Committee Chair or Chief Pharmacist

PART 7: COMPLETE FOR DEVICE INTERVENTIONS REQUESTS ONLY 15. Device Name:

16. Name of manufacturer:

Page 3 of 8

NHS NWL CCGs IFR form 2014-2015

17. Device life expectancy:

18. Detail any warranty issues

and associated costs

19. Detail any maintenance requirements and associated costs

PART 8: PLANNED PROCEDURES WITHIN A THRESHOLD (PPwT) For list of PPwT policies go to: http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx 20. Does the intervention

requested fall under a PPwT Policy?


21. If yes, please name the relevant PPwT Policy

22. If yes, which thresholds does the patient not meet? If the patient does not meet PPwT policy please ensure your answer to Part 10 addresses why the patient should be considered as an exception to policy

PART 9: EVIDENCE OF CLINICAL EFFECTIVENESS AND MONITORING 23. Is there standard intervention

at this stage? Yes No

If Yes, please specify details / standard algorithm of care for disease type. And why this inappropriate for this patient? If No, please describe the evidence and rationale which supports the use of the requested intervention

24. Summary of previous intervention(s) this patient has received for the condition

(Reason for stopping may include: course completed, no/poor response, disease progression, adverse effect/poorly tolerated)

Start Date:

Stop Date:

Name of Intervention: Reason for stopping or indicate if continuing:

25. What is the patient’s clinical severity? (where possible use standard scoring systems e.g. WHO, DAS scores, walk test, cardiac index, etc)

26. Please summarise current status of patient in terms of quality of life, symptoms, etc.

27. Give details of National or Local Guidelines / NICE

PUBLISHED trials/data (please forward papers / web links for peer-reviewed papers where available)




recommendation of other published data supporting the use of the requested intervention for this condition.

28. How will you monitor the clinical effectiveness of this intervention?

29. What is the minimum time frame/course of treatment at which a clinical response can be assessed?

30. Please outline any anticipated or likely adverse effects of the requested treatment for this patient.

31. What would you consider to be a successful outcome for this intervention in this patient?

32. What are the likely consequence for the patient is this request is not approved?

PART 10: STATEMENT OF EXCEPTIONALITY and RARITY 33. On which basis are you making

this request? Clinical Exceptionality

Rarity and exceptional clinical circumstances

34. If exceptionality, please describe why the patient’s clinical circumstances are exceptional

You must give specific information to indicate how this patient is significantly different to the cohort of other patients with the same clinical condition

35. If request is made on the basis of rarity and clinical exceptionality, please describe why this patient’s condition or clinical presentation is so unusual that there is no relevant commissioning arrangement and provide evidence demonstrating clinical exceptionality

36. How many patients with the same condition or presentation as this patient do you expect to see in the next 12 months?

PART 11: SUPPORTIVE DOCUMENTATION 37. Published supportive

evidence attached? YES/NO/NA(Delete as appropriate) List attachments or provide links to the full Journal evidence.


38. Relevant clinic letters attached?

YES/NO/NA(Delete as appropriate) List attachments:

PART 12: STATEMENT OF SUBMISSION 39. Name of clinician

40. Date completed


GUIDANCE NOTES FOR CLINICIANS COMPLETING THIS IFR FORM IFR Policy and further information The IFR Policy and other policy documents is available from http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx Before submitting an IFR, please check you are using the correct process. IFRs can be submitted by an NHS consultant, a GP, or an equivalent autonomous clinical practitioner where he/she will be responsible for administering the treatment. The requesting clinician is responsible for providing all supporting information and evidence. Uncertain? We WANT to help you! The IFR team would much rather answer your questions now than send the form back to you because it is not properly completed. If you would like help to complete this form, please don’t hesitate to contact the CCG IFR team (see instructions for sending your form below).

Why all these questions? Please be assured there is good reason for all the questions on this form. Not every question need be answered for every case; but please signify ‘not applicable’ rather than leaving a blank.

Part 1: Patient Consent The patient must be made aware that they are consenting for the Individual Funding Request Team to access confidential clinical information held by clinical staff involved in their care about them as a patient to enable full consideration of this funding request Part 2: Details of patient and clinician submitting the request We need to contact you –please provide full details every time including an nhs.net email address. We must be able to identify the patient, provision of the patient’s NHS number is essential. Please note that patient details will not be available to the Panel to ensure anonymity. Please help the IFR Team by not referring to the patient name or initials within the form – the only section which should contain patient demographic details is Part 1, which will be anonymised for Panel. Part 4: Diagnosis and the patient’s condition/ Intervention for which funding is requested The fullest possible information will help the panel make a decision. Please ensure all relevant sections are completed depending on the type of intervention. Part 5: Interventions Information on likely costs helps the CCG to be aware of potential cost pressures, the fullest possible information will help the panel come to their decision. Part 6: Interventions involving drugs Comprehensive information and accurate references will help to get your IFR through the process quickly. Part 9: Details of standard intervention. Please give information of the standard intervention which the patient would otherwise receive if the individual funding request was not being submitted. This is necessary so that the evidence on the proposed intervention can be assessed against evidence for the standard intervention. Part 10: Statement of exceptionality or rarity You must choose either clinical exceptionality or rarity with clinical exceptionality - otherwise the form will be returned. If request is made on the basis of clinical exceptionality, please state as clearly as possible, with reference to the existing policy if relevant, why your patient should be treated as an exception. You must demonstrate why the patient has exceptional clinical circumstances in comparison to the other patients with the same clinical condition. Please note that the IFRs made on basis on rarity only are not accepted. IFR can be either made on the basis of clinical exceptionality or rarity along with clinical exceptionality. Part 12: Statement of submission Completion of this section is equivalent to signature, validating the whole request and indicating that you have discussed the request with the patient and that the patient has given




consent to the submission. If this section is left incomplete the form cannot be accepted. The CCG aims to deal with all IFRs as quickly as possible. Each IFR can only be decided when sufficient information is available to inform the decision. Urgency will be evaluated on the basis of clinical need. If all clinical information is submitted the IFR Team will endeavour to provide a funding decision within 28 working days. Call for help, or send your form to: [email protected] Contact number for NHS staff and clinicians: 020 3350 4123 Contact number for public and patients: 020 3350 4242



REQUEST FOR URGENT CONSIDERATION OF AN INDIVIDUAL FUNDING REQUEST (IFR)

Please ensure the form is typed

IFRs will not be handled as urgent on grounds that waiting until the next IFR panel is inconvenient or problematic for the patient or requesting clinician. Pre-booked appointment is also not an acceptable reason for clinical urgency. Before considering an IFR as urgent careful consideration will be given as to whether sufficient information is available for the IFR Panel to make a decision without compromising any of the principles upon which decisions should be made. If your IFR request is considered to be at a level of such clinical urgency that it cannot wait until the next scheduled panel date, this form must be completed and submitted together with the NHS NWL CCGs IFR form-2014-2015. This can be found here:

NWL_IFR_request_form_-_2014-2015.do Alternatively the standard IFR form can be downloaded from our website, http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx An Urgent (virtual) Panel will be convened and a decision will be made within 3 working days from the date the case is received by NHS NWL CCGs IFR team via our dedicated inbox, [email protected], on condition that all the information to enable the panel to make a decision has been provided. Please note that cases can only be accepted as urgent if the criteria for Q1 and Q3 are met: 1. Are there immediate life

threatening consequences to this treatment not being commenced?*

Yes (Go to Q2) If you wish to add any further information to that already supplied in the standard IFR form, please do so here:

No (Then it is not urgent – please fill in a standard IFR form, the case will go to the first scheduled panel)

Please attach additional sheets if required CONFIDENTIAL Page 1 of 2



2. Has this request been agreed by the Trusts’ Multi-Disciplinary Team as the most appropriate therapy (If appropriate)?

Yes (Go to Q3) If minutes from the MDT meeting are available please include them to your application. No (Go to Q3)

3. Does treatment need to be started within a fortnight?

Yes Please explain why, if you have not already done so in the standard IFR form:

No (Then it is not urgent – please fill in a standard IFR form, the case will go to the first scheduled panel)

*Please do not withhold treatment if treatment is clinically necessary pending funding approval. However, treating without finding approval will be at the Trust’s own financial risk. Please note that Service Developments will not be considered. A Service Development is defined as a request pertaining to a cohort of patients and not reflective of an individual’s clinical circumstances. Please note that the IFR Panel is not the appropriate route for service developments. These requests should go through the appropriate procedures within the requesting Trust in the first instance.

Please attach additional sheets if required CONFIDENTIAL Page 2 of 2

INDIVIDUAL FUNDING REQUEST APPEAL REQUEST FORM 2014/15

Appeal requests must be received within 1 month from the date of the formal decision letter. Please complete this form electronically and email completed form to [email protected]. Incomplete forms will be returned to the applicant without processing. PART 1: ELIGIBILITY OF APPEAL REQUEST Tick box if appeal request has been submitted within 1 month from the date of the decline letter

PART 2: DETAILS OF ORIGINAL CASE

1. Case Reference Number

2. NHS Number

3. Intervention Requested

4. Date of decline decision letter

PART 3: APPEAL GROUNDS An IFR decision can be appealed on 1 of 3 grounds. Please tick ONE of the relevant grounds for appeal below.

1. Illegality: The refusal of the request was not an option that could lawfully have been

taken by the IFR Panel.

2. Procedural impropriety: There were substantial and/or serious procedural errors in the

way in which the IFR Process was conducted.

3. 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.

NHS NWL IFR Appeal Form 2014-15

1


PART 4: INFORMATION TO SUPPORT GROUNDS FOR APPEAL Please provide any additional information supporting the appeal application PART 5: PATIENT PARTICIPATION If the case is taken to an Appeal Panel, the patient is offered the opportunity to attend the hearing for 10 minutes to present any information they would like the Panel to consider

4. Tick if the patient wishes to attend the Appeal Panel hearing

PART 6: STATEMENT OF SUBMISSION 5. Name of clinician

6. Please confirm that you have

completed all relevant part of this form?

7. Date completed

NHS NWL IFR Appeal Form 2014-15 2

NHS NORTH WEST LONDON INDIVIDUAL FUNDING REQUEST PANEL

Case for Consideration

Reference. No

Date of meeting:

Referred by

Application for

Individual circumstances

Psychological assessment

Category

NICE guidance

Clinical Exceptionality/ rarity stated by referrer

Evidence submitted by the referrer

Evidence found by the IFR team

Safety

Cost effectiveness

Use of NHS Resources

Commissioning implications

Key points for consideration

Evidence Summary Sheet Page 1 of 1

Appendix 5: Ethical Framework for decision-making PLEASE NOTE: This is one of the eight supporting documents intended to be read in conjunction with the North West London Collaboration of Clinical commissioning Groups Individual Funding Request (IFR) Policy document. All of these are available at: http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx

Ethical Framework for decision-making Agreeing the important principles that will guide decision-making Public bodies are accountable for their decisions, and should be able to demonstrate that these are reasonable. CCGs have to demonstrate that their decisions about health policy are based on sound principles and have been made after careful consideration of all the relevant factors, with reference to local conditions, and with a conscious intent to avoid discrimination. The Policies Development Group also has authority to develop funding policies to support the decisions made by the Individual Funding Request Panel and the Appeals Panel. These decisions need to be made in the context of the duties of the eight CCGs. The eight North West London CCGs are under a statutory duty to promote the health of the local community. It is also under a duty not to exceed its annual financial allocation. Purpose of the Ethical Framework

The purpose of an ethical framework is to:

• Provide a coherent structure for discussion that ensures all the important aspects of each issue are considered

• Promote fairness and consistency in decision making from meeting to meeting and across different clinical topics

• To consider the implications of the Human Rights Act • Provide a format for expressing and recording the reasons behind the decisions made.

Although there is no objective or infallible measure by which such decisions can be based, the Ethical Framework enables decisions to be made consistently within a structure which respects the needs of individuals and the community. CCGs recognises that its discretion may be affected by National Service Frameworks, National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance and other NHS guidance and directions. Legal Duties

NHS NWL has certain legal duties as a public body and its decisions and actions should be able to withstand scrutiny with regards to

• Meeting statutory duties • Legality • Reasonableness • Proportionality

Ethical Framework for decision Making Page 1 of 4


• Procedural Propriety • Legitimate expectations • Equality and non discrimination

Five principles for decision-making

Five principles for decision-making have been identified. These key principles are the need for decisions to be rational, socially inclusive, and take account of economic factors. A further principle is that the policies themselves, and the process for taking decisions to determine policy, must be clear, consistent and transparent. Another principle is the requirement to balance the needs of the individual with the needs of the wider community, to consider public health issues, and to encourage preventative care and health promotion measures. Principle 1: rational

Aspects of this principle include:

• Being logical in the way reason is applied to reach a decision • Ensuring that the decision is based on evidence of clinical effectiveness • Making a realistic appraisal of the likely benefits to patients • Weighing up all relevant factors, including particularly risks and costs

The NHS is committed to evidence-based healthcare. Decisions are therefore be made on the basis of a reasonable evaluation of the available evidence of clinical effectiveness. Those involved in decision-making have an obligation to seek out the best evidence of clinical effectiveness to inform their decisions. Where available, existing national standards and authoritative guidelines must be considered. Local factors and existing care provision must also be considered. The approach to assessing the validity and credibility of evidence should be broad but maintain high standards of critical appraisal. Both qualitative and quantitative studies will be taken into consideration, with evidence from sources other than large scale randomised clinical trials given appropriate weight. Outcome measures should be considered in terms of their importance to the patients. This is particularly significant in the treatment of illness where no cure can be expected, in palliative care, and the care of people who are terminally ill. Rational decisions will weigh up likely outcomes, the wider contexts in which treatments can be provided, the implications for service delivery, clinical pathways, and the scale and nature of benefits, costs and risks. Principle 2: inclusive

The term ‘inclusive’ may be interpreted as covering:

• Equal opportunity of access to healthcare • Patient involvement in decision-making • Respect for individual needs

Decisions about health policy should be arrived at through a fair and non-discriminatory process, and should reinforce the concept of equal opportunity in access to healthcare. Policies should not discriminate on characteristics, such as race, religion or social status, which are irrelevant to health conditions and the efficacy of treatment.


The aim is to achieve consistent and equitable resource allocation, between individuals and groups in society, and to avoid the kind of arbitrary discrimination sometimes referred to with the term ‘postcode’ as in ‘postcode lottery’ (of health service provision). Policies should work in favour of patient choice at the individual level, respecting the individual’s preferences. In particular, the ethical framework calls for sensitivity to the patient’s perspective and the individual nature of choices based on quality of life. NWL CCGs will respect patient preference about where an IFR treatment, if agreed to be funded, is delivered, as far as this is compatible with IFR Panels’ judgments as to the clinical and cost effectiveness of procedures, against cost quotes that were presented for their decision making, and having regard to whether proposed providers have been commissioned by the NHS for the treatments in question.

Patient choice considerations may be particularly important in end-of-life circumstances. Decisions should also take account of local and societal sensitivities. There should be an active attempt to engage patients, carers and the wider public in the decision-making process to ensure that the perspectives of both healthcare providers and consumers are fully taken into account.

Principle 3: take account of economic factors

Resources are finite and must be managed responsibly. The cost of treatment must be considered. Investment in one area of healthcare will divert resources away from other areas of potential investment. Decisions should be based on careful consideration of the trade-offs between costs and benefits, both in the short and longer term, but also recognise that complex trade-offs cannot necessarily be reduced to simple cost-benefit calculations.

NWL CCGs will consider the extent to which the individual or patient group will gain a benefit from the treatment. NWL CCGs will also balance the needs of each individual against the benefit which could be gained by alternative investment possibilities to meet the needs of the community.

In general, low-cost treatments with high effectiveness will be preferred, whereas high cost treatments with low effectiveness are to be discouraged.

Principle 4: clear and open to scrutiny

Both the policies relating to the IFR Service on behalf of the eight CCGs themselves, and the way they are determined, will be clearly specified, consistent and easy to understand, and open to public scrutiny.

The formal process set out for the identification, prioritisation and review of policy issues has been designed with the need for clarity and scrutiny in mind. However, members of the Committee and sub-groups undertaking this process do have a responsibility to work towards achieving these goals. The information provided to decisions-makers will be fully documented. The process of decision-taking will also be documented, to show that it has conformed to the agreed process and to record the degree of consensus.

Principle 5: promote health for both individuals and the community

Policies which promote health and avoid people becoming ill are considered alongside curative


treatments and other interventions.

There may be times when it is appropriate to target some demographic groups or health issues in order to reduce inequalities and promote the well-being of the community as a whole.

Considerations

CCGs seek to achieve a balance between the ethical principles and to meet the legal duties of public bodies. When making resource allocation decisions the CCGs will therefore take the following considerations into account:

• The clinical needs of the patient, and the nature of the intervention including the

clinician’s treatment plan • The scientific evidence of clinical effectiveness of the proposed intervention and where

in doubt, normative practice • The cost effectiveness of the intervention • The balance of risk and benefit for the patient and the capacity to benefit • The impact of provision of this treatment on NWL CCGs resources and whether needs

can be met with an alternative provider • Consistency in decision making and the impact of providing similar treatment to other

patients with similar needs • The impact of the funding decision on other services or interventions for which money is

then not available • Patient views • Potential human rights considerations and proportionality • Procedural propriety in decision making, transparency and probity • The legality of the funding decision

References

In constructing this ethical framework, a number of existing ethical policy documents have been referred to, including:

• Andrew Harris, PCT decision making in Priorities Panels. A review of the literature and

management of decision making processes in resource allocation for commissioning treatments: Recommendations for PCTs and SHA. 12/10/06

• NHS South East Coast. Principles and Guidance for dealing with Individual Funding Requests, June 2009.

• NHS Thames Valley Ethical Framework, 2005. Available from http://www.mkpct.org.uk/content_files/Insert%20A%20_%20Thames%20Valley%20Ethi cal%20Framework%20Final%20Version%20CCL%20080705.pdf

• NHS Westminster Ethical Decision Making Framework • NHS Hounslow Ethical Decision Making Framework


http://www.mkpct.org.uk/content_files/Insert%20A%20_%20Thames%20Valley%20Ethi

http://www.mkpct.org.uk/content_files/Insert%20A%20_%20Thames%20Valley%20Ethi

Appendix 6:

INDIVIDUAL FUNDING REQUEST

DECISION MAKING FRAMEWORK

This framework provides the NWL CCG’s IFR Panels with a summary guidance for their decision making at IFR panels. It should be considered in the context of the NWL CCG IFR operational Policy.

JF/Sept14 V1.2

IFR Decision Making Framework Page 1 of 4

Appendix 6:

PLEASE NOTE: This is one of eight supporting documents intended to be read in conjunction with the North West London Clinical Commissioning Group (NWL CCG) Individual Funding Request Policy. All of these are available at http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx

The NHS Constitution (March 2013) provides a clear statement for both patients and the NHS 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”. The relevant health body is obliged to fund specified NICE Technical Appraisal 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 cases 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 basis of decision making within an IFR panel is to consider funding for treatments that are not usually funded in patients which clinically exceptional reasons. In this context exceptionality as per NWL CCG IFR operational Policy (v2014) defines this as:

• 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.



Decision Factor Principle for Panel Consideration

Guidance Notes

Service Development • Is there a likelihood of this being a service development and therefore making inequitable decisions?

Factors to consider include: • Previous applications with similar individual

exceptional circumstances. • Factors that would be likely to potentially affect a

wider cohort of the population. Exceptionality

• Can the Panel clearly demonstrate that this patient has exceptional/unique circumstances that would not affect a cohort in the population?

• What clinical evidence is there to back up any statements made by the referring clinician?

• Patient 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)?

• Does the patient have greater capacity to benefit?

Clinical Effectiveness

• What type of evidence has the panel considered in the decision?

Grading of evidence Ia: systematic review or meta-analysis of RCTs. Ib: at least one RCT. IIa: at least one well-designed controlled study without randomisation. IIb: at least one well-designed quasi-experimental study, such as a cohort study. III: well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, case-control studies and case series. IV: expert committee reports, opinions and/or clinical experience of respected authorities

Evidence with less strength could include:

• Patient evidence Local data identified through previous IFRs


Decision Factor Principle for Panel Consideration

Guidance Notes

Patient Outcomes/Capacity to Benefit

• Can the Panel clearly articulate and demonstrate that this patient has significant capacity to benefit from this treatment?

• Panel would need to consider whether the patient is 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 and this is demonstrated by measurable outcomes.

• Do the benefits of the procedure outweigh the risks/potential harm?

• Is there a clear and positive impact on length and quality of life?

Effective use of Resources/Commissioning Impact

• What is the cost to the CCG and how does this demonstrate value for money?

• Consideration of initial costs, on-going costs and any add-on treatment costs such as hospital outpatient appointments for example

• Panel would also need to consider whether there are any cost neutral considerations that can be clearly evidenced including reduction in hospital admissions etc.

Equity

• Is the decision equitable or will it impact on a group of patients within your CCG population?

• Is there a risk of the CCG discriminating against this patient or other unfunded patients on the basis of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion & belief, sex and sexual orientation?

Existing Policy

• Does the patient fall outside an existing CCG policy such as PPwT?

• Is there sufficient evidence to deviate from existing policy parameters?


Appendix 7: North West London Collaboration of Clinical Commissioning Groups Individual Funding Request Panel: Terms of Reference (2014 /2015) PLEASE NOTE: This is one of eight supporting documents intended to be read in conjunction with the North West London Collaboration of Clinical Commissioning Groups Individual Funding Request Policy. All of these are available at http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx

Purpose of IFR Panel The purpose of the NWL Individual Funding Request (IFR) Panel is to consider requests for healthcare funding from General Practitioners, Medical Consultants and secondary care Clinicians that fall outside the range of commissioned services and treatments, for drug or clinical interventions explicitly excluded from the national PbR tariff or from local contracts and where the patient has individual clinical circumstances that are considered clinically exceptional by the applicant. Delegated authority & financial consequences of approved requests The IFR Panel and the IFR Appeals Panel are empowered by the N W L CCG’s to take decisions on their behalf relating to requests for clinical interventions, including the financial consequences of those decisions. The Panel can approve requests up to £50,000 per patient treatment for the Brent, Harrow and Hillingdon (BHH) CCGs and £20,000 for Central London, West London, Hammersmith & Fulham, Hounslow and Ealing (CWHHE) CCGs. For applications over the Scheme of Delegation, approval must be sought from the CCG where the patient is registered with a GP or for non-registered patients, where the patient lives. To support them in the decision making the CCG will receive a case summary from the IFR team and the IFR team will be available to support the CCG governing body. Terms of reference (TOR) The IFR Panel’s role is to consider and determine requests for clinical interventions which:

• Fall outside the range of commissioned services • Have not been approved by a NICE Technology Appraisal (TAG) • Do not fall within the terms of NWL CCG’s funding policies endorsed by the

CCG Boards Fall outside the range of services routinely provided • Are not considered to be within the range of treatments that the NHS would

reasonably be considered to be responsible for funding. The Panel will only consider cases where:

• The application is made on basis of clinical exceptionality of the patient’s case Or

• Rarity of the condition along with the clinical exceptionality. IFR Panel will not consider case if:

NWL Individual Funding Request Panel Terms of Reference - (2014/15) Page 1 of 6



• The request is made on the basis of rarity only • The treatment request may apply to a cohort of patients. In this scenario the

request should be directed through the appropriate service development routes supported by a full business case.

Clinicians making requests to the IFR Panel on behalf of their patients will have to make a positive recommendation, using the NWL’s CCG IFR form, stating the reasons of clinical exceptional, expected outcomes, evidence of effectiveness and cost of the requested treatment. The NWL CCG’s IFR Ethical Framework (supporting document 1) will underpin the IFR Panel processes of decision making. The Chair of the Panel will ensure that the Ethical Framework is applied to the discussion and decisions of the panel ensuring that the various interests are considered in a balanced fashion Membership and Accountability The Panel will be made up of CCG Lead, lay representative, clinical and management staff who will consider requests for individual funding of healthcare treatments under this process. The IFR Panel will consist of voting members and supporting officers. The Panel’s voting members are:

• CCG Chief Operating Officer/ CCG Managing Director (Chair) • GP Medical Advisor or Nominated Deputy • Consultant in Public Health Medicine • Lay member representative

Supported by: Non-voting Panel members, who provide support and/or present cases for consideration:

• Head of IFR & PPwT Service or a Deputy • Medicines Management advisor • IFR Knowledge and Delivery Manager • IFR Administrator (Minutes) • Clinical Specialist (as required)

Management Support The Knowledge & Delivery Manager, supported by Public Health as appropriate, will be responsible for managing and ensuring resolution of all requests for clinical interventions which fall outside the NWL CCG’s portfolio of Service Level Agreements and contracts. The input of colleagues who are responsible for specific care groups or type of service will be available when specialist advice is needed.


The Knowledge and Delivery Manager with guidance from the Public Health Consultant will be responsible for assessing the evidence as to exceptionality and providing a report and recommendations to the Panel.

Frequency of meetings Meetings will be held weekly when there are sufficient cases for review. Cases will be scheduled for panels by the IFR Clinical Triage Panel. Documents will be sent one week prior to panel meetings to allow for circulation and consideration. In very urgent cases a virtual panel will be set up predominantly from the previous week’s panel and for consistency in decision making will follow the same terms of reference and ethical decision making. Decisions are captured in template based on the ethical decision making framework. Quorum To ensure effective, fair and transparent decision making the Panel must be quorate to agree decisions. In order to be quorate, the Panel should comprise of the Chair, GP advisor, Lay representative and consultant in Public Health Medicine. Decisions The IFR Panel will try to reach its decisions unanimously. Where a vote is taken, every question at a meeting shall be determined by a majority of the votes cast by those members present and eligible to vote. Voting may, at the Chair’s discretion, be determined by oral expression or a show of hands; a paper ballot may also be used if the majority of members present so request. In the event of a vote, the minutes will show the total votes cast, and the numbers voting in favour and against, together with any abstentions, but will not name the individual members of the Panel in terms of their voting preferences. If votes are evenly balanced, the Chair shall have a second or casting vote. Confidentiality The NWL CCGs as a public body have a statutory duty to safeguard the confidential information it holds, from whatever source, that is not in the public domain. The principle of this policy is that no individual or company working for or with the NWL CCGs shall not misuse any information or allow others to do so. Information governance policy framework The NWL CCGs have developed a framework for its Information Governance Policy. This will be supported by a set of Information Governance policies and related procedures to cover all aspects of Information Governance which are aligned with


the NHS Operating Framework and the Information Governance toolkit requirements. The Policy framework will encompass the following policies:

• Information Security Policy; • Confidentiality Policy; and • Records Management Policy.

The IFR Panel will protect patient confidentiality in accordance with the Caldicott principles. Patient identifiable information will not be circulated, but will be held by the designated manager. Letters and other information about individual patients must only be stored in the IFR folder to which access is restricted to the designated manager, administrative support and Medicines Management representatives. Precedent Every individual treatment request should be assessed on its individual merits. Previous agreement to fund a procedure does not constitute a precedent without recourse to the Panel. Whether a clinician can demonstrate “exceptional clinical circumstances” in relation to the circumstances of the patient for whom they are submitting a case will depend on the precise clinical facts of each individual case and whether those can genuinely be described as exceptional. However an IFR Panel may consider that a patient who has clinical circumstances which, taken as a whole, are outside the range of clinical circumstances presented by at least 95% of patients with the same medical condition at the same stage of progression as the patient could show that their clinical circumstances were sufficiently unusual that they could properly be described as being exceptional. The IFR Panel should take care to avoid adopting the approach described as the “rule of rescue”. The fact that a patient has exhausted all NHS treatment options available for a particular condition is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Equally the fact that the patient is refractory to existing treatments where a recognized proportion of patients with the same presenting medical condition at the same stage are, to a greater or lesser extent, refractory to existing treatments is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Conflicts of Interest All Panel members should declare any potential conflict of interest with applicants and potential treatment providers before the Panel meeting, and if necessary abstain from decision making about the particular case.


This may affect the quorum in the event that a panel member declares a conflict of interest, and in those unusual instances where the Panel is rendered not quorate and will have to be resumed with a replacement member.

Letter of Indemnity Every member of the Panel who is not an employee of the NWL CCG’s will be provided with a letter of indemnity by NWL CCGs relating to their work for and on behalf of the Panel. So long as that member is acting in a bona fide manner within the remit and scope of the work of the Panel they will not have to meet out of their own personal resources any personal civil liability which is incurred in the execution or purported execution of their duties as a member of the Panel, save where the person has acted recklessly. New Policies Requests that are considered to affect a particular cohort of the population the IFR panel will make a decision on whether to make a decision or refer for policy /service development based on the clinical risk to the patient. The IFR team will refer frequent requests triaged for the same health care intervention that are outside current contracts, such as for PPwT, to the Clinical Commissioning Group so that consideration may be given as to whether to commission the intervention in a service level agreement or contract. Where the IFR Panel considers three or more requests for the same intervention for the same condition, meeting criteria for exceptional circumstances, the provider will be notified and requested that this is discussed as part of the commissioning cycle as a service development. Where there is more than one provider the intervention will also be referred to the IFR Funding Policies Group for consideration as a service development. Record of panel meetings A dedicated IFR Administrator will be responsible for production of minutes of IFR Panel meeting. Minutes will capture the following:

• Details of the IFR Panel discussion • Evidence considered by the Panel in order to reach a decision • Decision rationale • Panel decision and caveats / conditions agreed by the IFR Panel with regards

to the finding decision. The minutes are validated by the Head of IFR/ deputy and signed off by the IFR Panel Chair in order to agree up as formal minutes within 5 working days. Wording of decisions The wording used to describe the panel’s decisions, conditions and rationales in the minutes will be translated exactly into the decision letters. Any error or ambiguity in


this wording is the responsibility of the Chair. The wording of key points in the letters will therefore be iterated for each decision, at the relevant Panel meeting. When preparing minutes, both the Administrator and the Chair should bear in mind that these are documents which could become subject to a Freedom of Information Act request, and use language accordingly. The decisions of an IFR panel are attributable to the panel as a whole. The minutes of discussion about specific concerns raised by individual submissions should avoid person views. Copies of the minutes will not be distributed to panel members for their retention and will not be placed in the public domain. This is in the interests of preserving patient confidentiality. Although patients’ names have been removed, the IFR process is by definition dealing with rare conditions. The singularity of these may be enough to identify an individual.

Communicating the Panel’s decision The Panel’s decision will always be communicated in writing by a secure means. The letters communicating the panel’s decision may be signed by or on behalf of the IFR Panel Chair.

Reporting Monthly CCG IFR Governance report An Annual Report will be prepared by the Head of IFR for the CCG Boards Review of the IFR Terms of Reference TOR will be reviewed on a bi-annual basis.


Appendix 8: North West London Collaboration of Clinical Commissioning Groups Individual Funding Requests Appeal Panel: Terms of Reference (2014 / 2015) PLEASE NOTE: This is one of eight supporting documents intended to be read in conjunction with the North West London Collaboration of Clinical Commissioning Groups Individual Funding Request Policy. All of these are available at http://www.hounslowccg.nhs.uk/what-we-do/individual-funding-requests.aspx Purpose of Panel The Appeals Panel exists to undertake a ‘quality assurance check’ on the decision making procedure and outcome originating from the IFR Panel following an appeal being lodged by the clinician responsible for the patient, the patient or a person with the authority to represent the patient. The IFR Appeal Panel will not reconsider the case itself. Appeal Panels can uphold initial decisions or recommend further consideration by an IFR Panel. Option to Appeal is not available for the cases where the funding request is denied by the IFR clinical Triage Panel. In this scenario if the applicant is dissatisfied with the decision, next step is to present the case to the full IFR Panel. Delegated Authority The IFR Panel and the Appeals Panel are empowered by eight North West London CCG’s to take decisions on their behalf for funding requests for clinical interventions. The IFR and Appeals Panel are accountable to the NWL CCG’s (Reference Standing Orders, Financial Instructions and Scheme of Delegation) Process for Appeal The patient (or parent/guardian in the case of minors) or responsible clinician may appeal against a decision of the IFR panel. The clinician will be informed of the right to appeal when they are informed of the decision of the original Panel; it is then the referring clinician’s responsibility to communicate the decision to the patient. The appeal must be in writing and state the reasons for disputing the IFR Panel’s decision. It is normally expected that any appeal by a patient or a patient’s representative will be supported by the clinician managing the patient’s case. Appeals that are not supported by clinician managing the patient’s case will only be considered if the Appeal Chair considers that there are compelling reasons in relation to the NWL CCGs policies and procedures for handling IFR cases. An Appeal can only be submitted for the applications that are declined by the IFR Panel and is to be based on one for the following grounds:

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1. Illegality: The refusal of the request was not an option that could lawfully

have been taken by the IFR Panel. 2. Procedural impropriety: There were substantial and/or serious procedural

errors in the way in which the IFR Process was conducted. 3. 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.

In the event of Appeal against the ‘rationality’, ‘Illegality’ or procedural process of an IFR decision, The Appeals Panel Chair will review the Appeal and decide whether to convene an Appeals Panel taking into consideration:

• Whether any further action can be taken to resolve the issue, other than by convening the IFR Appeals Panel

• What further value convening an Appeals Panel would add to the process • Whether there are sufficient grounds for an appeal

A decision to reject or accept an Appeal can only be made by the IFR Appeal Panel Chair. The Appeal Panel Chair’s decision will be supported by a recommendation from the clinical triage team. If the Appeal is accepted by the Chair then the IFR Appeal Panel will consider the Appeal Appeals Panel Duties If the Appeal is accepted by the Chair then the IFR Appeals Panel will consider the appeal, by thorough review of the documentation of the application, IFR Panel meeting minutes and decision letter in order to decide whether the IFR Panel:

• followed an appropriate decision making process • considered the information presented correctly and made a decision in line

with its terms of references • made a decision in line with relevant Policies & Procedures of NWL CCG’s • made a fair and reasonable decision

It is to be noted that the role of the Appeal Panel is to undertake a ‘quality assurance check’ on the decision-making procedure and outcome originating from the IFR Panel, not to reconsider the case itself.

The Appeals Panel will decide to either, uphold the original decision or make recommendations to the IFR Panel to reconsider the case.

Decisions will be made by consensus as far as is possible. In the event that the panel is unable to reach agreement by this method, then the decision making procedure as outlined in the Terms of Reference for the IFR Panel will apply. In the event of an Appeal, there is provision for patients to be fully involved in the process, by means of a written statement and/or presentation to the Appeal Panel.


In the event of a clinician, or patient/patient’s guardian or other recognised representative supported by a clinician, requesting to present their case to the Appeals Panel in person, then a presentation of no more than ten minutes may be made. No discussion of the presentation between Panel members and the presenter, other than for points of clarification will be permitted. The patient and or their clinician will be asked to leave after the presentation and the decision will be sent to the referring clinician. Where any of the above wishes to make personal representation, efforts will be made to schedule the appeal panel at a convenient date and time. However, this will be balanced with the need to convene a panel within the timescales stated in these Terms of Reference and so may not always be possible The Appeals Panel should be convened within 28 working days of acceptance of the Appeal by the Appeal chair.

Membership The IFR Appeal Panel will consist of voting members and supporting officers. The Panel’s voting members are

• CCG Lay Representative (Panel Chair) • CCG Director of Quality/Clinical Governance/CCG Director of

Nursing/Clinical Governance or nominated Deputy • IFR Lay Person • Commissioning / Contracts Director or nominated deputy • A General Practitioner

Supported by (as appropriate):

• Head of IFR & PPwT Service or a Deputy • Consultant in Public Health • Secondary Care Clinical Representative • Medicines Management Representative • Senior IFR Business Manager / IFR Knowledge & Delivery Manager • IFR Business Manager ( for Minutes)

In addition to the members of the Appeals Panel, any other person may also attend with the specific agreement of the Chair of the Appeals Panel Quorum To ensure effective, fair and transparent decision making the Panel must be quorate to agree decisions. In order to be quorate, the IFR Appeal Panel should comprise of all five voting members listed above. Frequency Meetings shall be held within 28 working days of the acceptance of an appeal.


Notification of Decision The process and timescale for notification of IFR Appeal Panel decision will be the same as with the IFR Panel. The letter will detail the grounds for this decision and the circumstances under which the Complaints Procedure of the responsible CCG may be relevant. Decision letter will be sent to the Appellant within five working days after the Appeal Panel.
