INDIVIDUAL CASE POLICY FOR

NHS BEDFORDSHIRE

Final 14/10/08

NHS BEDFORDSHIRE

INDIVIDUAL CASES POLICY

POLICY ON INDIVIDUAL ELECTIVE REFERRALS FOR CARE NOT ROUTINELY COMMISSIONED OR PROVIDED BY NHS BEDFORDSHIRE

1.0 AIM OF COMMISSIONING

1.1 Within the resources available to us, NHS Bedfordshire aim to commission and provide high quality clinical care to which access is available to all our population, equitably and consistently, based solely on clinical need. We believe that the best way to achieve this is by commissioning clear pathways of care which span the interfaces between primary and secondary care (and tertiary when required) and are supported by shared clinical protocols and arrangements for audit and outcome evaluation.

1.2 NHS Bedfordshire will pursue this approach to commissioning in line with current government policy¹. This will enable us to develop a comprehensive ¹ range of care pathways, linked to a variety of care providers, to which our population will have consistent and equitable access based on clinical need.

1.3 The mechanism through which investment and disinvestments decisions are taken is the Commissioning Plan process. NHS Bedfordshire will not expect to make decisions outside this process and in particular will not expect to commit new resources in year to the introduction of new healthcare technologies (including new drugs, surgical procedures, public health programmes) since to do so risks ad hoc decision making and can destabilise previously identified priorities.

1.4 To support the Commissioning Plan process, NHS Bedfordshire will use the Bedfordshire Commissioning Group (BCG) to advise it on the clinical and cost-effectiveness of new healthcare interventions and also on opportunities for disinvestments from less effective services. The BCG will do this through an ongoing programme of work throughout the year. The Bedfordshire and Hertfordshire Priorities Forum, the Bedfordshire and Luton Joint Prescribing Committee and NHS Bedfordshire Prioritisation Process will actively feed into the BCG decision-making process.

1.5 Since the Commissioning Group assesses individual interventions on their own merits it may be that not all interventions supported by the Group will be affordable from available budgets. The Commissioning Plan process will be the final determiner of those interventions prioritised for investment in the coming year.

1.6 NHS Bedfordshire accepts that there may be individual cases where a patient's needs cannot be met through existing care pathways. NHS Bedfordshire has set up an Individual Case Panel to consider the circumstances of individuals for whom a referral outside existing pathways may be appropriate. In considering individual cases, the Panel will apply the Ethical and Commissioning Principles. (Appendix 1).

¹ Commissioning a Patient-Led NHS; available at: http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4116716&chk=/%2Bb2QD

1.7 NHS Bedfordshire will use an Individual Case Panel to consider individuals who might have circumstances that make them an exception to the policies above. It is not the role of the Individual Case Panel to make commissioning policy on behalf of NHS Bedfordshire. Consideration by an Individual Case Panel will always start from the overall policy position (whether or not the intervention has been prioritised through the Commissioning Plan) and will seek to determine exceptionality on that basis.

1.8 Determination of `exceptionality':

There is no complete definition of the conditions which are likely to come within the definition of exceptionality. However, in order for individual funding to be agreed there must be some unusual or unique clinical factor about the patient that suggests that they are:

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

If a patient's clinical condition matches the 'accepted indications' for a treatment that is not funded, their circumstances are not, by definition, exceptional.

It is for the requesting clinician (or patient) to make the case for exceptional status.

Social value judgments are rarely relevant to the consideration of exceptional status.

1.9 The Individual Case Panel will not usually make a decision to fund a patient where by so doing a precedent would be set that establishes new policy (because the patient is not, in fact, exceptional, but representative of a group of patients) - however, if a drug is proposed before a policy decision has been reached by the PCT, this can be considered by the ICP pending a policy being agreed.

In cases where the Individual Case Panel feels strong evidence has been provided in support of a particular health technology, it should make a recommendation to the Bedfordshire Commissioning Group for further consideration by the Priorities Forum/Commissioning Plan process, but individual funding of the specific case must be refused.

2.0 CURRENT PATIENT PATHWAYS

2.1 Acute Referrals

2.1.1 NHS Bedfordshire's preferred providers for acute care are detailed on NHS Bedfordshire's “Choose and Book” and can be accessed via the patients' General Practitioners. In addition NHS Bedfordshire holds a portfolio of acute service level agreements with providers across the East of England and across the rest of the UK for a full range of services, should an alternative provider or a second opinion be required. Guidance on alternative referrals currently covered by SLAs can be obtained from the Commissioning Department. The provision of a referral for a second opinion is, as the term implies, for an opinion as to the appropriateness of future treatment options. It does not imply that NHS Bedfordshire will necessarily commissioning the treatment option recommended if this is outside of pathways of care that are normally commissioned by NHS Bedfordshire.

2.1.2 Patients requiring elective referral will be offered a choice of provider in line with the Choose and Book requirements at the point of referral. Where the referral required is of a specialist nature for which there are capacity issues or where the patient has particular needs it may be appropriate to offer a restricted choice². The provision of choice is to allow patients the opportunity to choose the provider of the service that is to be provided. It does not entitle the patient to choose any form of treatment if this is outside of the care pathways that are normally commissioned by NHS Bedfordshire.

2.2 Mental Health Referrals

2.2.1 These should be made in line with the service level agreements that exist for these services. A list of service level agreements can be obtained from the Commissioning department.

2.2.2 Referrals using these pathways can be made from primary care or secondary care if appropriate. NHS Bedfordshire believes that these pathways will meet the vast majority of care needs for their populations in line with NHS Bedfordshire's Ethical and Commissioning Principles.

2.2.3 Any proposed referrals outside these pathways will first need to be agreed for funding by NHS Bedfordshire before the referral can be made

3.0 POLICY GUIDANCE

3.1 In considering individual cases, NHS Bedfordshire will apply the Ethical and Commissioning Principles and the following guidance expanding upon it. A flow chart demonstrating the process is attached to this policy (Appendix 2).

3.2 Introduction of new drugs and technologies

3.2.1 NHS Bedfordshire does not expect to introduce new drugs/technologies in an ad hoc basis through the mechanism of individual case funding. To do so risks inequity, since the treatment will not be offered openly and equally to all with equal clinical need. There is also the risk that diversion of resources in this way will destabilise other areas of health care which have been identified as priorities by NHS Bedfordshire. NHS Bedfordshire expects consideration of new drugs/technologies to take place within the established planning frameworks of the NHS (ie the Commissioning Plan process) after consideration by the appropriate committees i.e., Bedfordshire Commissioning Group, the Bedfordshire and Luton Joint Prescribing Committee and the Bedfordshire and Hertfordshire Priorities Forum. This will enable clear prioritisation against other calls for funding and the development of implementation plans which will allow access for all patients with equal clinical need.

² “Choose & Book” - Patients' Choice of Hospital and Booked Appointments. Policy Framework for Choice and Booking at Point of Referral. DH, London, August 2004.

www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance.

3.2.2 There are high cost interventions which PCT is required to consider from time to time. The PCT will broadly follow the QALY/ICER system recommended by NICE for valuing the clinical and cost effectiveness of interventions but, in adopting commissioning policies for particular interventions, it may deviate from the NICE strict financial limits where there are compelling reasons to do so. However the PCT does not accept that additional NHS investment is necessarily justified because a medical condition is rare. An approach approving differential investment for those with rare conditions would seek to place a value on the lives of patients with rare conditions which was higher than those with more common conditions.

The PCT recognises that, from time to time, it will have to consider very high cost interventions. The PCT may conclude that the intervention is not cost effective even if the intervention were clinically effective to save or extend the lives of patients. The usual rule for the PCT is that where a decision is made that an intervention is not to be routinely funded, the PCT will always consider exceptional cases where funding may be provided. However if the PCT were faced with an intervention which it considered was not ever likely to be cost effective because it required investment which was very significantly greater than the QALY/ICER system recommended by NICE, the PCT shall be entitled to designate the intervention as one where it will not normally consider individual exceptions to the policy. The PCT does not wish to raise expectations of patients and their families by a reference to the Individual Case Panel if, whatever the individual clinical or social circumstances of the patient, an investment at that level for an individual patient cannot be justified.

In such circumstances the PCT will still be prepared to consider individual cases if the anticipated cost for that individual would be significantly less than the anticipated cost for the other patients who could benefit from the treatment. The PCT would also be prepared to keep the general commissioning policy for this intervention under review and would be prepared to reconsider the PCT's overall policy with respect to the intervention if an application were made for funding for an individual patient. However, where a PCT policy makes such a designation, no applications for individual patients will be possible to the Individual Cases Panel.

3.3 NICE New Technology Appraisals

3.3.1 Drugs and technologies that are approved as the result of a NICE technology appraisal need to be implemented within 3 months of the appraisal being published. NHS Bedfordshire will seek to ensure implementation of NICE technology appraisals without delay but recognises that delays may be inevitable where significant service change and/or development are required as part of the implementation. NICE also produces clinical guidelines, which are a valuable source of good practice, but the health service is not required to statutorily implement them in the same manner as applies to the technology appraisal guidance. Neither is NHS Bedfordshire statutorily required to fund NICE Interventional Procedure Guidance (IPG)

3.4 Treatments covered by PCT commissioning policies

3.4.1 Treatments not currently included in established pathways or identified for funding through the Commissioning Plan process are not routinely funded. For a number of these interventions NHS Bedfordshire has published specific policy statements setting out restrictions on access based on evidence of effectiveness or relative priority for funding.

For cases coming through the Prior Approval Process, details can be accessed on the Bedfordshire and Hertfordshire Priorities Forum website www.bhprioritiesforum.nhs.uk or by contacting the ICP coordinator. A flow chart demonstrating the process is attached to the this policy (Appendix 3)

3.4.2 Policy development is an ongoing process and future policy on further treatments, in response to NICE Guidance/Guidelines, health technology assessments, etc. will be produced by the Bedfordshire Commissioning Group for local implementation. Decisions taken by the Bedfordshire and Hertfordshire Priorities Forum and the Bedfordshire and Luton Joint Prescribing Committee will actively feed into the decision-making process of the BCG.

3.4.3 Clinicians uncertain about the status of a particular treatment should contact NHS Bedfordshire Commissioning Department for advice.

3.5 Treatments not covered by PCT commissioning policies

3.5.1 Patients with rare conditions and/or patients for whom first or second line treatments are inappropriate for some reason are unlikely to have potential treatment options that are covered by NICE or by local commissioning policies. In such circumstances the case that is being made by the treating clinician should be judged against the Ethical and Commissioning Principles in the Ethical Frame work document.

3.5.2 It is important that decisions on individual cases are not used as a means of “creeping implementation” for new technologies. Consideration therefore needs to be given as to the likelihood of other patients having the same clinical need and the danger of precedent setting for groups of patients. Such situations should be considered by the Bedfordshire Commissioning Group.

3.5.3 Patients with rare conditions should neither be advantaged nor

disadvantaged simply because their condition is uncommon.

3.6 Requests to continue funding for patients entering into or coming off drugs trials

3.6.1 NHS Bedfordshire does not expect to fund patients entering clinical trials unless prior approval for funding individual patients in such trials has been obtained from NHS Bedfordshire. In approving the funding of individual patients for clinical trials, NHS Bedfordshire will also make it absolutely clear what particular elements of the trial that it will be willing to fund.

3.6.2 NHS Bedfordshire does not expect to provide funding for patients to continue medication/treatment commenced as part of a clinical trial. In line with the Medicines Act 2004³ and the Declaration of Helsinki⁴, the responsibility for ensuring a clear exit strategy from a trial AND ensuring that those benefiting from treatment will have ongoing access to it, lies with those conducting the trial. The initiators of the trial (provider trusts and drug companies) have a moral obligation to continue funding patients benefiting from treatment until such time as NHS Bedfordshire agrees to fund through the Commissioning Plan process. Where the treatment is not prioritised through the Commissioning Plan, the responsibility remains with the trial initiators indefinitely.

3.7 Requests to continue funding of care commenced privately

3.7.1 Patients have a right to revert to NHS funding at any point during their care. However, if they wish to exercise this right, NHS Bedfordshire will expect their care to be transferred to local pathways. Funding for the individual to continue care in a private facility, or to transfer to an NHS provider with which a clinician consulted privately has a link, will not routinely be authorised. Where personal circumstances may make such funding appropriate, the case will require consideration by the Individual Case Panel.

3.8 Requests for referral to a specialist provider (tertiary, regional or

supra-regional centre or specialist private provider)

3.8.1 The majority of referrals to specialist centres are made by secondary care consultants. NHS Bedfordshire expects consultants to refer patients for tertiary/specialist care using established pathways covered by Service Level Agreements. Accordingly, requests for referrals to specialist providers outside existing pathways will need to be considered first by NHS Bedfordshire after assessment by appropriate specialists within the existing pathway.

Should a local consultant feel that a referral outside existing pathways is a priority for a particular patient, the consultant should ask for the case to be considered by the Individual Case Panel. The consultant should not refer the patient to another provider without first getting the approval of NHS Bedfordshire.

NHS Bedfordshire will decline to fund any patient referred to another provider without first getting the funding approval from NHS Bedfordshire.

3.9 Decisions inherited from other Primary Care Trusts

3.9.1 Occasionally patients move in to the area and become the responsibility of NHS Bedfordshire when a package of care or treatment option has already been started by another PCT that was previously responsible for the patient's care. NHS Bedfordshire will normally honour such decisions providing the care pathway has already been initiated.

³ http://www.legislation.hmso.gov.uk/si/si2004/20041031.htm

⁴ http://www.wma.net/e/policy/b3.htm

3.10 Request for funding for treatment abroad

Bedfordshire PCT will not routinely fund treatment outside the UK, in recognition that:

Applications for funding for treatment within an EEA country (or Switzerland) may be considered by the PCT in accordance with current Department of Health's Guidance (see www.dh.gov.uk for more details) where:

In determining whether there might be an undue delay, the PCT will have regard to the patient's estimated treatment time within the NHS, an objective assessment of the patient's clinical circumstances and treatment needs (and if appropriate other, non-clinical circumstances), the probable course of the patient's illness, the history of the patient's illness and, if appropriate, the level of pain or disability the patient is experiencing.

and/or

Bedfordshire PCT will not normally provide funding other than where prior approval has been sought, and confirmed, by the PCT and, where relevant, the Department of Health ahead of treatment commencing. The PCT strongly recommends that treatment is not undertaken without written funding approval on the assumption that retrospective NHS funding might be available.

4.0 Consideration Of Individual Cases

4.1 Where a doctor wishes to make a referral/request for funding for an intervention not routinely funded within current pathways the following process should be followed.

[NB: This will compulsorily include any consultant/clinician in a primary, secondary or tertiary centre who wishes to make a referral to another consultant either within or outside his/her own Trust hospital]

Referral forms which are required to be used within the process are attached to this policy.

[NB: For general practitioners, a detailed letter would usually be sufficient, however it needs to include the following]:

4.2 Initial Discussion with PCT Commissioning Manager

The Commissioning Manager/relevant commissioning clinician will be able to advise whether the proposed referral would be covered by our existing portfolio of SLAs or current individual case commissioning policies.

If not, the Commissioning Manager may be able to suggest an alternative that will meet the patient's clinical needs. The Commissioning Manager is unable to prioritise referrals outside existing pathways and is not able to take an individual's personal circumstances into account.

4.3 If the Commissioning Manager has reason to consider that simple application of SLAs and/or commissioning policies would be inappropriate for a case then the case should be considered by the weekly Case Review Panel.

Membership:

The group will be able to consider three options; agree the request without reference to the Individual Case Panel, refuse the request without reference to the Individual Case Panel, or refer to the Individual Case Panel.

4.4 Refusing the request is an option where there is a clear policy concerning the situation and where there is no evidence that the individual would constitute an exception. Where there is uncertainty, the case should be referred to the Individual Case Panel. All decisions made by the Case Review Panel will be recorded and will go to the Individual Case Panel for ratification which will be reported to the Bedfordshire Commissioning Group.

The Case Review Panel can approve individual episodes or packages of care up to the per request value of £25,000 in line with the criteria laid out in paragraph 4.4 above. If the per request value exceeds £25,000, the case will be automatically referred up to the Individual Case Panel, together with the details of the recommendation for funding.

4.5 The clinician can appeal against the initial refusal of NHS Bedfordshire to refer the case to the Individual Case Panel. He/she will have to completely fill in the application form for consideration of individual case funding, and only when the full information is received and reviewed by the Commissioning Manager and verified as to its completeness and validity, will the case be referred up to the Individual Case Panel. Incomplete forms will be rejected by the Commissioning Manager and will not be forwarded to the Individual Case Panel for consideration of funding.

4.6 The Individual Case Panel will consider all cases referred to it by the Case Review Panel. In reaching a decision on individual funding, the Panel will consider each case in line with NHS Bedfordshire's Ethical and Commissioning Principles. The Panel will set out its decision and the reasons for it in writing to the referring doctor.

4.7 If the referring doctor feels that he or she has further relevant information available which has not been considered by the Case Review Panel or feels that all the relevant information was available to the Case Review Panel when the decision was made, but remains unhappy with the decision, they may ask for it to be reviewed by NHS Bedfordshire's Individual Case Panel. The Individual Case Panel will set out its decision and the reasons for it in writing to the referring doctor.

4.8 Should the referring doctor remain unhappy with the (process) adopted in reaching Individual Case Panel's decision, they may ask for it to be reviewed by the Individual Case (Process) Appeals Panel.

4.9 Should the referring doctor or patient remain unhappy with the Appeals Panel decision, it is open to them to pursue the matter through the NHS Complaints Procedure. Information on how to do this is available from NHS Bedfordshire's Complaints Managers.

5. Preparing A Case For The Individual Case Panel

5.1 NHS Bedfordshire will have an Individual Case Panel and an Appeal

Panel.

5.2 Requests to consider an individual case will come from the clinician involved in the patient's care and who wishes to initiate a referral outside local pathways. It is the responsibility of the individual seeking Individual Case consideration to ensure that all relevant information is forwarded to NHS Bedfordshire. This should include:

a) An outline of the patient's problem and the circumstances of the case, including any previous treatment

b) A clear statement of the referral/treatment plan proposed for the patient, including at what point the patient would return to local pathways

c) Consideration of whether the patient's needs could be met within existing pathways

d) If the care could be provided within existing pathways, a statement of why an alternative referral, which would not be offered to others with similar clinical need, is a priority in this case

e) If the care is not routinely funded by NHS Bedfordshire, evidence to show that the patient is significantly different to the population of patients with similar clinical needs who would also not be offered the treatment. This should include evidence that the patient is likely to gain significantly more benefit from the treatment than would be expected for other patients not currently offered it.

5.3 NHS Bedfordshire's individual case administrator will write to the individual seeking consideration of the case confirming that the request has been received and seeking further information in cases where information is incomplete. If information is required from third parties, written consent shall be obtained from the patient prior to seeking such information.

5.4 The Individual Case Co-ordinator may also write to other health professionals with clinical involvement in the patient's care (for example consultant, therapist etc) for clarification of the patient's needs, evidence base etc, if appropriate.

5.5 The Commissioning Directorate, with support from public health and medicines management where appropriate, will produce a summary of the case for the information of the Panel. This will act as the front sheet to the attached documentation received from the referring clinician, patient, etc.

6.0 Individual Case Panel

6.1 The Individual Case Panel is a sub-committee of the Bedfordshire Commissioning Group. It has delegated authority from NHS Bedfordshire Board to make decisions in respect of funding for individual cases.

6.2 Membership:

The Non-Executive Director will be chair of the Panel.

NHS Bedfordshire reserves the right to amend the membership of the Panel, after due consultation with the Professional Executive Committee (PEC).

The pharmaceutical advisor/public health specialist/mental health commissioner/Commissioner for Adult Health Partnerships may be requested to attend the Panel meeting as and when necessary, in order to clarify funding issues around difficult and complex cases.

6.3 The Group will meet monthly, quorum being attendance by at least four members, one of which must be the Director of Public Health or representative. The decision of the Individual Case Panel will be carried on a majority vote. In the case of a tie in the voting, the Chair will have a casting vote.

Cases will be considered at the next available Panel meeting. If further information is required to prepare the case for consideration, this may delay presentation to the Panel until the next or subsequent month. All required information from the Trust/clinician must be sent to NHS Bedfordshire at least 5 working days before the scheduled date of the next meeting of the Panel.

6.4 In cases where urgent consideration can be justified, an “extraordinary” Panel meeting may be convened or another method of rapid discussion (eg via e-mail) will be considered. Rapid discussion via e-mail may also be used, subject to agreement of Panel members, on other occasions to expedite rapid decision making (for example, where it is difficult to achieve quorum for a scheduled meeting or where there is only one case to discuss).

In the rare but very extreme complex cases, where the patient's life is in imminent danger, the relevant Commissioning Manager can take an immediate funding decision on the patient without recourse to the Panel after urgent discussion with the Medical Director/Director of Public Health but the case must be reviewed at the subsequent Panel meeting by the full Panel.

6.5 Cases will be anonymised before consideration by the Panel. Panel members having clinical involvement with a particular case will be excluded from the discussion of that case. The clinician seeking the referral (usually the GP) may attend to provide clarification of the reasons for seeking referral as set out in para.5.2 above. Clinicians attending for this purpose will be excluded from the subsequent Panel discussion of the case. Patients will not be invited to attend the Panel meeting.

6.6 The Chair of the Panel will write, within ten working days, to the referring clinician setting out the Panel's decision and the reasons for it.

6.7 If the referring clinician is unhappy with a Panel's decision he/she may ask for further consideration or appeal as set out in paragraph 4.7 above.

6.8 The Panel will provide a summary of its decisions to the Bedfordshire Commissioning Group and will flag up to the BCG any individual decisions which may have implications for wider PC T policy

6.9 The Panel will have devolved responsibility to be able to approve individual episodes or packages of care up to the value of £25,000. For values greater than this additional approval will be required from the Chief Executive.

7.0 Individual Cases Appeals Panel

7.1 Membership:

[NB: the panel member at the Individual Case Panel cannot be a member of the Appeals Panel for the same patient]

The Non-Executive Director will chair the Appeals Panel.

NHS Bedfordshire reserves the right to amend the membership of the Panel, after due consultation with the Professional Executive Committee (PEC).

7.2 The Appeals Panel will be convened when necessary to consider appeals against Individual Case Panel decisions, the quorum being attendance by at least three members.

7.3 The doctor wishing to appeal against an Individual Case Panel decision must notify the Individual Case Co-ordinator at NHS Bedfordshire of their intention in writing, within three months of the date of the Panel's decision.

7.4 The Appeals Panel will consider whether the original decision of the

Individual Case Panel was valid in terms of process, factors considered and criteria applied⁵. In deciding an appeal, the Appeals Panel will consider whether:

a) the decision was consistent with the principles of NHS Bedfordshire, as set out in the Ethical and Commissioning Principles

b) the decision was consistent with the Individual Cases Policy

c) the decision was consistent with previous similar decisions

d) in reaching the decision the Panel had:

i) taken into account and weighed all relevant evidence;

ii) given proper consideration to the claims of the patient (or group of patients) under discussion and accorded proper weight to their claims against those of other groups competing for scarce resources;

iii) taken into account only material factors

iv) acted in utmost good faith

v) taken a decision that is in every sense reasonable

⁵ McCloskey, B. Judicial Review, A Good Practice Guide for Health Authorities. (1999)

Association of Directors of Public Health with Dearden Management, Bristol.

7.5 It is important to note that the Appeals Panel will not consider new information in support of a case. If new information becomes available, the Individual Case Panel should be asked to reconsider the case in the light of this.

7.6 The decision of the Appeals Panel will be carried on a majority vote. In the case of a tie in the voting, the Chair will have a casting vote.

The Appeals Panel Chair will write to the referring clinician within ten working days with the Panel decision.

7.7 The Appeals Panel will not be able to refer a decision back to the Individual Cases for further consideration. If the Appeals Panel finds that there was a failing in the process, as defined in paragraph 7.4, they will also have the responsibility of making the definitive decision on whether NHS Bedfordshire should approve the treatment being requested. A failure in the process of handling an individual case request does not necessarily mean that the decision that was made was incorrect.

7.8 Patients who remain unhappy with the Appeal Panel decision may pursue the matter through the NHS Complaints Procedure. Information on this can be obtained from NHS Bedfordshire Complaints Manager.

8.0 Evaluation and Audit

8.1 On-going evaluation will take place through regular reporting to the BCG. In addition process audits of, for example, time taken to consider cases, consistency of decisions, etc, will be undertaken.

9.0 Training and Support

9.1 Opportunities for training for Individual Case Panel and Appeals Panel members in evaluation of evidence and health care ethics will be established and provided on a rolling basis.

10.0 Policy Review

10.1 This policy will be reviewed annually by the Professional Executive Committee and Board.

APPENDIX 1

NHS BEDFORDSHIRE

ETHICAL and COMMISSIONING PRINCIPLES

NHS Bedfordshire receives a fixed budget from central government with which to commission all the health care required by their populations. NHS Bedfordshire has insufficient resources to fund all types of health care that might be requested for their populations. It is inevitable that NHS Bedfordshire has to make choices about which types of healthcare to commission. This document sets out the principles NHS Bedfordshire will use to make these decisions in order to make the process consistent, transparent and fair. These principles have been developed from the original Ethical Framework of the Bedfordshire and Hertfordshire Priorities Forum.

Our commissioning decisions will be based on the following principles:

The aim of commissioning is to achieve the greatest possible improvement in health outcome for our population, within the resources that we have available. In deciding which interventions to commission, NHS Bedfordshire will prioritise those which produce the greatest benefits for patients in terms of both clinical improvement and improvement in quality of life.

We will ensure that the care we commission is based on sound evidence of effectiveness. We will usually expect this to come from sources such as the National Institute for Public Health and Clinical Effectiveness, well designed systematic reviews and meta-analyses or randomised controlled trials.

The key success factors in evaluating clinical effectiveness are the need to search effectively and systematically for relevant evidence, and then to extract, analyse, and present this in a consistent way to support the work of prioritisation and commissioning. Choice of appropriate clinically and patient-defined outcome needs to be given careful consideration, and where possible quality of life measures and cost utility analysis should be considered. We will promote treatments for which there is good evidence of clinical effectiveness in improving the health status of patients and will not normally recommend treatment that is shown to be ineffective. Issues such as safety and drug licensing will also be carefully considered. When assessing evidence of clinical effectiveness the outcome measures that will be given greatest importance are those considered important to patients' health status. Patient satisfaction will not necessarily be taken as evidence of clinical effectiveness. Trials of longer duration and clinically relevant outcomes data may be considered more reliable than those of shorter duration with surrogate outcomes. Reliable evidence will often be available from good quality, rigorously appraised studies. Evidence may be available from other sources and this will also be considered. Patients' evidence of significant clinical benefit is relevant.

We will take into account cost-effectiveness analyses of healthcare interventions (where available) to assess which yield the greatest benefits relative to the cost of providing them. We will compare the cost of a new treatment to the existing care provided and will also compare the cost of the treatment to its overall benefit, both to the individual and the community. We will consider technical cost-benefit calculations (eg quality adjusted life years), but these will not by themselves be decisive.

We consider each individual within our populations to be of equal value. We will commission and provide health care services based solely on clinical need, within the resources available to us. We will not discriminate between individuals or groups on the basis of age, gender, gender identity, sexual orientation, race, religion, lifestyle, occupation, social position, financial status, family status (including responsibility for dependants), intelligence, disability, physical or cognitive functioning. However, where treatments have a differential impact as a result of age, sex or other characteristics of the patient, it is legitimate to take such factors into account.

NHS Bedfordshire has a responsibility to address health inequalities across our population. We acknowledge the proven links between social inequalities and inequalities in health, access to health care and health needs. Higher priority may be allocated to interventions addressing health needs in sub-groups of our population who currently have poorer than average health experience (eg higher morbidity or poorer rates of access to healthcare).

NHS Bedfordshire will ensure that the care we commission is delivered as close to where patients live as possible. Some services cannot be provided in local settings and we may need to commission some services from distant providers in order to ensure quality, safety and value for money. NHS Bedfordshire will also ensure that it commissions safe services for its population.

NHS Bedfordshire respect the right of individuals to determine the course of their own lives, including the right to be fully involved in decisions concerning their health care. However, this has to be balanced against NHS Bedfordshires' responsibility to ensure equitable and consistent access to appropriate quality healthcare for all the population. In commissioning healthcare, NHS Bedfordshire will:

i) ensure that in assessing the effectiveness of health care, we take account of outcomes that are important to patients and the patient's experience of the care.

ii) ensure, wherever possible, that within the care commissioned or provided there are a range of alternative options available, and that patients are given the necessary support to make an informed choice.

iii) recognise that evidence of effectiveness usually relates to groups rather than individuals. We have set up an “individual case” mechanism to allow individuals to be considered as an exception to commissioning policy where evidence is available to suggest that an intervention not routinely funded may be of particular benefit to them in relation to other patients who might not be funded.

iv) as a general rule, decline to provide individual funding for care that is not routinely commissioned or provided solely on the basis that an individual, or a clinician involved in their care, desires it. This is in line with our responsibility to ensure consistent and equitable access to care for all our population. It reflects our concern not to fund for one individual care which could not be openly offered to everyone in our population with equal clinical need.

vi) consider treatments which effectively treat `life time' or long-term chronic conditions equally to urgent and life-prolonging treatments

NHS Bedfordshire may not be able to afford all interventions supported by evidence of clinical and cost-effectiveness within their available budgets. Where this is the case further prioritisation will be undertaken based on criteria including national and local policies and strategies, local assessment of the health needs of the population, to ensure that we do not exceed our available resources.

NHS Bedfordshire is duty-bound not to exceed its budget, and the cost of treatment must be considered. The cost of treatment is significant because investing in one area of health care inevitably diverts resources from other uses. This is known as opportunity costs and is defined as benefit foregone, or value of opportunities lost, that would accrue by investing the same resources in the best alternative way. The concept derives from the notion of scarcity of resources. A single episode of treatment may be very expensive, or the cost of treating a whole community may be high.

Public health is an important concern of NHS Bedfordshire, and NHS Bedfordshire will seek to make decisions which promote the health of the entire community. Some of these decisions are promoted by the Department of Health (such as the guidance from NICE and National Service Frameworks). Others are produced locally. NHS Bedfordshire also supports effective policies to promote preventive medicine which help stop people becoming ill in the first place.

Sometimes the needs of the community may conflict with the needs of individuals. Decisions are difficult when expensive treatment produces very little clinical benefit. For example, it may do little to improve the patient's condition, or to stop, or slow the progression of disease. Where it has been decided that a treatment has a low priority and cannot generally be supported, a patient's doctor may still seek to persuade NHS Bedfordshire that there are exceptional circumstances which mean that the patient should receive the treatment.

9) Quality

NHS Bedfordshire will aim to commission high quality services as evidenced against national and international best practice. The quality of services will be measured where possible not only in terms of quality of outcomes and clinical effectiveness but also in terms of process and organisational efficiency; reducing dependency on health care; the quality of patient care; and the quality of the patient experience.

10) Policy Drivers

The Department of Health issues guidance and directions to NHS organisations which may give priority to some categories of patient, or require treatment to be made available within a given period. These may affect the way in which health service resources are allocated by individual PCTs. NHS Bedfordshire operates with these factors in mind and recognise that their discretion may be affected by National Service Frameworks, NICE technology appraisal guidance, Secretary of State Directions to the NHS and performance and planning guidance.

11) Exceptional Need

There will be no blanket bans on treatment since there may be cases in which a patient has special circumstances which present an exceptional need for treatment. Each case of this sort will be considered on its own merits in light of the clinical evidence. NHS Bedfordshire has procedures in place to consider such exceptional cases on their merits and this will be done through the Individual Case Policy of NHS Bedfordshire

12) Disinvestment

As well as commissioning new services on the basis of the criteria above, NHS Bedfordshire will keep existing services under review to ensure that they continue to deliver clinical- and cost-effective services at affordable cost. Where possible we will seek to divert resources from less effective services to more effective ones.

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