Public Health Document Number Policy Author Approved and Authorised By Date Signed Ratifying Committee Date Ratified Review Date Document Application Related Documents 17 Dr Cyprian Okoro, Consultant in Public Health Medicine Jackie Chin/Ruth Barnes, Joint Directors of Public Health May 2008 Trust Board 22nd May 2008 June 2009 Trust wide Individual Treatment Policy

Data Protection Act 1998 Data Protection issues have been considered with regard to this policy. Adherence to this policy will therefore ensure compliance with the Data Protection Act 1998 and internal Data Protection Policies. Freedom of Information Act 2000 Freedom of Information issues have been considered with regard to this policy. Adherence with this policy will therefore ensure compliance with the Freedom of Information Act 2000 and internal Freedom of Information Policies. Health and Safety Act 1974 Health and Safety issues have been considered with regard to this policy. Adherence with this policy will therefore ensure compliance with Health and Safety legislation and internal Health and Safety policies. Mental Capacity Act 2005 The Mental Capacity Act 2005 provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this. It enables people to plan ahead for a time when they may lose capacity. Guidance set out in the Act should be considered when implementing this policy. Human Rights Act 1998 The Human Rights Act 1998 has been considered with regard to this policy. Proportionality has been identified as the key to Human Rights compliance. This means striking a fair balance between the rights of the individual and those of the rest of the community. There must be a reasonable relationship between the aim to be achieved and the means used. Race Relations Amendment Act 2000 The Race Relations Amendment Act 2000 has been considered with regards to this policy. Adherence to this policy means that the Trust will eliminate discrimination on the grounds of race and will promote race equality and good race relations. Diversity Policies Equality issues have been considered with regard to this policy. Adherence with this policy will therefore ensure compliance with Equal Opportunity legislation and internal Equal Opportunity policies.

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Section 1.0 1.1 1.2 1.3 1.4 1.5 2.0 2.1 3.0 4.0 4.1 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 18.1 18.2 18.3 Appendix A Appendix B Appendix C Introduction Purpose Objectives Patients / Public, Stakeholders & Staff Involved in the Document Review Date Related Procedural Documents Duties Role and Membership of the Priority Setting Group Benefit Criteria for Priority Setting Priority Setting Tools – The MCDA Approach Priority Setting Using the MCDA Approach Supporting the Decision Makers The Individual Treatment Panel Feeding Priority Setting Decisions into CSP and LDP Criteria for in-year Service Development PCT’s NICE Horizon scanning Process and Service Development Use of Cost Effective Information in Funding Decisions Approach to Disinvestment Decisions Funding Orphan Diseases (Rare Conditions) PCT Position on Funding Decisions as Part of Research and Development Role of Stakeholders in Priority Setting Setting up Systems for Dealing with Political Pressure System for Appeal System for Obtaining Legal Advice Monitoring Compliance With And The Effectiveness Of Procedural Documents Process For Monitoring Compliance And Effectiveness Annual Reviews of Decisions Criteria for Internal Audit Priority Setting Score Cards NHS Institute Priority Selector Score Card The Modified Portsmouth Score Card Page 3 3 3 5 5 5 5 5 5 6 6 6 6 6 7 7 9 9 9 10 10 10 10 10 11 11 11 11 12 12 13

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1.1 Purpose The PCT is required to use its finite budgetary and other resources to maximise the general health of people within its population, reduce health inequalities, respond to acute life threatening conditions as well as meet national targets. There is therefore a need for a fair and explicit way of allocating these limited resources in such a way that balances the PCT’s short and long term objectives and enables the PCT to achieve its strategic goals. Making resource allocation decisions can be difficult and is often complex and managers often resort to intuitive methods in order to simplify the process. This leads to ad-hoc spending patterns which are mostly determined by local history. Such resource allocation decisions are unlikely to make the desired impact in terms of the broad PCT strategic goals referred to above. Priority setting in healthcare involves trade-offs of social values in order to maximise health by enabling more rational and transparent resource allocation decisions. It is a core component of World Class Commissioning (WCC) and various NHS organisations have published best practice guidance on the subject. The NHS Confederation published guidance on how PCTs can imbed priority setting in their resource allocation decisions last year while the NHS Institute has developed a priority setting score card in order to assist NHS organisations in developing a local process for priority setting. Further guidance has come from the recently published Department of Health (DH) paper titled Supporting rational local decision-making about medicines (and treatments): a handbook of good practice guidance. All new service developments need to be prioritised and fed into the PCT’s commissioning rounds using a clear set of process and frameworks. For the purposes of this policy a new service development is defined as any funding decisions that have recurrent resource implications. This could be a new treatment, changes to more expensive treatment protocols or expansion of access criteria to a particular treatment. This priority setting policy sets out an over arching framework under which the ITP policy will operate on the one hand, but more importantly, suggests a multi-criteria framework that should underpin how the PCT allocates its resources in order to achieve its objectives. Evidence from behavioural decision research shows that managers and policy makers make better decisions when aided by such frameworks. This policy and the related PCT’s Individual Treatment Panel (ITP) Policy will be revised to ensure full compliance with the DH guidance published in March 2009. There are also on-going developments on decision processes that support Individual Funding Requests (IFRs) on a sector wide basis across North West London. The PCT’s ITP policy will be updated to reflect any agreed sector wide changes in due course.



The PCT’s Core Commissioning Principles Ealing PCT’s commissioning decisions will be based on the following principles: 1.2.1 Health Outcome The aim of commissioning is to achieve the greatest possible improvement in health outcome for the Ealing population within the resources that are available. The PCT will prioritise health care interventions which produce the greatest benefits for patients in terms of both clinical improvement and improvement in quality of life. 1.2.2 Clinical Effectiveness The PCT will ensure that the care that is commissioned is based on sound evidence of clinical effectiveness. This will usually come from sources such as the National Institute for Health and
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Clinical Effectiveness, well designed systematic reviews and meta-analyses or randomised controlled trials.

1.2.3 Cost Effectiveness The PCT will take into account cost-effectiveness analyses of healthcare interventions (where available) to assess which interventions yield the greatest benefits relative to the cost of providing them. 1.2.4 Equity The PCT considers each individual within the Ealing population to be of equal value. We will commission and provide health care services based solely on clinical need, within the resources available. The PCT will not discriminate between individuals or groups on the basis of age (except where clinically necessary), sex, sexuality, race, religion, lifestyle, occupation, social position, financial status, family status (including responsibility for dependants), intellectual/cognitive functioning or physical functioning. However where treatments have a differential impact as a result of the age, sex or other characteristics of the patient it is legitimate to take such factors into account. The PCT has a responsibility to address health inequalities across the population. The proven links between social inequalities and inequalities in health, access to health care and health needs are acknowledged. Higher priority may be allocated to interventions addressing health needs in subgroups of the population who currently have poorer than average health experience (e.g. higher morbidity or poorer rates of access to healthcare). 1.2.5 Patient Choice The PCT respects 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 the PCT’s responsibility to ensure equitable and consistent access to appropriate quality healthcare for all the population. In commissioning healthcare, the PCT will: • • • 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 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; Recognise that evidence of effectiveness usually relates to groups rather than individuals. There is 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. Usually refuse 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.


1.2.6 Affordability The PCT may not be able to afford all interventions supported by evidence of clinical and costeffectiveness within the available budget. Where this is the case further prioritisation will be undertaken based on criteria including national and local policies and strategies, and local assessment of the health needs of the population, to ensure that the PCT does not exceed the available resources. 1.2.7 Disinvestment As well as commissioning new services on the basis of the criteria above, the PCT will keep existing services under constant review to ensure that they continue to deliver clinical and costeffective services at affordable cost. Where possible the PCT will seek to divert resources from
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less effective services to more effective ones. The PCT will seek, so far as is possible and equitable, to be fair as between existing users of services and new entrants as well as between patients who are applying for treatments for the first time. 1.3 Patients / Public, Stakeholders & Staff Involved in the Document

his document was developed by the Public Health Directorate. The paper has been discussed at the Directors and an earlier version was also discussed at the PCT board. The paper was discussed at a training workshop organised for PCT board and PEC members in July 2008, which was facilitated by a firm of specialist independent solicitors. Comments from these decision making groups have been used to revise and update the document. 1.4 Review Date This policy is to be reviewed in June 2009. 1.5 Related Procedural Documents

The Individual Treatment Panel (ITP) Policy

2.0 2.1

DUTIES Role and Membership of the Priority Setting Group

The PCT PEC should be charged with the responsibility of undertaking priority setting on behalf of the board. The PEC will decide a method for taking the views of patients and the public into consideration. The approved list of priorities should be sent to the Overview and Scrutiny Committee (OSC) of the LBE for comments and then to the PCT board for approval. The group should meet at least 6 monthly to prioritise all PCT approved projects and service development proposals. 3.0 BENEFIT CRITERIA FOR PRIORITY SETTING

The following criteria will be considered in the PCT’s priority setting decisions: • Severity of health problem or illness • Burden of disease in the population (in terms of size of population affected, distribution among population groups e.g. vulnerable groups, BME groups, children etc) • Impact of intervention on population health (will intervention maximise population health or benefit only a few? what will be the health gains and consequences?) • Clinically effective intervention (demonstrable capacity to benefit) • Availability of alternative interventions/treatments • Cost effectiveness • Impact on budget (cost of project/intervention, anticipated savings etc) • National targets and standards • Ease of implementation • Patient choice and acceptability • Impact on workforce • Strength of local feeling (OSC, public consultation etc) • Wider benefits to society (impact on local economy, enhances social capital ) • Equity issues (addresses health inequalities, and vulnerable groups) • Focus on prevention and well being • Emergency situations

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It is now recognised that prioritisation based on single criteria such as cost effectiveness, quality adjusted life years (QALYs), equity analysis or clinical effectiveness often lead to poor resource allocation decisions. Multi-criteria decision analysis (MCDA) is a tool routinely used in other disciplines and is increasingly being applied to the health care sector. The PCT will adopt the MCDA approach in this priority setting policy using the benefit criteria set out above. Tools developed by the NHS Institute such as the Priority Selector or the Modified Portsmouth Score are all based on the MCDA approach. Either of these tools can be used to assign scores to each criterion in order to obtain a weighted benefit score. The NHS institute scoring system is simpler and is web based. Whilst this may be an advantage, it limits its local applicability by not covering all the benefit criteria identified above. A Priority Setting Group or Committee should determine which scoring tool to use and apply this consistently. Where no score is available for a particular benefit considered locally important, the priority setting group should agree a score for that criterion. 4.1 Priority Setting Using the MCDA Approach

The MCDA approach described above will be used to generate a weighted benefit score (WBS) which is then combined with cost information to generate a cost-value ratio. A low cost-value ratio implies a better value for money programme than a higher cost-value ratio. There are 8 steps involved in this approach. • • • • • • • • Determine the benefit criteria Weight the criteria by applying a score against it Calculate the weighted benefit score for the programme/project Repeat steps 2 and 3 for each programme/project Combine the score with cost data to generate cost-value ratio Rank the interventions according to the order of cost-value ratio Discuss the results within the group Agree a priority list



Members of the priority setting group will receive training on the rationale for priority setting, the principles involved, the PCT agreed processes, and legal issues around resource allocation decisions. This will be done for new members and repeated annually for all members.



Decisions about funding requests for individual patients on the basis of exceptional circumstances are covered by a separate policy. It is desirable to have input from ITP members into priority setting but this is already the case and overlapping membership of the groups ensures this.

7.0 FEEDING PRIORITY SETTING DECISIONS INTO CSP AND LDP The Priority Setting Group will send a priority list of PCT projects/service developments to the PCT Board for approval. The approved list of priorities will form the basis for the PCT’s strategic and commissioning plans for the coming year.

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Because In-year service developments tend to bypass the prioritisation process in addition to the PCT’s limited contingency funds, unplanned investment decisions will be made only in exceptional cases. The PCT will as much as possible ensure that all new service developments are funded through its annual commissioning strategy plans and LDP rounds. However, in-year funding for a new service could be considered outside of the usual processes if the new service meets one or more of the criteria below: • A serious health risk develops in the population that demands immediate action. Examples will include an outbreak of a communicable disease or a severe chemical incident with toxic environmental consequences. • A major failure in clinical practice that creates an urgent service problem. An example might include serious clinical governance issues that need immediate remedial action such as a look-back exercise. • A new intervention that is of such importance strategically that immediate introduction into practice is necessary to achieve or enhance the PCT objectives stated above. • A new treatment becomes available, and having passed through the new PCT NICE Horizon Scanning process, is considered to have such degree of demonstrable and significant population health benefits that the PCT decides to implement it immediately, having considered the opportunity costs of doing so. • The PCT is made aware of a new directive from the Secretary of State for Health or a new legal ruling that requires immediate compliance. The PCT board will ratify all funding decisions agreed under these criteria.



A process of horizon scanning of new interventions approved or about to be approved by NICE will be developed in the Public Health Department. This process will set the framework for dealing with potentially controversial treatments, identify treatments likely to have a large impact on PCT’s budget, identify treatments which are better delivered collaboratively with other PCTs or along established networks, as well as identify new treatments which may warrant or support disinvestment decisions. The PCT will support a Pan-London approach to Horizon Scanning of new interventions that need to be prioritised. But until this becomes available, the PCT will develop its own Horizon Scanning Process using the template below.

Linking Horizon Scanning Into Commissioning Decisions • • Public Health will set up a system of monthly monitoring of NICE website for forthcoming TAs and Guidance. Documents still at the consultation phase will not be summarised. All new NICE TAs and Guidance will be screened for immediate impact using the unplanned In-year service development criteria above. If criteria for In-year service development are met, the PCT’s Commissioned Service Development Template will be used to develop a business case for the service for PEC review and Board approval. If the criteria for In-year service development are not met, the Horizon Scanning Template is used to develop a summary of key service issues to note. These will be considered at the ITP and then the PEC. The PEC will make a recommendation to the board as to whether the service should be put in the list of PCT’s bring-forward projects or service developments for priority setting and funding through the commissioning or LDP rounds. If the Horizon scanning process identifies a treatment to be of little value, or the priority setting process identifies a treatment to be of very low priority, the PCT will decide not to fund and will
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transfer such treatments to the list of treatments not usually funded. This is already covered by a separate policy. Assessment criteria 1. Disease or treatment description 2. Is this a Technology Appraisal (TA) or Guidance? 3. NICE recommendations 4. Service focus 5. Date expected to be released 6. Epidemiology of disease Comments for completion • Self explanatory • Note that TAs are mandatory for PCTs to implement

• Summarise and itemise recommendations • State if primary care or secondary/tertiary care intervention. • State if focus on wellbeing/prevention/screening or therapeutic Self explanatory • • • • State prevalence of disease nationally and locally if known. State eligibility criteria Use prevalence and eligibility information to calculate local population size likely to benefit from intervention. Use NNT information to determine the opportunity cost of implementing the intervention

7. Number Needed to Treat (NNT) to benefit one person or Number needed to harm (NNH) for side effects 8. Cost implications of intervention for Ealing PCT 9. Workforce implications

• • • • • • • • • • • • • • • • • • •

10. Time scale needed for planning/implementation 11. Options for implementation

12. How should this be funded if considered of sufficient value

13. Impact on prescribing policy

14. Important outcomes for monitoring progress

• •

Cost of intervention or drug per person/dose Determine estimated total cost by mutiplying unit cost with population or sub group expected to benefit Who will implement the TA or Guidance? What are the workforce/staff constraints? Will PCT need to redesign current care pathways? Does this warrant an in-year service development? Should it be put in the PCT’s bring-forward process for the annual commissioning rounds? Does the PCT need to implement this intervention? If Cost effectiveness threshold is above NICE cut off (£30,000), are there any exceptional reasons the PCT should still consider implementing it? If cost effectiveness is below NICE threshold, does intervention or drug offer any real health benefits regardless of the cost effectiveness ratio? Via the commissioning rounds? Via the LDP rounds? Via the ITP? In-year new service development? Will service be PCT wide or better PBC led? It is likely to be PbR excluded? Will a new Tick box application form for funding approval and Post Payment Verification check be needed? What are the generic alternatives? What are the alternative drugs for similar condition and what are the costs? Itemise NICE indicators for monitoring progress State recommended progress review intervals

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10.0 • •


Treatments that fall above the NICE threshold of £20,000 for cost effectiveness are likely to receive a low priority unless there are other exceptional and significant benefit criteria. Treatments that fall under the NICE threshold will also be subject to the same population benefit value assessment. Although interventions with favourable cost effectiveness will generally receive higher priority, it is unlikely that a favourable cost effectives alone will justify a funding decision. The MCDA score or rating will ultimately determine if a commissioning decision is approved.



As new treatments become available and new services are commissioned, the PCT will continuously review existing services for fitness of purpose and continuing patient benefit. The PCT’s approach to disinvestment will not automatically mean the cessation of treatments. Following service reviews, the PCT could decide to stop funding treatment for certain population groups if new information shows less benefit to them. The PCT can also decide to change the thresholds for a particular treatment following new national or local information. This could mean restricting access to such treatments to certain population groups. The triggers for a disinvestment decision will include; • • • • • A new NICE Technology Appraisal Guidance (TAG) or Guidance Service reviews Audits Evaluations Patient or public concerns



Orphan diseases are rare conditions that typically affect less than 5 people per 10,000 population, whilst Ultra Orphan diseases affect about 1 in 50,000 population. Not all PCTs consider rarity of disease in their funding decisions. Ealing PCT will adapt the recommendations of the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG) until further national guidance on these very expensive conditions. In considering treatment funding for a rare condition, Ealing PCT will take the following into account: • • • • • The degree of severity of the untreated disease in terms of quality of life and survival. Whether the drug can reverse rather than stabilise the condition. Overall impact on the PCT’s budget Whether the drug could bridge a gap to a ‘definitive’ therapy, and that such a definitive therapy is currently under development Any stated extensions to the use of the drug.

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The PCT has a tract record of supporting research and development but will not normally fund an experimental treatment. Where the PCT considers an experimental treatment to be of strategic or public health importance, it might consider funding treatments in the context of a clinical trial, provided that this could be arranged collaboratively with other PCTs or where it would be contributing to an existing trial. The PCT will not normally fund individual clinicians to collect local case series as these are unlikely to produce sufficient evidence. Where it is impossible to conduct blinded or randomised studies because of the nature of the treatment in question, the PCT might fund a treatment that meets the strategic or public health importance criteria, provided there are robust local mechanisms for evaluation. Patients already taking part in clinical trials for which the PCT is expected to continue funding after the trial has ended should make an application to the PCT’s ITP policy through their supervising consultants before joining the trial because the PCT will not agree to automatic funding at the end of the trial.



In order to have credibility especially with regard to transparency and explicitly stated benefit criteria, the priority setting group should consist of people outside of the PCT, but with interest in the local health economy. Literature evidence suggests that public involvement in priority setting works best if the process of consultation is less extensive than the usual rhetoric suggests. It is more important that transparent reasons for resource allocation decisions are provided to the public. The PCT should therefore publish approved priority lists on its intranet and disseminate this as widely as possible.



The PCT board will decide on a system for handling political and public pressures following resource allocation decisions.



The PCT board will determine system for appeals against resource allocation decisions. There may be advantages in having a unified appeals process for both the ITP and resource allocation decisions. The PCT’s current appeal processes are set out in the Individual Treatment Panel Policy.



The PCT’s Corporate Director who currently advises the Individual Treatment Panel on legal issues will play a similar role for the Priority Setting Group. Where necessary this role can be supported by external expert advice in keeping with current ITP processes.

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18.1 Process for Monitoring Compliance and Effectiveness In order to assure consistency, fitness for purpose and quality in resource allocation decisions, the Priority Setting Group will produce an annual report to the PCT Board. 18.2 Criteria for Internal Audit The criteria by which the PCT’s resource allocation decisions are judged will include: Use of appropriate principles • Have decisions been based on a set of coherent, specific set of acceptable principles – commissioning principles & benefit criteria? Public and stakeholder involvement • Evidence of public input into resource allocation decisions • Level of public support (number of appeals, challenges etc) • Involvement of academic units that support PCT’s policy development and evaluation or other external partners. Effect on Practice and Organisational Culture • Evidence of change in resource allocation practice • Establishment of a culture of review, evaluation and lessons from appeal processes Population Health Gain • Did evaluation of selected projects demonstrate health benefits? • Overall health gains from PCT health profile Role of External Audit The PCT should consider inviting periodic external review of its priority setting process. This will increase the credibility of the decisions to the public.

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Appendix A - Priority setting Score Cards

Appendix B - NHS Institute Priority Selector Score Card (web based - available via PCT commissioning managers)

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Appendix C: The Modified Portsmouth Score Card
Factor From your experience what is the strength of evidence that the service produces an effect Magnitude of Benefit Very Low Under 3 points if still experimental case series or opinion Under 3 points if negligible or no improvement in health or life expectancy Under 3 points if there is less than 1 person in your practice who would benefit Under 3 points if the cost is more than £1,000,000 Under 3 points if the saving is less than £50,000 Under 3 points if patients would find it highly unacceptable Under 3 points if not a requirement Under 3 points if it doesn't address an inequality or inequity under 3 points if none Low 10 points Scale Mid Scale 20 points if you have modest evidence that the service works 20 points if there are moderate improvement in health or life expectancy 20 points if there are between 10 and 49. Score High 30 points Top Points 40 points if you definitely have experience that the service works 40 points if there are large improvements in health or life expectancy 40 points if there are greater than 500 in your practice who would benefit 40 points if the cost is less than £50,000 40 points if the cost is more than £1,000,000 40 points if patients would find it highly acceptable 40 points if it addresses four target or national requirements 20 points if it completely address's an inequality or inequity 20 points if major benefit

10 points

30 points

Number of who will benefit in your practice (number can be adjusted for total PCT population) Total cost of the development Estimated savings from the development

10 points

30 points if there are between 50 and 499. 30 points if the cost is between £250,000 and £50,000 30 points if saving is between £500,000 and £1,000,000 30 points if patients would find it somewhat acceptable 30 points if it addresses three target or national requirements 15

10 points if cost is between £1,000,000 and £500,000 10 points if saving is between £50,000 and £250,000 10 points if patients would find it somewhat unacceptable 10 points if it addresses one target or national requirements 5

20 points if cost is between £5,00,000 and £250,000 20 points if saving is between £250,000 and £500,000 20 points if patients would have no view on acceptability 20 points if it addresses two targets or national requirements 10 points if it partially address's an inequality or inequity 10 points if moderate benefit to society

Patient acceptability

National requirement or NHS target

Addressing health inequality or health inequity (i.e. where patients have not had service in the past) Wider benefits to society (Could be omitted because most of PCT business will take a health service perspective and cost effectiveness focus only. This criterion is only useful where social factors are considered useful). Only treatment or alternative

5 points if some benefit

15 points if large benefit

Public engagement/feedback

Under 3 points if many other treatment options with best outcomes 0 points if no local interest in favour

5 points if other options with better outcomes 5 points if some local interest

10 points if other options but equivalent outcomes 5 points if moderate local interest in favour

15 points if limited options with poorer outcomes 7 points if large local interest in favour

20 points if there are no treatment options at all 10 points if massive local interest in favour.


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