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A series of publications that aims to help organisations review their current priority-setting processes and, if needed, provide a reference document for PCTs who still have to develop a comprehensive priority-setting framework.
Priority setting: an overview
Date: 2/10/2007 This is the first in a series of publications which aims to help organisations review their current priority setting processes and, if needed, provide a reference document for PCTs who still have to develop a comprehensive priority setting framework. more
Supported by:
The Primary Care Trust Network is part of the NHS Confederation. For further details of the Primary Care Trust Network, please visit www.nhsconfed.org/pctnetwork or contact David Stout on 020 7074 3322 or at david.stout@nhsconfed.org
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no. 1090329 Published by the NHS Confederation The NHS Confederation 2007 This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-143-2 BOK 58401
Contents
Introduction Why is priority setting so important? How to build up a priority setting framework Agreeing the key principles Conclusion The author Acknowledgments Glossary 2 3 5 8 12 13 14 15
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Introduction
The Department of Health has begun a push to create world-class commissioning and is developing a range of tools, approaches, outcome measures and competences to support this. This initiative is the most serious attempt to reposition commissioning as central to the way the NHS operates since the introduction of the purchaser provider split in 1990. The NHS Confederation welcomes this initiative and the Primary Care Trust Network is fully engaged in influencing policy in this area. One of the key skills that any commissioner will need is the ability to identify priorities. It is still the case that a large amount of the resources committed reflect historic patterns of provision, the particular approach of local providers or even individual clinicians. To change this there will be a need for high-quality, evidence-based and systematic decision making to support the development of the commissioning plan and to feed into the annual contracting round. In addition, the number of high-cost treatments and increasingly vocal interest groups makes the task of allocating resources one of the most politically sensitive and complex issues facing any part of the NHS. The purpose of this report, and the series of Briefings that follows it, is to support the development of decision making in this difficult area. Although it is aimed primarily at those directly involved in resource allocation, the series should also be helpful to a wider audience including providers and policy makers. The series has been written by practitioners in the field and so are based on experience in this evolving field. The evidence base is still in an early stage of development, so this should still be regarded as work in progress and primary care trusts will need to develop their own approach to this area. Improving the quality and transparency of decision making, involving the public, patients, providers and other stakeholders, and building the capacity of commissioners to take and then implement these decisions will be an important task over the next few years as we work towards a more world-class vision of commissioning.
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4. The adoption of protocol-driven decision making PCTs, like clinicians, come across the same scenarios time and again. Good commissioning practice, like good clinical practice, is policy and protocol-based. Organisations which adopt this approach have better documentation which leaves a more thorough audit trial. This all adds to consistent, efficient and timely decision making. Despite concerns that might exist to the contrary, protocol-based decision making does allow organisations to respond to unique and unusual individual need.
Despite concerns to the contrary, protocol-based decision making allows organisations to respond to unique individual need.
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Step 1 Agree key principles to underpin priority setting, and the factors which will be taken into consideration, and draw up a list of good practices required by the law
Develop a dedicated strategic plan to develop priority setting Consider manpower resources
Step 3 Consider how to approach a range of issues related to key relationships with stakeholders
Step 4 Produce key policy documents Step 5 Develop tools to aid decision making
Decision making
Decisions
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Step 3: Consider how to approach a range of issues related to key relationships with stakeholders
The third step is to consider a group of issues which can loosely be put under the umbrella of relationships. These include: patient and public engagement communications with patients and carers working with clinicians, providers and other PCTs, and the role of the NHS Contract responding to queries from politicians, the Department of Health and the media training and support for decision makers
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including how the annual commissioning round will be handled. The author is aware of at least one PCT which had its overarching policy document approved by both the local OSC and all the local Members of Parliament. There are a number of recurring issues to be usefully addressed as part of this step, through a series of policy statements. These statements can either be part of the overarching policy document or be addressed in a series of supplementary commissioning policies. Recommended policy statements include setting out the PCTs approach to: treatments under consideration in NICEs health technology programme requests seeking funding for patients coming off drug trials, and drug company sponsored funding requests from patients who have run out of private funds for private healthcare treatments not normally funded by the PCT patients seeking treatment abroad co-payment which refers to private practice within the NHS experimental treatments funding research and development.
how to efficiently gather and process large quantities of information how to systematically assess and compare very different types of services how to ensure that all individuals contributing to the decision making have sufficient knowledge about all the services and treatments under consideration how to spread the information gathering and assessment across the whole year how to adopt wider involvement that is sustainable how to fairly and effectively disinvest and redistribute resources. These are some of the most challenging issues PCTs currently face and as such are in need of urgent development.
A final consideration
Establishing and maintaining good priority setting requires an ongoing cycle of development, review and quality improvement. It should not be a oneoff exercise. PCTs are encouraged to develop dedicated strategic and implementation plans for the development of resource allocation and assess the manpower and other resource requirements to run both operational and developmental aspects of priority setting. The rest of this report will focus on aspects of Step 1.
Establishing and maintaining good priority setting requires an ongoing cycle of development. It should not be a one-off exercise.
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If organisations strive to distribute resources fairly and if they are of the view that consideration of opportunity cost is essential to that process, then they must construct their decision making in ways that reflect this. It is suggested, therefore, that the primacy of prioritisation be a fundamental principle of public sector resource allocation. Currently this translates into the primacy of the annual commissioning round although as other vehicles for priority setting emerge this might change. This principle has major implications for the management of individual funding requests (as opposed to dealing with unique individual circumstance) and the management of in-year service pressures as we will see in a later Briefing in this series. It also requires considerable organisational commitment to implement because of the external pressures to fund treatments to which all PCTs are subject to on a daily basis. But to fund requests for new treatments without regard to prioritisation seriously undermines both the PCT and fairness.
Agree a list of considerations which will be taken into account when making decisions
As well as key underpinning principles which might be set out in a PCTs mission statement and the primacy principle, the PCT will also need to generate a list of considerations which it will take into account when making a decision. There are no right or wrong answers but it has already been seen that this list is likely to be made up of a combination of principles and factors. This is a difficult task and some points of caution are needed.
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Firstly, the PCT should resist any attempt to simply import this list from examples of good practice elsewhere. To become embedded in local commissioning culture it is vital that the principles and factors are owned by all members of the PCT and by wider stakeholders (especially patients and the public) in the local community. It is worth spending time and effort working with stakeholders to determine the values that they feel should underpin prioritisation and resource allocation given that resources are finite and difficult choices have to be made. Secondly, the list has to apply in all settings; therefore, the PCT needs to take into account the full range of funding issues that it regularly faces. The risks of developing frameworks only in the context of individual funding requests is that these frameworks commonly omit key considerations such as clinical and service risks and quality issues (some of which might not represent any health gain at all). The role of risk assessment in decision making is probably more important than is commonly recognised. An example of a service risk which many commissioners will recognise is the need to invest in additional staff in a critical shortage specialty where a lack of investment would lead to a loss of staff, the result of which might lead to the population having no local service at all. Finally, focusing only on individual funding requests risks developing a framework that does not retain a population perspective, thereby creating the ethical dilemma, once again, of having the organisation allocate resources using different criteria in different settings. For example, the case for funding individual patients is frequently presented in terms of medical ethics and the principle of the duty of care to individuals. However, it is questionable whether the principles
of patient autonomy (the right of patients to make decisions about their medical care), beneficence (provide benefit and not withhold benefit) and non-maleficence (do no harm) are appropriate in this situation. This is because the principles focus the decision on the patients ability to benefit and give precedence to the values of the individual patient. Although these are relevant considerations, they cannot solely determine the outcome because the interests of other patients should also be considered. A list of factors which frequently appear in PCT documents are listed in Figure 2, not necessarily in order of importance.
Figure 2. Common factors which PCTs take into account when allocating resources
nature of the health gain confidence in the clinical evidence number of individuals benefiting cost effectiveness need to redress inequalities and inequities of access accessibility national priorities stated local priorities clinical risk service risk absolute cost of the development legislation and directives patient choice.
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The list the PCT finally arrives at and the weightings which may be given to each item is a key output of Step 1. An example is shown in Figure 3.
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Conclusion
Resource allocation and priority setting is a vital function, the responsibility for which rests with PCTs. Much progress has been made over the years and more can be anticipated. There is, more than ever, a need for PCTs to ensure that they carry out this task to the best of their ability and work in a systematic way towards ongoing improvement. The challenges facing the NHS in relation to scarcity of resource are best met with PCTs working collaboratively, both between themselves and with their own local community.
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The author
Dr Daphne Austin BSc MBChB FFPHM Dr Daphne Austin is a consultant in public health medicine, currently working for the West Midlands Specialised Commissioning Team. Dr Austin has an extensive background in public health, spanning 17 years. Dr Austin established the UK Commissioning Public Health Network, which she currently chairs.
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Acknowledgments
This series has emerged from an ESRC funded series on managing scarcity in healthcare, run by Professor Cam Donaldson. It has been funded by a grant from the NHS Institute for Innovation and Improvement. The author and the NHS Confederation would like to thank the following people for their input and involvement with this series of publications: Professor Cam Donaldson and the UK Forum for Priority Setting in Healthcare Professor Chris Newdick Claire Cheong-Leen Dr Henrietta Ewart
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Glossary
Resource allocation the task of deciding how healthcare resources are to be allocated. This usually refers to financial resources but can also refer to the deployment of manpower. Priority setting / prioritisation the task of determining the priority to be assigned to a service, a service development or an individual patient at a given point in time. Prioritisation is needed because claims (whether needs or demands) on healthcare resources are greater than the resources available. Service development a catch-all phrase referring to anything that needs investment. It refers to all new developments including: new services; new treatments, including drugs; changes to treatment protocols which have cost implications; and changes to treatment thresholds and quality improvements, such as reduced waiting times. It also refers to other types of investments which existing services might need, such as pump-priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms. Service disinvestment the mirror image of service development. Priority setting processes all the things needed to support priority setting, such as structures, policies, protocols and processes. Rationing a consequence of priority setting. A patient can experience rationing in many ways, including being denied access to a treatment or service, experiencing a delay or poor quality services which impact on the clinical outcome. It is advisable not to use the term rationing as a verb; to do so is to imply that rationing is an optional activity. All positive decisions to fund are inextricably linked with a rationing consequence somewhere in the system. Affordability the ability to do something without incurring financial risk or unacceptable opportunity cost. It is ultimately determined by the fixed budget of the PCT. Opportunity cost arises from alternative opportunities that are foregone in making one choice over another. Annual commissioning round the process by which new money coming into the NHS is allocated. The process has undergone many changes over the years but key elements of the process have remained unchanged. Funding decisions follow an annual cycle. Service developments are gathered and assessed during the autumn. Once PCTs are confident of the size of additional funding (usually known in December) priority setting intensifies. Final decisions have to be before the end of the year to ensure that new contracts can be placed with providers of healthcare for the new financial year which starts on 1 April. This annual process sits within a longer term strategic planning process. For the purposes of this series of publications this process will be known as the annual commissioning round.
Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
NHS Confederation 2007 This document may not be reproduced in whole or in part without permission
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329
15
ISBN 978-1-85947-143-2 BOK 58401
Supported by:
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no. 1090329 Published by the NHS Confederation The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-150-0 BOK 59601
Contents
Introduction What is judicial review? Duties of the Secretary of State Duties of PCTs The National Institute for Health and Clinical Excellence Prescribing rights under the GMS Regulations European law Human rights law Judicial review proceedings Conclusion and key action points The author Acknowledgments References Further reading 2 3 4 5 8 9 10 11 12 14 15 15 16 17
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Introduction
Judicial review continues to grow in significance, with public authorities of all types now regulating themselves so as to comply with it. Twenty years ago, the courts often deferred to the expertise of public authority decision makers but today things are different. Public authorities may have to account for their actions at judicial review and can be required to revisit their decisions. In the NHS, this is important in deciding which services the NHS can afford to commission and also with respect to individual funding requests. Reasonable priority setting should be central to primary care trust (PCT) corporate governance. Key individuals within PCTs should have some knowledge of judicial review to act as advisors, as well as maintaining good relationships with solicitors who specialise in this field. This is a complex and developing area of law and this report is not a comprehensive guide; PCTs must always refer specific issues to their own legal team. This report will consider the following: what is judicial review the duties of the Secretary of State for Health and PCTs the role of the National Institute for Health and Clinical Excellence prescribing rights in primary care European Union law and human rights law. It also covers judicial review proceedings and provides some tips on working with lawyers.
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3. Procedural impropriety A claim that a decision is procedurally defective may contend that the PCT has misunderstood a statutory procedural duty. Examples would be a failure under section 11 of the Health and Social Care Act 2001 to consult patients and the public about service changes, or coming to a firm conclusion before consultation is complete. But procedural impropriety may also apply to decisions relating to the PCTs individual funding request panels. If a decision of the panel will affect someones interests, that individual is entitled to know what factors are being considered, have the opportunity to make representations in writing and be reassured that the panel is independent.
Procedural impropriety also concerns whether PCTs have followed their own policies and procedures reasonably and consistently.
If a decision will affect someone's interests, that individual is entitled to know what factors are being considered.
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Duties of PCTs
Healthcare resource allocation is not performed by the Secretary of State personally. This task, and the duty that goes with it, has been delegated to PCTs.2 This is why judicial review litigation is normally conducted against PCTs, rather than the Secretary of State. In addition to PCTs duty to promote a comprehensive health service, Section 229 of the NHS Act 2006 states: Each primary care trust must, in respect of each financial year, perform its functions so as to secure that its expenditure does not exceed [its income]. Sections 6668 of the Act also give the Secretary of State power to remove from office those who fail in this duty. Board members, therefore, are under pressure to comply with ministerial instructions and not to exceed the budget that has been allocated to the PCT. So, within their finite allocations, PCTs must decide how best to promote a comprehensive healthcare service. The reality is that need and demand for healthcare exceeds the resources available to the NHS. As a result, hard choices have to be made between the competing claims of different patients. The law requires PCTs to exercise reasonable discretion in deciding how this is best done. What is reasonable discretion? A helpful starting point is the case of R v North West Lancashire Health Authority ex p A, D & G (2000)3, in which a refusal to fund transsexual surgery was overturned by the Court of Appeal. The court discussed some of the factors relevant to reasonable discretion. 1. Differences between PCTs The court confirmed that: The precise allocation and weighting of priorities is clearly a matter of judgment [for] each authority Authorities might reasonably differ as to precisely where [a treatment] should be placed and as to the criteria for determining the appropriateness and need for treatment. Therefore, postcode variations between PCTs are not unlawful of themselves. Equally, though, in a national health service wide variations are unattractive. PCTs should be aware of differences between neighbouring trusts and be able to explain why they are valid. 2. Need for a priorities framework In relation to the priority-setting process, the court observed: It makes sense to have a policy for the purpose indeed, it might well be irrational not to have one Each PCT should ensure it has a consistent priorities framework to guide the allocation of its resources. Throughout this series of priority-setting reports this is referred to as the overarching policy document on resource allocation. This policy should explain the principles of decision making in a way that can be easily understood by a lay readership. Since the statutory duty belongs to the PCT, it cannot delegate this duty. It is, however, reasonable and useful for PCTs to collaborate in developing a framework intended to be consistent across a larger area.
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Making choices between competing claims is a difficult and sensitive task because someone is generally dissatisfied and may be hostile to the outcome. For example, the court said in connection with transsexual surgery: It makes sense that an authority would normally place treatment of transsexualism lower in its scale of priorities than, say, cancer or heart disease or kidney failure. However, if decisions like these are required, it is crucial that they can be justified against a framework that is transparent and treats patients equally, fairly and consistently. The framework helps to manage the introduction of new treatments, the annual commissioning round and decisions about individual funding requests. (See the other reports in this series, where examples are given.)
Figure 1 provides an example of collaboration between PCTs. Of course, the discretion permitted to PCTs means that they may differ about similar cases, but the framework of analysis will be consistent. Some PCTs have their own priorities committees, while others take advice from clinical networks. Neither are statutory bodies and they have no statutory functions of their own. Their role is to make robust recommendations to the PCT board. Provided they are authorised to take a broad overview of the local health economy and can assess the competing claims of its differing sectors, their recommendations should normally be respected. A PCT board is at liberty to reject the advice but if it does so too often without good reason, the committee will quickly cease to be useful. Priorities committees must provide a fair balance of managerial and clinical interests. If the process becomes too corporate and unable to weigh and balance the clinical merits of a case, it will be criticised for under-valuing, or ignoring, relevant aspects of the decision, and for being irrational. The need for proper balance between managers and clinicians should be dealt with in the committees standing orders. 3. Absence of robust evidence of effectiveness Many treatments do not have the benefit of evidence from randomised controlled trials, or are too new to have been fully evaluated. Also, it may be difficult to conduct robust trials because of small patient numbers or lack of sponsorship. However, this does not justify an outright ban on a treatment. A reasonable clinical case in favour of a treatment must be met by a reasonable case against if the PCT is deciding not to fund it. As the Court of Appeal said in the case of A, D & G above:
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The mere fact that a body of medical opinion supports the procedure does not put the health authority under any legal obligation to provide the procedure However, where such a body of opinion exists, it is not open to a rational health authority simply to determine that the procedure has no proven clinical benefit while giving no indication of why it considers that is so. 4. Blanket bans The court was uncomfortable with blanket bans on treatment. Judicial review insists that the PCT must consider all the relevant circumstances, including the possibility that the patient has exceptional needs. In particular, it said: The more important the interests of the citizen that the decision affects, the greater will be the degree of consideration that is required of the decision maker. A decision that seriously affects the citizens health will require substantial consideration, and be subject to careful scrutiny by the court as to its rationality. Therefore, the policy framework must contain a procedure by which patients may say: I know my treatment is normally a low priority, but my circumstances are so exceptional that they deserve an exceptional response. This requires the existence of individual funding request panels capable of considering the clinical merits of such a claim. These panels are dealt with in more detail in the NHS Confederation publication in this series, Priority setting: managing individual funding requests. For example, in R (Otley) v Barking and Dagenham PCT 5, the patient had colorectal cancer and argued that she had exceptional capacity to benefit from Avastin. The PCT rejected her argument but the court held that the decision was irrational for not considering all the relevant evidence. The court
said that although the PCTs general policy was rational and sensible, its decision in this case was flawed because it had not properly considered a number of factors, including the fact that: Ms Otley was young by comparison with the cohort of patients suffering from this condition. Her reactions to other treatment, in particular to Irinotecan plus 5FU, had been adverse. Her specific clinical history suggested that her reaction to a combination of chemotherapy and Avastin had been of benefit to her. By comparison with other patients, she, unlike many of the subjects of the studies, had suffered no significant side-effects from a cocktail which included Avastin The matter was referred back to the PCT to be reconsidered. PCTs are not bound to support all exceptional cases. However, if they refuse to support the treatment, they should clearly show why. For example, the evidence of clinical effectiveness may be too uncertain. There may be pressure to conduct a clinical trial, yet the costs of the trial may be prohibitive. Or, even if a trial is conducted, its results may still be inconclusive. Or the treatment, even if it is effective, may be so expensive as to be unaffordable in any case (at least without reducing access to other patients). In these cases, it may be reasonable to refuse funding. The law is not yet clear as to the exact nature of exceptionality. Indeed, their very nature makes it impossible to anticipate every exceptional case. In particular, can personal circumstances ever be exceptional (for example, that the patient has young children and extending his or her life, even by months, is important)? Recent cases suggest that they may be. Further litigation will help clarify these issues.
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freely prescribed. However, this is a decision for Parliament, not PCTs. Put another way, if it is sensible to limit access to medicines under the GMS Regs, then it is for Parliament to do so by means of the lists. To this extent, supervising primary care prescribing is more difficult than controlling the costs of
treatments in secondary care. This suggests that PCTs should do so by agreement and negotiation, but not by issuing their own black lists that penalise prescribers for doing what the regulations require. Otherwise, PCTs could be at risk of judicial review in the same way as the Secretary of State in the Viagra case for contradicting the GMS Regs.
European law
The third area in which it is difficult for PCTs to exercise regulatory discretion over NHS costs is in connection with EU law. The basic principle of EU law is to promote the freedom of movement of goods, services, labour and capital between the member states of the EU. The question is whether public health services are included within the principle protecting the freedom of movement of services. The matter was first raised in respect of NHS care in 2006 in Watts v Bedfordshire PCT.14 At the age of 77, Mrs Watts required bilateral hip replacements. She was put on a hospital waiting list and assured of treatment within the usual waiting period, at that time, of one year. She declined to wait so long and arranged to have her care at a hospital in France. Although, shortly before she left, the PCT offered her treatment within four months, she declined the offer, had her surgery and returned with a bill of 4,700 for the PCT. It refused to pay and the matter was taken to the European Court of Justice (ECJ) to consider whether the provision of NHS care was a service subject to the rules on free movement. The ECJ ruled that it was such a service. However, it was not freely available in exactly the same sense as private banking, or insurance services. The right to obtain care elsewhere in the EU at NHS expense was available only if the treatment was normal in the sense that it had been sufficiently tried and tested by international medical science, and could not be provided without undue delay. Significantly, the existence of standard waiting times could not displace the right of a patient to treatment if he or she had urgent need. The ECJ said: Where the delay arising from such waiting lists appears to exceed in the individual case concerned
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an acceptable period having regard to an objective medical assessment of all the circumstances of the situation and the clinical needs of the person concerned, the competent institution may not refuse the authorisation sought on the grounds of the existence of those waiting lists, [or] an alleged distortion of the normal order of priorities linked to the relative urgency of the cases to be treated. The ECJs role is to advise domestic courts how to resolve the dispute, not to decide the merits of the case itself. So the matter was referred back to the Court of Appeal to be reconsidered in the light of this guidance. The PCT settled out of court before the need arose for further litigation.
Clearly, a widespread use of this freedom could destabilise patterns of resource allocation in the NHS. The problem is not so much in connection with undue delay because the new NHS 18-week waiting list target will probably satisfy most cases. But what if treatment is not provided within a PCT because it is considered low priority? If such treatment were normally available in (say) France and Germany, would it be normal treatment in EU law? Can patients simply obtain it in the EU and return with the bill? With respect, the European Court has not been conspicuous for its clarity in this area. This issue is now (in March 2008) before the European Commission for the purpose of a new directive on cross-border access to treatment within the EU.
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2. Pre-action protocol This is a stage at which the parties should search for a legal solution. Judicial review requires the claimant to identify the substance of the complaint and the documents that may be used, and explain why the authority is said to be wrong. New information may come to light that suggests that the original decision should be reconsidered. If this fails
3. Judicial review If pre-action protocol fails, the matter may proceed to judicial review. The claimant has three months from the date the claim first arose to issue judicial review proceedings, unless there is good reason for a delay.
We consider the two stages of judicial review proceedings below. Priority setting is a contentious area and judicial review is becoming increasingly common. What is the procedure and how should PCTs respond? It is important to contact solicitors as soon as there is a suggestion of legal action, both for their advice and because they may facilitate a solution. There are two stages to a judicial review. (a) Permission stage This stage requires the claimant to obtain the permission of the court to proceed with the case. To do so, the claimant must serve on the
defendant a Claim Form and detailed statement of the case, explaining the grounds for judicial review. This gives the defendant notice of the commencement of proceedings. The timetable for decisions about judicial review is short. If the defendant wishes to contest the claim, he must respond to the Administrative Court within 21 days with an Acknowledgement of Service and a summary of the defence. The defendant can also submit written argument that permission should be refused. At the hearing, if the judge refuses permission to proceed, the claimant can have the matter reconsidered at an oral hearing within seven days, which the defendant is entitled to attend and
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present argument. If permission to proceed is granted, the matter is taken to a full hearing. Both parties are under a duty of candour to disclose all the information connected with the case, including things that do not support their position. This is especially important for the public authority. (In any case, the Freedom of Information Act may compel disclosure of relevant documents). (b) Hearing stage The hearing stage could be within six months of permission being granted, and in an urgent case, much sooner. Judicial review is normally conducted on the papers alone. PCT officers will be required to give witness statements; they are not usually required to give oral evidence. Nevertheless, issues could arise during the hearing for which further instructions are required. For this reason, those familiar with the case should attend and assist if required. If the defendants decision is criticised and judicial review granted, the claimant will apply for a remedy. A frequent remedy is a quashing order, by which the court overturns the PCTs decision and refers it back to the PCT to be taken again. The court may also make a declaration (for example, declare that the PCT has acted unlawfully), the affect of which is very similar that is to require the matter to be reconsidered. It is uncommon in NHS cases for the court to make a mandatory order requiring the PCT to do something specific because the courts are conscious that giving resources to Peter may mean taking them from Paula.
In exceptional cases, if the claimant can prove that a decision was in breach of a duty and caused damage, the court may award damages under either the Human Rights Act or common law.
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Conclusion
Patients and the public should be engaged in the process of priority setting. Their involvement requires PCT policies and documents to be prepared in ways that are reasonable, accessible and transparent. In this way, the community may see and understand the need for choices in the NHS. The objective is to manage the risks of priority setting, and these risks are not just to the PCT; poor practice also puts at risk the community and individuals. Judicial review, therefore, is about reasonable systems for balancing the sometimes competing claims on finite resources. The law has developed rapidly but, within the limits we have discussed, still leaves much scope for reasonable discretion.
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The author
Christopher Newdick is Professor of Health Law at the University of Reading, Honorary Consultant to Berkshire West PCT, and a member of the Berkshire Priorities Committee and the BMA's working Group on NHS rationing.
Acknowledgments
This series has emerged from the ESRC-funded series on managing scarcity in healthcare, run by Professor Cam Donaldson. It has been funded by a grant from the NHS Institute for Innovation and Improvement. The author and the NHS Confederation would like to thank Dr Daphne Austin, consultant in public health for the West Midlands Specialised Commissioning Team, for her assistance with this report. Responsibility for errors and omissions are the authors alone.
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References
1 R v N and E Devon HA, ex p Coughlan [1999] Lloyds Rep Med 306 2 National Health Service (functions of strategic health authorities and primary care trusts and administrative arrangements) (England) Regulations 2002. HMSO SI 2002, no. 2375 3 R v NW Lancashire HA v A, D & G (2000) 53 BMLR 148; [1999] Lloyds Rep Med 399 4 The Thames Valley ethical framework. Thames Valley Public Health Resource Unit, 2005 5 R (Otley) v Barking and Dagenham PCT [2007] EWHC Admin 1927; [2007] LS Law 593 6 Funding of technology appraisal guidance from the National Institute for Health and Clinical Excellence. Department of Health, 2003 7 National Health Service (General Medical Services contracts) regulations 2004. HMSO SI 2004, No. 291. 8 Revisions to the GMS Contract 2006/07. Delivering investment in general practice, Schedule 8. BMA and NHS Confederation, 2006. 9 The new NHS. Modern and dependable. Developing primary care groups, HSC 1998/139, paras 52-53. Department of Health, 1998. 10 National Health Service (General Medical Services contracts) regulations. 2004, Schedule 6, paras 15 and 39. HMSO SI 2004, No. 291. 11 R v Secretary of State for Health, ex p Pfizer [1999] Lloyd's Rep Med 289 12 Revisions to the GMS Contract 2006/07. Delivering investment in general practice, Schedule 8. BMA and NHS Confederation, 2006. 13 National Health Service (General Medical Services contracts) (prescription of drugs etc) regulations 2004. HMSO SI 2004 No. 629. 14 R (Watts) v Bedfordshire PCT Case (2006) ECJ, C-372/04
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Further reading
Newdick C. 2005: Who should we treat rights, rationing and resources in the NHS. Oxford University Press. This book considers the managerial, political, clinical and legal pressures on NHS resource allocation. The Treasury Solicitor. 2006: The judge over your shoulder, 4th edition. This book is a layman's guide to judicial review generally. www.tsol.gov.uk/Publications/judge.pdf
Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329
15
ISBN 978-1-85947-150-0 BOK 59601
Supported by:
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no. 1090329 Published by the NHS Confederation The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-149-4 BOK 59501
Contents
Introduction What is an individual funding request? What approach should PCTs take to individual funding requests? The individual funding request decision-making process Service developments Other difficult areas Individual funding requests related to treatment-specific policies One-off decisions Conclusion and key action points The author Acknowledgments References Glossary 2 2 3 7 9 11 13 14 15 16 16 17 17
02
Introduction
In undertaking priority setting, one of the key challenges for primary care trusts (PCTs) is how to strike the right balance between providing services that meet the needs of the majority and accommodating the differing needs of individual patients. Commissioning by its very nature focuses on the larger scale. As a result, it cannot be undertaken in a way that meets all needs of all patients in any one clinical group or address the specific needs of patients with less-common conditions. Therefore, PCTs will always need an individual funding request (IFR) process to consider making additional NHS funds available for the atypical or uncommon patient. Decision making is compounded by the fact that legitimate demands for healthcare will always exceed PCT budgets. There have always been individuals whose need for healthcare has not been met by the NHS and this will inevitably continue in the future. Indeed, unmet need is an unfortunate feature of all healthcare systems. So, how should a PCT decide which individual patients should have their requests for special consideration funded? These are some of the most difficult decisions a PCT will have to face. This report explores this area of decision making and provides some good-practice points in relation to managing individual funding requests and dealing with clinicians and patients.
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Exceptionality
Patients' healthcare needs that are not currently met are still legitimate. They are judged to be of differing priority. A PCT cannot agree to support every claim but neither can it decide in advance to refuse to consider funding someone whose needs do not fit the established range of commissioned services. How does the PCT identify those cases that it should fund? In making these decisions,
PCTs must be able to explain coherently their decisions to clinicians, patients, the public and the courts.
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Stage 1. Understanding the meaning of exceptionality within the IFR process PCTs need to clarify what their organisation means by exceptionality by either defining or describing it. The approach that is gaining most popularity is one that Dr Henrietta Ewart developed, as shown in Figure 1. The text in italics can be considered to be the definition. Once the meaning of exceptionality is clearly understood, decision making becomes easier. Stage 2. Agreeing the factors that can be taken into account in deciding if a patient is exceptional The second consideration is the list of factors that the decision maker can take into account when judging whether or not a patient is different to other patients. PCTs are increasingly adopting policies that only allow clinical considerations. Using the definition in Figure 1 as an illustration, the PCT would first
consider whether there were any clinical features that made the patient unique or unusual compared to others in the same group. If so, then it would also consider whether there were sufficient grounds for believing that this unusual clinical factor meant the patient would gain significantly more benefit than that would be expected for the group. It is necessary to differentiate here between exceptional benefit for an individual and the identification of a patient subgroup for which outcomes are better. The latter issue should have been dealt with by the PCT when assessing the treatment (see Service developments, page 9). It must be recognised, however, that occasionally an IFR alerts the PCT to the existence of such a subgroup. In these instances, the PCT might have to go back and review its policy. Serious mental health issues should be viewed as clinical considerations and not put under the catch-all phrase of psychosocial factors.
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may have set a precedent that inadvertently leads to a policy that employed patients should be favoured in some situations. The nature of employment also has the potential to be discriminatory. Should a concert pianist who might benefit from a treatment to improve hand function be given preference when others such as plumbers and hairdressers, whose livelihoods also depend on hand function, are not awarded funding? Employment is not always irrelevant, however. For example, there are two ways of providing peritoneal dialysis for end-stage renal failure. The first method is a simple system that involves the patient draining fluid in and out of their abdomen. The second method, which is more expensive, has a machine do this while the patient is asleep. Some patients have to dialyse at work but strict hygienic conditions must be maintained. An individual who works in a dirty environment might be considered exceptional because the nature of the employment significantly increases the clinical risk. A decision to fund may be justified because it is based on clinical, not social, considerations. Many of the above arguments are relevant to other commonly cited factors such as having educational potential, being a parent and being young. Funding on the grounds of compassion may also be sought for terminally ill patients in order that key life events can be experienced, such as a patient wanting to live to see the marriage of a son or daughter. These events are laden with emotion and meaning for the patient and their family. It can be heart wrenching to have to consider these tragic circumstances, but can it be a reason to regard such a patient as exceptional, given that a favourable decision may affect others?
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The factors covered on page 5 illustrate how important it is that those making decisions be aware of their own prejudices and also those of society in relation to deservedness, as these are not always compatible with the principles underpinning healthcare provision in the NHS. No document on IFRs can ignore the issue of rule of rescue. AR Johnsen2 coined the term in 1986 to describe the imperative people feel to rescue identifiable individuals facing avoidable death. This is a complex subject and there is no consensus about its place in resource allocation. In common commissioning parlance, the term has come to mean the proclivity of people to rescue an identifiable individual who has a life-threatening condition, regardless of cost and the chances of success. Put more crudely, it is often viewed as the last heroic attempt to save a life against the odds. Its main significance for the practitioner is that it draws attention to the emotion of the decision maker. The need and urge to do something for the patient is very strong. Most of us share this impulse. PCTs, however, do not owe a direct duty of care to
individuals and are not rescuers in any real sense. To give in to the impulse to do something can result in inconsistent and unfair decision making because agreed principles and policies are set aside in order to meet the needs of the decision maker (i.e. to feel good, avoid feeling bad, avoid unpleasantness or reduce risk). Stage 3. The likelihood of exceptional cases Normally, when assessing a specific treatment, it is advisable for a PCT to consider the nature of potential exceptions, as different diseases and treatments have differing potential to generate exceptional circumstance. It is possible to anticipate some exceptions in advance and these can be individually addressed in a treatment-specific commissioning policy. Stage 4. Considering the individual funding request itself Having set the context, the PCT can take the IFR decision itself. This involves examination of the specifics of the case in relation to the above three considerations.
What does the law have to say in relation to what is considered material to IFR decisions?
The law relating to priority setting is not at all clear about the factors that PCTs should use and what they can rule out. There are a number of cases which have gone before the courts that suggest social factors may be taken into account, even though there may be good rational and ethical arguments against their consideration. Greater certainty can only be achieved through further litigation that addresses these issues. The courts can only consider the arguments that are put before them. Poorly argued cases may set uncomfortable precedents. PCTs need to balance a concern not to use social and demographic considerations in a way that is discriminatory against the risk that a court may be inclined to set aside a decision that failed to take such factors into account.
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If the appeals panel identifies a problem, the issue is referred back to the IFR panel for reconsideration. The patient or their clinicians should not normally be permitted to introduce additional evidence at the appeal stage. If there is new evidence to support a case, this does not mean that the original decision made on the evidence then available was wrong. Thus the policy should say that the case should be referred back to the IFR committee to decide whether the information is significant enough to merit reconsideration. There is good documentation of the process of decision making as well as the outcome. The reasoning, as well as the outcome, is communicated to the requesting clinician, and (and this should be the norm unless inappropriate) to the patient directly. There is a mechanism for dealing with emergencies. Urgent decisions will normally be delegated to senior public health staff. Decisions are regularly audited and the process reviewed if necessary.
Should the process allow patients to present their case at IFR or appeal panels in person? There is no single answer to this. One judicial review case has said that this is not necessary, provided the patient knows of all the arguments that have to be addressed, can submit written documents to the panel (with the doctors support if necessary) and is guaranteed an impartial hearing. The case noted the disadvantages of judicialising these procedures. This is a matter for PCTs. Some are not comfortable with patients presenting to panels, while others see it as a way to make their decisions more open and accountable.
If there is new evidence to support a case, that does not mean that the original decision made on the evidence then available was wrong.
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Service developments
Service developments have largely been dealt with in the NHS Confederation publication in this series, Priority setting: managing new treatments. However, a discussion is needed here because clinicians often use the IFR route as a means to gain early access to a new treatment. The NHS Contract for 2008/09 makes it clear that the hospital provider is expected to seek funding for new treatments through submission of a business case to the commissioner (Schedule 6, point 8.3). There is, therefore, an expectation that new treatments will be properly assessed and prioritised. It is not rational for a PCT to manage a new treatment by considering one patient at a time. Nor would this be fair, because it breaches a principle commonly adopted by PCTs, namely that: The PCT does not offer treatment to a named individual that would not be offered to all patients with equal clinical need. (See Figure 1, page 4). The use of the IFR system as a means to fund some patients ahead of others could be viewed as an abuse of the system. This is not the purpose of IFR processes but it has not stopped the reported rise in the number of requests in this category. This situation needs active management. There are several options open to PCTs, such as using the NHS contract to full effect and having an ongoing dialogue with provider executives and clinicians. A PCT can also use interim commissioning policies. for a policy vacuum. This makes managing service developments and IFRs extremely difficult. For drugs, this interim period can start well before the date of licensing. It is recommended that PCTs adopt an interim commissioning policy for use during this period. Logic suggests that a PCT should not fund treatment for some patients ahead of others and that time should be allowed for the assessment and prioritisation decisions to be made. Once a PCT has assessed a treatment, its conclusion may be one of the following: that the treatment provides good health gain, is value for money, has met the exceptionality criteria for in-year service development and will be funded that the treatment provides good health gain, is value for money and will be referred to the annual commissioning round for prioritisation that the treatment provides good health gain, is value for money for a sub-group of patients and a service development for this group alone will be referred to the annual commissioning round for prioritisation that the treatment will not be funded because there is insufficient evidence of clinical effectiveness, it represents poor health gain or is not cost effective. PCTs come under understandable pressure to fund treatments as soon as the claimed effects appear in the national media. It is recommended that, until such time as a treatment is actually funded, the policy should clearly say that the PCT will refuse to use the IFR process to fund service developments. That is not to say that exceptional cases cannot arise in this interim period. However, the reader is again referred to Figure 1.
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Equally problematic is the fact that the IFR panel in such instances considers only whether the patient will benefit not whether they are exceptional. Using the IFR route in such cases may be appropriate for highly unusual conditions, but if the PCT expects to see more than one case a year, a policy approach will deliver greater certainty and consume fewer PCT resources to manage.
The IFR panel in such instances considers only whether the patient will benefit, not whether they are exceptional.
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Trial pick-up
There are several situations in which an external organisation will take a decision to start treatment, either hoping or assuming that the NHS will pick
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These documents suggest that: there should be a plan that describes the arrangements for treating patients leaving trials the plan should be considered during the ethical approval process the exit strategy should enable the patient to have ongoing access to any healthcare that has been shown to be beneficial in the study. Neither of these documents states who should be responsible for ongoing access to treatment. PCTs are entitled to agree to pick up trial funding but they are not required to do so unless they commissioned the trial or agreed to fund at an earlier stage. In all other instances, liability cannot rest on the PCT unless it has given prior commitment. It is recommended that PCTs adopt an approach that makes it clear that they cannot be held responsible for decisions to which they were not party. Many PCTs adopt a policy of not generally funding patients coming off trials and only funding trial patients when the service development has been funded and the treatment is made available to all. For trial patients, in particular, it is difficult to anticipate what might constitute exceptional circumstances. Being in a trial is not, of itself, unique; nor is benefiting from the treatment being studied. Trials are also frequently designed to recruit a uniform patient group.
Patients who have part-funded themselves in the private sector for treatments
Another category of IFR that is on the increase comes from patients who have sought private care to access a treatment that their PCT is not currently funding, but who have not been able to afford the full course. Having run out of their own funds, they seek funding from the PCT to complete the course. To pick up funding routinely in these instances would place PCTs in an untenable position. However, if a PCT is faced with such an application, it is obliged to consider the application on the basis of all the evidence in the case. This situation raises two other issues. The first relates to questionable governance within the private sector for failure to ensure that a patient is able to fund a complete course and, if not, failure to agree an exit strategy for patients in much the same way as clinical studies are required to do. NHS pick-up of funding cannot be assumed. The other issue relates to the behaviour of clinicians. Clinicians are at liberty to treat patients privately. Having done so, however, it is unacceptable for a clinician to transfer moral responsibility for creating differential access to treatment onto a PCT. While the PCT cannot influence these behaviours, it is always worth raising such issues with clinicians and private providers.
There is often a real problem in instances where there is no prospect of evidence ever being gathered, such as in treatments for children.
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Experimental treatments
A cornerstone of the NHS today is that it provides treatments of proven cost effectiveness. When a treatment has not been subject to adequate study and where it would be possible to undertake a study (even if the research community is not currently prioritising it) the treatment should be classified as experimental and not generally funded. There is, however, often a real problem in instances where there is no prospect of evidence ever being gathered. These include many treatments for children. In these instances, the PCT might need to make a different assessment, as discussed in the section on one-off decisions (see page 14).
In certain circumstances, it may be worth considering funding a patient to enter an existing trial or even working collaboratively with other PCTs and organisations to establish a trial. There is no legal barrier to this. There is also the potential to fund what are known as n of 1 trials. These are formal trials where the patient acts as his or her own control. These cannot be used in all situations and their role in evaluating treatments has yet to be fully ascertained. Currently, there is no n of 1 trial unit operating in the UK, although there is at least one initiative to seek to establish one. The above list of potentially difficult areas is not exhaustive but illustrative.
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One-off decisions
Off-licensed use for unusual clinical conditions or complications, children with uncommon conditions and adults with rare diseases
As was discussed earlier, in some situations the principle of exceptionality cannot readily be applied. For some IFRs there is simply no reference point: the patient does not come from a sizeable group of patients (often they may be unique) nor is there much evidence about the treatment in question and there may never be. In these instances, the IFR panel has to assess only whether the patient is likely to benefit from the treatment and the priority to be given to the patient. Namely, it is treated as a service development for 1. Under these circumstances, in addition to questions about priority and value for money, the following need to be asked: What is the nature of the condition? What is the nature of the treatment? What is the evidence that this treatment might work in this situation? Is there biological plausibility that this treatment might work? The majority of these can be dealt with through the IFR process alone. However, occasionally the financial commitment is so large the decision needs to be referred to the PCT board. A decision to fund a treatment that costs 300,000 per patient per annum is probably not one the IFR panel alone can make.
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Conclusion
The IFR process is demanding but improvements can be made to make the system more efficient, robust and fair. Although this is a high-risk area for a PCT, funding individual treatments should contribute relatively little to the PCTs priority setting. However, if done poorly, it has the potential to drive the PCTs priorities, resulting in resources being committed to low-priority areas. This may adversely affect other patients. Exceptionality is difficult in ethics, medicine and law. It is impossible to be definitive as to its meaning at this stage. PCTs and clinicians should collaborate with one another to share best practice and learn from experience.
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The author
Dr Daphne Austin BSc MBChB FFPHM Dr Daphne Austin is a consultant in public health currently working for the West Midlands Specialised Commissioning Team. Dr Austin has an extensive background in public health, spanning 17 years. Dr Austin established the UK Commissioning Public Health Network, which she currently chairs.
Acknowledgments
This series has emerged from the ESRC-funded series on managing scarcity in healthcare, run by Professor Cam Donaldson. It has been funded by a grant from the NHS Institute for Innovation and Improvement. The author and the NHS Confederation would like to thank the following people for their input and involvement with this series of publications: Professor Cam Donaldson and the UK Forum for Priority Setting in Healthcare Professor Chris Newdick Claire Cheong-Leen Dr Henrietta Ewart The contributions of Professor Christopher Newdick and David Lock, barrister, to this report have been valuable. The author alone is responsible for the opinions expressed. Responsibility for errors and omissions are the authors alone.
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References
1. The standard NHS contract 2008/09. Schedule 3, part 1. www.dh.gov.uk/en/Publicationsand statistics/Publications/PublicationsPolicyAndGuid ance/DH_081100 2. AR Johnsen: Bentham in a box: technology assessment and health care allocation. Law, Medicine and Health Care 1986,14:172-4 3. National Institute for Health and Clinical Excellence. 2004: Appraisal process: guidance for appellants. www.nice.org.uk/aboutnice/howwework/devnice tech/technologyappraisalprocessguides/appraisal _process_guidance_for_appellants_reference_n0 520.jsp 4. National Health Service Bill 2006. www.dh.gov.uk/en/Publicationsandstatistics/Publi cations/PublicationsLegislation/DH_4134387 5. Department of Health. 2003: A code of conduct for private practice: guidance for NHS medical staff www.dh.gov.uk/en/Publicationsandstatistics/ Publications/PublicationsPolicyAndGuidance/ DH_4100689 6. World Medical Association. 2004: Declaration of Helsinki. www.wma.net/e/policy/b3.htm 7. The Stationery Office. 2004: The Medicines for Human Use (Clinical Trials) Regulations. www.opsi.gov.uk/si/si2004/20041031.htm
Glossary
Service developments a catch-all phrase referring to anything that needs investment. It refers to all new developments, including: new services; new treatments, including drugs; changes to treatment thresholds; and quality improvements, such as reduced waiting times. It also refers to other types of investments that existing services might need, such as pump-priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms. Overarching policy document on resource allocation the document that sets out a PCT's approach to resource allocation, which may be supplemented by more detailed policy documents and protocols. This document and any associated documents should comprehensively set out key principles, policies, protocols and any scheme of delegation for decision making.
Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329
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ISBN 978-1-85947-149-4 BOK 59501
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The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no. 1090329 Published by the NHS Confederation The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-147-0 BOK 59301
Contents
Introduction Why is managing new treatments so important? In-year service developments What information is needed to assess and prioritise a treatment? Cost effectiveness/value for money Commissioning policies Key action points The author Acknowledgements Glossary References 2 3 5 8 10 17 18 19 19 20 20
02
Introduction
Managing the constant demand for new treatments can be difficult for primary care trusts (PCTs). They are under pressure to invest in them, while ensuring cost effectiveness. Drugs, technologies and treatments appear throughout the financial year but PCTs rarely have large contingency funds. This report sets out some of the key considerations for developing priority setting in relation to new treatments, with a useful list of action points. Managing the introduction of new treatments can be interpreted in different ways. This report looks at those differences in understanding, specifically: the nature of funding decisions for new treatments what constitutes a service development the role of licensing the duties of PCTs to provide treatments that are effective and cost effective.
Cost effectiveness
PCTs do not generally measure cost effectiveness using health economics techniques. However, it is helpful to have a cost-effectiveness measure, particularly when considering disinvestment in a potentially controversial area or to identify a group of patients in whom an otherwise cost-ineffective treatment is highly cost effective.
Commissioning policies
Policies should state explicitly what PCTs will and will not fund. They should facilitate consistent decision making, and consider: what, if anything, is to be provided controls what information the PCT wants compliance checks and monitoring spending exceptionality criteria who can make which decisions.
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A service development is anything that has resource implications for the PCT.
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3. Differences in understanding about the role of licensing Licensing processes are designed to give confidence to the public that products are safe. In the UK, drugs and medical devices are made available under a strict regulatory framework. In addition, the National Institute for Health and Clinical Excellence (NICE) carries out a licensing function with its interventional procedures programme (which is to be distinguished from its technology appraisal programme.) Although it is not a regulatory body, NICE looks at the safety and efficacy of new interventional procedures and gives guidance to the NHS on whether procedures, such as new surgical operations, can be safely adopted into routine practice. Taken together, these organisations provide scrutiny over the safety of many new clinical interventions. Patients and healthcare professionals often view an approval from these organisations as a mandate for the intervention to be made available in the NHS. This is not the case. These processes make no judgement on the clinical effectiveness, cost effectiveness or relative priority of treatments.
4. Differences in understanding about the duties of PCTs to provide treatments that are effective and cost effective It goes without saying that in a system that operates with fixed budgets and significant unmet healthcare need, there can be no guarantee of funding for any service development, even those that are cost effective. Cost effectiveness, at least as presently defined, should generally be seen as a minimum requirement for a service development being referred to the annual commissioning round for prioritisation. Clinicians often see the provision any new effective treatments as an absolute duty for the NHS, which, legally speaking, is not correct. It is also impossible in a cash-limited system. The above four points illustrate the need for PCTs to work much more actively to raise awareness and understanding about how they go about priority setting.
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in 17 years and that example might be illustrative of exceptionality. On the evidence available at the time of licensing, there was very good reason to consider this treatment to be life saving, providing health gain that could be measured in years rather than weeks or months. The drug also appeared to provide this benefit to almost 100 per cent of patients who received it. This is an extremely rare occurrence. Even those treatments that are generally considered to be good fall well short of this. It is therefore reasonable to make an assumption that most unplanned investment will be reserved for the management of serious events or new legal requirements. It is self-evident that any new service or treatment that is considered important can be funded at any time if matched disinvestment of a lower-priority intervention or service can be found.
following this, the drug meets the criteria then the PCTs board will have to agree how it will be funded. A commissioning policy is produced. 3. If the treatment does not meet the criteria then time can be taken to assess it through the PCTs normal processes in readiness for the annual commissioning round. A PCT is likely to have a number of routes for this. A cancer drug, for example, might be referred to the cancer networks drug and therapeutics committee. Thereafter, the network would be asked to prioritise the drug against all other interventions related to cancer services (primary prevention, screening, treatment and palliation) and its recommendations would be considered as part of the priority setting of the annual commissioning round. An interim commissioning policy is produced to state that the treatment will not be available until it has been fully assessed and prioritised. 4. The treatment is then prioritised as part of the annual commissioning round. If it is given high priority and can be afforded, it can be made available to the local population. A commissioning policy is produced defining the access criteria. If it is low priority, a commissioning policy is produced saying the treatment will not be made available. If a treatment is desirable but cannot be afforded in the coming year, the PCT should ensure that there is a bring-forward system to enable it to be reconsidered in subsequent commissioning rounds.
Most unplanned investment is reserved for serious events or new legal requirements.
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before demand occurs. The point at which demand for a drug is most readily identified is its licensing date; this point is much less clear for medical devices and operations, which cannot always be identified in advance. In addition, early assessment of a forthcoming treatment is not always possible because the information needed may not be available. It is likely, therefore, that there will always be a mix of proactive and reactive management by a PCT. Horizon scanning can also identify potentially controversial treatments. There may only be one or two per year but a PCT needs to plan fully for them, sometimes collaboratively with other PCTs. Horizon scanning, therefore, is about preparedness not, as some might suggest, about avoiding controversy.
Horizon scanning
Horizon scanning enables a PCT to put new treatments in the annual commissioning round
Figure 2: Decision-making tree for a new treatment coming to market during the financial year
JULY NICE guidance due before the next ACR Annual commissioning round (ACR) NICE guidance due after the next ACR
New treatment
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Experimental treatments
The NHS has not yet developed a comprehensive approach to experimental treatments and it is an area that needs more attention. PCTs should, however, aim to set out an approach to this group. From the PCTs point of view, there are two key questions: 1. What does the PCT define as an experimental treatment? The simple answer to this is anything for which there is no robust evidence. The most likely types of interventions falling into this category are treatments for rare conditions, interventional procedures and medical devices. The way that the scope of existing treatments tends to expand is directly analogous to experimental treatments and PCTs may need to have systems in place to monitor this.
It is legitimate for PCTs to choose to fund a treatment in the context of a clinical trial.
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The number of people in the local population who are likely to be treated now and in the future. Information about key aspects of delivering the new treatment.
This provides information related to prioritisation (for example, related service costs that have to be taken into account), feasibility of introducing the service (for example, manpower requirements and potential shortages), policy making (for example, the need to impose controls on a treatments use) and planning implementation. This indicates the health gain that might be associated with the treatment. This indicates the level of confidence with which the treatment will provide the outcomes stated. This provides some policy options.
The evidence The health outcomes found in trials. The quality and nature of the evidence. Identification of subgroups of patients that might gain more or less benefit than other patients. The NNT (number needed to treat). For example, if the NNT is 20 then 20 patients will need to be treated before one patient will gain benefit. The costs The total cost of providing the new treatment. The cost of different policy options.
When combined with other information, this gives an indication of value for money.
This is needed to assess affordability and the size of the opportunity costs. This provides the opportunity cost and affordability of policy options. This is particularly useful if it is not possible to provide access to all patients. This indicates whether the PCT needs to initiate a piece of work to address wider policy questions. This, together with other information, helps shape the priority of the treatment within a programme area.
Other Identification of new ethical or policy principles. How does this treatment support the delivery of agreed priorities for the service area?
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Other treatments provide valued health gain but are too expensive. The PCT might consider providing such treatments if they were cheaper. One option for dealing with this group is to set a price for the treatment that the NHS is willing to pay. Currently, there is no legal mechanism for PCTs themselves to do this. Another option is to use a rebate scheme, whereby the NHS is reimbursed when a treatment has not been successful for a particular individual. So far there are only two rebates schemes in operation one for drugs for multiple sclerosis and one for the cancer drug Velcade. These schemes are controversial and many PCTs feel that they have not been fully thought through. With or without the ability to change the price PCTs pay for a treatment, there will always be treatments that sit above the cost-effectiveness threshold. It is possible that there are occasions when a PCT might wish to fund a treatment in this category. Here again, the concept of exceptionality arises.
In Figure 4 overleaf, two scenarios for agreed exceptions above a threshold are shown. The aim in developing a framework is that it results in scenario 1 namely, relatively few exceptions are agreed. Scenario 2, on the other hand, is a situation in which so many exceptions are agreed that the very notion of cost effectiveness is undermined. This can be viewed as unsustainable. The major problem facing PCTs is that it has been impossible to come up with criteria that do not eventually create scenario 2. The author is not aware of any that have been successfully developed. There is a growing suspicion that such a set of principles might not exist. This leads to a rather stark (and perhaps currently unpalatable) conclusion that the cut-off might point just be that a point above which nothing will be funded. The NHS urgently needs to find a resolution to this question or ad-hoc decision making will continue. The only organisation that has made some attempt at documenting potentially relevant principles is NICE, in its Guide to the methods of technology appraisal2. It has published the following considerations for agreeing treatments above the 20,000 / QALY level: the degree of uncertainty surrounding the calculation of the QALY the innovative nature of the technology the particular features of the condition and the population receiving the technology instances where there are wider societal costs and benefits. All of these, however, are ill defined and, as such, contestable. For example, what particular features of the condition is the decision maker looking for?
Applying the concept of exceptionality to treatments that are not cost effective
A policy framework is required to consider treatments that offer valued health benefits but are very expensive. Such decisions cannot be made on an ad-hoc basis. The framework that is adopted needs to be: coherent with overall decision making principled objective in the way it assesses treatments sustainable.
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Figure 4: Two possible outcomes for agreeing to treatments above the cost-effectiveness threshold
Scenario 1
COST
X X X X X
Scenario 2
COST
X X X X X X X X X X X X X X X X X
LD HO S RE TH
LD HO S RE TH
BENEFIT
BENEFIT
population) and the AWMSG4 for ultra-orphan conditions (one affected individual per 50,000 population). In both cases, additional consideration is given to the following factors: 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 budget impact; whether the drug may bridge a gap to a definitive therapy; and that such a definitive therapy is currently in development. The SMC also requires information on possible extensions to use. An illustration of the some of the ethical dilemmas that treating rarity different might create can be found in Figure 5 opposite. Another issue raised by high-cost drugs is whether or not there is a limit to the amount society is willing to pay to improve the health outcome for one individual. Ultra-orphan drugs, for example, can cost 350,000 per patient per year. Treating a
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patient for ten years would cost 3.5 million and some patients are expected to be on treatment for life. There are now a number of treatments that require the NHS to commit millions of pounds for the healthcare of one individual. This is compared with the average spend on healthcare of 80,000 per person over the course of 75 years, with the majority of people using about 40,000 (based on 2002/03 prices)5. The question that has to be asked is not whether a person is worth this amount of
money but can this level of expenditure be justified within a healthcare system subject to finite resources? There is no emerging consensus view on these questions, so PCTs are going to have to come to a view themselves. Given the potential to set major precedent when making decisions in this area, caution is advised for agreeing funding treatments above the threshold.
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It is possible to have a group of drugs that do roughly the same thing but are priced differently.
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In summary
Figure 6 provides a quick summary of some of the key decision points for assessing new treatments.
Assess whether the treatment If not, then is likely to deliver valued health outcomes
Assess whether the treatment If not, then represents value for money / is cost effective
If good but unaffordable, then If good but not affordable this year, then
the treatment is not funded and is logged onto the bring-forward system to be reconsidered next year
If low priority
Funded
If high priority
funding is agreed and a commissioning policy drawn up specifying what will be funded.
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PCTs often need to assess whether current clinical practice has drifted from licensed clinical practice.
Disinvestment
This report has focused on new treatments. However, PCTs also need to review what is currently provided. Disinvestment does not have to mean stopping a treatment altogether. It can mean stopping treatment to groups of patients that benefit less or changing the threshold for treatment. The process for assessing existing treatments is similar to that for new treatments, with one exception. An additional exercise is often needed to assess to what extent clinical practice has drifted from licensed practice.
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Commissioning policies
One of the key rules of priority setting is good documentation. Commissioning policies are part of the essential documentation that supports priority setting. They provide an explicit statement of what the PCT will and will not provide. They also facilitate consistent and efficient decision making. It is as important to develop commissioning policies for treatments that the PCT actively supports as it is for those that it wishes to restrict. Such policies are also useful to help shape a number of aspects of provision. In developing a commissioning policy, the following components are worth considering: What, if anything, is to be provided? What are the access criteria? Are there specific exclusions? What controls are wanted? How can these be specified? For example, does the PCT want the treatment offered only by a nominated provider or clinician? What information does the PCT want and is its provision going to be a condition of funding? Does the PCT want to check compliance or monitor spending? If so, then a prior-approval process is required What exceptionality criteria operate? (It is also always worth reiterating the PCTs general policy on exceptionality and management of individual funding requests within a specific commissioning policy.) Who can make which decisions? Delegated functions need to be specified. All policies must be ratified by the board of the PCT.
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19
The author
Dr Daphne Austin BSc MBChB FFPHM Dr Daphne Austin is a consultant in public health currently working for the West Midlands Specialised Commissioning Team. Dr Austin has an extensive background in public health, spanning 17 years. Dr Austin established the UK Commissioning Public Health Network, which she currently chairs.
Acknowledgements
This series has emerged from the ESRC-funded series on managing scarcity in healthcare, run by Professor Cam Donaldson. It has been funded by a grant from the NHS Institute for Innovation and Improvement. The author and the NHS Confederation would like to thank the following people for their input and involvement with this series of publications: Professor Cam Donaldson and the UK Forum for Priority Setting in Healthcare Professor Chris Newdick Claire Cheong-Leen Dr Henrietta Ewart
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Glossary
Opportunity costs arise from alternative opportunities that are foregone in making one choice over another. Affordability the ability to do something without incurring financial risk or unacceptable opportunity costs. It is ultimately determined by the fixed budget of the PCT. Service development a catch-all phrase referring to anything that needs investment. It refers to all new developments including: new services; new treatments, including drugs; changes to treatment protocols that have cost implications; changes to treatment thresholds; and quality improvements, such as reduced waiting times. It also refers to other types of investment that existing services might need, such as pump priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms. Service disinvestment the mirror image of service developments. The overarching policy document on resource allocation the document that sets out a PCTs approach to resource allocation, which may be supplemented by more detailed policy documents and protocols. This document and any associated documents should comprehensively set out key principles, policies, protocols and any scheme of delegation for decision making.
References
1. Dr Daphne Austin. 2007. Priority setting: an overview. NHS Confederation. 2. National Institute for Health and Clinical Excellence. 2004. Guide to the methods of technology appraisal. www.nice.org.uk/page.aspx?o=201974 3. Scottish Medicines Consortium. 2007. Statement on medicines for orphan diseases. www.scottishmedicines.org.uk/smc/3863.21.24.html 4. All Wales Medicine Strategy Group. 2007. Policy on ultra-orphan drugs. www.wales.nhs.uk/sites3/ docmetadata.cfm?orgid=371&id=81655 5. The Office of Health Economics. 2002/03. The economics of health care: estimated HCHS per capita expenditure by age group, England 2002/03. www.oheschools.org/ohech6pg7.html
Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329
15
ISBN 978-1-85947-147-0 BOK 59301
Supported by:
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org Registered Charity no. 1090329 Published by the NHS Confederation The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-153-1 BOK 59801 This publication has been manufactured using paper produced under the FSC Chain of Custody. It is printed using vegetable-based inks and low VOC processes by a printer employing the ISO14001 environmental accreditation.
Contents
Introduction How to break down decision making Strategic planning The annual commissioning round Other tools to aid decision making Resources Conclusion and key action points The author Acknowledgments References Glossary 2 3 5 10 12 18 19 20 21 22 23
02
Introduction
For primary care trusts (PCTs) the most important priority setting is done at the strategic level. It is here that the major decisions shaping local healthcare services are taken. This is done through the development of strategic plans which are then translated incrementally through serial resource allocation decisions. Strategic planning involves priority setting because it determines which healthcare needs will be met and which will not. Developing an implementation plan involves priority setting because it determines when needs will be met. Priority setting is as old as the NHS itself. It is surprising, therefore, that priority setting at these levels is most in need of development. It could be argued that the focus on health technology assessment has been to the detriment of the development of other tools. As a result, many challenges remain. These include: how to best manage a large number of decisions how to construct all decision making to ensure that the primacy of prioritisation is maintained (see the previous report in this series, Priority setting: an overview) how to fairly and efficiently compare very different sorts of interventions how to ensure that investments reflect priorities how to fully engage the wider NHS and the public and in doing so secure the trust of the local community. To meet these challenges PCTs will need to network with fellow PCTs and other partner organisations, including academic institutions, to develop understanding, tools and skills. Particularly important is the need to verbalise, capture and therefore give full account of the decisions PCTs currently make and how these are shaped by their unique perspective and responsibilities (for example: knowledge of opportunity costs, legal duties to provide comprehensive healthcare and being a budget holder). While this report acknowledges the developmental nature of priority setting at the strategic level, it sets out some well recognised considerations for the planning cycle and presents some tools which may be useful for PCTs to adopt and adapt.
For PCTs the most important priority setting is done at the strategic level. It is here that the major decisions shaping local healthcare services are taken.
03
Restoring health
04
Priority setting results, therefore, from a complex set of interrelated groups of decisions, all aimed at identifying: What are the areas/issues to focus on? What are the needs and priorities of each particular service, patient group, condition?
What is the next investment/disinvestment? Figure 2 gives an example of how a series of decisions might contribute to overall priority setting.
Major priority areas on which the organisation(s) will focus attention are decided
Decisions between competing needs from different programme areas are agreed
Strategic planning occurs at a programme level priority areas for investment and disinvestment are identified
Providers identify their own priorities that may or may not relate to strategic plans Bottom-up
Strategic plan implemented incrementally, supported by resource allocation decisions some of which may require additional investment over budget. If so, they need to compete with other programmes for additional resources to be added to the programmes budget
05
Strategic planning
Healthcare needs
Healthcare needs and their assessment were first fully described by Stevens.3 A healthcare need is a health problem that would benefit from a known effective intervention. The term intervention should not be restricted to the type of service provided by the NHS. This is particularly so in relation to primary prevention, where the intervention is aimed at preventing a health problem. The epidemiological this gives a picture of the condition of interest and potential interventions. The comparative this gives a picture of the existing services and interventions, comparing them with established standards or what is available to other populations. It also includes a strategic analysis of service issues and trends and identification of current spends and contracts used to commission those services. The corporate this provides the views of stakeholders. One objective of this exercise is to map out the relationships between need, demand and supply (also described by Stevens). Figure 3 shows the potential relationships that might exist. Every segment of the Venn diagram is of significance. Strategic plans should be designed to better align these elements.
E
Need
A B C
Demand
The overlap between need and demand represents healthcare needs that are expressed. Zone B represents need which is met while Zone A represents need that is not. Zone D represents services that are provided to meet a demand but do not meet a healthcare need. A classic example is prescribing antibiotics for a cold.
D
Supply
Zone C represents a service that meets a legitimate need but is one which is not wanted or valued by patients. An example is a terminally ill patient being treated in an acute hospital setting.
06
The outcome of a healthcare needs assessment should include: an understanding of the nature and size of the health problem and the current and future need for intervention and services a hierarchy of interventions arranged in terms of their ability to produce health gain and the costs incurred in doing so an understanding of the service currently being provided and an assessment of its quality a view on what a model service would look like and what changes and developments are potentially achievable in the short, medium, and long terms locally an analysis of constraints (for example, manpower shortages) and analysis of potential obstacles to implementation (for example, lack of commitment by a key organisation) minimum and target quality standards that might be introduced an understanding of the current spend and preliminary costs for key service developments and potential sources for releasing cash (for example, providing services more efficiently, service redesign, disinvestment) identification of any procurement/contracting issues.
Involving stakeholders
The local authority will have been involved in the joint strategic needs assessment. Depending on how the programme areas have been developed, wider stakeholder engagement will have occurred, to a greater or lesser extent, through the healthcare needs assessment process itself. Wider involvement in developing strategies (and therefore setting priorities) is important for many reasons, not least of which is that a better strategy is likely to result from having a richer experience and wider range of perspectives on which to draw. Other reasons for widening involvement are to build relationships, consensus and legitimacy. PCTs need to carefully consider what structures they might need to help with strategy development at the programme level and how to involve the key perspectives: users, professionals, managers who run services, public health, the commissioning team, and other key agencies. Ideally, each programme area should have a supporting planning forum, chaired by a senior individual from either the PCT or the local authority. However, establishing and maintaining all the groups that are needed is an impossible task for any PCT at present and so a phased approach will need to be taken. Unfortunately, public policy over the last 20 years has not delivered structures which bring together the key stakeholders in the right balance. In particular, PCTs have inherited a number of clinical networks established over the last ten years, and there is considerable confusion over the role of many of these. Functionally, there are three types of networks, listed on page 8.
07
08
Professional networks Generally, these are informal networks of professionals who share the same interest, and often comprise of individuals coming from the same discipline. They are largely educational and support networks. Clinical networks These are more formal multi-disciplinary networks primarily, but not exclusively, comprised of healthcare professionals working across a patient pathway for a service area. They largely have an operational focus, concentrating on quality and ensuring that patients move between different parts of the service. A clinical network can be a subgroup of a strategic network. Strategic networks These are formal planning groups of the PCT or joint planning groups of the PCT and local authority. They are multi-disciplinary and multi-agency groups. Strategic networks should have responsibility for undertaking priority setting within a programme area. In the future it is both likely and desirable that they will also have some responsibility for the total budget for that programme. Problems currently exist in a number of areas where a clinical network has been given or adopted a strategic function without sufficient accountability to local PCTs. Patient and public involvement and the role of overview and scrutiny committees is a major area in itself and is not covered in this report. However, it is worth reiterating that the roles of the citizen and user should not be confused it is the citizens voice that is needed for high-level decision making. Users and carers should help shape priorities for the services they use. This also follows the principle of involving those who have detailed knowledge of an area involved in the early stages of priority setting.
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10
4. Can any existing services be provided as effectively but with fewer resources, so releasing resources to fund items on the growth list? 5. If some growth areas still cannot be funded, are there any services that should receive fewer resources, or even be stopped, because greater benefits would be reached by funding the growth options as opposed to the existing service? This approach is relevant for priority setting at any level, both in provider and commissioning organisations. So this tool can, for example, be used to increase efficiency and focus resources optimally within a providers departmental budget. The major constraint in being able to answer these five questions is the lack of information on how existing budgets are spent. This should improve the more the tool is adopted within the NHS. Currently, NHS decision making is often not constructed to fully address all five of the above
questions. Strategic planning (or goal setting for a programme area) helps to answer question 3 and, in part, question 2. It does not, however, compare funding with other programme areas. Programme budgeting, however, aims to answer the first two questions and marginal analysis the remaining three. The relationship between HNA and PBMA is an interesting one. Set in the context of PBMA, there should be greater emphasis on identifying areas for disinvestment and increasing efficiency. The emerging strategic plan should also be set within any financial constraints defined by the programme budget. Practically, PBMA can also operate in the absence of a strategy. Here the focus is on identifying more limited short-term goals or dealing with specific funding issues. Priority setting using this approach re-emphasises the inappropriateness of singular decision making, as discussed in Priority setting: an overview.
11
Scores: Option 1 = 7, Option 2 = 5, Option 3 = 6, and Option 4 = 0 Priority rankings: Option 1 is the highest priority, then Option 3, then Option 2, and the lowest priority is Option 4.
12
Scoring systems
Many organisations have developed systems for comparing service developments and virtually all of them use a scoring system. A scoring system aims to assess priorities against an agreed set of factors. Those most commonly used include: the nature of the health gain confidence in the clinical evidence the number of individuals benefiting cost-effectiveness/value for money the need to redress inequalities and inequities of access accessibility
national priorities stated local priorities clinical risks service risks quality issues cost legislation and direction from the Secretary of State patient choice. Factors are often weighted. So, factors considered most important may be given the maximum score of 100 while those of less significance only five or ten. A greater level of sophistication can be
(Date of Analysis)
(Name of Service/Therapy/Treatment)
( S C OR E )
(Maximum of 290)
13
introduced if multipliers are used as this enables greater discrimination between interventions. So, for example, the scores for health gain, rather than being added to the score for number of individuals benefiting, is multiplied by the score. As with paired decision analysis those assessing interventions need to be familiar with the topic area. They also need to understand and apply the scoring system in the same way. One of the simplest scoring systems is the Portsmouth Scorecard, first developed by Dr Paul
Edmundson-Jones at Portsmouth City PCT. His original scorecard is shown in Figure 5. The Portsmouth Scorecard has been further developed by others. One such modification, overseen by Dr Khesh Sidhu, is summarised in the box below and illustrated in Figure 6. A key issue for all scorecards is how the scoring is weighted; another is how they are assessed. A welcome development would be making the measures for determining the scores for each factor increasingly objective.
14
Scale
Low
10 points
Score
Mid scale
2 0 p o i n t s if you ha ve mo de s t ev i d e n c e t h a t the service works 20 points if there are mo derate improvement in heal th or life e x p e c ta n c y 20 points if th ere are 10 - 49
High
30 points
Top points
4 0 p o i n t s if you definitely have experience that the service works
Magnitude of benefit
10 points
30 points
10 p oi nt s
40 points if there are > 50 0 people in your practice who would benefit 40 points i f t h e c o s t is less than 50,000
Patient acceptability
10 po in ts i f patients would find it somewhat unacceptab le 10 points i f i t addresses one target or national requireme nt
20 points if patients would have no vi e w on acceptabili ty 20 points if it addresses two targets or na tional requiremen ts 10 points if i t part ial ly addresss an inequality or inequity
30 points i f p a ti e n t s wo uld f ind it somew hat acceptable 3 0 p oi nt s i f i t addresses three targets or national requ irements
N a ti o n al r eq u i r e me n t o r NH S target
Addressing health inequality or health inequity ie where patients have not had service in the past
5 points
15
5 points if some 10 points if 15 points if large benefit to society moderate benefit benefit to society to society 5 points if other options with better outcomes 10 points if other options but equivalent outcomes 15 points if limited options with poorer outcomes
TOTAL SCORE
15
Yes Yes
1 1
Yes
Redesign of 2 local community hospital beds C Level 2 facility town C Increased capacity focusing on Zone X Increased capacity focusing on Zone Y 3 1
Not planned
2010
Await details
Yes
1 2
Not planned 2
Increased Yes access to Marie Curie and night sitting Increased Yes access to Marie Curie and night sitting Etc
Not planned
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They are best managed at a programme level, held and constantly updated by the programme lead, and can be set up in Excel. An example is shown in Figure 7. All the tools presented above are useful when addressing different aspects or problems of decision-making. As such, they complement each other. In addition, PBMA, paired comparison analysis and scoring systems can both be used to identify priorities for investment and areas for disinvestment.
The capacity of the NHS to undertake fair and informed decision making requires a seismic shift in knowledge, understanding, attitudes and behaviours.
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Resources
In the first report in this series, Priority setting: an overview, the need to consider the resources dedicated to priority setting was raised. Hopefully, the case for ensuring that the PCT has sufficient dedicated time and funds to support and develop this task has become apparent in the course of this series. Unfortunately, all too often responsibility for overseeing this function sits with the busiest people in an organisation. Priority setting should not be seen as an add-on but should command its own strategy, implementation plan and a dedicated team.
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Conclusion
Priority setting is a complex but important task. As resources become more scarce, and both need and demand increase, PCTs will have to develop the best systems they can in order to allocate resources fairly and to optimum effect. This report the last in the current series has covered some of the important principles in relation to priority setting at the strategic level. It is not, however, meant to be a comprehensive guide and there are some notable areas that have been not been covered, such as patient and public involvement, practice-based commissioning, working with local authorities, engaging with the media, strategies to influence the wider debate, disinvestment and the role of contracting in both delivering priorities and using resources most efficiently. It is hoped, nevertheless, that this series of reports has provided a useful guide for practitioners and introduced some key concepts. If you would like to comment on any of the issues raised in this series, please contact nigel.edwards@nhsconfed.org
19
The author
Dr Daphne Austin BSc MBChB FFPHM Dr Daphne Austin is a consultant in public health currently working for the West Midlands Specialised Commissioning Team. Dr Austin has an extensive background in public health, spanning 17 years. Dr Austin established the UK Commissioning Public Health Network, which she currently chairs.
20
Acknowledgments
This series has emerged from the ESRC-funded series on managing scarcity in healthcare, run by Professor Cam Donaldson. It has been funded by a grant from the NHS Institute for Innovation and Improvement. The author and the NHS Confederation would like to thank the following people for their input and involvement with this series of publications: Professor Cam Donaldson and the UK Forum for Priority Setting in Healthcare Professor Christopher Newdick Claire Cheong-Leen Dr Henrietta Ewart The author would also like to thank Andrew Donald and Dr Khesh Sidhu for their contributions to this report.
21
References
1 Programme budgeting and marginal analysis: a framework for health improvement, commissioning and accountability. Presentation by P. Brambleby, Birmingham, June 2007 2 Joint Strategic Needs Assessment, Department of Health, 2007 www.dh.gov.uk/en/Publications andstatistics/Publications/PublicationsPolicyAnd Guidance/DH_081097 3 Stevens, A. 1991: Needs assessment, Health Trends, 23:203 4 This section draws heavily on Cook, J., Austin, D. 1999: Commissioning in Williams A (ed), Patient care in neurology, pps 399416 5 For Donabedians seminal paper on quality read: Donabedian, A. 1966: Evaluating the Quality of Medical Care, Milbank Memorial Fund Quarterly: Health and Society, 44(3; pt. 2):166203 6 www.afro.who.int/healthpromotion/ strategies/html 7 Programme budgeting and marginal analysis: a framework for health improvement, commissioning and accountability. Presentation by P. Brambleby, Birmingham, June 2007 8 Brambleby, P., Fordham, R. 2003: What is PBMA?, What is, volume 4, number 2 9 Brambleby, P., Fordham, R. 2003: Implementing PBMA, What is, volume 4, number 3 10 Ruta, D., Mitton, C., Bate, A., Donaldson, C. 2005: Programme budgeting and marginal analysis: bridging the divide between doctors and managers, BMJ, 330: 150103 11 The National Programme Budgeting Project, Department of Health www.dh.gov.uk/en/ Managingyourorganisation/Financeandplanning/ Programmebudgeting/index.htm 12 McGuire, R. 2002: Decision making, The Pharmaceutical Journal, 269: 6479 13 www.mindtools.com/pages/article/ newTED_02.htm
22
Glossary
Annual commissioning round the process by which new money coming into the NHS is allocated. The process has undergone many changes over the years but key elements of the process have remained unchanged. Funding decisions follow an annual cycle. Service developments are gathered and assessed during the autumn. Once PCTs are confident of the size of additional funding (usually known in December) priority setting intensifies. Final decisions have to be before the end of the year to ensure that new contracts can be placed with providers of healthcare for the new financial year which starts on 1 April. This annual process sits within a longer term strategic planning process. For the purposes of this series of publications this process will be known as the annual commissioning round. Healthcare needs assessment (HNA) the process by which the need for services and other interventions is fully assessed. It is a vital analysis which underpins any strategic plan. It is comprised of three elements: the epidemiological, the comparative and the corporate. Paired comparison analysis (PCA) a well-established tool for decision making which requires the ranking or prioritisation of options. If used properly, it can be an efficient way of reaching consensus when decision making has stalled. Programme budgeting and marginal analysis (PBMA) a long-established tool for decision making which could now be considered the most important development within priority setting. Redeployment of resources is integral to the thinking of this methodology. Service development a catch-all phrase referring to anything that needs investment. It refers to all new developments, including: new services; new treatments, including drugs; changes to treatment thresholds; and quality improvements, such as reduced waiting times. It also refers to other types of investments that existing services might need, such as pump-priming to establish new models of care, training to meet anticipated manpower shortages and implementing legal reforms.
Supported by:
Supported by:
Supported by:
Supported by:
Supported by:
Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
The NHS Confederation 2008 This document may not be reproduced in whole or in part without permission
The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329
15
ISBN 978-1-85947-153-1 BOK 59801