Challenges for the National Institute for Clinical Excellence
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《英国医生杂志》
1 Department of Health Sciences, University of York, York YO10 5DD, 2 Department of Primary Care and General Practice, University of Birmingham, Birmingham B15 2TT
Correspondence to: A Maynard akm3@york.ac.uk
So far NICE has focused on evaluating new technologies rather than existing ones. But this approach is creating inflationary pressure that the NHS cannot afford
Introduction
Rawlins has stated that there is "no role for NICE in the rationing of treatments to NHS patients."3 These weasel words belie the inevitability of healthcare rationing, which is ubiquitous in all healthcare systems. Rationing involves depriving patients of care from which they may benefit and which they wish to have4; this is inescapably the business of NICE. Indeed, rationing is the inevitable corollary of prioritisation, and NICE must fully inform rationing in the NHS.
The issue is not whether but how to ration. The criteria determining access to care depend on the health goals society is seeking to achieve. Are we solely interested in efficient use of resources—maximising health from a given budget? Or does society seek efficiency and equity and, if so, is it prepared to sacrifice some efficiency to achieve equity goals? The central nature of NICE as a prioritisation (and hence rationing) body means that four fundamental challenges emerge. These challenges need to be managed carefully and robustly if NICE is to prosper, as we discuss below.
Restricting access to NHS funding
Society is clearly not concerned only with efficiency and using NHS budgets to maximise improvements in population health. The NHS, in its usual fragmented and implicit way, illustrates different value systems—for example, by investing "inefficiently" in low birthweight babies because our society values highly the lives of the newly born. In some cases NICE has also operated a rule of rescue approach to its recommendations rather than one based solely on effectiveness or cost effectiveness.5
If the NHS seeks to achieve greater fairness—for example, by making quality adjusted life expectancy more equally distributed through the population—it follows that NICE must not focus on clinical or cost effectiveness alone. Its work has to recognise the equity dimension of healthcare rationing and elicit appropriate trade-offs between efficiency and equity. This could be achieved, for example, by implementing a fair innings approach, reflecting the belief that everybody is entitled to a "normal" span of health.4 Under this approach, resources would be allocated in order to achieve equitable distributions of health rather than to simply maximise health benefits regardless of who benefits.4
The NHS and other public healthcare systems were created to improve equity by equalising access to care in the hope of reducing inequalities in health. With NICE providing national guidance on the use of healthcare interventions in the English and Welsh NHS, it is inappropriate that it continues to avoid its responsibilities in terms of achieving equity.
Selecting technologies for approval
As Rawlins and Culyer describe,2 NICE does not have a set threshold at which it is prepared to approve treatments. This has led to the approval of some therapies with small benefits—for instance, in cancer treatment.6 NICE approvals cause NHS provider organisations considerable difficulty because of the other cost pressures they face. These include inflationary pay settlements, the working time directive, and pressure to achieve access and national service framework targets. Although practitioners who benefit from NICE induced service development may be enthusiastic, the opportunity costs for other service providers are considerable.
Summary points
Rationing health care is inevitable, and NICE should inform NHS decision making
Adoption of new technologies by NHS clinicians should be informed by costs as well as effectiveness
The NHS needs better information from NICE on the equity implications of new and existing technologies
NICE appraisal should focus not only on service enhancement but also on withdrawal of existing ineffective or inefficient therapies
Giving NICE a real budget to fund its recommendations would encourage it to examine the effect of its decisions on the whole NHS
Current consideration of other aspects of the pharmaceutical market may further increase NHS expenditure. These include the proposed reform of the Pharmaceutical Price Regulation Scheme, with "free" pricing of products as one policy option,7 and recent pressure from the commissioner of the US Food and Drug Administration for higher prices in Europe, so that a larger proportion of research and development costs is borne there.8
Against this background, and given the NICE threshold for approval is essentially arbitrary, ways have to be found to economise the use of drugs and other technologies. This issue could be approached in several ways:
Acquire the preferences of key decision makers—for instance NHS chief executives (motivated by the solvency of their organisations as well as patient health) and use them to determine the threshold. This could lower threshold, perhaps to ￡12 000-15 000/quality adjusted life year ($22 000-28 000, 18 000-23 000) and result in NICE rejecting many more technologies for NHS use.
Give NICE an annual notional budget to fund its recommendations. For example, NICE could be given ￡500m a year and would have to cost carefully its proposals and stay within that notional budget or recommend services suitable to withdraw to fund the new services
Give NICE an annual, top sliced, real budget and require it to fund all its advice within that expenditure envelope with allocations to trusts to fund its recommendations.
The most efficient of these three options is likely to be the third. This would force NICE to determine the value of the additional therapies at the margin, examine the effect of their decisions on the whole NHS, and also provide incentives to balance cost enhancing against cost reducing recommendations.
The pharmaceutical industry is unlikely to react positively to these proposals, as they would make rationing tighter and potentially shrink its UK market. Such a reversal of NICE's current propensity to be the marketing arm for companies would have political consequences and requires careful management.
Conclusions
Bloor K, Maynard A. Regulating the pharmaceutical industry. BMJ 1997;315: 200-1.
Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and its value judgments. BMJ 2004;328: 224-7.
Association of the British Pharmaceutical Industry. The expert patient. London: ABPI, 1999. www.abpi.org.uk/publications/publication_details/expert_patient/power_point_doc_NICE.asp (accessed 14 October 2003).
Williams A. Intergenerational equity: an exploration of the fair innings. Health Economics 1997;6: 117-32.
Freemantle N, Bloor K, Eastaugh J. A fair innings for NICE? Pharmacoeconomics 2002;20: 389-91.
Garattini S, Bertele V. Efficacy, safety and the cost of new anticancer drugs. BMJ 2002;325: 269-71.
Department of Health. Pharmaceutical price regulation scheme: discussion document. London: DoH, 2003. www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en? (accessed 28 June 2004).
Hopkins J. FDA chief wants other rich countries to share drug development costs. BMJ 2003;327: 830.(Alan Maynard, professor1,)
Correspondence to: A Maynard akm3@york.ac.uk
So far NICE has focused on evaluating new technologies rather than existing ones. But this approach is creating inflationary pressure that the NHS cannot afford
Introduction
Rawlins has stated that there is "no role for NICE in the rationing of treatments to NHS patients."3 These weasel words belie the inevitability of healthcare rationing, which is ubiquitous in all healthcare systems. Rationing involves depriving patients of care from which they may benefit and which they wish to have4; this is inescapably the business of NICE. Indeed, rationing is the inevitable corollary of prioritisation, and NICE must fully inform rationing in the NHS.
The issue is not whether but how to ration. The criteria determining access to care depend on the health goals society is seeking to achieve. Are we solely interested in efficient use of resources—maximising health from a given budget? Or does society seek efficiency and equity and, if so, is it prepared to sacrifice some efficiency to achieve equity goals? The central nature of NICE as a prioritisation (and hence rationing) body means that four fundamental challenges emerge. These challenges need to be managed carefully and robustly if NICE is to prosper, as we discuss below.
Restricting access to NHS funding
Society is clearly not concerned only with efficiency and using NHS budgets to maximise improvements in population health. The NHS, in its usual fragmented and implicit way, illustrates different value systems—for example, by investing "inefficiently" in low birthweight babies because our society values highly the lives of the newly born. In some cases NICE has also operated a rule of rescue approach to its recommendations rather than one based solely on effectiveness or cost effectiveness.5
If the NHS seeks to achieve greater fairness—for example, by making quality adjusted life expectancy more equally distributed through the population—it follows that NICE must not focus on clinical or cost effectiveness alone. Its work has to recognise the equity dimension of healthcare rationing and elicit appropriate trade-offs between efficiency and equity. This could be achieved, for example, by implementing a fair innings approach, reflecting the belief that everybody is entitled to a "normal" span of health.4 Under this approach, resources would be allocated in order to achieve equitable distributions of health rather than to simply maximise health benefits regardless of who benefits.4
The NHS and other public healthcare systems were created to improve equity by equalising access to care in the hope of reducing inequalities in health. With NICE providing national guidance on the use of healthcare interventions in the English and Welsh NHS, it is inappropriate that it continues to avoid its responsibilities in terms of achieving equity.
Selecting technologies for approval
As Rawlins and Culyer describe,2 NICE does not have a set threshold at which it is prepared to approve treatments. This has led to the approval of some therapies with small benefits—for instance, in cancer treatment.6 NICE approvals cause NHS provider organisations considerable difficulty because of the other cost pressures they face. These include inflationary pay settlements, the working time directive, and pressure to achieve access and national service framework targets. Although practitioners who benefit from NICE induced service development may be enthusiastic, the opportunity costs for other service providers are considerable.
Summary points
Rationing health care is inevitable, and NICE should inform NHS decision making
Adoption of new technologies by NHS clinicians should be informed by costs as well as effectiveness
The NHS needs better information from NICE on the equity implications of new and existing technologies
NICE appraisal should focus not only on service enhancement but also on withdrawal of existing ineffective or inefficient therapies
Giving NICE a real budget to fund its recommendations would encourage it to examine the effect of its decisions on the whole NHS
Current consideration of other aspects of the pharmaceutical market may further increase NHS expenditure. These include the proposed reform of the Pharmaceutical Price Regulation Scheme, with "free" pricing of products as one policy option,7 and recent pressure from the commissioner of the US Food and Drug Administration for higher prices in Europe, so that a larger proportion of research and development costs is borne there.8
Against this background, and given the NICE threshold for approval is essentially arbitrary, ways have to be found to economise the use of drugs and other technologies. This issue could be approached in several ways:
Acquire the preferences of key decision makers—for instance NHS chief executives (motivated by the solvency of their organisations as well as patient health) and use them to determine the threshold. This could lower threshold, perhaps to ￡12 000-15 000/quality adjusted life year ($22 000-28 000, 18 000-23 000) and result in NICE rejecting many more technologies for NHS use.
Give NICE an annual notional budget to fund its recommendations. For example, NICE could be given ￡500m a year and would have to cost carefully its proposals and stay within that notional budget or recommend services suitable to withdraw to fund the new services
Give NICE an annual, top sliced, real budget and require it to fund all its advice within that expenditure envelope with allocations to trusts to fund its recommendations.
The most efficient of these three options is likely to be the third. This would force NICE to determine the value of the additional therapies at the margin, examine the effect of their decisions on the whole NHS, and also provide incentives to balance cost enhancing against cost reducing recommendations.
The pharmaceutical industry is unlikely to react positively to these proposals, as they would make rationing tighter and potentially shrink its UK market. Such a reversal of NICE's current propensity to be the marketing arm for companies would have political consequences and requires careful management.
Conclusions
Bloor K, Maynard A. Regulating the pharmaceutical industry. BMJ 1997;315: 200-1.
Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and its value judgments. BMJ 2004;328: 224-7.
Association of the British Pharmaceutical Industry. The expert patient. London: ABPI, 1999. www.abpi.org.uk/publications/publication_details/expert_patient/power_point_doc_NICE.asp (accessed 14 October 2003).
Williams A. Intergenerational equity: an exploration of the fair innings. Health Economics 1997;6: 117-32.
Freemantle N, Bloor K, Eastaugh J. A fair innings for NICE? Pharmacoeconomics 2002;20: 389-91.
Garattini S, Bertele V. Efficacy, safety and the cost of new anticancer drugs. BMJ 2002;325: 269-71.
Department of Health. Pharmaceutical price regulation scheme: discussion document. London: DoH, 2003. www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en? (accessed 28 June 2004).
Hopkins J. FDA chief wants other rich countries to share drug development costs. BMJ 2003;327: 830.(Alan Maynard, professor1,)