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

Bloor, K

Freemantle, N

Maynard, A

English

PubMed

Maynard, AK

Freemantle, Nick

University of Birmingham Research Portal

Challenges for the National Institute for Clinical Excellence

White Rose Research Online

This is a repository copy of Challenges for the National Institute for Clinical Excellence.White Rose Research Online URL for this paper:https://eprints.whiterose.ac.uk/54/Article:Maynard, A, Bloor, K orcid.org/0000-0003-4852-9854 and Freemantle, N (2004) Challenges for the National Institute for Clinical Excellence. BMJ. pp. 227-229. ISSN 1756-1833 eprints@whiterose.ac.ukhttps://eprints.whiterose.ac.uk/Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. 7 Culyer AJ. The rationing debate: maximising the health of the wholecommunity. BMJ 1997;314:667-9.8 National Institute for Clinical Excellence. Anakinra for rheumatoid arthritis.London: NICE, 2003. (Technology appraisal No 72.) www.nice.org.uk/page.aspx?o = 94670 (accessed 25 Jun 2004).9 National Institute for Clinical Excellence. Beta interferon and glatirameracetate for the treatment of multiple sclerosis. London: NICE, 2002. (Technol-ogy appraisal No 32.) www.nice.org.uk/page.aspx?o = 27588 (accessed 25Jun 2004).10 National Institute for Clinical Excellence. Guidance on the use of imatinib forchronic myeloid leukaemia. London: NICE, 2002. (Technology appraisal No50.) www.nice.org.uk/page.aspx?o = 37604 (accessed 25 Jun 2004).11 NICE Citizens Council. Report of the first meeting: Determining clinical need.London: NICE, 2003. www.nice.org.uk/pdf/FINALNICEFirstMeeting_FINALReport.pdf (accessed 25 Jun 2004).12 NICE Citizens Council. Report on age. London: NICE, 2003.www.nice.org.uk/pdf/Citizenscouncil_report_age.pdf (accessed 25 Jun2004).13 Brazier JN, Jones N, Kind P. Testing the validity of the Euroqol and com-paring it with the SF-36 health survey questionnaire. Qual Life Res1993;2:169-80.14 Anderson RT, Aaronson NK, Bullinger M, McBee WL. A review of theprogress towards developing health-related quality-of-life instrumentsfor international clinical studies and outcomes research. Pharmacoeconom-ics 1996;10:336-55.15 Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53-72.16 Roset M, Badia X, Mayo NE. Sample size calculations in studies using theEuroQol 5D. Qual Life Res 1999;8:539-49.17 Kind P, Hardman G, Macran S. UK population norms for EQ-5D. York:Centre for Health Economics, 1999 (Discussion paper No 172).18 Culyer AJ, Wagstaff A. Equity and equality in health and health care. JHealth Econ 1993;12:431-57.19 Culyer AJ. Economics and ethics in healthcare. J Med Ethics 2001;27:217-22.20 Culyer AJ. Equity—some theory and its policy implications. J Med Ethics2001;27:275-83.21 Culyer AJ. Need: the idea won’t do—but we still need it. Soc Sci Med1995;40:727-30.Challenges for the National Institute for Clinical ExcellenceAlan Maynard, Karen Bloor, Nick FreemantleSo far NICE has focused on evaluating new technologies rather than existing ones. But thisapproach is creating inflationary pressure that the NHS cannot affordEven with recent large increases in NHS expenditure,acute funding difficulties continue to emerge. It isessential that a national mechanism to prioritise newand existing technologies is available to informdecision making. The National Institute for ClinicalExcellence (NICE) was created to meet this need.1However, despite Rawlins and Culyer’s essay onconsultation and equity,2 NICE has yet to mature intothe efficient prioritisation mechanism that is requiredto ensure the best use of NHS resources.RationingRawlins has stated that there is “no role for NICE in therationing of treatments to NHS patients.”3 These weaselwords belie the inevitability of healthcare rationing,which is ubiquitous in all healthcare systems. Rationinginvolves depriving patients of care from which theymay benefit and which they wish to have4; this isinescapably the business of NICE. Indeed, rationing isthe inevitable corollary of prioritisation, and NICEmust fully inform rationing in the NHS.The issue is not whether but how to ration. The cri-teria determining access to care depend on the healthgoals society is seeking to achieve. Are we solely inter-ested in efficient use of resources—maximising healthfrom a given budget? Or does society seek efficiencyand equity and, if so, is it prepared to sacrifice someefficiency to achieve equity goals? The central nature ofNICE as a prioritisation (and hence rationing) bodymeans that four fundamental challenges emerge.These challenges need to be managed carefully androbustly if NICE is to prosper, as we discuss below.Restricting access to NHS fundingCurrently the role of NICE is too peripheral to theNHS. For instance, the government should make itimpossible for the NHS to adopt expensive newtechnologies until they are approved by NICE. Theadditional benefits of most technologies are small—forexample, taxanes may add only a few more months tolife and have adverse side effects for cancer patients.The function of NICE is to reach a consensus aboutclinical and economic evidence. This does not implythat only cost effective treatments should be fundedbut that decisions to fund interventions under the NHSshould be taken after careful consideration of the bestpossible information. Such consideration should bedone before, not after, the introduction of newtechnologies.Equity and efficiency trade-offsSociety is clearly not concerned only with efficiencyand using NHS budgets to maximise improvements inpopulation health. The NHS, in its usual fragmentedand implicit way, illustrates different value systems—forexample, by investing “inefficiently” in low birthweightbabies because our society values highly the lives of thenewly born. In some cases NICE has also operateda rule of rescue approach to its recommendationsrather than one based solely on effectiveness or costeffectiveness.5Education and debateDepartment ofHealth Sciences,University of York,York YO10 5DDAlan MaynardprofessorKaren Bloorsenior research fellowDepartment ofPrimary Care andGeneral Practice,University ofBirmingham,BirminghamB15 2TTNick FreemantleprofessorCorrespondence to:A Maynardakm3@york.ac.ukBMJ 2004;329:227–9227BMJ VOLUME 329 24 JULY 2004 bmj.comIf the NHS seeks to achieve greater fairness—forexample, by making quality adjusted life expectancymore equally distributed through the population—itfollows that NICE must not focus on clinical or costeffectiveness alone. Its work has to recognise the equitydimension of healthcare rationing and elicit appropri-ate trade-offs between efficiency and equity. This couldbe achieved, for example, by implementing a fairinnings approach, reflecting the belief that everybodyis entitled to a “normal” span of health.4 Under thisapproach, resources would be allocated in order toachieve equitable distributions of health rather than tosimply maximise health benefits regardless of whobenefits.4The NHS and other public healthcare systemswere created to improve equity by equalisingaccess to care in the hope of reducing inequalities inhealth. With NICE providing national guidanceon the use of healthcare interventions in the Englishand Welsh NHS, it is inappropriate that it continuesto avoid its responsibilities in terms of achievingequity.Selecting technologies for approvalProblems also exist with the political process throughwhich topics are chosen for NICE. Although someeffort has been made to broaden the sources ofsuggestions for appraisals, there continues to beoveremphasis on new technologies and relatively littleattention paid to old technologies that may beredundant. Such technologies could potentially createresource savings to fund the inflationary pressures ofNICE.Careful discussion is needed about how toimprove the selection processes further. It might beuseful to experiment, by canvassing a wider groupof NHS decision makers, with some form ofreward for nominating appraisals that could save theNHS appreciable resources. NICE has developedpatient forums to inform its work but could takesteps to increase the involvement of NHS staff(who bear the burden of translating NICE guidanceinto practice) in selecting appraisal topics. Suchgroup decisions should be informed by usingactivity and prescribing data to identify theprocedures for which expenditure is greatest andestimate the relative financial burdens of commonprocedures.This information would induce NHS decisionmakers to focus more on withdrawing ineffective orinefficient marginal therapies. Perhaps decisionmakers who initiate such appraisals should be able toretain their local savings? At present, the selectionprocess remains largely political and only indirectlyinfluenced by those who face difficult decisions inservice delivery.Mechanisms to constrain NICE inducedinflationAs Rawlins and Culyer describe,2 NICE does not havea set threshold at which it is prepared to approve treat-ments. This has led to the approval of some therapieswith small benefits—for instance, in cancer treatment.6NICE approvals cause NHS provider organisationsconsiderable difficulty because of the other costpressures they face. These include inflationary pay set-tlements, the working time directive, and pressure toachieve access and national service framework targets.Although practitioners who benefit from NICEinduced service development may be enthusiastic, theopportunity costs for other service providers areconsiderable.Current consideration of other aspects of the phar-maceutical market may further increase NHS expendi-ture. These include the proposed reform of thePharmaceutical Price Regulation Scheme, with “free”pricing of products as one policy option,7 and recentpressure from the commissioner of the US Food andDrug Administration for higher prices in Europe, sothat a larger proportion of research and developmentcosts is borne there.8Against this background, and given the NICEthreshold for approval is essentially arbitrary, wayshave to be found to economise the use of drugs andother technologies. This issue could be approached inseveral ways:x Acquire the preferences of key decision makers—forinstance NHS chief executives (motivated by thesolvency of their organisations as well as patienthealth) and use them to determine the threshold. Thiscould 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 moretechnologies for NHS use.x Give NICE an annual notional budget to fund itsrecommendations. For example, NICE could be given£500m a year and would have to cost carefully its pro-posals and stay within that notional budget orrecommend services suitable to withdraw to fund thenew servicesx Give NICE an annual, top sliced, real budget andrequire it to fund all its advice within that expenditureenvelope with allocations to trusts to fund itsrecommendations.The most efficient of these three options islikely to be the third. This would force NICE toSummary pointsRationing health care is inevitable, and NICEshould inform NHS decision makingAdoption of new technologies by NHS cliniciansshould be informed by costs as well aseffectivenessThe NHS needs better information from NICEon the equity implications of new and existingtechnologiesNICE appraisal should focus not only on serviceenhancement but also on withdrawal of existingineffective or inefficient therapiesGiving NICE a real budget to fund itsrecommendations would encourage it to examinethe effect of its decisions on the whole NHSEducation and debate228 BMJ VOLUME 329 24 JULY 2004 bmj.comdetermine the value of the additional therapies at themargin, examine the effect of their decisions on thewhole NHS, and also provide incentives to balancecost enhancing against cost reducing recommenda-tions.The pharmaceutical industry is unlikely to reactpositively to these proposals, as they would makerationing tighter and potentially shrink its UK market.Such a reversal of NICE’s current propensity to be themarketing arm for companies would have politicalconsequences and requires careful management.ConclusionsIt is not sufficient for Rawlins and Culyer2 to claim thatthe resource implications from NICE decisions are theresponsibility of government. A new approach has tobe found to manage the use of drugs and othertechnologies within the NHS. We believe NICE shouldbe given a real, annual, top sliced budget and requiredto fund all its advice within that expenditure envelope.This will have the advantage of forcing NICE to exam-ine the cost effectiveness of existing treatments as wellas new ones.The success of commercial, provider, and regula-tory interests in focusing NICE’s work on new,expensive technologies has been self serving and infla-tionary. This inflation should be controlled throughmanipulation of the NICE threshold for approval. TheNHS cannot afford NICE generosity, even withincreased NHS funding, because of the resourcedemands of other access and national serviceframework targets, many of which have yet to be evalu-ated by NICE.Greater success in rationing will bring greaterpolitical and media challenges. These should beanticipated and managed carefully. This will beespecially important as over the next few years the cur-rent substantial growth in NHS expenditure is likely tofade, and NICE will have to make hard choices in amuch more difficult economic climate.An earlier draft of this paper has been improved considerablywith advice and comments from Diane Dawson, MikeDrummond, Mark Sculpher, and Alan Williams and waspresented at NICE’s annual conference by Alan Maynard inDecember 2003. We thank them for their help and apologise ifwe have misinterpreted any of it. We also thank Anne Burtonand Sandi Newby for administrative help.Contributors and sources: The authors have longstandingresearch interests in health economics and health policy. Thisarticle arose from discussions following the NICE annualconference, and from consideration of these issues since beforethe inception of NICE. AM wrote the first draft of this articleafter discussions with the other authors and acts as guarantor.All authors contributed to later drafts.Competing interests: AM is chair of York Hospitals NHS Trustand KB is non-executive director of Selby and York PrimaryCare Trust.1 Bloor K, Maynard A. Regulating the pharmaceutical industry. BMJ1997;315:200-1.2 Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and itsvalue judgments. BMJ 2004;328:224-7.3 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).4 Williams A. Intergenerational equity: an exploration of the fair innings.Health Economics 1997;6:117-32.5 Freemantle N, Bloor K, Eastaugh J. A fair innings for NICE? Pharmacoeco-nomics 2002;20:389-91.6 Garattini S, Bertele V. Efficacy, safety and the cost of new anticancerdrugs. BMJ 2002;325:269-71.7 Department of Health. Pharmaceutical price regulation scheme: discussiondocument. London: DoH, 2003. www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en? (accessed 28June 2004).8 Hopkins J. FDA chief wants other rich countries to share drugdevelopment costs. BMJ 2003;327:830.(Accepted 23 June 2004)A memorable patientHow life events change patients’ perspectives of their conditionsIn September 1939 the second world war had just begun asGermany invaded Poland, and 12 year old Agnes was evacuatedfrom Liverpool to a family in Northwich, Cheshire, for safetyfrom bombing. Within a few months her dormant atopic eczemahad flared, and she was treated at a local clinic. By March 1940,her mother was missing her and decided, as most Liverpoolmothers did, to bring her child back home to the city as shepreferred to have all the family together if the worse shouldhappen.Around this time the government implemented a Children’sOverseas Reception Board, a plan designed to keep children safefrom German attack by placing them in Commonwealthcountries (New Zealand, Australia, Canada) or the United Stateswith relatives or willing host families for the duration of the war.Agnes was placed on the list as her father had a sister living inNew York at the time.The eczema flared again, starting on her neck, and a few dayslater it extended. Her excoriated eczematised skin wascomplicated by extensive herpes simplex over the face. It was sosevere that she was only able to drink through a straw. Regularmedical check ups were mandatory for would-be evacueechildren, as they had to be fit and ready to leave at a moment’snotice. Agnes attended the Sugnall Street Clinic behind thePhilharmonic Hall. She was prescribed sulphur ointment, whichbegan to heal her infected skin.A ship then arrived in the port of Liverpool to take thechildren away from the very real dangers of war. However,Agnes’s mother received a letter stating that her daughter wouldnot be included because her rash had not cleared and the risk ofspreading infection to others aboard was still present. This was amajor disappointment, as the family was having to shelter underthe Anglican Cathedral from the German bombs. Agnes’smother, however, consoled her by saying “Man proposes, but Goddisposes.”She was proved right, as the ship on which Agnes had beendue to sail was the ill fated City of Benares. This ship wastorpedoed 600 miles and five days out from Liverpool by theGerman U-boat 48 on 17 September 1940 at 10 30 pm with theloss of 294 lives, including 73 children, 11 of whom were fromLiverpool. This tragedy ended the Children’s Overseas ReceptionBoard.Agnes never complains when she has a flare of her eczema asshe realises it ultimately saved her life.Julian Verbov professor of dermatology, Royal Liverpool Children’sHospital, LiverpoolEducation and debate229BMJ VOLUME 329 24 JULY 2004 bmj.com

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Challenges for the National Institute for Clinical Excellence

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