NICE & Alzheimer's Drugs

Dr Colin Mitchell MSc Geriatric Medicine – Ethics & Law Justice in Health Care: NICE &Alzheimer’s Disease

Objectives  Case – A patient with mild Alzheimer‟s disease  Review NICE‟s decision process relating to Alzheimer‟s drugs  Examine recent High /Appeal Court judgments on this process  Review legal precedents in health resource allocation  Discuss the ethical underpinnings of distributive justice  Examine how these influence practical healthcare rationing  Assess NICE‟s role in health resource allocation

Clinical Case  74yr old man, referred with „funny turns‟  Wife gives history of dizzy spells on standing  Mild postural drop, probably related to BFZ  Main issue for wife – husband‟s failing memory  MMSE: 23/30  Bloods / CTB – NAD  Referred to Memory Clinic

Drug Treatment for Alzheimer‟s  Cholinesterase inhibitors (CE-Is)  Donepizil, Galantamine, Rivastigmine, (Memantine)  Trials show benefit for patients with MMSE 10-26  NICE (Guideline 42, 2006)  Donepizil, Galantamine, Rivastigmine for  Alzheimer‟s Dementia of moderate severity  MMSE 10-20 Olden M & Kelly C, 2002. Use of cholinesterase inhibitors in Dementia. Advances in Psychiatric Treatment 8:89-96

NICE – Background  Set up in 1999 to provide 3 main services to the NHS  Appraisal of health technology  Clinical guidelines  Advice on safety and effectiveness of procedures  NICE „constitution‟  Comprehensive, evidence-based, fair, transparent  Right to appeal  Topics chosen by DoH DoH, 2005. Directions and Consolidating Directions to the National Institute for Health and Clinical Excellence

NICE and CEIs – Timeline  2003 – CE-I review begins  June 2005 – Final Appraisal Determination  Recommends no CE-Is to be available on the NHS  Unusually, NICE Guidance executive postpone final publication pending new data  May 2006 – Final Appraisal Document Approved for Mod. Alzheimer‟s disease (10-20)   This excludes around 60% of Alzhimer‟s patients

NICE and CEIs  Decision appealed by interest groups  Nov 2006 – Appeals rejected, guidance issued  2007 – Proceeds to Judicial Review Procedural unfairness 1. Perversity in light of evidence submitted 2.

R (Eisai Ltd) v NICE [2007]  Arguments submitted to Dobbs J:  Procedurally unfair (read-only Excel spreadsheet)  Irrationality  Too much weight on one, flawed, trial  Cumulative / Long term benefits not taken into account  Care costs not correctly weighted  Out-of-date care costs used  Failure to show consideration to statutory duties under race relations act (1976) and disability discrimination act (1995) Eisai Ltd v NICE [2007] EWHC 1941 (Admin) Syrett K, 2008. “Nice and Judicial Review: Enforcing Accountability for Reasonableness through the Courts?” Medical Law Review 16:127-140

Dobbs J, 2007  “It is important to stress that this is not… a challenge to a decision by NICE… Nor is it… a case of the claimant asking the court to rule that NICE recommend treatment… for mild Alzheimer‟s disease sufferers. It is also not about the court to decide whether an Alzheimer‟s disease sufferer is worth £2.50 a day”

NICE and CE-Is (cont)  Sept 2007 – Revised guidance issued by NICE  Changed guidance relating to learning difficulties / language  NICE claims its position has been vindicated  Appeal decision in May 2008…

Appeal Court 2008  Justices Richards, Tuckey and Jacob disagree with Dobbs J on the question of procedural unfairness (the „read-only model‟) “The robustness or reliability of the model is… a key question”   “[the] remarkable degree of disclosure and of transparency in the consultation process… cuts both ways, because it also serves to underline the… importance of the exercise”  The Lords denies NICE the right to appeal in Oct 2008 R (Eisai Ltd) v NICE [2008] EWCA Civ 438

Challenges to Allocation Decisions  R v Central Birmingham Health Authority, ex P Collier (1988)  HA repeatedly cancelled necessary paediatric cardiac surgery  Court refused to order the surgery be carried out immediately  R v Cambridge District Health Authority, Ex P B (1995)  HA refused to fund experimental chemotherapy  Laws J ordered the HA to reconsider:  HA must do more than „merely toll the bell of tight resources‟  Court of Appeal rejects Laws J‟s judgment:  „Agonisingjudgements have to be made as to how a limited budget is best allocated… That is not a judgement which the court can make‟

Challenges to Allocation Decisions  R v North Derbyshire Health Authority (1997)  NDHA refused to fund B-interferon in MS  HA found to have failed to take a reasoned decision about the provision of B-interferon, by ignoring DoH advice and not individually assessing patients‟ needs.  R vSwindon NHS PCT (2006)  Herceptin unlicensed for early-stage CA Breast  Court of Appeal decides that the PCT‟sblanket refusal policy was irrational and unlawful

Health Resources – The Court‟s Role  Eisai v NICE is the only legal challenge so far to NICE  Actual effects on guidance are limited (so far)  Appraisal process more transparent  Rulings may increase complexity of process and time taken to produce recommendations  Courts seem reluctant to become activist in making judgments on resource allocation decisions  However it is clear that the decision process must be both thorough and transparent.

ETHICS

Justice v Beneficence  How can we reconcile our requirement to do the best for our patient with the need to do the best for ALL patients?  With finite resources, you can‟t have all 3 of:  Comprehensive care  Best quality care  Care based on need rather than ability to pay  Therefore healthcare must be rationed But we pretend it‟s not being rationed (Covert rationing)  Weale A, 1998. “Rationing Healthcare” – BMJ Vol.316

Justice  Aristotle‟s (circa 350BC) formal principle of justice is widely accepted:  Justice is not equal division of benefit / burden  Equals should be treated equally and unequals unequally in proportion to the relevant inequalities  Fair and proportionate treatment – „Just desserts‟  How to assess proportionality? Aristotle. Nicomachean Ethics. Translated by Crisp R, 2000, Cambridge University Press

Traditional Theories of Justice  Libertarianism  Stresses autonomy, right to life and property  Marxism  To each according to his needs, from each according to his ability  Utilitarianism  Welfare maximisation at the expense of autonomy

A Theory of Justice  John Rawls‟ Theory of Justice Renders impartiality through „veil of ignorance‟   Result is two principles: 1. Maximal liberty compatible with same degree of liberty for everyone 2. Deliberate inequalities are unjust unless they work to the advantage of the least well off  Blending of utilitarianism and respect for autonomy Rawls J, 1971 “A Theory of Justice”

NICE‟s role in distributive justice  Rationing must be thoroughly, fairly and transparently assessed  NICE is THE model of fair / transparent healthcare assessment  However its role in distributive justice is limited  Only assesses a small proportion of healthcare  QALY is a crude tool  Problems with disinvestment  Targeted towards expensive / controversial treatments  Prone to political / interest-group pressure  Technical experts not suited to a role making value judgments about the nature and purpose of the NHS Hill S et al, 2003 “Technology Appraisal Programme of NICE: Review by WHO”

Conclusions  NICE‟s decision on funding CE-Is for Alzheimer‟s disease has thrown up new questions about its role and processes  Courts have traditionally been reluctant to challenge health resource allocation decisions  Eisai v NICE has been heralded as a landmark decision, but results in only a small change in NICE‟s deliberative and appeal processes

Conclusions (2)  NICE, while a remarkably high-quality institution, is not the solution to the difficulties of fairly allocating health resources  The question of distributive justice is far bigger than NICE, and the courts are even less able to intervene.  Healthcare rationing is an ethical and political issue, more than purely a legal, technical or medical one.  So far, little substantive debate outside of specialized settings  So covert rationing continues and healthcare is unfairly distributed  And my patient does not receive donepizil

NICE & Alzheimer's Drugs

by Colin Mitchell on May 01, 2009

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NICE & Alzheimer’s Drugs — Presentation Transcript

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