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NICE & Alzheimer's Drugs
1. Dr Colin Mitchell
MSc Geriatric Medicine – Ethics & Law
Justice in Health Care:
NICE &Alzheimer’s Disease
2. 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
3. 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
4. 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
5. 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
6. 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
8. 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.
9. 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Out-of-date care costs used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
10. 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
11. 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”
12. 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…
13. 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
14. 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‟
15. 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
16. 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.
18. 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
19. 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
20. 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
21. 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”
22. 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”
23. 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”
24. 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
25. 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