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UNIVERSITÄTHEIDELBERG
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
1 © Michael Schlander 2009
A Global PerspectiveA Global Perspectiveon Comparative Effectiveness Programson Comparative Effectiveness Programs::Discussing Germany and the UKDiscussing Germany and the UK
Lessons from abroad for health care reform in the U.S.Lessons from abroad for health care reform in the U.S.Conference hosted by the International Policy Network and the Galen Institute
Washington, DC, March 09, 2009
Michael SchlanderMichael Schlander
Medizinische Fakultät Mannheim & Hochschule für Wirtschaft Ludwigshafen
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UNIVERSITÄTHEIDELBERG
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
2 © Michael Schlander 2009
“restricting use”
“containing costs”
“issuing guidance to potential users”
“prioritizing for further evaluation”
“alerting users to future possibilities”
A Broad Range of Expectations:What Are Health Technology Assessments for?
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
3 © Michael Schlander 2009
New Product Availability
1P. Danzon et al. (2006); OFT (2007)
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
4 © Michael Schlander 2009
1. Safety¬ Does it harm?
(controlled conditions)
2. Efficacy¬ Can it work?1
(controlled conditions)
3. Effectiveness¬ Does it work and is it safe?1
(normal practice)
4. Efficiency¬ Do its benefits outweigh its costs?
(often: “Is it cost-effective”?)
1cf. D. Schwartz and J. Lellouch (1967); 2EBM: “evidence-based medicine”
EBM2: How sure
can we be?
Economic Evaluation:The Logic of Cost-Effectiveness
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
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“A comparative analysis of alternative courses of actionin terms of their costs and consequences”
Costs Therapeutic Action Results
CostDirect cost
Indirect cost(Intangible cost)
Avoided CostsDirect cost
Indirect cost(Intangible cost)
Health StatusMortalityMorbidity
Clinical effect
Health Preferences
Quality of life / utility / QALYs
Cost Minimization
Cost Effectiveness
Cost Utility
Social Choice / PreferencesWillingness-
to-pay
Cost Benefit
Economic Evaluation
CMA
CEA
CUA
CBA
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
6 © Michael Schlander 2009
Health
Costs
Value
Resources
A
B
Evidence Based Medicine (A) & Economic Evaluation1
(B)
1cf. Victor R. Fuchs: “Health Care and the United States Economic System”, The Milbank Memorial Fund Quarterly, April 1972: 211-237.
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
7 © Michael Schlander 2009
ICER: Incremental Cost-Effectiveness Ratio
CA
O
CB
UA
Treatment B
Treatment A
Effect (Utility, Benefit)
Co
st
UB
UB-UA
CB-CA
UB-UA
ICER = CB-CA
The Logic of Cost-Effectiveness:Incremental Analysis
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
8 © Michael Schlander 2009
QALY
C
E
CICER
!
The Cost-Effectiveness Decision Rule …
A. Gafni and S. Birch (1993)
“Guidelines for the adoption of new technologies:
a prescription for uncontrolled growth in
expenditures…”
… and An Early Warning:
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
9 © Michael Schlander 2009
2833
47 48 51
6372 75
90
111
99
81
17
0
20
40
60
80
100
120
D I CH DK NL GR F IRE FIN CAN USA AUS S
Total Pharmaceutical Spending (real per-capita growth 1990-2001)1
Australia and Canada introduced cost-effectiveness analysis in 1992 and 1994
1Source: OECD Health Data 2003; Australia and Switzerland: 1990-2000; Germany: 1992-2001; from Schlander (2004)
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
10 © Michael Schlander 2009
¬ Three (distinct) “Centres of Excellence“:
¬ Centre for Public Health Excellence
¬ Public health guidance on the promotion of good health and the prevention of ill health
¬ Centre for Health Technology Evaluation
¬ Technology appraisals (recommendations on the use of new and existing medicines and treatments within the NHS)
¬ Interventional procedure guidance (evaluates the safety and effi-cacy of such procedures where they are used for diagnosis or treatment)
¬ Centre for Clinical Practice
¬ Clinical guidelines (recommendations, based on the best available evidence, on the appropriate treatment and care of people with specific diseases and conditions)
NICE
National Institute for Health and Clinical Excellence
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
11 © Michael Schlander 2009
¬ Three (to four) phases
¬ Scoping
¬ Assessment
¬ Appraisal
¬ Appeal (if lodged by one or more consultees)
¬ Frequently acclaimed features
¬ NICE objective of appraising the evidence in a way that is “objective, unbiased, and methodologically sound”1
¬ An appraisal process that can be described as being“inclusive, consultative, transparent”1
NICE Technology Appraisal Process (‘MTA’)
1C. Longson, ISPOR Annual Meeting, Arlington, VA, May 20, 2001
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
12 © Michael Schlander 2009
Pro
bab
ility
of
reje
ctio
n by
NIC
E
Incremental Cost-Effectiveness Ratio (ICER: cost per QALY gained)
‘Probabilistic’ NICE Cost-Effectiveness ‘Benchmarks’1
1N. Devlin and D. Parkin (2004)
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
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“A QALY is a QALY is a QALY
– regardless of
who gains and who loses it.”1
“The principal objectiveobjective of the National Health
Service oughtought to be to to maximize the maximize the
aggregate aggregate improvementimprovement in the health status of the whole community.”2
2Anthony J. Culyer (1997)
1D. Feeney and G.W. Torrance (1989)but there are reasons to suspect that the utility of health states may be influenced by wealth – cf. C. Donaldson et al. (2002)
“The underlying premisepremise of CEA in health problems is
that for any given level of resources available, societysociety (or
the decision-making jurisdiction involved) wisheswishes to maximize the total aggregate
health benefit conferred.”3
3M.C. Weinstein and W.B. Stason (1977)
A Promise and a Premise
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
14 © Michael Schlander 2009
¬ Pearson and Rawlins (2005):
“The conditions seem ripe for a NICE The conditions seem ripe for a NICE in the United Statesin the United States …”
¬ Smith (2004):
“The triumph of NICEThe triumph of NICE”:
“NICE is conquering the world … and may prove to be one of Britain’s one of Britain’s greatest cultural exportsgreatest cultural exports along with Shakespeare, Newtonian physics, The Beatles, Harry Potter, and the Teletubbies …”
¬ WHO (2003):
“Published technology appraisals are already being used as international international benchmarksbenchmarks …”
“What Could Be Nicer Than NICE?”1
1A. Williams (2004)
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
15 © Michael Schlander 2009
¬ Planned as a state-independent scientific institute
¬ Initiated with the “Statutory Health Insurance Modernization Act” (GMG) in 2003
¬ Established as a private foundation in July 2004
¬ Legal basis: Social Code Book (SGB) V, § 139c
¬ Financed through additional fees (“Systemzuschlag”)¬ for each hospital visit in Germany (SHI) - € 0.40 each (2007)
¬ for each outpatient doctor consultation (SHI) - €1.20€ each (2007)
¬ Employees (2008): 92 ¬ hereof, 62 scientists
¬ Annual Budget (2008 / 2009): 15 m € (2007: 11m€)
IQWiG
Institute for Quality and Efficiency in Health Care
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
16 © Michael Schlander 2009
IQWiG
Legal Assignments (SGB V § 139a)
¬ Evaluation of the current level of evidence on diagnostic and therapeutic techniques for selected diseases
¬ Evaluation of the quality and efficiency of services provided under statutory health insurance with regard to characteristics related to sex, age, and living conditions
¬ Evaluation of evidence-based guidelines for prevalent diseases
¬ Recommendations related to Disease Management Programs
¬ Provision of evidence-based information on the quality and efficiency of health care to the general public, patients and physicians
¬ Evaluation of the “benefit” of drugs
¬ Health Care Reform Act (GKV-WSG) as of April 2007:Health economic (“cost benefit”) evaluation of drugs
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Assignments
Recommendations
Decision Making
IQWiG
Assignment of Tasks
Federal Ministry of Health
IQWiG
Federal Joint Committee
IQWiG Assignments¬ by Federal Joint Committee (G-BA)1
¬ by Federal Ministry for Health (BMG)¬ IQWiG may be independently active in pertinent
topics related to medical care (“Generalauftrag”)1Application through the Federal Joint Committee possible for (a) patient organizations, (b) organizations of the German health care self-administration system; not possible for (a) companies, (b) private persons, and (c) interest or lobby groups
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
18 © Michael Schlander 2009
THE QALY SURPRISETHE NEW YORKER 1925
?
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
19 © Michael Schlander 2009
THE QALY SURPRISETHE NEW YORKER 1925
!
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
20 © Michael Schlander 2009
¬ An Empirically Falsified Hypothesis
¬ Neither Policy-Makers Nor Patients Are QALY Maximizers
¬ The Consistency Argument
¬ A Thinly Disguised Normative Claim (unsustainable)
¬ Context Matters
¬ Severity of Condition, Life-Saving Interventions (and “Rule of Rescue”?)
¬ Capacity to Benefit of Secondary Importance Only
¬ Mapping of Individual Utility and Societal Value?¬ League Tables from Sildenafil … to Orphan Treatments?
¬ Small Benefits for Many … Outweighing Important Benefits for Few?
¬ ICER Benchmarks, Program Size, and Opportunity Cost
Some Issues with QALYs:
(1) Concerns Concerning QALY Maximization
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
21 © Michael Schlander 2009
¬ Normative Issues
¬ Methodological Issues
¬ Spanning critical assumptions and measurement issues
¬ A Common Defense
¬ “High Face Validity” ¬ But: plausibility not a scientifically respectable criterion!
¬ But: dubious criterion validity (failing tests of reflective equilibrium)!
¬ “A Pragmatic, Workable Approach”¬ But: what does it really mean that (sometimes sophisticated)
computations can be performed on the basis of an(y) artificially defined objective formula?
¬ “Good Enough”¬ But: whose criteria; cui bono?
Some Issues with QALYs:
(2) Despite an Impressive Research Agenda
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¬ QALY Maximization Not Supported by Economic Theory
¬ A purely technocratic approach (with a narrow perspective) !
¬ No device to control growth of drug spending !
¬ QALY Maximization Hypothesis Empirically Falsified
¬ Absence of virtually any basis for valid thresholds !
¬ France and Germany Resist “NICE-Mania”¬ ‘NICE to Put QALY Under Examination’ [Agence Presse Medicale 27/01/2009]
¬ Rescue attempts: ¬ definition of an “ultra-orphan” category
¬ ‘consistency’ of cancer drug appraisals
¬ NICE “Threshold Technical Workshop” February 02, 2009
¬ Higher value might be placed on “end-of-life QALYs”
Issues with QALY Maximization:
(3) Implications
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¬ ‘Cost-Benefit Analysis’ [in line with ‘international standards’?]
¬ providing that previous “Benefit Analysis” was positive¬ heavy reliance on concepts of evidence-based medicine
¬ Cost-Consequence Analysis (?)¬ no reliance on cost-utility analysis using QALYs
¬ ‘Efficiency Frontier’ Concept¬ focus on ’technical efficiency’
¬ Budgetary Impact Analysis¬ notion of ‘affordability’ [and legal requirement to consider R&D outlays?]
¬ Designed to Increase Transparency¬ not to determine maximum reimbursement prices (?)
¬ Feasibility Assessment of Draft Methods Ongoing [Feb. 2009]
IQWiG 2008: “The Luck of Being Late”?
Draft Methods for Economic EvaluationConsultation Documents V 1.0 (Jan. 24, 2008) and V1.1 (Oct. 09, 2008)
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
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Cost
“Benefit” (Effectiveness)
A
B
C
D
‘Efficiency Frontier’ Approach
¬ Are There Alternative Treatments for the Condition in Question?
¬ Which Alternatives Have Been Reimbursed in the Past?
¬ Dominance of New Treatment “Nd”?=> Reimbursement
¬ Extended Dominanceof New Treatment “Ne”?=> Reimbursement
¬ Issue: Were the Decisions Made in the Past Justified?
IQWiG 2008:
Focus on “Technical Efficiency”
E
F
G
Ne
Nd
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A Global Perspective on Comparative Effectiveness Programs:Discussing Germany and the UK
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“It may well bring
about immortalit
y –
but it will take
forever to test
it.”