health technology assessment and i methods - hta-rus.ru · barriers and limitations to use of ee...
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Health Technology Assessment and Its’
Methods:Should we use it? Can we use it? How to use it?
J.L. (Hans) Severens PhD
Professor of Evaluation in Health Care
Institute of Health Policy & Management
& iMTA, Institute of Medical Technology Assessment
Erasmus University Rotterdam, The Netherlands
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1637Descartes paradigmof modern science
Period 1Slow accumulation ofmedical knowledge:- knowledge of anatomy- classification of diseases- description of relation betweenillness, autopsy and pathology
Period 2Rapid development of knowledge:-microscope, stethoscope, bloodpressurecuff, x-ray- Pasteur, vaccines, desinfectans, narcotics,morphine, penecillin- intravenous, subcutanous drug delivery
Before ancient Greeks
Early 1900s
Period 3Biological revolution:- mass production of medicine- DNA and biotechnology- lab tests- imaging techniques- organ transplants
A short history of medicine
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A history on HTA
• Three decades of HTA
• 1980’s
• Informing decision on health insurance coverage
• HTAi, INAHTA, EU, World Bank, WHO
• National HTA capacity
Banta and Jonsson, Int J Techn Assessm Health Care 2009; 25 Suppl 1: 1-6.
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Why HTA?
• rapid development of medical technological possibilities
• limitations of human resources
• budget constraints; (unlimited) rise of health care costs
Thus: choices have to be made (in case a health care
system is considered to be a ‘ public property’)
WHO-report Health Systems Financing; the path to universal
coverage:
• promoting efficiency and eliminating waist
• ‘more health for money’
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Clinical effectiven
essSocial
aspects
Costs andfinancing
Organisatio-nal
aspects
Ethical conse-quences
Medical & biological knowledge
EpidemiologyHTA
Based on Habbema et al., 1989
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Health Technology Assessment
• What is a health technology?
• What is health technology assessment?
– systematic evaluation
– properties, effects, impacts of health technology
– intended or unintended consequences
– to provide structured, evidence based input to decision
making
– to promote safe, effective, cost-effective patient-
focused health policies
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Clinical effectiven
essSocial
aspects
Costs and financing
Organisatio-nal
aspects
Ethicalconse-quences
Medical & biological knowledge
EpidemiologyHTA
Based on Habbema et al., 1989
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Components of economic evaluation (Torrance, 1986)
Intangible
benefits
Indirect
benefits
(prod. gains)
Economic
benefits
direct
Economic
benefits
Value of
health
improvement
per se
Ad hoc
numeric
scales
Willingness
to pay
Utilities
(Qaly’s)
Resources
consumed
(costs)
Direct
costs
Indirect
costs
(prod. Loss)
Intangible
cost
Health care
programme
Health
improvement
(consequences)
mortality
Health
effects
morbidity
1st ed 1987
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Economic Evaluations
Intervention A Consequences A Cost A
Cost B
Difference
in costs?
Consequences BIntervention B
Difference in
consequences?
Relationship?
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Quality Adjusted Life Year
0
1
Health state value or utility
Life expectancy 9 years
4 * 0.9 = 3.6
3 * 0.7 = 2.1
2 * 0.2 = 0.4
Total QALY: 6.3
11 years
5 * 1.0 = 5.0
2 * 0.8 = 1.6
4 * 0.2 = 0.8
7.4
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Negative
consequences
Positive
consequences
More expensive
Less expensive
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• Should we use it?
• Can we use it?
• How to use it?
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Scheen AJ et al., Lancet 2008; 372: 1197-8
Drug development
for treatment of type 2 diabetes
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Why HTA?
• Endografts for aortic
aneurysm
• Weights loss drugs
• Radical mastectomy for
breast cancer
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• Should we use it?
• Can we use it?
• How to use it?
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To inform decision making?
Decision making levels:
1) national/regional decision making
2) institutional/profession decision making
3) individual doctor-patient decision making
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0
50
100
150
200
250
Co
st
per
life
ye
ar
gain
ed
in
Au
s$
Recommended at price Recommended at lower price Rejected
George et al. Center for Health Program Evaluation, Australia 1999
The relation between reimbursement of
pharmaceuticals and cost effectiveness
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• Objective: to evaluate impact of cost-effectiveness information
on clinical decision making
• Methods:
• Discrete choice experiment (3x2x3)
• Italian cardiologists (N=129, 1143 observations)
• Choices between paired scenarios:
• Quality of evidence: high – moderate – low
• Health gain: high – moderate
• Cost-effectiveness: favorable - moderate – unfavorable
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Results
• All three dimensions had a significant impact on a
clinicians’ decision on the use of an innovative drug
• Marginal effects:
– of high quality evidence larger than medium quality
evidence
– of favorable cost-effectiveness larger than moderate
cost-effectiveness
• Relative importance of favorable cost-effectiveness higher
that evidence quality and health gain
• Heterogeneity of preferences:
– Age <45yr
– Good knowledge of economic evaluations
Torbica & Fattore, Soc Sci Med 2010; 70: 1536-1543
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Total degree of influence of economic
evaluation on actual decision making
Degree of
influence
Macro
(n=11)
Meso
(n=11)
Micro
(n=3)
1 Unknown 11,1% 9,1% -
2 Big 5,6% 27,3% 33,3%
3 Moderate 11,1% 9,1% 33,3%
4 Small/No 66,7% 54,6% 33,3%
Van Velden et al., PharmacoEconomics 2005; 23: 1075-1082
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Barriers and limitations to use of EE
Decision maker-related factors
– access and time constraints
– poor understanding of concepts, principles, and methods
– ethical and value-based concerns
Context-related factors
– organizational, budgetary, political, and social factors
– levels of decision making differ in
structure, objectives, responsibilities
Economic evaluation-related factors
– complexity of studies
– generalizability and relevance to context
– concerns QALY modelBrousselle and Lessard, Soc Sci Med 2011; 72: 832-839
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So, can we use it?
• (pharmaco-) economic evaluation is potentially useful to
inform decision making
• decision makers should be trained in research methods
• HTA ≠ (pharmaco-) economic evaluation
• HTA is context-specific
• HTA is evidence based decision making
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• Should we use it?
• Can we use it?
• How to use it?
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Follow NICE?
National (regional) HTA essential
• health care situation is local
• comparison is local
• decision making context is local
International HTA
• do not follow foreign decisions automatically, but assess
critically
• be ware of using foreign evidence and data
• use a transferability assessment tool
• core HTA?
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How to organise HTA
Roles:
• coordination of assessments and appraisals
• providing evidence
• conducting assessment
• advising
• decision making
Parties involved:
• assessment agencies and/or academia
• advisory bodies
• regulatory bodies
• stakeholders: policy makers, health care
providers, industry, patients
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Stages in HTA
Assessment:
• clinical effectiveness
• evaluation cost and consequences
• review of available evidence
• mostly quantitative research
Appraisal:
• interpretation and consideration
• stakeholder involvement
• Increasing patient involvement
Sorrenson, Euro Observer 2009; 11: 1-4
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TAIL:
‘Technology Assessment’ Iterative Loop
1. Burden of illness
2. Aetiology or causation
3. Efficacy andcommunity
effectiveness
4. Efficiency
5. Synthesis and implementation
6. Monitoring
7. Reassessment
Based on Tugwell et al., J Chron Dis 1986; 4: 339-351
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HTA needs transparency
• what subjects need priority
• what decision needs to be made
• distinguish assessment and appraisal
• assessment without conflict of interest
• double check the assessment
• include stakeholders in the appraisal
• who decides
• learning by doing
• continuity
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In conclusion
HTA and the strive for ‘More health for money’
• Can we use it?
• Should we use it?
• How to use it?