IHS Healthcare and Pharma expert slides from the Ukrainian Pharmaceutical Forum on HTA in the Ukraine.

1. HTA:
What Can Ukraine Learn from
the International Experience
Milena Izmirlieva, Senior Manager
29 October 2013
Presentation at 2013 Ukrainian Pharmaceutical Forum

2. Agenda
• What is HTA?
• Why do HTA?
• HTA role and criteria
• HTA process
• What are the benefits of HTA?
• What are the costs of HTA?
• “Best practice” in HTA
• Does Ukraine need HTA?
© 2013 IHS
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3. What is HTA?
• Health Technology Assessment (HTA):
• the systematic evaluation of the properties and effects of a health
technology, addressing the direct and intended effects of this technology, as
well as its indirect and unintended consequences, and aimed mainly at
informing decision-making regarding health technologies
• HTA aims to inform health policy and decision-making in a bid to optimise
care using the available resources, so that the most effective technologies
are promoted while taking consideration of organisational, societal and
ethical issues.
© 2013 IHS
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4. Why Do HTA?
• New health technologies of proven clinical value pose a dilemma:
their application may require additional (financial and nonfinancial) resources or redistribution of existing resources within
the health system.
• Is funding the given technology a good use of limited resources
compared to existing options?
• Support funding decisions!!!
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5. HTA is One Element of Decision-Making
HTA is not the
decision!!!
HTA serves to help
make the decision.
It provides a bridge
between research and
a real-life situation
where multiple priorities
need to be balanced.
HTA brings rationality to
health policy decisionmaking.
© 2013 IHS
Source: WHO, adapted from Davies, 2005
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6. HTA Role Depends on Various Factors
• Existence of HTA agency
• Remit of HTA agency
• Timing of HTA review
• Link between HTA and funding decision
• Other cost-containment tools in use
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7. HTA Criteria Applied by Country
Criteria Applied to
HTA for
Pharmaceuticals
Budget Impact
Costs
Cost Effectiveness
Efficacy
Degree of Innovation
Need
Germany
Denmark France Hungary
√
√
(not
systematically
used)
√
√
√
√
Italy
√
√
(since
Oct.
2013)
√
√
√
Poland
√
√
Netherlands
√
√
√
√
√
√
√
√
√
√
√
UK Brazil
√
√
√
√
√
√
√
√
√
√
Safety
Relative Effectiveness
√
√
√
√
√
√
√
√
√
√
√
Source: IHS
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8. HTA Process
• Assessment request (submission or identification of research
•
•
•
•
need); prioritisation; commissioning
Developing the remit and scope (treatment, comparators, outcome
measures, measures of costs and length of time, stakeholders)
Appraisal of the evidence: clinical and cost effectiveness and
financial analysis in terms of the limits agreed at the scoping stage.
Draft recommendation (potential to appeal, submit additional data)
Final recommendation
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9. Decision Outcome
• Full or partial funding/reimbursement recommendation
• Coverage with evidence generation
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10. HTA Recommendation Implementation
HTA
Outcome
Recommendation to
decision-making body
HTA outcome is binding
HTA
Outcome
© 2013 IHS
Government or other reimbursement
body makes final decision
(France, Switzerland, Poland, Romania)
Payers/National Health System
( UK, Germany, Finland)
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11. Benefits of HTA
• Bring rationality to healthcare decision making
• Improve transparency
• Help decision-maker to balance different priorities
• Improve fairness
• Reflect societal expectation/ideals
• And the unexpected: protect government/insurers from litigation
(e.g., in Brazil)
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12. Costs of HTA
• HTA agencies tends to be non-profit bodies, funded by public
funds, with some contributions from the industry
• HTA agency budgets vary from EUR1 million to substantially
more than EUR10 million depending on function
• Opportunity cost: with limited resources, time spent on one
appraisal could have been used to appraise another technology
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13. “Best Practice” in HTA
• There is no agreement on best practice in terms of methodology
for conducting HTA even if the steps of the process are agreed:
• Cost-effectiveness measured in ICER per QALY is the favoured approach in
UK and certain other Anglo-Saxon countries
• Cost effectiveness or cost utility analysis based on relative effectiveness to
treatment alternatives is favoured in France and Germany
© 2013 IHS
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14. Does Ukraine Need HTA?
• A decision for Ukraine to make.
• When it comes to pharmaceuticals, HTA is typically used for
originator medicines (i.e., pointless to use if you plan to reimburse
only generics).
• HTA needs to be seen in the context of the healthcare system: no
point in conducting HTA if other cost-containment tools invalidate
its effect (e.g., Bulgaria, Romania)
• If the answer is “yes”, help is at hand: e.g., EUnetHTA initiative,
NICE International.
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