HTA cooperation in the EU
EPF workshop
Jérôme Boehm
18 May 2010
Presentation outline
Definitions and concepts
EC messages on HTA cooperation
Patients’ perspective
Instruments to support the
cooperation
Conclusions
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HTA definitions
Healthcare technology is defined as prevention
and rehabilitation, vaccines, pharmaceuticals
and devices, medical and surgical procedures,
and the systems within which health is
protected and maintained.
Health technology assessment (HTA) is an
approach to evaluate the relative effect a given
health technology has on a medical condition:
Is the technology effective?
For whom does it work?
What costs are entailed?
How well does it work compared to alternative
technologies?
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HTA definitions
Pharmaceuticals:15-20% of overall
health care budgets but 80% of all HTA's
produced. HTA methodologies are rather
well elaborated.
Medical devices: the efficacy depends
not only on the device itself, but on how
it is used. HTA methods are complex
For health interventions: only ad-hoc
HTA methods
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Key EC messages on HTA
HTA decisions should serve patients
overall interest and reward
innovation
HTA objective is broader than costs
containment
HTA should not only focus on
pharma products but also MD and
interventions
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Key messages (2)
Implementation of HTA decisions more
relevant at national level, because of
values issues… and economic capacities.
EU cooperation added value is significant
to address clinical issues, where
substantial scientific questions are at
stake
Core methods and data can be jointly
developed for possible reuse at national
level
6
Key messages (3)
Pooling of expertise will avoid duplication
of efforts/ resources for industry, HTA
bodies and payers
New decision making processes between
regulators, HTA bodies and stakeholders
are needed
All Member States should benefit from
HTA expertise
Sustainable cooperation is needed
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Patients’ perspective
The “big issues” on HTA
Should there be a price for life?
Should it meet overall or conditions
specific interests?
Should patients be involved in the HTA
process?
8
Patients’ perspectives
The paradigms:
Sustainability of HCS is at stake: need to meet
challenges of the ageing populations within
given financial resources
Patients have increased expectations on life
expectancy & access to treatment but are also
payers
Patients tend to pledge for their own condition:
there should be no disease specific
discrimination but severity criteria
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Patients’ perspectives
SANCO views on patients’ perspectives
Keep in mind the three objectives:
patient satisfaction, reward for
innovation, cost containment
Promote overall interest: one patients’
voice is welcome, as for consumers
Engage in the HTA process: develop
expertise, gather solid evidence on
treatment, QoL… to deal with HTA bodies
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Available instruments to support
the cooperation on HTA
1. The joint action Member States/
Commission on HTA 2010/2012
(Iris’ intervention)
2. The Health and the Research
programmes
3. The directive on cross border
care
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2. The EU public health and
research programmes
Draft public health program 2010:
Call for proposals on the development
of HTA capacities in MS
Study on possible scenarios for
hosting cooperation on RE of orphan
drugs
Research call 2009: 64 Mio€ (22
projects) dedicated to research on
optimizing delivery of health care
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3. The directive on crossborder
care
SW presidency compromise
EP supportive in 1st reading,
discussions on going in Council
Agreement on a long term and
sustainable cooperation on HTA
Implementation issues to be
discussed. Several scenarios to be
envisaged
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Conclusions
There is a strong added value in
considering HTA at EU level:
Pooling of expertise, for instance to face the
challenges specific to personalized medicine
Minimised duplication of efforts
Final objective is not harmonisation of
the decisions. But some standardisation
may be agreed between MS
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Conclusions (2)
Stakeholders’ involvement is a key
success factor of cooperation at EU
level
A sustainable cooperation is
needed. Long term solutions are
currently being evaluated.
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