HTA cooperation in the EUHTA cooperation in the EU

EPF workshopJérôme Boehm18 May 2010

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Presentation outline

Definitions and conceptsEC messages on HTA cooperationPatients’ perspectiveInstruments to support the cooperationConclusions

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HTA definitionsHealthcare 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 definitionsPharmaceuticals: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 complexFor health interventions: only ad-hoc HTA methods

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Key EC messages on HTAHTA decisions should serve patients overall interest and reward innovation HTA objective is broader than costs containmentHTA 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 stakeCore methods and data can be jointly developed for possible reuse at national level

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Key messages (3)Pooling of expertise will avoid duplication of efforts/ resources for industry, HTA bodies and payersNew decision making processes between regulators, HTA bodies and stakeholders are neededAll Member States should benefit from HTA expertise Sustainable cooperation is needed

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Patients’ perspective

The “big issues” on HTAShould there be a price for life?Should it meet overall or conditions specific interests?Should patients be involved in the HTA process?

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Patients’ perspectivesThe paradigms:

Sustainability of HCS is at stake: need to meet challenges of the ageing populations within given financial resourcesPatients have increased expectations on life expectancy & access to treatment but are also payersPatients tend to pledge for their own condition: there should be no disease specific discrimination but severity criteria

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Patients’ perspectivesSANCO views on patients’ perspectives

Keep in mind the three objectives: patient satisfaction, reward for innovation, cost containmentPromote overall interest: one patients’ voice is welcome, as for consumersEngage 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 programmes3. 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 MSStudy 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 compromiseEP supportive in 1st reading, discussions on going in CouncilAgreement on a long term and sustainable cooperation on HTAImplementation issues to be discussed. Several scenarios to be envisaged

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ConclusionsThere is a strong added value in considering HTA at EU level:

Pooling of expertise, for instance to face the challenges specific to personalized medicineMinimised 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 levelA sustainable cooperation is needed. Long term solutions are currently being evaluated.