HTA cooperation in the EU

EPF workshopJrme Boehm 18 May 2010

Presentation outlineDefinitions and conceptsEC messages on HTA cooperationPatients perspectiveInstruments to support the cooperationConclusions

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?

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

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

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

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

Patients perspectiveThe 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?

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

Patients perspectivesSANCO views on patients perspectivesKeep 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

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

2. The EU public health and research programmesDraft 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 drugsResearch call 2009: 64 Mio (22 projects) dedicated to research on optimizing delivery of health care

3. The directive on crossborder careSW 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

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 effortsFinal objective is not harmonisation of the decisions. But some standardisation may be agreed between MS

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.

These are questions I hear from patients organisationsPrice for life: so should HTA confine to clinical issuesSupport of Article 15 by most MS: Text of the SW presidency compromise:1.The Community shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States. The members of the network shall participate and contribute to the networks activities according to the legislation of the Member State where they are established.2.The objective of the Community support referred to in paragraph 1 shall be:(a)to support Member States in their cooperation through between the national authorities or bodies referred to in paragraph 1; (b)and to support Member States in the provision of objective, reliable, timely, transparent and transferable scientific information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between the national authorities or bodies.