1. HTA cooperation in the EU EPF workshop Jérôme Boehm 18 May 2010

2. 2 Presentation outline Definitions and concepts EC messages on HTA cooperation Patients’ perspective Instruments to support the cooperation Conclusions

3. 3 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?

4. 4 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

5. 5 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

6. 6 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

7. 7 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

8. 8 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?

9. 9 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

10. 10 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

11. 11 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

12. 12 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

13. 13 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

14. 14 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

15. 15 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.