STRUMENTI E METODOLOGIE PER LA VALORIZZAZIONE DELL’INNOVAZIONE

1. STRUMENTI E METODOLOGIE PER LA VALORIZZAZIONE DELL’INNOVAZIONE Pascale Brasseur Chair of Eucomed HTA Working Group

2. Agenda HTA Key principles Specificities of Medical Devices Ad-hoc process for Medical Devices? Collaboration Conclusion

3. Health Technology Assessment Summarizes the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Informs the formulation of safe, effective health policies that are patient focused and seek to achieve the best value."

4. Key Princinples for conducting HTA

5. Key Princinples for conducting HTA • Structure of HTA programs • The goal and scope of the HTA should be explicit and relevant to its use • HTA should be an unbiased and transparent exercise • HTA should include all relevant technologies • A clear systems for setting priorities for HTA should exist • Methods of HTA • HTA should incorporate appropriate methods for assessing costs and benefits • HTAs should consider a wide range of evidence and outcomes • A full societal perspective should be considered when undertaking HTAs • HTAs should explicitly characterize uncertainty surrounding estimates • HTAs should consider and address issues of generalizability and transferability • Processes for conduct of HTA • Those conducting HTAs should actively engage all key stakeholder groups • Those undertaking HTAs should actively seek all available data • The implementation of HTA findings needs to be monitored • Use of HTAs in Decision Making • HTA should be timely • HTA findings need to be communicated appropriately to different decision makers • The link between HTA findings and decision-making processes needs to be transparent and clearly defined

6. Medical Device Industry’s position The Purpose of HTA Health technology assessment should be used to support patient access to innovative technologies by promoting the use of technologies that are clinically and cost effective. Conversely, HTA should be used as a mechanism to support disinvestment in current services and technologies which are cost ineffective, thus creating ‘headroom’ for new technologies when they become available... HTA should not be positioned as an additional barrier to regulatory approval. The focus of regulatory approval for CE marking (safety, quality and performance) and HTA (clinical and cost effectiveness) are fundamentally different.

7. HTA for Medical Devices

8. Clinical Studies with Medical Devices • RCTs difficult to undertake • What do we really compare? Different devices/procedures or different level of expertise? • Is blinding ethical if requires a sham procedure? • Is randomization possible if patients are aware of a less invasive procedure? Source : Ergina P et al, Surgical Innovation and Evaluation 2- Challenges in evaluating surgical innovation Lancet – Vol. 374 – September 2009

9. Learning Curve Source : Ergina P et al, Surgical Innovation and Evaluation 2- Challenges in evaluating surgical innovation Lancet – Vol. 374 – September 2009

10. Other specificities of Medical Devices • Devices change rapidly • Miniaturisation, micro-systems • relevance of operator skills, learning curve • statistical aspects • Digitisation, visualisation, imaging • additional benefit of more precise images and details • Use of new materials, biomarkers • Long term of safety of new materials • Information technology, telemetry • Impact on organisation of health care services  Other sources of evidence such as well designed comparative and non comparative observational studies must be considered

11. Specific assessment process “In this report, we proposed the framework for a future procedure for the assessment of new and emerging technologies in Belgium, in particular for new implants and invasive devices, within the current existing legal possibilities of the health insurance law. In the first place, the availability of procedures in other countries was investigated. The international overview of the available procedures demonstrates that the managed uptake of new and emerging technologies is in a relatively initial stage, with UK and Australia providing the relatively most advanced procedures.”

12. Specific assessment process

14. http://ec.europa.eu/enterprise/sectors/medical-devices/files/exploratory_process/final_report_en.pdfhttp://ec.europa.eu/enterprise/sectors/medical-devices/files/exploratory_process/final_report_en.pdf

15. Background The medical devices industry constitutes a key sector for healthcare. It is one of the most innovative sectors, improving and saving lives every day by providing innovative solutions for diagnosis, prevention and treatments. The medical devices industry is also a major employer in Europe. However these companies face challenges of national, European and international dimensions that may have an impact on their innovation capacity and their competitiveness. These difficulties might have consequences on the health of European citizens. An exploratory process on the future of the medical devices sector has been put in place over the second semester 2009 to map the existing public health and industrial challenges in the sector and investigate possible topics of reflection at the European level. This process will provide for industry, users, and consumers of medical devices with an opportunity to share existing challenges Objective The objective of the exploratory process on the future of the medical devices sector is to gather at the end of the process an overview of existing public health and industrial challenges, to identify current dynamics of the industry and highlight key topics of interest at the European level which should result in a set of suggested themes of potential further reflection to be adopted by the members of the exploratory process

17. http://ec.europa.eu/enterprise/sectors/medical-devices/competitiveness/exploratory-process/index_en.htm#h2-objectivehttp://ec.europa.eu/enterprise/sectors/medical-devices/competitiveness/exploratory-process/index_en.htm#h2-objective

18. EUnetHTA Joint Action

19. EUnetHTA Joint Action

20. In Summary • Key principles for the conduct of HTAs: • inclusiveness • transparency • review • timeliness • HTA is not as an additional regulatory barrier • Specificities of medical devices • Evaluation of entire treatment pathway • Harmonization / collaboration

21. Grazie per l’attenzione !