Value, Access, and Regulatory Strategy Conference

Paving the Way to the Future by Building Bridges

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Session 4: Quest for Value of Medical Devices in the Era of Growing Real World Evidence and New EU Regulations

Session Chair(s)

Katarzyna Kolasa, PHD

Professor of Health Economics, Head of Dept. of Health Economics and Health Mgmt

Kozminski University, Poland

This session will explore how new regulatory requirements regarding medical devices (MDs) can be implemented, so that clinical programs could also provide relevant data for pricing & reimbursement. To set up the scene, we will discuss the key concepts introduced by the new EU Medical Devices Regulation, and how key differences between MDs and pharmaceuticals impact the need for collaboration between regulatory and HTA bodies, including examples of challenges, e.g. combined technologies. We will also look at the perceived value of MDs and how recent legal development influenced the perspective in that respect, as well as the lessons the EU can learn from the FDA’s RWD regulations for MDs. In that respect, we will discuss whether it is time to replace clinical trials with real world evidence (RWE).

Finally, all speakers will join a panel discussion on stakeholders’ involvement in the RWE collection, the value of HEOR data collection early on in the clinical development program, the future need of HEOR data in the era of artificial intelligence and robotics, and the assessment of the value of digital health solutions.

Speaker(s)

European Commission Perspective

Vincent Houdry

DG GROW, European Commission, Belgium

Policy Officer, Unit D4 – Health Technology and Cosmetics

HTA Body Perspective

Hubert Galmiche

French National Authority for Health (HAS), France

Head of Medical Device Assessment Department

Academic Perspective

Cynthia Iglesias

Department of Health Sciences, University of York, United Kingdom

Senior Health Economist/Health Services Researcher