ISSUE: England, France and the Netherlands are among the few countries in Europe dedicating a chapter or document within their health technology assessment (HTA) methods and processes to medical devices. The National Institute for Health and Care Excellence in England published its first medical technologies guidance in 2010 via its Medical Technologies Evaluation Programme (MTEP), set up specifically to undertake health technology assessment (HTA) of medical devices. The Haute Autorité de santé (HAS) issued a practical guide on medical device evaluation in 2009, last updated in 2019, and publishes a dashboard of device assessments. Zorginstituut Nederland (ZIN) dedicates a chapter of its guidelines for conducting economic evaluations in health care to medical devices. This issues panel will consider the approaches taken in each of the three countries and provide an opportunity for debate around the processes and methods used for the HTA of medical devices. The panel will compare and contrast the experiences of the 3 countries as well as identifying key learnings identified to date. 

OVERVIEW: Dr Matthew Taylor will introduce this issues panel by providing an overview of health technology assessment in the context of medical devices and introducing the panellists. Each panellist will speak for ten minutes. Professor Mark Nuijten will describe main differences between cost-effectiveness analyses for pharmaceuticals and devices at ZIN highlighting specific issues for devices. Michelle Green will discuss submissions to MTEP from the perspective of an External Assessment Centre for the programme at NICE. Professor Isabelle Durand-Zaleski will review the challenges for devices claiming a high medical benefit with non-generic pricing, and the HAS reports on the cost effectiveness models. Twenty minutes will be allowed for discussion with the audience following the presentations. The issues panel will be of interest to the medial device industry and HTA agencies evaluating medical devices.