ECONOMIC EVALUATION TRANSFERABILITY- A COMPARATIVE EXAMINATION OF ASSESSING MEDICAL DEVICES ACROSS THE EU IN THE CONTEXT OF NEW HTA PROPOSAL OF THE EUROPEAN COMMISSION
Author(s)
Orsi Nagy, PhD, Head of Sector, European Commission, Brussels, Belgium
Presentation Documents
PURPOSE: To comparatively examine economic evaluation evidentiary requirements and practices across the EU, assess convergence and heterogeneity, and present realistic options for moving forward towards a centralised full HTA rather than simply Joint Clinical Assessment, whilst, at the same time, ensuring Member-States maintain control of their own reimbursement and coverage decision-making.
DESCRIPTION: Following a presentation of the Commission's HTA legislative proposal, particularly of the Joint Clinical Assessment (JCA) as a contribution to the national HTA process, focusing only on ‘clinical’ components and leaving out any economic evaluation, the Commission will outline the rationale for its proposal explaining proposed avenues for further collaboration in this area. This presentation will be followed by a brief elaboration on the diverse classification of medical devices, and the ones the proposal includes provisions for. An overview of current requirements and practices regarding economic evaluation across the EU will, also, be provided, with a detailed mapping of project work facilitating economic evaluation transferability, with illustrative examples indicative of feasibility. An overview of pros and cons of including economic evaluation in a centralised assessment will be given, considering the relative lack of high quality economic evaluation evidence on devices, implications for countries with limited scientific capacity and financial resources [Eastern/South Eastern Europe], i.e., de facto simple transfer of foreign inputs in economic evaluation, and considering implications for researchers, regulators, and the industry. Each presenter will provide input/views on two alternative scenarios for assessing medical devices and the feasibility of the assessment i.e. a) a more centralised JCA for a selected type of devices or b) a more ambitious scenario covering full HTA, beyond JCA. The workshop will elucidating less well-known and discussed aspects of the new HTA proposal, and will be of value to regulators, policymakers, clinicians, health technology producers, and, of course, HTA methodologists and researchers alike.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Code
W13
Topic
Health Technology Assessment