ISSUE: To harmonise the innovative health technology assessment procedures across Europe, a European Taskforce has been generated by France, Germany, coordinated by EIT Health and co-chaired by EUnetHTA, with the overall goal of enabling a joint approach for European access to reimbursement for digital medical devices (DMDs). The Taskforce - composed of academic experts, policy makers and representatives of national competent authorities - is committed to harmonise the taxonomy of the digital medical devices, evidence criteria and (re-)assessment methodologies in order to support Europe-wide patient access to DMDs through reimbursement.

OVERVIEW: The session will start with emphasising the need for a harmonised health technology assessment procedure to avoid a fragmented European approach on reimbursement of DMDs and improve patient access to digital health solutions. Mr. Guardian will elaborate on the scope and goals of the Taskforce as well as the External Advisory Group, responsible for external validation of recommendations from an industry perspective (10 min). Prof. Dr. Klucken will present the proposed framework to operationalise a harmonised regulatory and assessments framework across Europe with a special focus on (A) the conceptual clarity around DMDs, (B) the evidence criteria for reimbursement and (C) the healthcare system integration & social health evaluation framework (13 min). Taking into account the similarities and disparities of already existing evidence outcome categories and clinical study design definitions across EU Member States (including France, Germany, Belgium, Luxemburg, etc.), a recommendation for harmonisation of evidence criteria and assessment methodologies will be made (Stuwe, 13 min). Considering the practical implementation of the recommendations, perspective of technology developers and industry players will be discussed, including how real-world evidence and other innovative study designs can be utilised in assessment and re-assessment procedures of DMDs (Verboven, 13, min). The session will be concluded by a discussion between audience and panel members (11 min).

ISPOR Europe 2022

6 - 9 November

Program