Objectives: We conducted a multi-stakeholder survey to assess stakeholders’ perceptions of the progress made towards the implementation of the European Regulation on Health Technology Assessment (EU HTA R) and to identify and prioritize the remaining challenges for implementation.
Methods: Using two iterative Delphi cycles, an exploratory, semi-quantitative survey was developed to identify how stakeholders 1) experienced preparatory activities of the Regulation, and 2) prioritized remaining challenges for successful implementation. The survey was distributed among the network of the European Access Academy and via social media to ensure coverage of key stakeholders. Descriptive analyses were performed on quantitative response items, and relative importance was calculated for ranking items. Free-text responses supplemented participants’ answers to quantitative questions.
Results: N = 61 responses were received from N = 15 countries including Global/ EU-wide institutions (Patients and Patients’ representatives: 7; Clinicians’ representatives: 5; Regulators: 3; Health Technology Developers (HTDs): 20; HTA bodies: 10; Payers: 7; Policy Makers: 2; Academic representatives: 7). The majority of respondents were aware of preparatory activities, with 74 % (N = 45) observing the drafting of Guidance Documents and 64 % (N = 39) noting the establishment of the Coordination Group. Respondents ranked the success of preparatory activities neutral with a slight tendency towards a positive ranking. Key challenges were Member States’ readiness for Joint Clinical Assessments, HTA capacity/ capability constraints, and the applicability/feasibility of the methodological framework.