Evaluating progress towards implementation of the European HTA Regulation: Insights generated from the European Access Academy's multi-stakeholder survey

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. Conclusions This study identified the key remaining challenges for the successful establishment of the EU HTA process. Key findings emphasize the readiness of national systems and procedures as pivotal factors. Balancing operational efficiency with strategic objectives, including the development of a European Value Framework, is imperative for harnessing the full potential of the joint HTA process and enhancing patient access to innovative technologies on a pan-European scale. Public interest summary In January 2022, the European Union (EU) adopted the European Regulation on Health Technology Assessment (HTA). By harmonizing HTA practices and promoting collaboration across Member States, the joint procedure as set out in the regulation aims to improve efficient use of resources and ensure long-term sustainability of EU-wide HTA cooperation. Close to reaching the half-way mark of the preparation phase in mid-2023, we conducted a multi-stakeholder survey to assess perceptions of the progress made towards implementation of a joint procedure and to prioritize remaining challenges. The responses indicated a neutral to positive perception of the preparatory activities (i.e., establishing a coordination group and a stakeholder network, and creating guidance documents). Respondents prioritized challenges related to the readiness of Member States, limitations in HTA capacity and capability, and applicability of the assessment methods. Further research is needed to define targeted strategies for specific stakeholder groups to effectively address the identified challenges.