How to Overcome the Remaining Challenges for Successful Implementation of the EU HTA Regulation: Key Insights From the 2023 European Access Academy Spring Convention and Survey

OBJECTIVES: The European Regulation on Health Technology Assessment (EU HTAR) seeks to create a harmonized system for Joint Clinical Assessments (JCAs) of new health technologies across Member States. As the preparation phase nears completion, we aimed to identify and prioritize remaining challenges and action points for implementation.

METHODS: In a two-phased approach, stakeholder perspectives on the EU HTAR implementation were explored. First, a survey was utilized to assess perceptions of progress and identify remaining challenges, incorporating quantitative and qualitative elements. The survey was distributed (January-April 2023) via the European Access Academy (EAA) network and professional social media to ensure diverse stakeholder participation. Second, a convention organized by the EAA (April 2023, Utrecht, the Netherlands) facilitated in-depth stakeholder discussions, building upon the survey findings. Participants from health policy, patient associations, clinical societies, health technology developers, HTA bodies, payers, regulators, and academia were divided into working groups focusing on health policy, stakeholder readiness, management of uncertainty, and methodology. These groups identified and prioritized action points for successful implementation.

RESULTS: The survey yielded 61 responses from diverse stakeholders. Key concerns included: national readiness for JCAs; HTA capacity limitations across Member States; feasibility of the proposed methodological framework. While most respondents were aware of preparatory activities like guidance development, the success of these activities received neutral ratings. At the EAA Convention, the following action points were identified: assessing the need to adjust Member State laws and health policy processes; building HTA capacity; implementing guidelines as living documents; clarifying the Population, Intervention, Comparator(s), and Outcomes (PICO) identification process.

CONCLUSIONS: Stakeholder perspectives highlight the need for continued efforts in national readiness, HTA capacity building, and addressing methodological concerns. Prioritized action points center around harmonization, standardization, capacity building, collaboration, and uncertainty management with robust data. Addressing these topics is crucial for successful implementation of the EU HTAR.