Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy

Francine Brinkhuis, Elaine Julian*, Hendrika van den Ham, Fabrizio Gianfrate, Valentina Strammiello, Michael Berntgen, Mira Pavlovic, Peter Mol, Jürgen Wasem, Walter Van Dyck, Antonella Cardone, Christian Dierks, Anja Schiel, Renato Bernardini, Oriol Solà-Morales, Jörg Ruof, Wim Goettsch

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At “midterms” of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. Methods: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation’s implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. Results: Overall “readiness” for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. Conclusions: At “midterms” of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA’s Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

Original languageEnglish
Article number74
Number of pages12
JournalHealth Research Policy and Systems
Volume22
Issue number1
DOIs
Publication statusPublished - 2 Jul 2024

Keywords

  • Access
  • EUHTA
  • Health Policy
  • Health Technology Assessment
  • Stakeholder involvement

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