The Heads of HTA Agencies Group (HAG) met in Oslo on May 20th 2025 for its 13th meeting. The meeting, with more than 70 participants from 34 member agencies, was hosted by the Norwegian Medical Products Agency (NOMA).
During the meeting, the focus was on defining strategic priorities, enhancing collaboration, and addressing developments in relation to the application of the EU HTA Regulation. A key highlight was the approval of the Heads of HTA Agencies Group Strategic Plan 2025-2028, along with the adoption of a new Memorandum of Understanding. This memorandum establishes a renewed collaboration framework for the organisation and functioning of the HAG, ensuring a robust strategic partnership while promoting effective and efficient solutions for European HTA collaboration.
A pivotal segment of the meeting was a seminar dedicated to real-world data, evidence generation, and the management of uncertainties in health decision-making. David McConnell, from the Irish National Centre for Pharmacoeconomics (NCPE), presented insights from the Joint HTAb-regulatory perspectives on understanding evidence challenges, managing uncertainties and exploring potential solutions report. Peter Arlett, Head of Data Analytics and Methods Task Force of the European Medicines Agency (EMA) provided an overview of ongoing initiatives in the generation of Real-World Evidence (RWE), including the DARWIN EU® initiative. Both presentations highlighted possible opportunities for collaboration between HTA and regulatory bodies, in the areas of evidence generation strategies and addressing complex methodological challenges.
The members of the HAG discussed the latest developments and actions on the implementation of the HTAR. The European Commission, represented by Maya Mathews, DG SANTE, and the HTA Coordination Group, through the Chair Roisin Adams, provided updates on ongoing and future key-activities, including on the first joint clinical assessments (find more here) and for the first joint scientific consultations. Francis Arickx,RIZIV-INAMI, shared developments from the HTA Framework Contract Consortium (FWC) and Marco Marchetti,AGENAS, provided updates on the HAG-INSIGHT Consortium for capacity-building. Both initiatives are endorsed by the HAG.
The HAG Communication Working Group discussed the revision of the HAG Communication Plan, in light of the new Strategic Plan. The HAG Digital Medical Devices (DMD) Working Group shared updates on current activities, including the results of a survey conducted to gather valuable insights into the HTA process for DMDs, as well as the pricing and reimbursement frameworks for DMDs in the participants’ countries.
In the afternoon, through a series of case studies, participants outlined practical examples of successful capacity building and efficiency-enhancing strategies from different national agencies, reinforcing the group’s commitment to shared learning, continuous improvement and long-term collaboration
During the meeting, the HAG members approved the application of the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA), an HTA body dedicated to medical devices. The HAG now comprises 36 members from 23 EU/EEA Member States.
The next face-to-face HAG meeting will be in Copenhagen, on 4th November 2025.
