A new report summarizing key insights from a series of workshops between Health Technology Assessment bodies (HTAbs) and regulators collaboration has been published. These discussions focused on improving mutual understanding of the evidence challenges faced by decision-makers, particularly in managing uncertainties arising from current approaches to evidence generation.
Through this series of workshops participants from HTA bodies and regulatory explored common methodological challenges, assessed the available evidence at market entry, and identified potential solutions. The report presents agreed conclusions and key considerations provide an important framework for future HTAb and regulatory collaboration on both improved evidence generation strategies as well as methodologies for mitigating the identified uncertainties.
The Regulation (EU) 2021/2282 on health technology assessment (HTAR) sets a framwork for European cooperation between medicine regulators and HTA bodies. This cooperation is meant to build synergies between regulatory evaluation and HTA.
The full report is available here
This workshop series was organised by a team of experts consisting of assessors, statisticians, health
economists and scientists from HTA and regulatory agencies around Europe, under the coordination of
David McConnell (Senior Statistician, NCPE, Ireland) and Dominik Karres (Senior Scientific Officer,
EMA).
