EU HTA Regulation Insights Report

Are you ready for the implementation of the European Union (EU) health technology assessment (HTA) regulation in 2025?

The new EU HTA Regulation (EU) 2021/2282 is set to begin in 2025 for advanced therapeutics and oncology assets and be fully implemented by 2030. The goals are to reduce duplication of efforts for national HTA authorities and industry and improve the evidence base for HTA assessment. Many questions still exist, however, as companies strive to adequately prepare.

In March 2023, Evidera brought together stakeholders from life sciences and HTA bodies to discuss the implications and implementation of the new European HTA regulation.

Topics discussed included how to:

  • Strengthen a Joint Clinical Assessment (JCA) dossier
  • Mitigate issues with the Population, Intervention, Comparator(s), Outcomes (PICO) framework
  • Optimize evidence planning with Joint Scientific Consultations (JSCs)

This insights report provides a summary of the presentations and discussions during the event.

EU HTA Regulation Event: Are you ready for the implementation of the European Union (EU) regulation in 2025?

Complete the form to access the report.