EU HTA Regulation Insights Report

Are you ready to navigate the European Union (EU) health technology assessment (HTA) regulation?

The new EU HTA Regulation (EU) 2021/2282 has begun for advanced therapeutics and oncology assets and will 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 struggle to adequately prepare for implementation.

In November 2024, Evidera brought together stakeholders from life sciences and HTA experts to discuss the strategies needed to successfully navigate the new European HTA regulation.

Topics discussed included how to:

  • Overcome challenges in Joint Clinical Assessment (JCA) submissions
  • Optimize evidence planning with Joint Scientific Consultations (JSCs)
  • Master the Population, Intervention, Comparator(s), Outcomes (PICO) framework
  • Build organizational readiness
  • Collaborate across functions for seamless execution

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

EU HTA Regulation Report: Are you ready to navigate the European Union (EU) health technology assessment (HTA) regulation?

Complete the form to access the report.