HTA Early Scientific Advice Metrics (HEAM) Programme

The landscape of early HTA scientific advice is rapidly evolving, emphasising collaborative engagement with various stakeholders. The CIRS HTA Early Advice Metrics (HEAM) Programme builds on previous CIRS work to offer companies unique insights into the early advice landscape and its potential impact on HTA outcomes in key markets. Conducted in collaboration with participating companies, this study systematically follows individual products, offering an understanding of the dynamics of early HTA advice and providing a baseline to capture the evolvement of Joint Scientific Consultation under the EU HTA Regulation. The study’s findings aim to contribute actionable insights that can inform decision-making processes related to early HTA, ultimately enhancing the strategic approach of companies.

Key research questions include:

  • What type of products undergo early HTA advice?
  • What are the reasons behind some products opting not to seek early advice?
  • Which agencies are offering early HTA advice?
  • Which agencies are commonly approached for EU Joint Scientific Consultation?
  • What topics are covered in early HTA advice meetings?
  • When is early advice typically sought, and how does it impact the development plan?

Annual deliverables of the Programme include:

  • Executive summary and company-specific report
  • Country-specific summaries
  • Results of a focused study on a topic of interest to participant companies
  • Industry Discussion Meeting to review trends and discuss potential for new analyses
  • Periodic updates on the Programme and CIRS advocacy activities

Example analysis: Comparison of development time with and without early HTA advice

(HTA recommendations 2018-2023)

Time from pivotal dose to first regulatory authority submission