Are You Scoping Ready for the New EU HTA Regulation Implementation?

Speaker(s)

Paulina Rolska-Wójcik, PhD, Evidera, part of PPD, Warsaw, Poland and Jessica Griffiths, BSc, MEnt, Evidera, part of PPD, London, UK

The European Union’s new regulation for health technology evaluation (Regulation (EU) 2021/2282), focusing on reducing duplication of efforts by national HTA bodies and ensuring efficient use of resources, will be applied starting in January 2025 with oncology treatments and advanced therapy medicinal products (ATMPs), with full implementation in all therapeutic areas by 2030. This regulation affects all companies wanting to market products in the EU, so it is critical to be adequately prepared for new submissions.

One significant consideration, and potential challenge, to anticipate is Population, Intervention, Comparator, and Outcomes (PICO) scoping. Given the short timeframe between scoping and submission, companies developing healthcare products will need to identify the most likely PICOs and do the associated analytics well in advance. This session will discuss some of the challenges, issues and considerations when preparing for this major step of the new EU HTA process, including:

  • The number of potential PICOs
  • Variable levels of management within companies
  • Key tradeoff decisions in trial design and operations

Additionally, the speakers will compare the new EU HTA approach with NICE’s approach for perspective and will discuss ways to optimize success with the new submission process moving forward. Please join us to better understand how to effectively prepare for your HTA submissions moving forward!

Sponsored by Evidera, part of PPD

Code

215

Topic

Health Technology Assessment