38th Workshop of the EURORDIS Round Table of Companies (ERTC): Bridging Perspectives: Preparing for Success in Joint Clinical Assessments in EU HTA

June 2024

Wednesday, 9th October 2024, Recinte Modernista Sant Pau, Barcelona Spain

09:00-17:00 CET

Overarching goal and scope

The latest workshop of the EURORDIS Round Table of Companies focussed on Health Technology Assessment (HTA) cooperation in Europe. In the context of the EU Regulation on HTA (HTAR 2282/2021), a framework for joint work between Member States was introduced, including new rules for conducting joint clinical assessments of medicines and medical devices.

In this workshop, participants heard from HTA experts, patient representatives, public officials and industry representatives on how all need to prepare as the EU Cooperation and Joint Clinical Assessments become mandatory for oncology products and ATMPs starting 12 January 2025, in parallel to CHMP marketing authorisation evaluations. This provision will be applicable to all other orphan medicinal products from 2028 onwards. Discussions got participants prepared for this joint assessment approach and invited them to reflect on the conditions towards a successful implementation that ultimately improves transparency of the HTA process and accelerates national decision-making (reimbursement decision).

In addition to sharing perspectives from each stakeholder group on their appropriate involvement in the clinical assessment of medicines, the programme provided time for small group discussions. Break out sessions covered a range of topics, including methodological guidelines as well as timeframe in joint clinical assessments, novel approaches to assess real-world medical data using new technologies, and voluntary cooperation exploring new models of economic evaluation in HTA. Moderated flash debates concluded the workshop on other specifics of joint clinical assessments, including the engagement of patient experts in this process.