The HTA Regulation, adopted in December 2021, entered into application on 12 January 2025. ESMO welcomes the entry into application of the Regulation as it is set to strengthen cooperation on HTA in Europe and enhance patient access to new innovative cancer treatments.
The new EU legislation replaces the previous project-based cooperation (through the EUnetHTA Joint Actions) with a permanent EU framework for joint work and collaboration on HTA. As part of the reforms, Joint Clinical Assessments (JCAs) are introduced which are assessments of clinical aspects of novel medicines that can be considered for use in HTA at the national level. JCAs for new medicines will mandatorily start when health technology developers submit their application for a marketing authorisation under the EU’s centralised procedure.
During the political negotiations on the HTA Regulation, ESMO advocated for using cancer medicines as a pilot to jointly assess medicines under the legislation. The Society in that regard much welcomes that JCAs will start exclusively with cancer medicines (and ATMPs) for the first 3 years of application. The recently adopted 2025 Work Programme of the Member State Coordination Group on HTA (HTACG) sets out that an estimated 17 JCAs for cancer medicines will be conducted in 2025.
The Society has also provided input to the public consultations on the draft deliverables of the EUnetHTA21 consortium and shared its feedback on most draft Implementing Acts - put forward by the European Commission in 2024 - that will govern the new processes.