Press release
May 4th 2026
Major milestone under the EU HTA Regulation: First Joint clinical assessment of benefit complete.
On April 30th 2026, The HTA Coordination Group (HTACG) approved the first-ever Joint Clinical Assessment (JCA) report, marking a major milestone for European HTA. The NCPE, Ireland, worked as the assessor on this JCA together with IQWiG, Germany, as the co-assessor. The report will now be forwarded to the European Commission for procedural review and upon completion will be published on the Europa website.
The assessment was conducted on tovorafenib (Ojemda®), an anticancer medicine for the treatment of paediatric low-grade glioma.
“After many years of preparation through EUnetHTA joint actions, it is wonderful to see joint EU HTA become a reality with the endorsement of the first JCA. We are proud to have contributed as assessors, supported by the strong engagement of the JCA Subgroup throughout the process. The assessment also provided an important opportunity to apply, in practice, the methodological guidance developed over several years under the HTACG and EUnetHTA, ensuring a high-quality final report. The close collaboration with our co‑assessors IQWiG, whose exceptional commitment to excellence ensured the highest quality in our joint work, and with whom we thoroughly enjoyed working contributed to the success of this first JCA. We look forward to continuing this spirit of open and constructive collaboration with other HTA bodies in future joint assessments” said Roisin Adams, Head of HTA Strategy, NCPE, Ireland.
This first JCA report demonstrates the transition of the HTA Regulation from a legislative framework to an operational reality. It reflects the ability of HTA bodies across Europe with different perspectives to engage in robust scientific exchange and reach a jointly agreed outcome which will be used as a foundation for national decision-making. The next step, as detailed in the new 2026 Framework agreement for Pricing and Supply of Medicines will be an application by the company involved, Ipsen, for reimbursement in Ireland.
The NCPE is committed to European collaboration of assessment of evidence for medicinal products entering the European markets. The NCPE continues to contribute to the European HTA system and work on other joint assessments.
This important milestone comes at advent of Ireland’s Presidency of the Council of the European Union from 1 July to 31 December 2026, during which Ireland will support continued cooperation, of joint EU HTA seen as key enablers of innovation, competitiveness and access to effective treatments for patients.