EU HTA Regulation reaches operational milestone as first Joint Clinical Assessment endorsed

The first Joint Clinical Assessment under the EU HTA Regulation has been endorsed, marking a step toward implementation of the new framework. The assessment of tovorafenib (Ojemda®) follows its recent EU conditional marketing authorization and will now proceed to European Commission review ahead of publication.

The Baseline

• The HTA Coordination Group endorsed the first JCA, on tovorafenib (Ojemda®) for paediatric low‑grade glioma.
• Led by Ireland’s NCPE with Germany’s IQWiG as co‑assessor, the JCA will support national HTA decisions once published.
• Market access and HTA professionals now await the final report, expected imminently, which should clarify how the JCA was conducted and evidence expectations.

The European Union’s Health Technology Assessment (HTA) Regulation has reached a key implementation milestone, with the endorsement of the first Joint Clinical Assessment (JCA) report by the Member State Coordination Group on Health Technology Assessment (HTACG).

Approved on April 30, 2026, the assessment relates to tovorafenib (Ojemda®), an orphan medicine developed by Ipsen for the treatment of pediatric low-grade glioma, a slow-progressing brain tumor affecting more than 800 children each year. The endorsement follows an earlier regulatory step, with the European Commission granting conditional marketing authorization for tovorafenib 12 days earlier on April 22, 2026.

The JCA, assessed under the project identifier JCA-MP-2024-06, was led by the National Centre for Pharmacoeconomics (NCPE), Ireland, acting as assessor, with the Institute for Quality and Efficiency in Health Care (IQWiG) serving as co-assessor. The assessment was developed with input from the health technology developer, as well as patient and clinician stakeholders, and was reviewed during the 19th meeting of the HTACG.

The Coordination Group endorsed both the full JCA report and its summary by consensus. The report will now be submitted to the European Commission for procedural review in line with the HTA Regulation. Subject to compliance with procedural requirements, the Commission will publish the report, the summary, and the health technology developer dossier on the Europa portal. According to Alexander Natz, Secretary General at EUCOPE, this will occur “in the coming days.”

Commenting on the milestone, Roisin Adams, Head of HTA Strategy at NCPE, noted the significance of the endorsement following years of preparatory work, including joint efforts through earlier European initiatives. She also pointed to the importance of working closely with partner organizations in delivering the assessment, saying:

“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.”

Beate Wieseler, Head of IQWiG’s Drug Assessment Department, also emphasized the collaborative nature of the work, stating:

“The collaboration with our Irish colleagues, and indeed at the European level as a whole, was excellent. Working together was very valuable; we were able to learn a great deal from one another and, at the same time, demonstrate that the new EU HTA process works.”

During the meeting, the HTACG also addressed aspects related to transparency and publication, noting that information already in the public domain, including clinical trial methodologies, results, and evidence synthesis approaches, should not be considered commercially confidential.

The JCA is one of a number of assessments currently underway under the Regulation. A total of 15 JCAs are in progress, with one discontinued following the withdrawal of a marketing authorization application by the developer.

At the national level, the joint assessment is expected to serve as a basis for further evaluation. In Ireland, the next step will involve a reimbursement application by Ipsen under national pricing and supply arrangements. In Germany, the assessment will feed into the AMNOG early benefit assessment process, where orphan medicinal products are evaluated by the Federal Joint Committee (G-BA).

Analysts and stakeholders will now be looking ahead to the publication of the final JCA report, which is expected to provide greater visibility into how the assessment was conducted in practice. In particular, the report will offer insight into the evidence considered, the questions raised during the process, and how methodological guidance has been applied. This level of detail is likely to be important for companies and HTA bodies alike, helping to inform expectations and shape the preparation of future submissions under the EU HTA framework.