The European Commission released the first joint clinical assessment (JCA) report on 9 June for the orphan medicine tovorafenib (Ojemda®), developed by Ipsen, used to treat paediatric low-grade glioma (a type of brain tumour), after being endorsed by all member states. This marks an important milestone for European cooperation on health technology assessments (HTA) under the HTA regulation which came into force January 2025. The JCA was conducted with the Irish National Centre for Pharmacoeconomics (NCPE) as the assessor and the German Institute for Quality and Efficiency in Health Care (IQWiG) as the co-assessor.
HTAs evaluate health technologies against factors such as clinical effectiveness, economic impact and social implications, to ensure new technologies introduced into healthcare systems are both beneficial and cost-effective. These assessments are currently conducted nationally across Europe, reflecting differences between member states, such as varying healthcare systems. The EU HTA Regulation 2021/2282 entered into force in January 2022 and became applicable from January 2025, with the aim of driving efficiency and strengthening HTA collaboration between EU Member States through Joint Clinical Assessments (JCA), among other cooperation efforts.
JCAs assess a technology’s clinical effectiveness and safety at EU-level, while economic evaluations, pricing and reimbursement decisions remain at national level. JCAs are conducted once the European Medicines Agency (EMA) receives a marketing authorisation application on an applicable product, such as new oncology medicines, ATMPs, orphan medicines, all centrally authorised medicinal products will fall in scope from 2030. The aim is for the Health Technology Assessment Coordination Group (HTACG) to endorse the JCA report at roughly the same time as the Commission’s marketing authorisation decision (Ojemda® received conditional marketing authorisation on 20 April 2026). This allows companies to begin national-level clinical HTA discussions without waiting for the regulatory decision to be finalised, and the JCA report should also help prevent divergence on the clinical assessment between member states.
In an NCPE press release on 4 May 2026, Roisin Adams, Head of HTA Strategy, said:
‘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’.
Industry will be watching closely to see how the JCA methodologies, evidence requirements and assessment processes have been implemented in practice, as well as how JCA outputs are used in national reimbursement decisions, national agencies have been adapting their guidance since the EU JCA framework was introduced in 2025. While this is the first JCA report published, many others are underway, with more expected to be launched this year, including five for medical devices (in which certain high-risk medical devices and class DIVDs are in scope from June 2026), according the HTACG workplan. Time will tell whether the initiative achieves the aim for greater efficiency and reduced duplication.
