Statement from the Heads of HTA Agencies Group on the publication of the first Joint Clinical Assessment report under the EU HTA Regulation

The Heads of HTA Agencies Group (HAG) welcomes the publication of the first Joint Clinical Assessment (JCA) report. This marks an important milestone in the implementation of the Health Technology Assessment Regulation (HTAR).

The first JCA concerns tovorafenib, an orphan medicinal product for the treatment of paediatric low-grade glioma. The assessment was endorsed by the Member State Coordination Group on Health Technology Assessment (HTACG) on 30 April 2026. The report, the summary report, and the underlying dossier have now been published by the European Commission (EC).

The publication of the first JCA represents the culmination of extensive preparatory work and close collaboration among national HTA bodies and lawmakers, the EC, health technology developers, and other relevant stakeholders. This milestone also marks the beginning of a new operational phase in which JCAs are made available to national decision-making systems.

The HAG emphasises the central role of national HTA bodies within this framework. National HTA bodies collaborate with their European partners to produce JCAs and contribute to the effective implementation of JCA results into national healthcare systems. This dual role highlights the importance of close cooperation within the network to support effective national implementation, while recognising the diversity of HTA structures, healthcare systems and policy contexts across Member States.

As implementation of the HTAR progresses, the focus will be on learning from practical experience, refining processes, building capacity, and strengthening collaboration. The first JCA represents the starting point of a broader evolution of European HTA cooperation, aimed at ensuring the effective uptake of EU HTA outputs and maximising the value of the significant effort invested in their production. While acknowledging that challenges lie ahead, the HAG expresses strong confidence in the long-term success of European HTA collaboration.

As a forum for strategic exchange on matters relevant to HTA bodies across Europe, the HAG will continue to contribute actively to the implementation of the HTAR. The HAG will also continue to work closely with actors involved in the process, as part of its commitment to strengthening HTA capability, capacity, and knowledge across EU/EEA HTA bodies.

Statement from the Heads of HTA Agencies Group on the publication of the first Joint Clinical Assessment report under the EU HTA Regulation - Background EU flag - HAG logo