EU’s Joint Clinical Assessment system still finding its footing
The EU's Joint Clinical Assessment (JCA) system, launched in January 2025, aims to streamline clinical evaluation for new treatments, with Ipsen's Ojemda being the first to initiate the 30-day countdown for JCA report endorsement. Industry experts have raised concerns over the conservative approach to non-randomised evidence, process complexities, and resource pressures.
The European Commission's (EC) Joint Clinical Assessment (JCA) system is still finding its footing after its launch in January 2025. Ipsen's Ojemda, approved for relapsed or refractory paediatric low-grade glioma, is the first treatment to initiate the 30-day countdown for JCA report endorsement. The JCA process aims to replace duplicative efforts by Member State HTA bodies with a single, centralised scientific report. Industry experts have raised concerns over the conservative approach to non-randomised evidence and the voluntary use of JCA reports by national HTA bodies. The process requires a health technology developer to submit a dossier within 100 days of scope confirmation, posing a substantial challenge due to the complexity of evidence required and the tight timeline. The JCA subgroup appoints an assessor and co-assessor to assess the relative clinical benefit of new technologies.
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