European Commission releases details of first joint clinical assessments

The EU’s new framework for joint health technology assessments (HTAs), aimed at improving consistency and efficiency in national decision-making, is now underway starting with the evaluation of two oncology treatments. 

The European Commission has announced the launch of the first two Joint Clinical Assessments (JCAs) under the EU HTA Regulation (HTAR). These initial assessments focus on two innovative therapies: one for pediatric low-grade glioma and another for advanced melanoma. Both assessments formally began on March 27, 2025. 

The JCA process is carried out in parallel with the European Medicines Agency (EMA)'s centralized marketing authorization procedure. This parallel approach is designed to streamline access to new therapies by producing shared clinical evaluation reports for use by national HTA bodies across EU Member States. The assessments are led by designated assessors and co-assessors, who will deliver draft reports and summaries. These must be endorsed by the Coordination Group on HTA within 30 days of the EMA's marketing authorization decision. 

For pediatric low-grade glioma, the medicinal product under review is tovorafenib, licensed by Ipsen in partnership with Day One Biopharmaceuticals. The treatment is already FDA-approved in the US for relapsed or refractory for pediatric low-grade glioma with a BRAF fusion, rearrangement, or V600 mutation, following the results of the ongoing pivotal Phase 2 FIREFLY-1 trial. As recently reported by Ipsen, EMA accepted the regulatory filing for review earlier this year. The joint assessment is being conducted by Ireland’s National Centre for Pharmacoeconomics, with Germany’s Institute for Quality and Efficiency in Health Care serving as co-assessor. 

The second JCA is being carried out for lifileucel (autologous melanoma-derived tumor infiltrating lymphocytes [TIL], ex vivo-expanded), an advanced therapy medicinal product (ATMP) from Iovance Biotherapeutics for the treatment of advanced melanoma. Lifileucel is the first FDA-approved TIL therapy for a solid tumor indication, offering a novel option for patients who have progressed on prior anti-PD-1 and targeted therapies. The US FDA granted approval in February 2024, based on data from the C-144-01 trial. In the EU, an application for marketing authorization is under EMA review, with a regulatory decision expected in the second half of 2025. France’s National Authority for Health is leading the assessment, with Poland’s Agency for Health Technology Assessment and Tariff System acting as co-assessor. 

The JCA initiative aims to reduce duplication of effort and accelerate national reimbursement decisions by providing Member States with shared clinical data. While pricing and reimbursement decisions remain national competencies, JCAs represent a significant milestone in the EU’s effort to harmonize evidence requirements and improve timely access to innovative treatments. 

The Commission will host a one-day hybrid conference in early July to review the progress of EU HTAR halfway through its first year of implementation, while also exploring its broader impact on Member States and the global HTA landscape.