Joint Clinical Assessment

Joint Clinical Assessment: bridging European assessment with national patient access solutions

Within the European cooperation on Health Technology Assessment (HTA), the Joint Clinical Assessment (JCA) of medicines plays a central role. This European JCA is conducted in parallel with the marketing authorisation process at the European Medicines Agency (EMA).
For Belgium, the European JCA will become the first step in the national reimbursement application process, forming the basis for evaluation by the Commission for Reimbursement of Medicines (CRM).
The JCA will be introduced gradually: it already applies to oncology and high-technology medicines such as gene and cell therapies, will extend to orphan medicines by 2028, and will apply to all medicines from 2030 onwards.
Insights Axes Health: The introduction of the European Joint Clinical Assessment marks a fundamental shift in how medicines are evaluated for reimbursement in Belgium and across Europe. By aligning clinical assessment at EU level with regulatory approval, the process places greater emphasis on early evidence generation and consistent demonstration of clinical value.
For pharmaceutical developers and access stakeholders, this evolution underscores the need for early access strategies, real-world evidence generation, and patient-centred programmes that anticipate both European and national requirements. Axes Health sees the JCA framework as an enabler for more coordinated, faster, and value-driven access to innovation—bridging European assessment with national patient access solutions.