From Joint Clinical Assessment to National Decisions: EU HTA Implementation and Implications for Patient Access.

The introduction of Joint Clinical Assessments (JCAs) under the European Union Health Technology Assessment Regulation (EU HTAR) represents a major structural reform aimed at reducing fragmentation and duplication in clinical evidence assessment across Member States. While JCAs are intended to support national health technology assessment (HTA) processes through a common EU-level clinical evaluation, their integration into established national HTA and reimbursement systems remains untested at this early stage of implementation. This paper reports findings from two surveys conducted in 2025 among local affiliate representatives with expertise in relevant HTA and market access activities across 25 European countries (comprising 24 EU Member States and Norway), capturing early national perspectives on key aspects of JCA implementation. The surveys explored anticipated impact on national reimbursement timelines, current opportunities for early HTA advice and PICO input, approaches to handling post-JCA data availability, and nationally prioritised policy and implementation issues. Results indicate mixed expectations regarding the potential impact of JCA on reimbursement timelines, with perceived risks of delay largely viewed as possibly transitional and mitigable through national process adaptation. Respondents emphasised the importance of transparency in PICO consolidation and clarity on the use of JCA reports in national appraisals. Overall, the findings suggest that JCA may represent a reconfiguration rather than a centralisation of evidence assessment, with national influence exercised earlier in the assessment lifecycle. These insights provide policy-relevant input to inform ongoing EU HTA implementation and future refinement of the JCA framework.