Presentation (CTI)

OBJECTIVES: The JCA has applied to oncology products and ATMPs since 2025, with the first report published in June 2026. As Member States (MS) continue to adapt national HTA processes, this research aimed to: (1) provide an update on MS implementation readiness, and (2) assess how JCA reports may support national HTA by comparing the first report(s) with selected country-specific requirements.
METHODS: A review of national policy updates, conference and expert insights (Q3 2025-H1 2026) was conducted to assess MS preparedness, including procedural and methodological adaptations, expected JCA outputs’ use, timeline implications, and stakeholder engagement. In parallel, the first JCA report(s) were compared with selected national HTA requirements to identify local submissions implications.
RESULTS: Member State readiness for JCA is increasing but remains heterogeneous. Approaches range from formal integration into national submission templates to incorporation within broader HTA reforms aimed at aligning with EU processes and facilitating rapid uptake of JCA outputs. Stakeholder engagement is also evolving, with stronger patient and developer involvement in some markets while others pursue a developer-independent JCA implementation.Comparative assessment of initial JCA reports and national HTA requirements indicates that JCA outputs provide a partial foundation for local submissions, but do not fully meet country-specific requirements. Key challenges include PICO divergence, variability in evidence expectations, and limited incorporation of value considerations in JCA reports.
CONCLUSIONS: Continued monitoring of JCA implementation will be critical to inform future policy evolution and methodological convergence. Early JCA reports support but do not replace national HTA requirements, highlighting the continued need for proactive and tailored evidence strategies.