Presentation (CTI)

OBJECTIVES: Joint Clinical Assessment (JCA) implementation required European Union (EU) Member States (MS) to adapt national Health Technology Assessment (HTA) frameworks to determine how JCA processes and findings inform decision-making. This research evaluated the nature and extent of these adaptations across all EU MS.
METHODS: A qualitative review of publicly available legislation, HTA agency guidance, and stakeholder communications published until June 2026 was conducted. Four dimensions were assessed: (1) governance adaptations and resource readiness, (2) JCA dossier integration, (3) national HTA timeline strategies, and (4) Health Technology Developer (HTD) involvement in Population, Intervention, Comparator, Outcome (PICO) scoping activities.
RESULTS: National policies adaptation to JCA was widespread yet heterogeneous. Most countries initiated HTA legislative or procedural updates (n=25), with 3 updating economic evaluation guidelines. New governance structures or HTA Regulation (HTAR) committees were established in 15 countries. HTAR implementation supported through EU Technical Support Instrument programs was identified in 5 countries. Resource readiness varied: dedicated staffing expansion (n=8) versus funding constraints (n=7). Regional collaborations, including Joint Nordic HTA Bodies and Beneluxa, potentially facilitated adaptation. JCA report integration approaches varied. Some countries used JCA reports as primary source of clinical evidence (n=10); others adapted dossier templates to incorporate JCA findings alongside additional national requirements for comparator selection, therapeutic positioning, or contextual assessment (n=7). National HTA processes differed in timelines alignment. Three implementation models emerged: parallel timelines enabling early national assessment before JCA publication (n=5), dependent timelines requiring JCA availability (n=1), and hybrid combining early preparation with formal JCA reports dependence (n=5). Formal opportunities for HTD input during PICO scoping were identified in 7 countries.
CONCLUSIONS: HTAR implementation prompted widespread national adaptation, creating opportunities for cross-country learning. Sponsors should tailor their strategies to implementation models, prepare country-specific evidence where needed, engage early in PICO processes, and leverage regional alignment to streamline submissions and accelerate EU market access.