Presentation (CTI)

OBJECTIVES: The EU Health Technology Assessment Regulation (HTAR) introduced the Joint Clinical Assessments (JCAs) to support harmonisation of assessments across Member States. This research compares early national implementation across selected EU countries, identifying areas of convergence and divergence in JCA integration, scientific advice interaction, dossier requirements, and assessment processes.
METHODS: A structured comparative policy review examined publicly available HTA-body, government and official sources published up to 10/06/2026. Eight countries were included: Germany, France, Italy, Spain, the Netherlands, Sweden, Poland and Hungary. Data were extracted across four domains: legislative/procedural readiness, joint scientific consultation (JSC)-national advice interaction, JCA integration and timeline alignment. Findings were compared to identify patterns of convergence and divergence in national implementation approaches.
RESULTS: All countries had modified dossier requirements to avoid duplication of EU-level clinical evidence submission, however national implementation remained heterogeneous across domains. Five of eight countries (Germany, France, Italy, the Netherlands and Sweden) showed advanced procedural readiness through published manufacturer guidance, while Spain, Poland and Hungary had legislated for HTAR alignment but lacked manufacturer-oriented procedural guidance. JSC-national advice interaction was limited across markets: France was the only country where JSC participation precluded subsequent national early advice. JCA integration approaches fell into two groups: Sweden and the Netherlands require JCA report availability before HTA initiation, while in other countries national assessment initiation is not tied to JCA availability. Explicit timeline alignment with JCA publication was uncommon, with Spain being the only country specifying national clinical assessment publication within 15 days of JCA report availability.
CONCLUSIONS: Early implementation suggests that HTAR is reducing duplication in clinical evidence submission but has not yet demonstrated full convergence of national clinical assessment approaches. National-level heterogeneity, despite EU harmonisation aims, creates a persisting layer of uncertainty for manufacturers seeking pan-European evidence planning, sustaining the need for early national advice and country-specific strategies.