Presentation (CTI)

OBJECTIVES: The EU Joint Clinical Assessment (JCA) aims to harmonize the assessment of comparative clinical effectiveness and safety across Member States, while preserving national autonomy over pricing and reimbursement decisions. This study describes similarities and key differences between JCA requirements and national health technology assessment (HTA) processes across EU Member States, with implications for evidence generation and access planning.
METHODS: A comparative policy and methodological review was conducted to map JCA requirements for key domains against national HTA expectations across EU Member States. Information was synthesized from the EU HTA Regulation, JCA methodological guidance, and established national HTA frameworks to identify areas of alignment and divergence.
RESULTS: Across EU Member States, JCA provides a single, centralized assessment of comparative clinical effectiveness and safety based on an agreed population-intervention-comparator-outcome framework, and duplication of clinical assessment at the national level is not permitted. However, substantial differentiation remains across Member States in downstream HTA requirements. Economic evaluations, budget impact analyses, and most subgroup analyses are conducted exclusively at the national level, with varying methodological expectations and decision criteria. Comparator relevance, the role of subgroup evidence, and the use of RWE differ markedly across markets, reflecting local clinical practice, payer priorities, and access frameworks. JCA specifies shorter timelines (3 months) for SLRs, aligning with G-BA requirements but differing from NCPE and HAS guidance (6 months). While JCA conclusions are mandatory inputs, final reimbursement decisions, pricing negotiations, and access conditions remain nationally determined.
CONCLUSIONS: JCA represents a significant shift toward harmonized clinical assessment in Europe, reducing duplication and increasing consistency across markets. However, national HTA bodies continue to apply distinct requirements, highlighting the need for early and well-planned evidence development. Aligning global evidence generation with JCA timelines while anticipating country-specific HTA needs is critical to support efficient access pathways across EU Member States.