Presentation (CTI)

OBJECTIVES: With the EU HTA Regulation mandating Joint Clinical Assessments (JCAs), health technology developers (HTDs) must navigate increasingly burdensome requirements at both EU and national levels. Inconsistent evidentiary expectations and growing dossier complexity risk delaying patient access and straining internal resources. This study aimed to compare EU JCA and national HTA submission templates to identify alignment, divergence, and evidentiary gaps, and to support HTDs with strategic recommendations for evidence generation and dossier preparation.
METHODS: A structured framework was applied to analyze submission templates from the JCA, France (HAS), Germany (G-BA), Denmark (DMC), and the Netherlands (ZIN). Comparison focused on clinical evidence requirements, PICO definitions, literature review standards, and economic components.
RESULTS: Templates align across core domains such as disease overview, current management, and product description. However, key divergences persist. The JCA issues consolidated PICOs, while ZIN expects HTDs to define their own based on Dutch practice. Only the JCA and G-BA request justifications for deviations from scientific advice, while only HAS and the JCA request information on organizational impact. Literature review standards are stricter under the JCA, with national variation in accepted sources. Additional national requirements include ZIN’s focus on Dutch treatment context and trial applicability, HAS’s emphasis on therapeutic positioning, post-registration studies, and early access data, and G-BA’s annual per-patient cost comparisons. DMC, ZIN, and HAS (if eligible) also require health economic and budget impact analyses, which are outside the JCA scope.
CONCLUSIONS: HTDs should adopt a modular value dossier strategy anchored in JCA requirements while anticipating national adaptations. Early gap analyses versus JCA requirements and proactive engagement with EU and national agencies are critical to optimize evidence generation. Internally, cross-functional coordination and capacity-building will be essential to align teams with emerging JCA timelines and expectations.