Presentation (CTI)

OBJECTIVES: The introduction of the EU Joint Clinical Assessment (JCA) under the EU Health Technology Assessment (HTA) Regulation aims to harmonize clinical evaluations across Member States. In Germany, integrating EU JCA elements into the existing Arzneimittelmarktneuordnungsgesetz (AMNOG, Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance) process introduces both alignment opportunities and areas of potential friction. This study examines early implementation features of the EU JCA and its strategic implications for manufacturers navigating the German AMNOG process, focusing on PICO determination, and dossier submission.
METHODS: We conducted a qualitative policy analysis using publicly available guidance from the Gemeinsamer-Bundesausschuss (G-BA, Federal Joint Committee) and the EU HTA Coordination Group, supplemented by early observations from manufacturer interactions and the PICO development process. A qualitative synthesis was performed to map structural changes across dossier modules, timelines, comparators, endpoint definitions, and submission workflows between the EU JCA and AMNOG processes.
RESULTS: Early implementation of the EU JCA within the AMNOG process reveals procedural alignment alongside persistent national distinctions. PICOs are defined earlier at the EU level, with G-BA contributing but retaining national authority. While EU JCA mandates broader outcome inclusion, for health-related quality of life (HRQoL) for example, G-BA continues to prioritize the Short-Form 36 (SF-36) over tools like EuroQol five-dimension questionnaire five levels (EQ-5D-5L). Comparator frameworks are partially harmonized, though national considerations and exemptions remain. While the national template and submission standards are maintained, AMNOG dossiers should reference EU JCA data in modules 2 and 4 to avoid duplication Nonetheless, label changes, timing mismatches, and methodological divergences present ongoing challenges for manufacturers navigating both systems.
CONCLUSIONS: While EU JCA integration offers harmonization potential, manufacturers must plan strategically to meet Germany-specific requirements. Timely G-BA engagement and clear referencing of EU JCA materials are essential to streamline submissions and minimize regulatory friction.