Presentation (CTI)

OBJECTIVES: In 2025, Joint Clinical Assessment (JCA) under the European Health Technology Assessment (HTA) regulation was initiated for oncology drugs and advanced therapy medicinal products (ATMPs). This major shift in clinical evaluation requires alignment between European national HTA processes and the JCA framework. This analysis explores potential challenges in integrating JCA submissions with Germany’s established AMNOG framework.
METHODS: The JCA dossier submission template, AMNOG templates and publicly available information on procedural adjustments and legal requirements under AMNOG were compared. The focus was on assessing the commonalities and divergences between JCA and AMNOG submissions and identifying potential challenges.
RESULTS: Research revealed that German national law prevails and requirements for early benefit assessment under §35a SGB V must be met. This may cause some methodological challenges, including differing valuation of outcomes and varying expectations for comparator therapies. While referencing relevant sections of the JCA submission is encouraged, German-specific requirements - such as subgroup analysis, timing of systematic literature reviews, preferences for QoL and PRO instruments, and validation of surrogate endpoints - must always be addressed. Operational challenges include time constraints in dual dossier preparation, resource-intensive adaptation strategies, and potential misalignment between the availability of the JCA report and the timing of AMNOG’s benefit evaluation, which may prevent consideration of the JCA outcome.
CONCLUSIONS: Integrating JCA submissions and reports into the German AMNOG framework presents both opportunities and obstacles. While adapted AMNOG templates support cross-referencing to JCA content, national requirements remain binding and may necessitate additional submissions. Hence manufacturers must navigate dual submission strategies and HTA bodies face increased appraisal complexity. Key hurdles include aligning methodological standards, ensuring evidence acceptance, and managing timing discrepancies between JCA reporting and AMNOG evaluations.