EU Joint Clinical Assessment (JCA): Uncertain Impact on German Amnog Timelines and Potential Delays

OBJECTIVES: One of the main aims of the new European JCA process, which will come into force from January 2025, is to improve patient access to new medicines across the EU. Whilst the centralised EU procedure aims to reduce duplication and hasten the clinical assessment of local HTA processes, it remains unclear what the implications for the local German HTA process (AMNOG) are. This research seeks to compare JCA timeline scenarios with those of the German AMNOG process, focusing on scenarios that could impact local access.

METHODS: JCA timelines were mapped using information provided in the HTA regulation, the JCA implementing act on JCA and regulatory timelines. Milestones in the assessment timelines, including submission, review, and the publication of a report, were compared to the current AMNOG timelines, which are outlined in the G-BA’s rules of procedure and Germany’s Social Code 5 (SGB V).

RESULTS: Comparing the timelines revealed three critical milestones in the JCA process that potentially impact the start of AMNOG: (1) JCA final scope (120 days before CHMP opinion^A), (2) JCA draft report with potential additional evidence requests (35 days after CHMP opinion^A), (3) JCA final report (30 days after EMA marketing authorization^A (MA)). Outcomes from these JCA milestones may require manufacturers to adapt their AMNOG dossiers causing an increased risk of resource scarcity at manufacturer side, a potential postponement of their market launch and start of AMNOG. Most importantly, AMNOG dossiers for indication extensions need to be submitted 30 days after MA making it thus impossible to consider the JCA’s outcome.

CONCLUSIONS: It is currently suggested that JCA will not delay AMNOG timelines. However, there is a risk of delays and until the G-BA adapts its processes and rules of procedure there remains high uncertainty for manufacturers seeking reimbursement in Germany.