Insights
EU HTA & AMNOG insights: topics, analysis and guidance for Germany
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JCA Insights
Tovorafenib after the JCA: What the first G-BA benefit assessment reveals about the EU-to-Germany evidence transfer
The first German benefit assessment of a medicinal product following a Joint Clinical Assessment shows concrete differences between the European and national evaluation of clinical evidence. In the case of tovorafenib, these differences primarily concern comparative evidence, the patient relevance of endpoints, the data cuts used, and the timing of the JCA report. The case therefore confirms a central point for the delta dossier: the delta dossier is not an official regulatory term, but a working term used in the German market access context for the national content and adaptations required between the JCA dossier and the AMNOG dossier.
Joint Clinical Assessment: What the First Four JCA Reports Reveal About Evidence Assessment
The first four published Joint Clinical Assessment (JCA) reports reveal recurring methodological challenges in European evidence assessment. Key issues include PICO scoping and comparators, indirect treatment comparisons, the selection of prognostic factors and effect modifiers, and the handling of non-randomised evidence and post-hoc analyses. For manufacturers, the critical question is therefore whether the evidence for each PICO can be planned, generated and presented in a methodologically robust and transparent way.