📢 The new EU HTA reality: first insights from JCA and G-BA

 

The tovorafenib (Ojemda®, Ipsen) procedure in pediatric low-grade glioma therefore provides the first real-world case of how the JCA and a subsequent national HTA assessment interact, and it already offers some remarkable insights 👇:

🔹 Ipsen presented indirect comparisons in the form of MAICs in the JCA dossier, but none of this appears in the AMNOG dossier. This, even though one of the comparisons would have been quite relevant for the German healthcare context.

🔹 The G-BA nevertheless looked at the MAIC presented in the JCA dossier and dismissed it for its own benefit assessment with the predictable reasoning of being “not appropriate”.

🔹 The results of the pivotal arm of the non-comparative FIREFLY-1 study appear in the AMNOG dossier under “further investigations”, largely by referencing the JCA dossier. Still, the usual summary of results can be found under section 4.4.2.

🔹 The G-BA itself goes further in its assessment: it considers a larger patient pool (pivotal arm plus expansion arm) and relies on a more recent data cut-off than the one presented in the JCA dossier.

🔹 And one procedural point on the side: the JCA report itself was not included in the assessment, as it had not yet been published at the start of the procedure. However, as it was published before the benefit assessment was finalized, the JCA report can still be considered as part of the written statement procedure and, in particular, be addressed during the oral hearing.

 

What does this show ❓

💡 A JCA report is no shortcut for the AMNOG dossier. The national “translation” work – selecting the evidence, handling indirect comparisons – remains crucial. And the G-BA demonstrates that it continues to assess independently and with a critical eye on methodology, regardless of the European framework.

 

It will be interesting to see how this plays out in the consultation procedure and the decision in November.