Key Updates on AMNOG & EU HTA Alignment

Thrilling news ahead: the previously proposed 3-month suspension of the AMNOG process is not included in the final version of the First Regulation Amending the Ordinance on the Benefit Assessment of Medicinal Products (AM-NutzenV), published in the Bundesgesetzblatt on March 7th.

What happens if the JCA report is not available at the time of the German benefit assessment publication?
🤫 If the JCA report is not published by the time of the German benefit assessment report (i.e., 3 months after the start of AMNOG), the health technology developer (HTD) must provide the G-BA with a version of their JCA submission dossier within 3 days for publication.
🫣 This interim version will be immediately published on the G-BA website and later replaced with a link to the official JCA report once available.
 
Additionally, the updated regulation clarifies the integration of EU HTA into AMNOG:
✔️ The German benefit assessment will now consider both the national and JCA dossier as well as published JCA reports.
✔️ The HTD can decide to what extent it uses information from the European dossier and refer to the corresponding content in the national dossier.
✔️ If the JCA report becomes available after the start of the process but before publication of the German benefit assessment, the G-BA will include it in the oral hearing and consider it in the final resolution.

These adjustments reinforce Germany’s approach to synchronizing EU HTA & AMNOG, ensuring timely and transparent assessments.

💡 What are your thoughts on this update? Let’s discuss!