Presentation (CTI)

OBJECTIVES: After EU-HTA (JCA), AMNOG dossier submission remains mandatory for HTA in Germany. The requirements for AMNOG dossiers are currently under revision by G-BA to better align AMNOG with JCA and avoid content duplication. We aimed to identify remaining challenges HTDs are likely to face when preparing AMNOG dossiers post-JCA.
METHODS: We qualitatively compared G-BA’s current Rules of Procedure (RoP) and AMNOG dossier requirements with anticipated EU-HTA-related dossier changes by reviewing information on the alignment of AMNOG and JCA, provided on the G-BA website and in informational meetings. We derived key issues HTDs should consider when preparing AMNOG dossiers following JCA. The analysis will be repeated once the updated G-BA’s RoP become effective.
RESULTS: Referencing JCA content in AMNOG dossiers is possible in some parts. However, at least 4 challenges are likely to limit synergy effects between AMNOG and JCA dossiers, preventing reductions in workload. Referencing is particularly limited when new data is required for AMNOG, due to new data cuts or additional studies, that were not covered by JCA. Additional data analyses become necessary when the G-BA-defined appropriate comparator therapy changes after JCA PICO-scoping, following adaptations in label or relevant clinical guidelines. Referencing is also limited by redactions made by HTDs in the JCA dossier. Moreover, systematic literature reviews must be updated if older than 3 months or methodologically non-compliant with AMNOG criteria.
CONCLUSIONS: G-BA shows clear intent to align AMNOG with JCA. While HTDs may leverage synergy effects, they should be aware of challenges arising at the interface between JCA and AMNOG dossiers. Main risks for HTDs result from the uncertainty of potential changes during JCA that limit the possibility of referencing. Conclusive assessments can only be drawn once the updated RoP are published in summer 2025 with further adjustments expected after first practical experience with JCA.