Einfluss der Änderung der AMNOG-Leitplanken durch das GKV-FinStG auf die Nutzenbewertungen des G-BA

The central aim of the study was to analyze possible changes in the benefit assessment by the Federal Joint Committee (G-BA) following the GKV Financial Stabilization Act (GKV-FinStG) by examining whether the tightening of AMNOG guardrails has led to more restrictive assessment practices. This was operationalized through a comparative analysis of German and French benefit assessments before and after the GKV-FinStG. Two central research questions were pursued: (1) Can statistically significant changes in the G-BA's additional benefit assessments be demonstrated? (2) Can observed changes be causally attributed to the tightening of AMNOG guidelines?A quasi-experimental difference-in-difference (DiD) design was employed to analyze changes in benefit assessment. Germany served as the intervention group, France as the control group. German benefit assessments were captured via the AMNOG Monitor for the period 2020-2024, French assessments via the Haute Autorité de Santé (HAS). Separate analyses were conducted according to patent protection status of the appropriate comparator therapy (ACT).The study provides the first empirical evidence of a potential influence of tightened AMNOG guidelines on G-BA assessment behavior. The statistically significant difference-in-difference effect of -9.74% (p=0.028) shows that the proportion of at least considerable additional benefit assessments in Germany declined by nearly 10 percentage points more strongly than in France after the reform. For procedures with patent-protected ACT, the strongest effect of -14.56% was observed, while for generic ACT, no relevant effect (0.88%) occurred as expected.The tightening of AMNOG guardrails has led to a systematic reduction in the proportion of at least considerable additional benefit assessments. The observed change could be attributed to unconscious cognitive adaptations or conscious strategic considerations to limit GKV expenditures. The findings suggest that savings arise not only through direct price effects but also through more restrictive assessment practices.