Fifteen years of AMNOG: evidence base is the strongest driver of added benefit

At ISPOR Europe 2026 in Vienna (8–11 November 2026), Tomeczkowski et al. presented an analysis of 962 benefit assessment dossiers completed between July 2011 and July 2026. Orphan drugs whose added benefit is deemed proven by law were excluded. The data source is the AMNOG-Monitor.

The GBA granted an added benefit in 39.5% of the dossiers. The evidence base shows the strongest association with the outcome: with a direct comparison (head-to-head, H2H) the rate was 68.5%, with an indirect comparison 6.3% and with other evidence 9.6%. Medium-sized patient populations (49.4%) and a non-active appropriate comparator therapy (60.8%) were also more often associated with an added benefit.

The success rate fell from 46.2% (decisions up to 2019) to 35.8% (from 2020). At the same time, patient populations are shrinking and H2H evidence is becoming rarer. Where randomised H2H trials are not feasible, the AMNOG procedure should, in the authors’ view, give greater consideration to alternative comparative evidence.

Source: Tomeczkowski J, Mueller G, Heidbrede T, Herrmann KH, Bussilliat P, Dintsios CM, Leverkus F. Fifteen Years of German HTA (AMNOG): Trends and drivers of added benefit. ISPOR Europe 2026, Vienna, poster HTA251.