Is an AMNOG Benefit Reassessment After Time Limitation Really a Risk to Drug Prices?

OBJECTIVES: Since the implementation of AMNOG in Germany in 2011, pharmaceutical companies must demonstrate the additional medical benefits of newly approved drugs. The determination of potential added medical benefits is assessed by the Federal Joint Committee (GBA) and may be time-limited, leading to a reassessment at a later date. This study aims to examine the reasons behind time limitations and their impact on the additional medical benefit-level and price discounts.

METHODS: A database encompassing all AMNOG benefit assessments released up to April 2024 was screened to identify time-limited procedures. Data on reasons for limitations were extracted and analyzed in relation to additional benefit-level and price discounts, considering changes in manufacturer prices in the Lauer Taxe.

RESULTS: A total of 142 (15%) time-limited procedures were identified, with durations ranging from 5-97 months, predominantly observed in oncological indications (65%). Time limitations were primarily imposed due to insufficient safety and efficacy data, alongside issues such as inadequate study methods, lack of statistical power and challenges in applicability to the German healthcare system. 68 procedures have undergone reassessment thus far and were subjected to a second round of price negotiations. In 49% of cases, the second benefit assessment resulted in further price reductions ranging from 37-0.4%. Notably, the absence of safety and long-term data correlated with the most substantial price reductions. In 28% of instances, the second price negotiation had no impact on discounts, while in 24% of cases, prices increased by amounts ranging from 0.9-15%.

CONCLUSIONS: Most likely a time limitation on GBA's benefit assessment stems from insufficient safety and efficacy data at the time of initial application, which may lead to increased price discounts following subsequent pricing negotiations—particularly when long-term data are required but not provided.