OBJECTIVES: Since the enactment of the AMNOG in Germany in 2011, pharmaceutical companies are required to prove the benefit of newly approved drugs within the therapeutic area(s) of interest. The potential benefit is evaluated by G-BA/IQWiG forming the basis for price negotiations with the statutory health insurance providers. Aim of this study was to investigate the distribution and the outcomes of the assessments from 2011 to May 2022.

METHODS: A database containing all evaluated AMNOG assessments was analysed. Information on G‑BA assessments and decisions on added benefit were extracted. Prices at the time of launch including changes after G-BA decision were obtained from Lauer-Taxe^®. Benefit assessments were qualitatively and quantitatively analysed for predictors of assessment outcome and impact on price negotiations.

RESULTS: Overall, 741 concluded benefit assessments were published including 1,304 subpopulations predominantly in the indications of oncology (458), metabolic (271), infectious (183) and neurological diseases (52). The most frequent outcome of no added benefit ranged between 38-64% of assessed subpopulations. No definitive trend for quantifiable added benefit categories (major, considerable and minor) was found with major always being the rarest outcome (1-3%). Comparing the outcomes on benefit assessment level, no added benefit was granted in 41%. However, the G-BA determined no added benefit in 58% on subpopulation level. In the subsequent price negotiations, the mean rebate on the initial launch price was 24% and 32% for the categories added benefit and no added benefit, respectively.

CONCLUSIONS: Since 2011, benefit assessments have become the key component in pricing of new drugs in Germany. To receive an added benefit that positively influences price negotiations, evidence must be generated in accordance with G-BA/IQWiG regulations. Our analysis shows that most subpopulations were not granted an added benefit, indicating that the provided evidence did not meet either sufficient efficacy, safety or methodological criteria.