OBJECTIVES: Since the enactment of the AMNOG in Germany in 2011, pharmaceutical companies are required to prove the benefit of newly approved drugs over the standard of care within the therapeutic area(s) of interest. This benefit is evaluated by G-BA/IQWiG and forms the basis for price negotiations with the statutory health insurance providers. The aim of this study was to investigate the distribution of the awarded added benefit from 2011 to 2019 and to examine the development of outcomes in this timeframe.

METHODS: A database containing all evaluated AMNOG dossiers from 2011 to 2020 was analysed. Information on G-BA assessments and decisions on added benefit were extracted. Results were grouped by completed calendar year and added benefit category. Trends in development of the benefit categories for regular as well as orphan drugs (OD) were evaluated.

RESULTS: In total, 455 concluded benefit assessments were published including 889 subpopulations. The most frequent outcome was no added benefit for 43% to 64% of assessed subpopulations from 2011 to 2019. There is no definitive trend for either of the three quantifiable added benefit categories (major, considerable, minor) with major added benefit always being the rarest outcome. However, the number of subpopulations granted a non-quantifiable additional benefit increased in recent years which correlates with increased numbers of OD assessments. OD are by law granted at least a non-quantifiable additional benefit. In 8 years, only 4 subgroup assessments resulted in less benefit than the comparative therapy.

CONCLUSIONS: Since 2011, benefit assessments have become a key component in pricing of new drugs in Germany. To receive an additional benefit positively influencing price negotiations, the evidence must be generated in accordance with G-BA/IQWiG regulations. Our analysis shows that most subpopulations are not granted an additional benefit, indicating that the provided evidence did not meet the required criteria.