OBJECTIVES: Since the AMNOG was implemented in Germany in 2011, pharmaceutical companies must demonstrate an added benefit of newly approved drugs within their specific therapeutic area(s). The benefit assessment is conducted by G-BA/IQWiG and serves as the basis for price negotiations with the National Association of Statutory Health Insurance Funds. This study aims to examine the outcomes of these assessments from 2011 to November 2023.

METHODS: A database containing all evaluated AMNOG assessments was analysed and information on assessments and decisions made by G-BA regarding the added benefit was extracted. Pricing data from Lauer Taxe^®, which captures prices at launch and after G-BA decisions, were also obtained. Qualitative and quantitative analysis was conducted to identify predictors of assessment outcomes and their impact on price negotiations.

RESULTS: Overall, 944 benefit assessments were published, covering 1,614 subpopulations, predominantly in the indications of oncology (598), metabolic (308), infectious (236), and neurological diseases (102). No added benefit was assigned in 42% of the benefit assessments but in 59% of the subpopulations. A minor added benefit was found in 16% of the assessments (12% for subpopulations), a considerable added benefit in 17% (11%), and a major added benefit in 2% (1%). In 18% (13%) of cases, the added benefit could not be quantified. Subsequent price negotiations resulted in a mean rebate of the launch price of 24% for drugs with an added benefit and 33% for drugs without an added benefit.

CONCLUSIONS: Benefit assessments have played a crucial role in determining drug pricing since 2011 in Germany. Pharmaceutical companies must provide compelling evidence that meets G-BA/IQWiG regulations to secure an added benefit that positively impacts price negotiations. However, our analysis suggests that an added benefit was not granted frequently, indicating that the evidence provided often did not sufficiently demonstrate efficacy, safety, or meet methodological criteria.