10 Years of AMNOG: Importance of Real World Evidence Studies in the German Benefit Assessment Process

OBJECTIVES: Since the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2011, the Federal Joint Committee provides access to all benefit assessments of pharmaceutical products. The aim of this study was to assess the relevance of Real World Evidence (RWE) studies for estimating prevalence and incidence of the underlying disease and quantifying target populations after 10 years of AMNOG in Germany.

METHODS: All published AMNOG dossiers until 31 December 2021 were included. The epidemiological section of each dossier (section 3.2.3/3.2.4 of module 3) was screened for the integration of RWE studies using Statutory Health Insurance (SHI) claims data, registry data, surveys, and/or other data sources (e.g., chart reviews) to define the underlying disease and target populations.

RESULTS: Between 2011-2021, 855 separate modules 3 were submitted representing 342 active compounds. Most common indication areas included oncology (38%), followed by metabolic (25%) and infectious (8%) diseases. RWE studies were used to quantify ~45% of epidemiological figures. SHI claims data (~35%) and other data sources (~40%) were the most frequent sources of RWE. Following a downward trend regarding the integration of RWE studies in German AMNOG dossiers between 2013-2019, a sharp increase of RWE utilization was observable in 2020 (~60%), with claims data used in ~50%. In 2021, RWE studies were performed to quantify ~30% of epidemiological measures. For all RWE data sources, there were fluctuations regarding their relevance over time and no clear trend could be identified.

CONCLUSIONS: Since the implementation of AMNOG, RWE studies have become a standard component in German AMNOG dossiers. Besides other data sources, German SHI claims data are a valid and valuable data source for the determination of epidemiological evidence, which offers a meaningful, more current, and complementary contribution to existing literature.