OBJECTIVES: Since introduction of the Health Technology Assessment (HTA) concept to Germany with the Act on the Reform of the Market for Medicinal Products (AMNOG) regulation in 2011, all benefit assessments are publicly accessible on the website of the Federal Joint Committee. Aim of this study was to investigate the integration of Real World Evidence (RWE) studies in German AMNOG dossiers for the determination of the incidence and prevalence of the underlying disease and the quantification of target populations and thereby exploring the relevance of different data sources over time.

METHODS: All published AMNOG dossiers until 31 December 2018 were included. Relevant sections of the dossiers were screened for the integration of RWE studies in terms of Statutory Health Insurance (SHI) claims data, registry data, surveys, and/or other data sources (e.g. chart reviews) to assess epidemiological inputs. In addition, trends over time from 2011 to 2018 were explored for each data source.

RESULTS: In the study period, 456 different target populations could be extracted from 228 different AMNOG dossiers with active compounds. RWE studies were incorporated in 222 (48.7%) to explore overall patient numbers in the underlying diseases and the target populations. Most common indication areas integrating RWE included oncologic indications (35.1%), followed by metabolic disorders (34.2%), and infectious diseases (6.3%). Other data sources (50.5%) and SHI claims data (27.5%) were the most prominent source of RWE. Over time, the incorporation of RWE studies varied from 38.4% in 2017 to 66.7% in 2014.

CONCLUSIONS: This study revealed that the integration of RWE studies has become almost a standard component in German AMNOG dossiers since its introduction in 2011. 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.