OBJECTIVES: In 2011, the Act on the Reform of the Market for Medicinal Products (AMNOG) introduced Health Technology Assessment (HTA) standards in Germany. Core of this process is the submission of an AMNOG dossier where current epidemiological data for the underlying diseases and relevant target populations are a mandatory component. A common option to generate these data is the analysis of German claims data. The submitted information is evaluated by the Institute for Quality and Efficiency in Healthcare (IQWiG) focusing on applied methodology and transparency. Aim of this study was to investigate criticism and potential improvements discussed over time in the assessments from IQWiG on epidemiological data using claims data analyses.

METHODS: All published AMNOG assessments and the respective IQWiG evaluations from 01 January 2011 until 31 December 2018 were downloaded from the Federal Joint Committee’s homepage. The materials were screened for the inclusion of studies using claims data. The IQWiG evaluations were analyzed regarding criticism of methodology, scope, transparency, missing critical discussion, and further points of criticism.

RESULTS: A total of 46 claims data analyses representing 61 different patient populations were included. In 37 (80.4%) cases IQWiG raised at least some concerns about the data. The most frequent point of criticism concerned the applied methodology (75.7%), followed by a lack of transparency (70.3%), and further identified points of criticism (32.4%). The proportion of criticized claims data studies remained stable over time. Methodology, scope, and transparency gained more importance, while a missing discussion was criticized less frequently.

CONCLUSIONS: Claims data are a well-established source for the determination of epidemiological evidence in the AMNOG HTA process. However, for acceptance, IQWiG’s quality requirements regarding methodology and transparency need to be considered. To ensure adequate reporting quality, new regulations will be in place as of 2020 demanding standardized reporting according to the STROSA, GEP, and GPS guidelines.