OBJECTIVES: With the Act on the Reform of the Market for Medicinal Products in 2011, Health Technology Assessment (HTA) standards were introduced in Germany. Core element is the submission of an AMNOG dossier presenting recent epidemiological data for the underlying disease and relevant target populations (TP). In Germany, epidemiological information is commonly generated through claims data analyses (CDA). Within the benefit assessment, applied methodology, scope, and transparency are evaluated by the Institute for Quality and Efficiency in Healthcare (IQWiG). Aim of this study was to examine criticisms discussed within the IQWiG assessments on epidemiological data generation through CDAs until the inception of a new code of procedure in April 2020 committing to STROSA reporting standards.

METHODS: All AMNOG processes with publicly available benefit assessments between January 1^st, 2011 and December 31^st, 2019 were included. AMNOG dossiers and respective IQWiG evaluations were screened regarding the inclusion of CDAs analyzing incidence, prevalence, and TP. IQWiG’s criticism on the applied methodology, the scope, and transparency of the CDA presented as well as a missing critical discussion and further criticisms was analyzed.

RESULTS: 55 CDAs representing 70 different TPs were included. IQWiG expressed at least some concerns about the data presented in 46 (83.6%) CDAs with the most frequent criticisms relating to the methodology used (37; 80.4%) and a lack in transparent presentation (33; 71.7%). The proportion of criticized CDAs over time demonstrated no explicit trend. IQWiG deprecated methodology, transparency, and a lack of discussion more frequently, while the analysis scope was rarely criticized.

CONCLUSIONS: Over time, CDAs have become a sound foundation for generating evidence in the AMNOG process. For acceptance, however, IQWiG’s quality requirements regarding methodology and transparency have to be considered. To ensure adequate reporting quality, a standardized reporting routine according to the guidelines of STROSA, GEP, and GPS is applied from April 1^st, 2020.