OBJECTIVES: In 2020, the Federal Joint Committee (G-BA) amended the Rules of Procedure to include an application-accompanying data collection (anwendungsbegleitende Datenerhebung, AbD) for drugs with conditional approval, approval under exceptional circumstances or an orphan designation (OD). The intention was to close evidence gaps identified during the market authorization procedure or the added benefit assessment. Study aim was to provide a detailed description of the AbD assessment, current procedures and to assess similarities and potential parameters that lead to an AbD.

METHODS: A systematic search of present AbD assessments published on the G-BA website was performed and all initiated procedures since the start in 2020 were examined.

RESULTS: Until June 2023, 8 drugs had an AbD imposed on them with one having started the data collection by now. All were categorized as OD and represent innovative technologies such as gene therapies. Other identified similarities were study-related methodological uncertainties that did not allow a definite benefit assessment.

CONCLUSIONS: Our study identified the innovative therapeutic character as a major similarity. As these technologies deal with uncertainties in the evidence generation, this could potentially indicate a main reason for the assignment for an AbD. Since not all innovations receive a mandate to conduct an AbD, it is assumed that other factors related to the evidence gap could also be considered as reasons for imposition. Based on the few assessments that have been initiated until now, no distinct predictive factors for a mandatory AbD can be identified.

In summary, AbD is a continuously evolving process that will become clearer over time. In case of uncertainties of evidence, pharmaceutical companies should anticipate to actively consider collecting evidence early on in their clinical development program through registries to comply with G-BA’s information needs.