Routine practice data collection for benefit assessment

Since the introduction of the „Act for greater safety in the provision of medicinal products" (German: Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV) in August 2019, the German Federal Joint Committee (German: Gemeinsamer Bundesausschuss, G BA) has been authorized to demand a continuous data collection concurrently to clinical practice. This so-called routine practice data collection (German: Anwendungsbegleitende Datenerhebung, AbD) serves to close evidence gaps existing at the time of the initial benefit assessment decision, while still making the drug available for patients in need. It is important to note that the data assessment must also include the treatment with the appropriate comparative therapy as determined by the G BA in order to allow for a comparative assessment.

Eventually, the AbD will provide sufficient data for a benefit re-assessment, subsequently leading to a re-negotiation with the umbrella association of the statutory health insurances in Germany (German: gesetzliche Krankenkassen-Spitzenverband, GKV-SV). Here, the law contains a mechanism for automatic price reduction, should the requirements of the G BA for this in-use data collection not have been met by the pharmaceutical manufacturer (pU). In order to ensure sufficient data quantity, the law empowers the G BA to restrict reimbursement of the drug to centers and physicians participating in the in-use data collection.

Since 2019, several manufacturers have been obliged to set-up an AbD. It is therefore important to draw an interim conclusion and assess

• ... how the AbD requirement has been handled to date,
• ... which requirements have been set-up for the manufacturer and the respective treating physicians,
• ... how the manufacturer can optimally anticipate and prepare for (or to avoid) an AbD.

For this purpose, we have compiled a comprehensive analysis of the active substances commissioned to date (Feb 2023) regarding the respective circumstances leading to and the actual handling of the AbD.