Presentation (CTI)

OBJECTIVES: The Federal Joint Committee (G-BA) revised the requirements for Module 3 dossiers under the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2024. The updated guidelines shift the obligation for trend estimates away from the previous prevalence and incidence metrics to the expected number of patients in statutory health insurance (SHI) in the target population for the next five years. The aim was to assess the utilization and sources of real world evidence (RWE) in AMNOG dossiers submitted in accordance with the new requirements.
METHODS: All AMNOG dossiers published between November 2024 and February 2025 were included. The presence and type of RWE applied in sections 3.2.3 and 3.2.4 of Module 3 were evaluated. Two independent reviewers verified the categorization of the data sources.
RESULTS: Of the 45 AMNOG dossiers assessed, 30 (66.7%) incorporated RWE, such as public data browsers, disease registries, and claims data. The most frequently used RWE data source was the Zentrum für Krebsregisterdaten (ZfKD) (76.7%), followed by registries (30.0%), claims (16.7%), and the German Institute for the Hospital Remuneration System (InEK) (6.7%). RWE was applied equally to orphan and non-orphan drug submissions (66.7% each). Oncology was the most represented therapeutic area (73.3%), with ZfKD data utilized in all oncology-related dossiers using RWE data.
CONCLUSIONS: The 2024 revision of the requirements for Module 3 has further emphasized the importance of RWE for AMNOG assessments. This is particularly true given that the target population often requires a more complex identification process than standard epidemiological measures such as prevalence and incidence. In oncology, the most represented therapeutic area, ZfKD data plays a pivotal role. The ZfKD offers both a basic, publicly accessible dataset and, upon request, more detailed clinical data, enabling deeper, more tailored insights to support complex target population identification.