OBJECTIVES: For benefit assessment of new pharmaceuticals in Germany, G-BA defines appropriate comparators of four categories: one specific drug, a list of drugs, patient individualized therapy, and best supportive care (BSC). The aim of the study was to reveal the impact of the category on the added benefit.

METHODS: Information on appropriate comparators and benefit assessment were retrieved from a databank containing information on all AMNOG dossiers in the field of oncology. Dossiers were analyzed for data on indication, target population, line of therapy, appropriate comparator, and added benefit.

RESULTS: CONCLUSIONS: A specific drug or BSC are the most commonly assigned appropriate comparators in oncology dossiers. If a specific drug is the appropriate comparator, it seems inevitable to present direct evidence in order to gain an added benefit. For BSC and patient individualized therapy, G-BA seems to be more permissive regarding the acceptance of evidence not directly matching the appropriate comparator.