German Amnog Benefit Assessment: The Type Of Appropriate Comparator Makes The Difference

Abstract

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. 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. 66 relevant dossiers including 129 separate (sub-)labels were identified. Appropriate comparators assigned by G-BA were distributed as follows: 33 (26%) specific drug, 39 (30%) list of drugs, 23 (18%) patient individualized therapy, and 34 (26%) BSC. About 50% of all assessed sublabels within the categories “specific drug” and “list of drugs” gained an added benefit (45.5% and 46.2%, respectively). In nearly all of these dossiers direct evidence to the assigned comparator was presented. 41.2% (n=14) of the indications in the category “BSC” gained an added benefit. In 3 dossiers no direct evidence to the appropriate comparator was presented. Nevertheless, 2 of these dossiers achieved an added benefit. In contrast, an added benefit was granted for only 30.4% (n=7) of sublabels, which belonged to the category “patient individualized care”, 9 of the dossiers in this category did not show direct evidence to the appropriate comparator; however, 3 of these dossiers achieved an added benefit. 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.