OBJECTIVES: In Germany, with each label extension the additional benefit of a product is assessed according to §35a SGB V and the reimbursed drug price is renegotiated with the National Association of Statutory Health Insurance Funds (GKV-SpiBu). With this study, we aimed to investigate the price development of pharmaceuticals with at least one label extension and potential factors for price decreases in the therapeutic areas oncology and metabolic diseases.

METHODS: First, the data from all AMNOG dossiers evaluated by the Federal Joint Committee (G-BA) from January 2011 until December 2017 were extracted. Information on the active substance, product name, therapeutic area, orphan status, decision date, for all dossiers including the initial submission and label extension dossiers, were included in the analysis. In a second step, the product prices of the SmPC recommended packages were taken from the official German database for drug prices (LAUER-Taxe). The initially negotiated prices and negotiated prices after each label extension were then linked to each dossier. Finally, the correlation between price development after label extension and size of patient populations as well as extent of additional benefit was analyzed.

RESULTS: Altogether, n=102 (oncology: n=77 and metabolic diseases: n=25) dossiers were included into the analysis. Of those, n=80 were non-orphan dossiers and n=22 were orphan dossiers. Mean decrease of product prices after first label extension was -17.8% among all products, -19.5% among oncological and -13.5% among the metabolic disease products. The most common price reduction after first label extension was in the category between 0% and -20.0%.

CONCLUSIONS: The analysis shows that the negotiated prices decrease with each label extension. Hereby, the price decrease per label extension is directly correlated with the amount of increase in the number of patients and indirectly with the extent of additional benefit. However, it remains unclear which other factors may influence this development.