OBJECTIVES: The AMNOG procedure has significantly reduced prices of pharmaceutical products in Germany which are now even below the European average. However, the small segment of extremely high-priced drugs (annual therapy costs (ATC)>300.000€) is continuously growing, posing a considerable financial burden on the Statutory Health Insurance. The aim of this study was to analyze this market segment, specifically regarding the performance in the AMNOG process and to understand the underlying and consecutive market dynamics.

METHODS: We analyzed data sets from the proprietary MAIS database, including all publicly available G-BA procedures until June 2020. The ATC along with the total rebates were calculated based on the information provided in the benefit assessment and the official price list (Lauer Taxe).

RESULTS: Of the 502 completed procedures to date, 26 equivalent to 22 pharmaceuticals were the most expensive products with net minimum annual therapy costs of 312.129€. The most expensive drug with 1.575.000€ annual therapy costs was betibeglogene autotemcel, a gene therapy. 77% of these pharmaceutical products were orphan drugs with no previously existing therapy. Several of these showed positive effects in survival endpoints. The remaining 23% were hemophilia products with no additional benefit. Furthermore, metabolic disease (42%) and hematology (35%) were the most frequent therapeutic areas in the high cost segment. All high-priced products possess specific, advanced mechanisms of action including recombinant proteins (58%), monoclonal antibodies (15%), synthetic nucleic acids (12%), gene therapies (11%) and kinase inhibitors (4%). The total net rebates after negotiation varied between 14.86% and 39.05% and did not correlate with the benefit category nor with the cost level.

CONCLUSIONS: Our results confirm the general German notion, that also in the high-price segment of pharmaceutical drugs, there is no correlation between the negotiated rebate and the category of the additional benefit nor with the cost level of the treatments.