OBJECTIVES: Exploration the impact of the GKV-FinStG on (future) AMNOG procedures and identification of associated controversies.

METHODS: Based on a systematic analysis of the arbitral awards published since the GKV-FinStG came into force, the impact of the stricter pricing regulations on the reimbursement prices of new drugs in Germany is captured. Subsequently, findings and implications are transferred to new drugs in therapeutic areas that are characterized by generic and patent-protected as well as (non-)benefit-assessed products and/or the appropriate comparative therapy (ACT) is defined as several products with an “or”-linkage, a patient-specific therapy, a therapy according to physician’s choice or a combination therapy.

RESULTS: Up to date, four arbitral awards were published - two for oncological indications and two for multiple sclerosis. For the latter, stricter pricing regulations, triggered by non-quantifiable/minor additional benefit combined with a clear price differential between generic and patent-protected drugs as part of ACT, were decisive. The stricter regulations limit the formal scope of the arbitration board and, therefore, may lead it to make unpredictable discretionary decisions to correct for otherwise resulting controversies. In the landmark decision on Ponvory^® the arbitration board had to determine the monetization of the additional benefit against the most economic ACT (a generic drug), while ensuring that the resulting price exceeds the price for the study comparator, against which a minor additional benefit was proven. In the AMNOG case of Rybrevant^®, the manufacturer withdrew the product from the German market after benefit assessment since it faced an inadequate reimbursement price level due to the stricter regulations. Other manufacturers directly refrain from a market launch (e.g., Opdualag^®).

CONCLUSIONS: The stricter pricing regulations and their interpretation by the arbitration board may have controversial implications regarding pricing structure within therapeutic indications, price conservation and associated corporate planning, incentives for commercialization, innovation, and quality of care.