OBJECTIVES

Since AMNOG regulation was introduced in 2011, a dossier submission to the Joint Federal Committee (G-BA) is required for the demonstration of additional benefit by new active substances over current standard of care (SoC) in Germany . After G-BA has released the results of its health technology assessment (HTA), the manufacturer enters reimbursement price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV). If the GKV-SV and the pharmaceutical manufacturer are unable to negotiate a price within six months of the HTA assessment results publication, an independent Arbitration Board mediates the price between the parties (§130b SGB V). The results of the decisions have a significant influence on all price negotiations between health insurance companies and manufacturers. The criteria influencing the arbitration decisions have yet to be systematically and comprehensively examined. Therefore, our objective is to identify and understand possible decision patterns of the Arbitration Board.

METHODS

All accessible written decisions of the Arbitration Board from January 2011 to February 2019 were examined (n= 43). The disputed factors between the parties were qualitatively extracted. Recurring points of contention as underlying decision factors were then subjected to a qualitative and quantitative evaluation.

RESULTS

In our analysis, 12 factors in the arbitration process were identified to have an influence on prices. This analysis also explored how the weighting of the 12 factors varied in accordance to e.g. orphan drug status, specialty vs primary care drugs and multiple subpopulations.

CONCLUSIONS

Arbitration decisions do not follow a rigid pattern. However, the results of this analysis provide a preliminary basis to support manufacturers in the identification of suitable analogues to inform different price strategies for the price negotiation between the GKV-SV and the manufacturer. By analyzing potential selection and decision criteria, a hypothesis for the potential arbitration decision can be derived.