When the Arbitration Office Must Decide

After the benefit resolution of the German health technology assessment (AMNOG) for new drugs, the pharmaceutical companies negotiate with the Sickness Funds about reimbursement amounts and general conditions. If no agreement is achieved, an arbitration procedure (AP) must be initiated, and the reimbursement amount is determined by the arbitration office. The aim of this study was to analyze the APs regarding benefit assessment ratings, rebate outcomes, and market exit after arbitral verdict to examine the impact on and of the AP.

The results of AMNOG procedures with a subsequent AP on reimbursement amounts were compared with all other AMNOG procedures without an AP using a database containing relevant information of all AMNOG procedures ever conducted. Using the Lauer-Taxe, drug availability on the German market was verified.

No relevant differences in the distribution of benefit levels between procedures with and without AP could be identified. Net box rebates were on average higher after an AP, both for procedures with added benefit ratings (36% vs. 27%) and without (62% vs. 33%). In 19 out of 54 APs, the drug exited the German market after arbitral verdict. Moreover, 14 of those 19 drugs did not receive an additional benefit in the benefit assessment and the arbitration office decided on an average net box rebate of 75%.

The appointed level of benefit for a drug in the benefit resolution had no influence on whether the arbitration office was involved. However, undergoing the AP leads on average to higher rebates for drugs, i.e., APs seem to be decided to the disadvantage of pharmaceutical companies. These high rebates lead to a significantly increased withdrawal rate from the German market. The reimbursement amount, which is highly dependent on the benefit level, seems to correlate with the frequency of market withdrawals.