How to Preserve Patient Access in Germany: A Performance Analysis of Products That Are No Longer Available on the German Market

OBJECTIVES: The AMNOG process in Germany assesses the added benefit of all reimbursable drugs with new active ingredients. Some drugs that underwent the AMNOG process are no longer available. This analysis explores the performance factors within the AMNOG process and the subsequent price negotiations that could prevent a drug’s withdrawal from the German market.

METHODS: A comprehensive database served as the basis for comparing all AMNOG procedures related to drugs currently available in the German market against those related to drugs that have been withdrawn. The performance analysis focused on the evidence provided in the dossier, the additional benefit claimed within the dossier and those confirmed in the resolution, as well as the initial launch price and the negotiated rebate of the drug.

RESULTS: As of June 2024, 961 completed AMNOG procedures were analyzed. Of these, the drugs from 67 procedures have been withdrawn. Both groups differed in launch-price setting and withdrawn products showed significantly lower added benefit categories (9.0% vs. 19.5% with at least a considerable added benefit and 64.2% vs. 44.2% without an added benefit). Subsequently, the negotiated rebate was considerably higher (31.7% vs. 14.7%) and reimbursements amounts were arbitrated more frequently (23.9% vs. 5.9%) for withdrawn products.

CONCLUSIONS: Our analysis reveals that the lower ratings by the G-BA have significantly impacted the chances of securing an appropriate reimbursement amount for the German market. This has led to a notable number of products exiting the market before the negotiation and public availability of the reimbursement amount (known as “Opt-out”). It was evident that a successful benefit rating hinges on the quality of the submitted evidence, the choice of comparator, and a sound pricing strategy.