Price Regulation of Combination Drug Therapies in Germany: Can Real-World Data Drive Flat-Rate Discounts?

OBJECTIVES: In Germany, a 20% flat-rate discount was implemented at the end of 2022 for new medicinal products used in combination therapy, excluding those with significant additional benefits. Disagreements between health insurance funds and pharmaceutical associations led the Federal Ministry of Health to propose an implementation plan/algorithm. The identification of a drug combination involves dispensing on the same day or at least twice within three months in an outpatient setting. Currently, this is to be applied to 57 drug combinations listed by the Federal Joint Committee. We aim to evaluate feasibility of the proposed combination drug identification algorithm.

METHODS: Real-world prescriptions from 5.5 million insured individuals of DAK-Gesundheit between January 2017 and December 2023 are evaluated. Outpatient and inpatient drug prescriptions for the 57 listed drug combinations will be examined within a rolling window of 180 days for each insured individual from their initial recorded prescription.

RESULTS: Annually, 270,000 patients have two predefined combination drug prescriptions within 180 days. The current algorithm identifies 65.1% of individuals receiving both defined drugs of a combination at least once in the 180-day period. In patients undergoing specific oncological treatments (66.7%) or managing metabolic diseases (74.0%), most prescribed drug combinations within a 180-day period are either dispensed on the same day or split into two instances over 90 days. 10.1% of potential oncology combinations are missed due to the exclusion of inpatient data. The algorithm could yield approximately 99 million euros in annual savings, but about 7 million euros would remain unrealized due to omitted inpatient oncology data.

CONCLUSIONS: While the proposed algorithm shows promise in addressing flat-rate discounts for combination therapies, criticisms may arise regarding the 90-day window and the lack of hospital turnover consideration. Meeting the legislated goal of 185 million euros in annual savings may be challenging with the current algorithm.