Inpatient Drug Reimbursement in Germany: Exploring the Differing Decision-Making Processes Between InEK and G-BA

OBJECTIVES: There are two national bodies in Germany that decide pricing and reimbursement for drugs used in the hospital inpatient setting. The G-BA conducts a benefit assessment independent of price, whilst InEK establishes the price and appropriate funding pathway. This research investigated the relationship between the G-BA and InEK’s decision-making criteria and outcomes for securing reimbursement of inpatient drugs.

METHODS: A quantitative comparison of NUB status 1 (positive outcome) or status 2 (negative outcome) vs. the benefit assessment outcomes of 103 inpatient drugs included in the 2022 NUB list was performed from January – December 2023. Additionally, a 60-minute qualitative interview with a German payer advisor was conducted in June 2023 to explore differences in decision-making processes and criteria.

RESULTS: 77.7 percent of drugs received NUB 1, 22.3 percent received NUB 2, 68.9 percent received added benefit and 31.1 percent received no added benefit. However, 56.3 percent of drugs with no added benefit received NUB 1, whilst 20 percent of drugs with added benefit received NUB 2. Payer insights revealed InEK considers novelty, DRG funding viability, and a justified cost-differential, but not clinical benefit. Benefit ratings apply until new data is presented, but NUBs require annual applications. After sufficient utilization of a NUB 1 drug, DRGs may be updated to absorb the cost differential (this occurs for ~3-6 drugs/year).

CONCLUSIONS: Access to high-cost inpatient drugs in Germany is complicated by the contrasting decision-making methodologies employed by G-BA and InEK, each conducting their assessments according to different criteria. To achieve inpatient reimbursement outside of the current DRG scheme, manufacturers must meet InEK’s criteria, justify their drug’s cost-differential, and ensure all hospitals apply annually with an identical application text in well-written German.