OBJECTIVES: In Germany, there are two national bodies that determine the pricing and reimbursement of inpatient drugs. The G-BA conducts a benefit assessment that precedes a price negotiation whilst InEK establishes the price and appropriate funding route. This research explores the relationship between the G-BA and InEK in driving successful reimbursement outcomes.

METHODS: A quantitative analysis of inpatient drugs in the 2022 NUB list plus a 60-minute qualitative interview with a German payer advisor.

RESULTS: 100 NUB outcomes were identified: 77% achieved NUB 1 (positive outcome) and 23% achieved a NUB 2 (negative outcome). Of these, 69% received an additional benefit and 31% received no additional benefit from the G-BA. Notably, there were discrepancies between favourable outcomes by InEK vs. those by the GBA: 28.6% of therapies that received NUB 1 received no additional benefit whilst conversely, 60.9% of therapies that received NUB 2 received additional benefit. Payer insights revealed that the G-BA and InEK operate independently with different criteria. The G-BA focuses on added clinical benefit, which informs national price. In contrast, InEK assesses a drug’s novelty, whether it can be funded from DRGs, and how justified the cost-differential is. The two bodies only convene if the nationally negotiated price is lower, which is then also applied by InEK. After at least 5 years, the DRG may be updated to absorb the cost differential.

CONCLUSIONS: The contrasting decision-making processes complicate patient access to inpatient drugs in Germany, with the G-BA and InEK performing their assessments according to different criteria. To secure inpatient reimbursement following the G-BA’s benefit assessment, manufacturers must also ensure they meet InEK’s criteria, assess and justify their drug’s cost-differential, prepare a well-written submission, and ensure all hospitals apply annually with the same application.