Author: Lukas Heinrich Schoppmeyer, Consultant, Germany
Implementation regulation of the combination discount according to section 130e SGB V named by the BMG
On 7 October 2024, the German Federal Ministry of Health (BMG) announced more detailed regulations for the implementation of the additional discount on drug combinations.
Combination Discount
Following a delay of almost two years after the “Act for the Financial Stabilisation of Statutory Health Insurance – Strategic Implications for Market Access in Germany (GKV-FinStG)” came into force (November 2022), the regulation for implementing the 20% discount on combinations not demonstrating at least a considerable additional benefit for at least one indication or patient group has now been adopted.
Previously, despite intensive negotiations, the GKV-SV and representatives of the pharmaceutical industry at federal level were unable to reach an agreement on how to implement the combination discount. As a result, the BMG has defined the specifics for its practical application. The regulation will come into force on 10 October 2024 and may have significant implications for the reimbursement of innovative combination therapies.
A key prerequisite for applying the combination discount under Section 130e (1) sentence 1 SGB V is the designation by the G-BA of a medicinal product with a new active ingredient as a potential combination partner in a free combination, pursuant to Section 35a (3) sentence 4 SGB V. This designation applies both to the product evaluated by the G-BA and to any designated combination partners, effective from the day after the designation.
For the discount to apply, these named combination partners must not only be designated by the G-BA but must also have been prescribed together in practice as a combination therapy. The most contentious issue in the practical implementation—between the GKV-SV and pharmaceutical associations—was how to identify and define such combination use from the health insurance funds’ billing data.
According to the BMG’s substitute provision, combination use subject to the discount is deemed to exist if the relevant medicinal products were prescribed to the same insured individual on the same day, or at least twice within a rolling five-month period. This is considered an irrebuttable presumption, meaning that many therapies not prescribed as a combination in practice—hence not legally subject to a discount—may still be classified as such and become discountable. This aspect has already drawn strong criticism from the pharmaceutical industry and may result in legal challenges to the regulation. The extension of the observation period from three to five months, as compared to the BMG’s May 2024 draft, further intensifies this concern and could lead to even more prescriptions being wrongly categorised as discountable combination therapies.
In addition, open issues concerning entitlements and obligations, invoicing, invoice verification by pharmaceutical companies, as well as due dates and payment terms have now been addressed in the implementation regulation. As the combination discount was already enacted on 15 October 2023, companies must now anticipate corresponding repayments due to the retroactive application of the discount for all medicinal products designated by the G-BA as potential combination partners in free combinations since that date.
The combination discount remains a complex and controversial instrument for stabilising the financial position of Germany’s statutory health insurance system. Now that it is being operationalised, it is essential to familiarise oneself with the regulation and its implications to fully understand the potential impact on innovative therapies. As specialists in market access, Kintiga is pleased to support its clients in navigating the strategic implications of the combination discount.
Sources:
Press release, vfa: Doppelrabatte mit der Brechstange eingeführt (vfa.de)
Festsetzung der Regelung des Näheren zur Umsetzung des Kombinationsabschlags durch das Bundesministerium für Gesundheit gemäß §130e Absatz 2 Satz 3 SGB V (GKV-SV/BMG)
Bundesverband der Pharmazeutischen Industrie (BPI)
