Combination discount - a bureaucratic monster

After a delay of almost two years after the "Act for the Financial Stabilization of the Statutory Health Insurance - Strategic implications for market access in Germany (GKV-FinStG)" came into force (November 2022), the regulation for the implementation of the 20%-discount on combinations without at least a considerable additional benefit for at least one indication or patient group was adopted. Previously, despite intensive negotiations, the GKV-SV and the representatives of the pharmaceutical industry at federal level were unable to agree on the implementation of the combination discount. The BMG has therefore defined the content for the practical implementation of this regulation, which will come into force on October 10, 2024 and could have drastic effects on the reimbursement of combinations of innovative medicinal products.

The decisive prerequisite for the application of the combination discount in accordance with Section 130e (1) sentence 1 SGB V is the designation of a medicinal product with a new active ingredient as a possible combination partner in a free combination by the G-BA in accordance with Section 35a (3) sentence 4 SGB V. The designation takes effect for both the combination partner assessed by the G-BA and the designated combination partners from the first day after designation.

For the combination discount to be applied, the named combination partners must have been prescribed as a combination therapy in practice in addition to being named by the G-BA. The determination and delimitation of a combination use subject to discount from the billing data of the health insurance funds was the most controversial point of a possible practical implementation between the GKV-SV and the pharmaceutical associations. According to the BMG's substitute measure, it is now clear that a combination use subject to deduction exists if the combination drugs were prescribed for the same insured person on the same day or at least twice within the same rolling five-month period. This is an irrebuttable presumption, that potentially many sales not subject to a discount under the law, i.e. therapies not prescribed as a combination in practice, are nevertheless classified as combination use and are therefore subject to a discount. This aspect has already been strongly criticized by the pharmaceutical industry and could result in lawsuits against the regulation on the combination discount. The extension of the observation period from three to five months, in contrast to the BMG's draft from May of this year, further exacerbates this aspect and could lead to even more prescriptions being wrongly classified as combination prescriptions subject to discount.

Furthermore, open topics regarding entitlements and obligations, invoicing, invoice verification by the pharmaceutical company as well as due dates and payment deadlines were determined as part of the implementation regulation. As the combination discount already came into force on October 15, 2023, companies must now expect corresponding repayments due to the retroactive application of the combination discount for all medicinal products that have been named by the G-BA as possible combination partners of free combinations since this date.

The combination discount is a complicated and still controversial instrument for stabilizing the financial situation of statutory health insurance in Germany, which is now being put into practice. Accordingly, it is important to familiarize oneself with the regulations and their implementation to understand the potential impact on innovative medicines. As market access special forces, SKC is happy to advise its clients on 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)