Act: Financial Stabilization of the SHI

In January 2023, the SHI Financial Stabilization Act (GKV-FinStG) came into force, which has brought and will bring far-reaching changes for the pharmaceutical industry as well as for Germany as a pharmaceutical site. The legal changes of particular relevance to pharmaceutical manufacturers, which are examined in this whitepaper from the perspective of the market access of new medicinal products in Germany, are

• the newly introduced guard rails with the associated reduced valuation of a non-quantifiable and minor additional benefit of a medicinal product in comparison to the appropriate comparative therapy,
• the shortening of the free pricing period to six months,
• the reduction of the revenue threshold for orphan drugs to 30 million euros,
• the contractually binding consideration of price-quantity agreements in the context of price negotiations,
• the newly introduced combination discount,
• the new discard regulation,
• the increase of the mandatory manufacturer's rebate to 12% as well as
• the extension of the price moratorium by four years.

SKC analyzes and summarizes the strategic implications after the first few months since the GKV-FinStG was passed and came into force, also based on an analysis of the first reactions of relevant decision-makers for pharmaceutical companies. Despite the now tightened framework conditions and increased financial burden for pharmaceutical companies, there is strategic potential for market entry and the further development of innovative medicinal products at long-term economic prices. Core strategic elements to meet the challenges posed by the GKV-FinStG are

• careful analyses of the potential risks and benefits of a possible benefit assessment according to § 35a SGB V, for example, after applying for exemption from the price moratorium or exceeding the revenue threshold for orphan drugs,
• close cross-divisional cooperation within the pharmaceutical company (especially between Market Access and Clinical Development) in the precise definition of the intended field of application and the choice of comparators in clinical trials,
• as well as thorough preparation of the market for new drugs.

In this way, the consequences of the GKV-FinStG for the business case can be anticipated and the best possible precautions can be taken to minimize risk. This whitepaper describes which precautions these can be and shows how the German health care market can remain attractive even under the currently valid legal regulations.