Presentation (CTI)

OBJECTIVES: Germany's statutory health insurance (SHI) faces a structural financing gap driven by expenditure growth consistently outpacing contribution income. Three converging pressures shape the current reform debate: fiscal consolidation within the SHI, political ambitions to strengthen Germany as a pharmaceutical investment location, and growing international pressure on German drug prices - most notably through most-favoured-nation pricing discussions originating in the United States. Within this tension, the proposed GKV-Beitragssatzstabilisierungsgesetz introduces selective contracting for patent-protected pharmaceuticals with therapeutically comparable alternatives - so-called focus lists - as a novel regulatory paradigm. This analysis evaluates its budget impact potential and feasibility under realistic assumptions, modelling both the five indication groups explicitly named in the legislative draft and selected additional therapy areas representative of potential future expansions.
METHODS: Scenario-based simulations were conducted for three indication areas characterised by multiple competing patent-protected products and the absence of meaningful generic or biosimilar competition: rheumatology, dermatology, and migraine. For each indication, one reference product was selected and modelled across varying discount rates (5% and 20%) and adoption rates (40% and 80%), using 2024 as the reference year.
RESULTS: Estimated budget impact ranges are: rheumatology EUR 62-230 million; dermatology EUR 37-202 million; migraine EUR 24-62 million.
CONCLUSIONS: Selective contracting demonstrates a plausible but modest budget impact potential. The wide scenario ranges reflect substantial regulatory and operational uncertainty - including unresolved implementation parameters and a statutory re-evaluation clause in 2030. Given the scale of Germany's SHI financing challenge, selective contracting may contribute at the margin, but cannot constitute a primary consolidation instrument. Its more significant implication may lie in its paradigmatic character: introducing market-based price competition into a segment of the pharmaceutical market structurally resistant to it.