From Evidence to Enforcement? Implications of the 2025 SVR Report for Pharmaceutical Pricing and Orphan Drug Policy in Germany
Author(s)
Stefan Walzer, MA, PhD1, Lutz Michael Vollmer, MSc1, Thomas Hammerschmidt, MSc, PhD2.
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2University of Applied Sciences Rosenheim, Rosenheim, Germany.
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2University of Applied Sciences Rosenheim, Rosenheim, Germany.
OBJECTIVES: The 2025 report by the German Council of Experts on Health (SVR) outlines sweeping reforms to the country’s pharmaceutical pricing system, including external interim pricing, changes to the orphan drug framework, and proposals to decouple industrial policy from pricing regulation. These recommendations aim to enhance the value orientation of the healthcare system but raise significant concerns for pharmaceutical innovation and market access.
METHODS: We conducted a critical policy analysis of the SVR report, focusing on chapters addressing AMNOG pricing, dynamic pricing adjustments, and orphan drug evaluation. This was triangulated with peer-reviewed literature on rare disease economics, international HTA practices, and policy documents including the German Medical Research Act. We also assessed the political feasibility of implementation within the 2025-2029 legislative period, considering party positions, institutional constraints, and industry influence.
RESULTS: The SVR recommends: (1) externally determined interim pricing based on the cost of the appropriate comparator therapy (zVT); (2) removal of the assumed added benefit for orphan drugs upon market entry; and (3) a rejection of price incentives tied to local clinical trials. These changes would significantly shift Germany’s pricing logic from negotiation-based to comparator-referenced. However, they may erode R&D incentives in rare diseases and conflict with ongoing efforts to enhance Germany’s role as a research hub. Politically, the fragmented political landscape and likely pushback from industry stakeholders make swift implementation uncertain.
CONCLUSIONS: While the SVR proposals seek to strengthen evidence-based pricing, their practical adoption during the 2025-2029 legislative term is far from guaranteed. Pharmaceutical manufacturers should prepare for regulatory volatility, advocate for workable orphan drug policies, and engage proactively to shape a pricing environment that balances sustainability with innovation.
METHODS: We conducted a critical policy analysis of the SVR report, focusing on chapters addressing AMNOG pricing, dynamic pricing adjustments, and orphan drug evaluation. This was triangulated with peer-reviewed literature on rare disease economics, international HTA practices, and policy documents including the German Medical Research Act. We also assessed the political feasibility of implementation within the 2025-2029 legislative period, considering party positions, institutional constraints, and industry influence.
RESULTS: The SVR recommends: (1) externally determined interim pricing based on the cost of the appropriate comparator therapy (zVT); (2) removal of the assumed added benefit for orphan drugs upon market entry; and (3) a rejection of price incentives tied to local clinical trials. These changes would significantly shift Germany’s pricing logic from negotiation-based to comparator-referenced. However, they may erode R&D incentives in rare diseases and conflict with ongoing efforts to enhance Germany’s role as a research hub. Politically, the fragmented political landscape and likely pushback from industry stakeholders make swift implementation uncertain.
CONCLUSIONS: While the SVR proposals seek to strengthen evidence-based pricing, their practical adoption during the 2025-2029 legislative term is far from guaranteed. Pharmaceutical manufacturers should prepare for regulatory volatility, advocate for workable orphan drug policies, and engage proactively to shape a pricing environment that balances sustainability with innovation.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR103
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas