Eligibility and Strategic Implications of Germany’s 2025 Confidential Pricing Reform
Author(s)
Joshua Smith, MMath, Max D. Gregory, MBiochem.
Wickenstones Ltd, Oxfordshire, United Kingdom.
Wickenstones Ltd, Oxfordshire, United Kingdom.
OBJECTIVES: This research aimed to estimate how many pharmaceutical companies qualify for confidential pricing in Germany under the new 2025 regulation and analyse their pipeline products. This supported a broader objective of exploring the strategic implications of confidential pricing for global pharmaceutical launch sequencing and international pricing strategies.
METHODS: Amendments to the German Social Code Book V in 2025 allow companies to opt for confidential net prices following AMNOG negotiations, if specific eligibility criteria are satisfied. A database of companies receiving Federal Joint Committee (G-BA) benefit assessments for new active substances between 2019 and June 2025 was created using data from the G-BA and Institute for Quality and Efficiency in Health Care (IQWiG). Each company was assessed for eligibility based on public sources and company disclosures. For companies fulfilling the criteria, pipeline data were extracted from company websites to identify phase II/III assets that may launch in Germany between 2025 and 2030.
RESULTS: To be eligible for confidential pricing, companies must (a) maintain a pharmaceutical R&D department in Germany, and (b) demonstrate active engagement in R&D through in-house programs and collaborations with public institutions. Companies must also accept a mandatory 9% rebate on the negotiated net price. Of 717 benefit assessments identified, 245 (34%) involved a new active substance across 13 G-BA disease areas, most frequently oncology (35%). These assessments involved 104 companies (1-14 assessments each) where <50% met both criteria, resulting in over 140 phase II/III pipeline products potentially eligible in the next five years.
CONCLUSIONS: Although uptake of confidential pricing is expected to be low due to eligibility constraints, confidential pricing could still reshape global pricing strategies, particularly for launches in countries that use German prices in international reference pricing (IRP). Companies may increasingly localise R&D and form public partnerships to preserve strategic flexibility.
METHODS: Amendments to the German Social Code Book V in 2025 allow companies to opt for confidential net prices following AMNOG negotiations, if specific eligibility criteria are satisfied. A database of companies receiving Federal Joint Committee (G-BA) benefit assessments for new active substances between 2019 and June 2025 was created using data from the G-BA and Institute for Quality and Efficiency in Health Care (IQWiG). Each company was assessed for eligibility based on public sources and company disclosures. For companies fulfilling the criteria, pipeline data were extracted from company websites to identify phase II/III assets that may launch in Germany between 2025 and 2030.
RESULTS: To be eligible for confidential pricing, companies must (a) maintain a pharmaceutical R&D department in Germany, and (b) demonstrate active engagement in R&D through in-house programs and collaborations with public institutions. Companies must also accept a mandatory 9% rebate on the negotiated net price. Of 717 benefit assessments identified, 245 (34%) involved a new active substance across 13 G-BA disease areas, most frequently oncology (35%). These assessments involved 104 companies (1-14 assessments each) where <50% met both criteria, resulting in over 140 phase II/III pipeline products potentially eligible in the next five years.
CONCLUSIONS: Although uptake of confidential pricing is expected to be low due to eligibility constraints, confidential pricing could still reshape global pricing strategies, particularly for launches in countries that use German prices in international reference pricing (IRP). Companies may increasingly localise R&D and form public partnerships to preserve strategic flexibility.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR68
Topic
Health Policy & Regulatory, Methodological & Statistical Research
Topic Subcategory
Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Infectious Disease (non-vaccine), No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Rare & Orphan Diseases