SPILLOVER EFFECTS OF US MFN POLICY ON EUROPEAN DRUG ACCESS
Author(s)
Cecile Remuzat, PharmD, MSc1, Agata Famulska, MPH, MSc2, Clement Francois, MSc, PhD1, Eric Faulkner, MPH3.
1Putnam, Paris, France, 2Putnam, Krakow, Poland, 3Putnam, Durham, NC, USA.
1Putnam, Paris, France, 2Putnam, Krakow, Poland, 3Putnam, Durham, NC, USA.
OBJECTIVES: The US revived external reference pricing (ERP) through the May 2025 “most favored nation” (MFN) model. This study examines its implications for pharmaceutical pricing and market access in Europe.
METHODS: A targeted literature review examined MFN-related policy analyses, stakeholder communications, and recent European pricing policy developments (since May 2025), alongside evidence from Europe’s experience with ERP.
RESULTS: The US MFN policy links US branded drug prices to those in developed countries with GDP per capita at least 60% of the US level. Because the US is typically the earliest and highest-priced launch market, this amplifies the global consequences of European launch and pricing decisions. Experience with European ERP suggests MFN may similarly incentivize delayed or foregone launches in low-price markets and increased reliance on confidential discounts. Recent European policy developments reflect these pressures. In France, the Pricing Committee President emphasized protecting net prices while preserving list prices flexibility, signalling adaptation to MFN pressures. In parallel, French debates on the 2026 Social Security Financing Act raised proposals to increase drug pricing transparency; although ultimately rejected, it echoed similar debates in Spain. Germany had already introduced confidential AMNOG prices under defined conditions (2024). In the UK, higher NICE cost-effectiveness thresholds and reduced VPAG rebate pressure aim to support net price sustainability.
CONCLUSIONS: Although a US policy, MFN is likely to generate global spillovers that risk widening access gaps across Europe, potentially undermining EU efforts to accelerate access to innovation. Referencing net prices would threaten Europe’s confidential discount model, while referencing list prices could still drive more selective launch sequencing based on US-European price differentials. Combined with the EU launch obligation, MFN may intensify tensions between pricing sustainability and access, particularly in lower-price markets. Changes in Germany and UK policies mean they remain early-launch markets.
METHODS: A targeted literature review examined MFN-related policy analyses, stakeholder communications, and recent European pricing policy developments (since May 2025), alongside evidence from Europe’s experience with ERP.
RESULTS: The US MFN policy links US branded drug prices to those in developed countries with GDP per capita at least 60% of the US level. Because the US is typically the earliest and highest-priced launch market, this amplifies the global consequences of European launch and pricing decisions. Experience with European ERP suggests MFN may similarly incentivize delayed or foregone launches in low-price markets and increased reliance on confidential discounts. Recent European policy developments reflect these pressures. In France, the Pricing Committee President emphasized protecting net prices while preserving list prices flexibility, signalling adaptation to MFN pressures. In parallel, French debates on the 2026 Social Security Financing Act raised proposals to increase drug pricing transparency; although ultimately rejected, it echoed similar debates in Spain. Germany had already introduced confidential AMNOG prices under defined conditions (2024). In the UK, higher NICE cost-effectiveness thresholds and reduced VPAG rebate pressure aim to support net price sustainability.
CONCLUSIONS: Although a US policy, MFN is likely to generate global spillovers that risk widening access gaps across Europe, potentially undermining EU efforts to accelerate access to innovation. Referencing net prices would threaten Europe’s confidential discount model, while referencing list prices could still drive more selective launch sequencing based on US-European price differentials. Combined with the EU launch obligation, MFN may intensify tensions between pricing sustainability and access, particularly in lower-price markets. Changes in Germany and UK policies mean they remain early-launch markets.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR92
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas