当地药品价格现在与全球息息相关

How MFN schemes are reshapingEuropean drug launch and pricingstrategies AUTHORS FILIP CONICPartner MORRIS HOSSEINISenior Partner The United States is tying drug prices to international benchmarksfor the first time. Three new Most Favored Nation-style programsmandate that European prices should now feed back into US drugeconomics. For pharmaceutical companies launching products inEurope, this fundamentally raises the stakes of local pricingdecisions. MATTHIAS BÜNTESenior Partner MELISSA COYLESenior Consultant International reference pricing comes to the US In response to US drug prices that remain substantially above international levelseven after rebates, and building on the Inflation Reduction Act (IRA) drug-pricenegotiation program, the current US administration has introduced three programsthat, for the first time, bring international reference pricing into the US publichealthcare system. The underlying premise of Most Favored Nation (MFN) pricing is simple: if amanufacturer sells a drug for less abroad, the United States – which is typically themain customer - should not pay more. Under these new models, manufacturers facerebate obligations when US prices exceed benchmarks derived from prices in up to19 OECD reference countries, including all major European markets.1 Three models, one clear message The three models cover the main pillars of US public drug spending. The GlobalBenchmark for Efficient Drug Pricing Model(GLOBE)applies to physician-administered drugs under Medicare Part B, targeting sole-source drugs andbiologics in seven therapeutic categories with annual spending above aroundUSD100 million per drug. Guarding U.S. Medicare Against Rising Drug Costs(GUARD)mirrors this structure for pharmacy-dispensed drugs under Medicare Part D,covering 17 therapeutic categories with annual spending above around USD 70million per drug. Both are mandatory and would each initially apply to approximately25 % of Medicare beneficiaries, selected through geographic randomization. GLOBEis proposed to begin in October 2026, GUARD in January 2027. Both remain proposedrules; the public comment period closed in February 2026 and final rules have not yetbeen published. Both models extend the drug pricing framework introduced by theIRA in 2022, which followed a similar sequencing: its inflation rebate and pricenegotiation provisions began with Medicare Part D before being extended to Part B. GENErating cost Reductions fOr U.S. Medicaid(GENEROUS)covers Medicaid. Unlikethe Medicare models, participation is voluntary for both manufacturers and states. Itis also the only model already in effect, with its performance period having begun inJanuary 2026. As of early 2026, 33 state Medicaid agencies have signed participationagreements. 1The Medicaid model, calledGENEROUS, references Canada,Denmark, France, Germany, Italy, Japan,Switzerland and the United Kingdom.The two Medicare models, GLOBE andGUARD, additionally include Australia,Austria, Belgium, the Czech Republic,Ireland, Israel, the Netherlands, Norway,South Korea, Spain and Sweden. The calculation logic is simple: international prices set the benchmark, US prices arecompared against it and manufacturers owe rebates if the gap is too large. GLOBEand GUARD reference 19 OECD countries, 14 of them in Europe. In practice, a lowprice in one reference market can influence what manufacturers owe in the UnitedStates. GENEROUS uses a smaller basket of eight countries and benchmarks againstthe second-lowest manufacturer-reported net price. The gap is large. Centers for Medicare & Medicaid Services (CMS) estimates suggestthat international benchmarks were on average 71 % below 2024 US average salesprices for GLOBE drugs and around 49 % below estimated Medicare Part D net pricesfor GUARD. The gap varies by therapeutic area, but selected fields such ascardiovascular disease and oncology appear to carry a particularly large USpremium over non-US peers. "Pharma needs to fundamentallyrethink its approach to pricing andaccess in Europe. Under internationalreference pricing, a local price canquickly contaminate pricingachievement in the US." FILIP CONICPartnerAustria Some design questions remain open, including how international drug equivalentswill be matched to US products. Stakeholders have also questioned whether CMShas the legal authority to implement mandatory models of this scope. Direct-to-consumer (DTC) models are emerging in parallel as another way to limit MFNexposure. Europe is now part of the US pricing equation While all three models draw their benchmarks from baskets dominated by Europe,the underlying mechanism differs in an important way. Under GLOBE and GUARD'sdefault calculation, CMS selects the lowest adjusted country-level price as thebenchmark. A single low-priced European market can therefore shape what amanufacturer owes in the United States, and once set, this benchmark is locked forthe full five-year model period. GENEROUS, by contrast, uses the