A paper by the World ACCESS Consortium (WAC), the research arm of ACCESS Forum, found biopharmaceutical companies assessing possible delayed or forgone European launches amid U.S. most-favored-nation (MFN) pricing policy. The findings are based on a confidential survey of 16 manufacturer respondents.
Of those respondents, 81.3% identified the EU5 as a potential non-launch market for at least one pipeline medicine, while 68.8% saw a risk of a delay of at least 12 months. No respondent named the United States as a possible non-launch or delayed-launch market. Interviews portrayed the United States as companies’ primary launch market.
Among 15 respondents asked about the next three years, 60% chose a reshuffling of launch order among markets as the most consequential effect. The paper says no one selected large-scale geographic pruning as the leading outcome.
Companies also reported changes to pricing decisions. Two separate findings each stood at 68.8%: more centralized global pricing governance and tighter coordination between U.S. and global teams. Another 62.5% reported expanded scenario modeling or stress testing. A higher evidence bar at launch was reported by 75%, while 37.5% said they had made additional investments in health economics and outcomes research or real-world evidence.
The confidential, nonrandom survey ran from June 14 to July 16, 2026, alongside five executive interviews. The paper, dated Oct. 9, says its findings are directional and do not represent an industrywide estimate. It could not establish whether interviewees also took the survey or isolate MFN as the cause of companies’ responses; other policy and market factors may play a role. ACCESS Forum announced the paper Oct. 28.
WAC says MFN can bring international prices more directly into U.S. commercial calculations, giving companies a reason to reconsider launch timing and locations. Executive Order 14297, signed May 12, 2025, directed the U.S. Department of Health and Human Services to communicate MFN price targets to drugmakers and propose a rulemaking plan if significant progress is not made. The Centers for Medicare & Medicaid Services’ voluntary five-year GENEROUS Medicaid model began in January 2026. International benchmarks inform supplemental rebates intended to align participating states’ Medicaid net prices for included drugs with prices in certain other countries. CMS says the model aims to reduce Medicaid drug spending.
WAC’s review of external reference pricing found mixed evidence about effects on launch timing and medicine availability. Omar Dabbous, ACCESS Forum’s chief scientific officer, said, “The impact will not be uniform.” Dabbous said more selective country sequencing could disproportionately affect smaller or lower-priced markets and people with rare diseases. The paper urges policymakers to compare U.S. pricing outcomes with evidence on when medicines launch and how widely they become available.
The paper identifies no upcoming policy decision date. ACCESS Forum’s next listed event focused on MFN launch and pricing effects is scheduled for Feb. 16-18, 2027.
