World ACCESS Consortium 白皮书：美国最惠国定价正重塑生物制药全球上市规划

Survey of 16 manufacturers points to changes in launch sequencing and pricing governance, rather than broad portfolio withdrawal

, /PRNewswire/ -- The World ACCESS Consortium (WAC), the expert and evaluative arm of the ACCESS Forum, has published The MFN Ripple Effect: An Evaluation of Biopharmaceutical Companies Navigating Most-Favored-Nation Pricing. The white paper examines how manufacturers are responding to the evolving U.S. Most-Favored-Nation (MFN) pricing environment.

The paper combines a confidential survey of 16 biopharmaceutical manufacturers, five executive interviews, and a review of the U.S. MFN policy landscape and international pricing literature. It was prepared by Ruslan Horblyuk, Martin Rost, Omar Dabbous and Eric Faulkner, with contributing members of the WAC Industry Panel and Executive Advisory Committee.

Key findings include:

• Launch sequencing: (81%) identified the EU5 as a potential non-launch risk for at least one pipeline asset, and (69%) as a delayed-launch risk.
• Governance: (69%) reported more centralized global pricing governance and tighter U.S.–global coordination, and (63%) reported expanded scenario modeling.
• Evidence and portfolio: (75%) reported a higher evidence bar, but only (38%) reported incremental HEOR or real-world evidence investment. The authors conclude that MFN's earliest effects are visible in how companies make decisions, rather than yet in where they launch. They describe the findings as directional and call for additional studies/efforts to monitor launch timing and geographic access alongside U.S. price outcomes.

"Uncertainty is often viewed as something that prevents organizations from making decisions. What we are seeing with MFN is almost the opposite: it is forcing companies to challenge long-established assumptions about launch strategy, pricing, and global market access," said Ruslan Horblyuk, lead author and Chief Strategic Consulting Officer, AESARA.

"MFN connects the U.S. price to decisions made around all aspects of global launch," said Eric Faulkner, Executive Director of the World ACCESS Consortium and Partner, Inizio Ignite Putnam. "Our findings show companies are not retreating but are rethinking approaches asset by asset. How actual pricing policy details and launch responses unfold will influence patient access to innovation and is a key global issue to watch."

"The impact will not be uniform," said Omar Dabbous, Chief Scientific Officer, ACCESS Forum. "Smaller and lower-price markets, and patients with rare diseases, may carry a disproportionate share of the risk if launch sequencing becomes more selective."

"This is exactly the kind of fast-moving policy question where our members benefit from shared evidence rather than anecdote," said Joe Boswell, President, ACCESS Forum. "The survey gives companies and policymakers a common baseline as MFN policy continues to evolve."

The full white paper is available at theaccessforum.org.

MFN's effect on launch sequencing and pricing will be a focus of ACCESS Forum US '27, February 16–18, 2027, at the Loews Coral Gables in Miami including a Pre-Forum Executive Course on February 16. Register with code MFN-US27-20.

About the World ACCESS Consortium
The World ACCESS Consortium (WAC) is the expert and evaluative arm of the ACCESS Forum. Drawing on a multi-disciplinary group of executives, WAC publishes independent white papers that bring evidence to the access questions shaping patient access worldwide.

About the ACCESS Forum
The ACCESS Forum's vision is to accelerate access to healthcare innovation for every patient, everywhere. It convenes the world's foremost market access leaders across industry, payers, providers and policymakers to generate the insights and best practices that drive faster, fairer access to the health solutions patients need.

Media contact: Vipan Sood • [email protected] • (888) 364-5690

SOURCE ACCESS Forum