MFN pricing reshapes biopharma launch strategies

TAMPA, Fla. — U.S. most-favored-nation drug pricing policy is beginning to reshape how biopharmaceutical companies approach global launches, prompting manufacturers to reconsider launch sequencing, pricing governance and evidence requirements, according to a new World ACCESS Consortium white paper.

The report, “The MFN Ripple Effect: An Evaluation of Biopharmaceutical Companies Navigating Most-Favored-Nation Pricing,” draws on a confidential survey of 16 biopharmaceutical manufacturers, five executive interviews and a review of the U.S. policy landscape and international pricing literature.

The findings suggest that manufacturers are adjusting decision-making rather than broadly withdrawing products from international markets. Among respondents, 81% identified the EU5 as a potential non-launch risk for at least one pipeline asset, and 69% saw a risk of delayed launches.

The survey also found that 69% have centralized global pricing governance and tightened U.S.-global coordination, while 63% have expanded scenario modeling. Three-quarters reported a higher bar for evidence, though only 38% increased investment in health economics and outcomes research or real-world evidence.

The authors said the earliest effects of MFN pricing are showing up in how companies evaluate individual assets and markets, not in widespread changes to where medicines launch.

“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 at Inizio Ignite Putnam. “Our findings show companies are not retreating but are rethinking approaches asset by asset.”

Omar Dabbous, chief scientific officer of ACCESS Forum, cautioned that the effects may vary across markets and patient populations.

“Smaller and lower-price markets, and patients with rare diseases, may carry a disproportionate share of the risk if launch sequencing becomes more selective,” Dabbous said.

The authors characterized the findings as directional and called for additional research that tracks launch timing and geographic access alongside U.S. drug-price outcomes as the policy environment evolves.

The full white paper is available at theaccessforum.org.