Policy is the New Payer: Why Access Strategy Must Now Navigate HHS, MFN, and Tariffs Together
If your brand forecast still begins with “payer landscape”
and ends with “Medicaid exposure,” you’re already behind.
In today’s environment, CMS price negotiations, MFN pricing proposals, and pharmaceutical tariffs are no longer siloed issues. This article explores how manufacturers must evolve market access planning to account for these intersecting forces—before they reshape global launch strategy.
In the June 2025 Navigating Market Access with Magnolia webinar, experts from across the market access ecosystem came together to examine the forces reshaping how manufacturers plan for pricing, reimbursement, and access. The panel included:
Together, they explored how CMS forced price negotiations, proposed Most Favored Nation (MFN) policies, and potential pharmaceutical tariffs are no longer unrelated considerations—they are intersecting realities that must be addressed in an integrated way.
CMS Price Negotiation Is Already Reshaping the Landscape
Through the Inflation Reduction Act, CMS has begun negotiating Medicare drug prices—resulting in an average discount of 63 percent off wholesale acquisition cost (WAC) for selected therapies.
These are not isolated one-year pricing events—they are structural precedents. Launch planning, forecast modeling, and payer communications must now be built with negotiated pricing as a foundational consideration.
“There will be an ever-increasing number of Medicare beneficiaries who have access to discounted drugs,” said Tracy Baroni Allmon. “And obviously, a growing number of drugs that will have MFPs. Every brand needs to understand what that means for future sales and marketing.”
MFN Pricing Could Trigger Global Launch Disruption
The MFN pricing proposal would tie U.S. drug prices to the lowest price in OECD countries with a per capita GDP at least 60 percent of the U.S.—including markets such as Germany, Canada, and Switzerland. The policy’s sole focus on cost control introduces complex risks, particularly because these countries rely heavily on laws governing pharmaceutical pricing and spending, with governments being deeply involved in the pharmaceutical marketplace.
Global launch sequence, pricing corridors, and payer engagement strategies will all need to evolve if MFN policies advance.
“The U.S. has traditionally relied on a free-market economy to foster and reward innovation. Imposing international prices that are the result of government price controls would threaten the U.S. pharmaceutical market and the innovation it has generated. And while many details of the MFN policy remain nebulous, there are steps manufacturers can take now to prepare,” explained Chris Schott.
Tariffs: The Underrated Access and Cost Risk
While CMS and MFN reforms are more familiar to access teams, tariffs are fast becoming a real and under-modeled threat.
A Section 232 investigation is underway to determine whether pharmaceutical imports pose a national security risk—potentially justifying the imposition of tariffs on active pharmaceutical ingredients (APIs) and even finished products. This matters because over 50 percent of U.S. prescription drug APIs are sourced from India and the European Union, while fewer than five percent are produced domestically.
“We’re seeing companies shift significant quantities of finished product into U.S. warehouses,” said David Murphy. “It’s a hedge—but it reflects real concern.”
Tariffs would not only increase the cost of goods—they could affect rebate contracting, product availability, and overall supply chain resilience, with downstream consequences for access. There is also a real possibility of sales to other countries being taxed in response to a U.S. tariff on pharmaceuticals.
What Forward-Looking Manufacturers Are Doing Now
Manufacturers that are best positioned for this convergence aren’t responding with isolated adjustments—they are scenario-planning across the board. That includes:
This is not about being reactive. It’s about embedding structural readiness into the way market access strategies are developed, validated, and operationalized.
“We’ve never had a client ask about tariffs before this year,” Amanda Forys noted. “But now? It’s becoming a regular conversation.”
Magnolia Market Access’s Perspective
At Magnolia Market Access, we help clients connect pricing policy, trade risk, and payer strategy through practical, cross-functional planning. That includes:
In an environment where policy shapes pricing and trade shapes availability, resilience isn’t just operational—it’s strategic. And the manufacturers who plan with foresight will have a clear advantage in 2026 and beyond.
Want to scenario plan for your brand portfolio or pipeline strategy? Connect with Magnolia Market Access.