How most favored nation policy is reshaping pharmaceutical pricing and market access

In July 2025, MFN policy moved from conceptual pilot to active enforcement, with formal compliance letters issued to pharmaceutical manufacturers and subsequent implementation steps reshaping pricing and access considerations into 2026.

MFN pricing links U.S. drug prices to international benchmarks, fundamentally changing how global pricing, launch planning, and market access decisions must be approached. While the policy has been discussed for several years, recent enforcement activity has elevated MFN from theoretical risk to an operational pricing reality.

For pharmaceutical leaders, the core challenge is not understanding the existence of MFN, but understanding where and how exposure materializes across assets and markets, and how pricing, access, and value decisions must now be made under tighter global constraints.

This white paper examines how most‑favored nation policy affects pharmaceutical pricing and market access decisions across assets, markets, and launch strategies.

What changed after enforcement began in July 2025?

In July 2025, federal agencies issued compliance letters to a group of pharmaceutical manufacturers requiring action within defined timelines, signaling a shift from policy intent to enforceable expectations. These actions were followed by additional steps later in 2025, including voluntary manufacturer agreements, expanded expectations for new product launches, and the introduction of structured CMS payment models affecting Medicare and Medicaid programs.

Pricing and market access implications

MFN introduces sustained downward pressure on U.S. list prices by tying them directly to prices in select high‑income countries. Because launch prices are now subject to immediate international benchmarking, decisions made in ex‑U.S. markets can carry direct consequences for U.S. pricing and access outcomes.

This dynamic alters traditional pricing corridors, heightens payer scrutiny, and places increased importance on cross‑market price consistency. For many products, especially high‑cost specialty therapies, these effects extend beyond pricing into access timing, reimbursement conditions, and real‑world uptake.

The role of evidence, value, and scenario planning

As pricing flexibility compresses, evidence and value positioning play a more central role in sustaining access across markets. Robust economic models and outcomes data are increasingly required to support pricing rationale under MFN constraints.

Scenario‑based planning is critical in this environment. The white paper examines how different launch sequencing and pricing strategies produce materially different long‑term outcomes, demonstrating that when and where products launch can influence global value capture under MFN pricing frameworks.

Download this policy brief to understand how the most‑favored nation policy is reshaping pharmaceutical pricing and access strategy, and how recent developments translate into real‑world decision considerations. Reframe what’s possible in pricing and access decision‑making.

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Meet the Experts:

Nic Gwatkin
Nic Gwatkin
Partner, Global Value and Access

Nic is a senior global and regional leader with a proven track record in developing innovative strategies and executing them effectively. With extensive experience in both large-scale and mid-sized pharmaceutical companies, as well as a background in market access and operational expertise spanning the EU, US, Japan, and China, Nic brings a wealth of knowledge to the table. Beyond his corporate roles, Nic has successfully established three consulting firms specializing in market access and early commercialization. His expertise lies in guiding pharmaceutical development from phase 2 onwards, with a remarkable portfolio boasting the launch of 14 market-leading medicines across various therapeutic areas such as Cardiovascular, Hematology, Ophthalmology, CNS, CG&T, and Infectious Diseases.

Esther Nzenza
Senior Partner, Global Value and Access Practice Lead

Esther founded Decisive Consulting in 2020 following 23 years’ experience in the pharmaceutical and biotechnology industry at national, regional and international levels. Over her career, Esther has built and led Market Access and HEOR organizations and additionally has led all commercial functions across international markets. She is best known for her ability to solve complex problems, from optimizing organizational ways of working to addressing specific external challenges and finding the hidden opportunity. Recently recognized as “One to Watch” in the 2024 Times and LDC Top 50 Most Ambitious Business Leaders awards Esther is passionate about diversity and inclusion and champions “rebel thinking” to uncover new possibility.

Karl Freemyer
Karl Freemyer
Head of Business Development

Karl leads strategy and implementation, helping pharma and biotech clients address evolving market access challenges. With over 15 years of experience, he brings deep expertise in business development and operations in HEOR and market access consulting, commercial experience at multinational pharmaceutical and laboratory diagnostics companies, and market research expertise in nutrition, functional foods, and beverages. His expertise includes diabetes, renal disease, hyperlipidemia, beta thalassaemia, essential tremor, asthma, COPD, and multiple myeloma, with publications in real-world evidence and access strategy.