Most-Favored-Nation Pricing Expands, Reshaping Global Access and Market Dynamics
The ISPOR Policy Brief offers concise insights into emerging developments in the global health policy space that shape access, innovation, and affordability. Each monthly installment spotlights timely issues with relevance for the health economics and outcomes research (HEOR) community and beyond, which provides readers with a rapid overview of how policy shifts are influencing global markets and stakeholders.
Ana Amaris, MD, MPH, Director, Health Policy Initiatives, ISPOR, Lawrenceville, NJ, USA
Overview: This May issue examines the continued expansion of Most-Favored-Nation (MFN) drug pricing arrangements in the United States and their broader implications for pricing, market behavior, and global policy dynamics. As agreements with pharmaceutical manufacturers grow in scale and scope, MFN is increasingly shaping how companies approach pricing, access, and investment decisions.
US Updates & Perspectives
MFN Agreements Expand, Reshaping Pricing Dynamics
Additional agreements between the administration and pharmaceutical manufacturers have been signed in the United States. A recent agreement with Regeneron marks the latest development, with 17 companies—representing a substantial share of the branded drug market—now participating. These agreements include commitments to align prices with those in other high-income countries, expand access through public programs, and invest in domestic manufacturing and research. While the long-term implications remain uncertain, the growing scale of these arrangements suggests that MFN is increasingly influencing pricing strategies and market behavior. Questions also remain regarding the transparency of these agreements and the extent to which they will translate into sustained reductions in overall drug spending.
CMS Proposes Reforms to Accelerate Access and Increase Transparency
The Centers for Medicare & Medicaid Services (CMS) has proposed reforms aimed at accelerating patient access to therapies and increasing transparency in drug coverage decisions. The proposed rule would require faster prior authorization timelines, expand the use of electronic authorization processes for prescription drugs, and introduce new reporting requirements for approval rates and decision timelines. Public comments are due by June 15. While still under consideration, the proposal reflects broader efforts to streamline administrative processes and improve the predictability of access to treatments.
International Updates
Concerns Emerge Over Access to New Medicines in MFN-Referenced Countries
Early signals from Europe suggest that MFN pricing policies may already be influencing market behavior. In Sweden, a recent industry survey indicates that a significant proportion of pharmaceutical companies may delay or avoid launching new medicines in response to evolving global pricing dynamics. Concerns also extend to potential reductions in clinical trial activity and broader investment decisions. While the long-term effects remain uncertain, these findings highlight the potential for MFN-linked policies to affect access to new treatments in countries referenced in international pricing frameworks.
Pricing Pressures Raise Questions About Europe’s Competitiveness
Additional signals from industry point to growing concerns about the impact of pricing policies on Europe’s competitiveness. Recent commentary from AstraZeneca suggests that cost-containment measures under consideration in Germany could affect the launch of new medicines, reflecting broader uncertainty about the region’s attractiveness for pharmaceutical investment. These dynamics may reinforce ongoing shifts in research, development, and manufacturing activity toward other markets, including the United States and China. Similar signals are emerging across the pharmaceuticals industry, with companies like Roche highlighting growing uncertainty around how evolving pricing dynamics may affect future launches and innovation across European markets.
What to Watch
As US pricing policies continue to expand and interact with broader reforms, several signals may shape how stakeholders respond across markets:
Increasing global interdependence in pricing and access decisions: As US pricing policies reference international markets, actions taken in one country may have cascading effects on launch strategies, pricing negotiations, and access conditions in others.
Growing alignment between pricing policy, access mechanisms, and industrial strategy: Efforts to control costs are increasingly accompanied by reforms aimed at accelerating access and strengthening domestic investment, suggesting a more integrated approach to managing affordability and innovation.
Rising uncertainty around real-world impact and implementation: While early signals point to potential effects on access, investment, and competitiveness, questions remain regarding how these policies will translate into sustained changes in pricing, availability, and health system outcomes.
As these dynamics evolve, they are likely to shape ongoing policy discussions around pricing, access, and value, including global forums such as ISPOR 2026, where stakeholders are increasingly focused on the role of evidence in navigating complex trade-offs across health systems.