Drug pricing will remain a policy priority across the U.S. political landscape in 2026. As the Trump Administration’s initiatives continue to evolve, drug pricing considerations will remain a focus of market access teams as well as the C-suite and foreign affiliates, with manufacturers of all sizes navigating a complex regulatory environment in 2026.

Throughout much of 2025, the Trump Administration's push to adopt "Most Favored Nation" (MFN) pricing – under which U.S. prices would be linked to those paid in other countries – generated headlines, but few details. Towards the end of 2025, however, the Administration announced three specific MFN regulatory actions:

• In November, the U.S. Centers for Medicare and Medicaid Services (CMS) released the Generating Cost Reductions for U.S. Medicaid Model (GENEROUS) Model from the Center for Medicare and Medicaid Innovation (CMMI), which is a voluntary model to extend MFN-based prices to Medicaid programs via manufacturer rebates, to be effective retroactively to 1 January 2026.
• In December, CMMI followed up by releasing two proposed rules to implement mandatory MFN models: the Medicare Part B Global Benchmark for Efficient Drug Pricing Model (GLOBE) Model, to be effective Q4 2026; and the Medicare Part D Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model, to be effective Q1 2027. If finalized, these models will test alternative methods for calculating manufacturer rebates under the Part B and Part D inflation rebate programs by tying pricing benchmarks for model drugs to international pricing information.

Assuming CMMI finalizes these models, drug and biologic manufacturers will face numerous challenges, including:

• Tracking pricing in the comparator countries,
• Reporting such pricing on a periodic basis where voluntarily agreeing to do so,
• Considering the Medicaid and Medicare impact of such pricing when assessing whether (and at what price) to sell products abroad,
• Building all of those considerations into gross-to-net calculations, and,
• Broader strategic considerations that are a necessary part of product development and commercialization decisions in a global marketplace.

While these MFN models may be one of the highest profile drug pricing issues facing manufacturers, there are plenty of others worth noting, including:

• The implementation of the first year of “maximum fair prices” (MFPs) under the Medicare Drug Price Negotiation Program alongside the expansion of that program to Part B (physician-administered) drugs.
• The ever-expanding 340B Program – which is now the second largest government drug pricing program in the U.S., second only to Medicare Part D – and its increasingly central role in manufacturer strategic decisions as to policy and commercial matters alike.

Both of these topics and their related pending legal challenges will continue to generate news and impact manufacturer strategies in 2026.