What is the market opportunity in the US as MFN approaches?

Pfizer’s MFN pricing announcement sheds light on administrative priorities relevant for companies planning product launches in the coming years. While the agreement is restricted to Pfizer products, the underlying principles and administrative shifts offer important lessons for all biotech firms considering entry into the US market. The preliminary understanding of the Pfizer agreement limits the direct effect to Medicaid (77-79 million patients) and cash customers using the government TrumpRx site; however, Medicaid already receives significant discounts, which may not be as significant if restricted to this population. However, effect on the 340b program remains unclear, given its pricing ties to Medicaid; the Pfizer deal is silent on that detail so far. As of mid-2025, Drug Channels Institute counted 32,069 unique locations acting as 340B contract pharmacies, “nearly 60% of all U.S. retail, mail, long-term care, and specialty pharmacy locations.”⁽¹⁾

MFN will apply to all new medicine developed by Pfizer, but details on extension beyond Medicaid, and how future country-based net pricing will be implemented, are not addressed specifically and still need to be clarified by the Administration.⁽²⁾ The broader implication for biotech companies is that future product launches in the US will likely require careful navigation of evolving MFN regulations and a readiness to adapt strategies as further guidance emerges. Pfizer products will benefit from a three-year tariff exemption linked to price concessions and by committing to future US investments in manufacturing, a model which may influence broader industry approaches.

Regardless of the ultimate rollout, planning for the effect of MFN will need to be understood and monitored. Let’s address some of these key considerations for launching new products in the US.

What is the order of indication sequence for new assets with multiple potential indications?

Traditionally, determining the order of indication sequence was a straightforward assessment, especially in the US. However, with the introduction of the MFN policy and the insights gained from the Pfizer announcement, new variables have emerged. The lead indication or total launch indications may now vary more significantly than in previous years. In the US, pricing is not typically indication-specific, as the reimbursement system is based on units administered. Variances are largely driven by changes in dosing. Additionally, price decreases commonly associated with indication expansion in ex-US territories are not the norm in the US. However, with MFN, downward pricing adjustments occurring outside the US may now have implications for the US market. Initial pricing may not prevent entry into a country, but future decisions like indication expansion and competitor dynamics now carry new significance.

Which countries do you intend to launch in for new entities?

In addition to the US, it's important to identify countries to launch that results in a more profitable opportunity. It will be vital to consider the per capita GDP of these countries compared to the US to understand the direct implications to the US market. If a country's per capita GDP is under 60% of that of the US, it may not directly impact the MFN analysis for the US. However, these countries could still influence the pricing policies of prioritized markets. Therefore, it's essential to map out all the countries where you plan to launch and the countries influencing them through an international reference pricing model (IRP) that enables you to evaluate and monitor activity.

Reference pricing has always involved a multi-territory price/volume analysis to determine the value of a market. Within a single country, the assessment needs to capture public and discounted prices within each market. In many countries, national, regional and local cost drivers can result in significant pricing variation with a county. The “net” pricing guidance in the original executive order was not clarified in the Pfizer announcement and remains an exposure. As the analysis widens to include multi-country influences, the weighting of this analysis is likely to change even more as guidance is provided by how or if the net prices may be normalized. The details of how the reference price will be defined will have a direct implication on which countries you choose to enter commercially. Now the US market may be affected by entry into a country, even one that does not directly qualify under the US MFN policy if it materially influences a country that does qualify, so the model needs be able to incorporate both direct and indirect referencing sensitivities to be a useful tool.

While the two points above are the most discussed elements, there are several other issues that should be considered in the analysis of where and how to commercialize a product in the US. Some the common questions often asked as part of market access include:

• Have you licensed or sold the asset to other partners for non-prioritized countries that may compromise your ability to price your product in the US?
• Do you have new obligations to sell directly to patients in the US?
• How will distribution decisions and patient services programs affect prescription pull-through in the US because of pricing pressure?
• How might commercial payers react to the MFN, IRA and other key programs that affect coverage?

The analysis goes beyond modeling alone; it is a strategic framework supported by multi-dimensional decision-making and global pricing and access expertise. This framework, coupled with advanced analytics, is essential for making informed decisions and answering the key investor question: “What is the value of the US market?”

Assessing the US market's value requires considering strategic, pricing, reimbursement, and access factors. Addressing these, especially amid the Pfizer MFN announcement and similar upcoming changes will help companies manage MFN policy complexities and optimise decisions. Pharmaceuticals remain highly cost-effective, and companies should aim to benefit patients worldwide. Maintaining global access depends on safeguarding major markets. There are solutions to achieve this while capturing product value.

I will be attending Bio Europe from November 3rd to 5th, along with my associate Jasim Uddin, Global Market Access Lead. If you have any questions about the US or other markets or indeed broad questions around how we can provide strategic support to inform investment, out-licensing or in-licensing decisions, we would be delighted to arrange a meeting through the partnering event or simply catch up over a quick coffee.

1. Drug Channels: The 340B Contract Pharmacy Market in 2025: Big Chains and PBMs Tighten Their Grip
2. Fact Sheet: President Donald J. Trump Announces First Deal to Bring Most-Favored-Nation Pricing to American Patients – The White House