Ron Lanton Discusses U.S. MFN Pricing Agreements with APM Market Access

In a September 23 article for APM Market Access, reporter Jen Brogan spoke with Lanton Strategies International President Ron Lanton about the differing terms of the U.S. government's most-favored-nation (MFN) drug pricing agreements with Eli Lilly and Pfizer.

The discussion focused on the challenges of implementing MFN pricing when individual agreements apply different methodologies, exclusions and conditions. The treatment of high-spend GLP-1 medications is one example of how these differences can complicate the assessment of potential savings.

Lanton also discussed the implications for state governments, including provisions that may require states to waive certain pricing restrictions to participate in negotiated arrangements.

As the administration continues to pursue MFN pricing, understanding which drugs are covered, how prices are determined and what conditions apply will be important for manufacturers, payers and state Medicaid programs.

Read Jen Brogan's full article in APM Market Access: Differing U.S. MFN deals make 'one consistent pricing policy' difficult – lawyer.

U.S. Drug Pricing Policy Is Starting to Reshape Europe’s Launch Map

U.S. drug pricing policy is beginning to influence decisions that happen far beyond the United States.

A recent Pink Sheet report by Francesca Bruce examined how the U.S. Most Favored Nation drug pricing framework could change the way pharmaceutical companies think about European launch sequencing.

If prices in certain European markets can ultimately affect U.S. pricing, companies may have a stronger incentive to reconsider which countries they enter first.

That could make smaller European markets that historically have not been early launch priorities more attractive.

The strategy, however, is more complicated than simply avoiding countries included in U.S. reference baskets.

Central and Eastern European markets often look to pricing, reimbursement decisions, and health technology assessments from larger Western European countries. A company that delays entry into Germany, France, or other established markets may therefore find that it lacks some of the evidence or reimbursement precedent needed elsewhere.

European pharmaceutical reform could add another layer. Proposals intended to improve access to medicines across EU member states may also affect how much flexibility manufacturers have in sequencing launches across Europe.

The result is a much more interconnected launch environment.

Pharmaceutical companies increasingly need to consider U.S. pricing policy, European reimbursement systems, reference pricing, HTA requirements, and market-access obligations as parts of the same commercial strategy.

The question is becoming less about where a company can secure the strongest price first and more about how one launch decision may affect pricing, reimbursement, and access across multiple markets.

That is why MFN is becoming more than a U.S. drug-pricing policy.

It is becoming a global market-access and launch-strategy issue.

Francesca Bruce explores the broader implications of U.S. drug-pricing policy for Europe in Pink Sheet, including whether the USTR’s investigation into German pharmaceutical pricing is turning reimbursement policy into a trade issue. Read the full Pink Sheet article here.

Most-Favored-Nation Pricing Is Becoming a Global Management Problem

For pharmaceutical companies, the latest U.S. drug-pricing developments are getting harder to look at one at a time.

President Trump announced that all 50 states, Washington, D.C. and Puerto Rico intend to participate in the GENEROUS Medicaid model. The program is designed to give Medicaid access to net prices for certain medicines that are comparable to prices paid in selected foreign countries.

At the same time, newly released contract language involving Pfizer reportedly shows that the company agreed to share with the Department of Health and Human Services a portion of additional net revenue generated when prices for certain medicines increase outside the United States.

Those two developments matter together because they show how pricing decisions made in Europe and other markets can affect U.S. reimbursement and U.S. government agreements.

GENEROUS Brings International Pricing Into Medicaid

The immediate importance of GENEROUS is its reach. Every state has now expressed interest in participating in a model that uses international pricing as part of the way Medicaid rebates are calculated for participating medicines.

That does not mean every drug suddenly gets an international reference price. Manufacturers still have to participate, products will differ, and many of the details matter. But there is enough here for management teams to pay attention.

A price negotiated in Europe or another reference market may affect the economics of the same product in the United States. That makes it harder to treat global pricing as a collection of separate country-by-country decisions.

The Pfizer Agreement Adds Another Layer

The Pfizer disclosure makes the issue more interesting.

According to the reported contract language, Pfizer must share with HHS part of the additional revenue generated when prices for certain medicines rise outside the United States. The public version does not reveal the percentage, the covered medicines or several other important terms.

Even with those gaps, the structure is worth watching.

A higher price overseas could improve revenue in that market while also creating a separate financial obligation in the United States. That is different from a traditional reference-pricing model, where the main concern is how a foreign price may affect a U.S. benchmark.

Here, a commercial decision in one country may create an economic consequence somewhere else.

This Is a Management Issue

That is why this is becoming more than a pricing issue.

The practical management question is whether the company understands which decisions made outside the United States can affect its U.S. economics.

That requires market access, finance, legal, government affairs and commercial teams to work from the same picture. Each group may be making a reasonable decision on its own, but problems can arise when those decisions are made without understanding what they mean for another market.

A locally successful pricing decision can still create an unexpected consequence elsewhere.

What Management Should Be Looking At

Companies should start by mapping their major products against the pricing arrangements that could matter in the United States. Management should understand which international prices could affect GENEROUS or other U.S. pricing arrangements, which products are covered by company-specific agreements, and what happens when the price of a medicine changes in another market.

There should also be a clear process for bringing pricing, legal, finance, government affairs and commercial leadership together before a significant pricing decision is made.

The goal is not to predict every future policy change. It is to make sure a decision in one market does not create an expensive surprise in another.

The Bigger Picture

There is still a lot we do not know. Many of the pharmaceutical agreements being negotiated with the administration remain confidential, and some of the most important commercial terms have not been made public.

But companies already have enough information to see the broader issue.

International pricing is becoming more closely tied to U.S. reimbursement. GENEROUS does that through Medicaid rebates linked to prices in other countries. The Pfizer agreement reportedly adds another connection by tying increases in overseas revenue to payments back to HHS.

For executives, the question is becoming less about what price should be negotiated in a particular country and more about what that decision does to the economics of the product across markets.

That is the issue management teams should be thinking about now.

About Lanton Strategies International & Lanton, Lanton and Sosa Law, PLLC

Lanton Strategies International works with executives and organizations on policy, market access, government affairs and strategic issues affecting investment, commercialization and growth across the United States and Europe. We help leadership teams understand what policy developments mean for their business and determine practical next steps.

For legal and regulatory matters, Lanton, Lanton & Sosa Law PLLC advises companies on issues affecting healthcare, life sciences, technology, commercialization and business strategy.

This article is provided for informational and educational purposes only and should not be relied upon as legal, investment or other professional advice. Reading it does not create an attorney-client relationship.

When Drug Pricing Policy Starts to Shape Where Medicines Are Made

For years, European pharmaceutical companies have treated manufacturing location as an operational decision. That is changing.

Ipsen is reportedly considering a U.S. manufacturing site while continuing to expand production in the United Kingdom. The company has not made a final decision, but the question itself reflects a broader shift facing European drugmakers. The Wall Street Journal, September 11, 2026

A company deciding where to manufacture a medicine now has to consider more than labor, capacity and logistics. It must also think about tariffs, domestic-production incentives, political pressure, reimbursement rules and the order in which products should be launched in different markets.

A U.S. facility may help a company respond to trade demands or qualify for incentives. It may also bring higher construction and operating costs. Building in Europe may preserve existing expertise and infrastructure, while exposing the company to a different set of political and commercial risks.

The decision becomes even more complicated when a product is approaching launch. A company may have to determine whether the economics justify a new facility, a contract manufacturing arrangement, an acquisition or an expansion of an existing site. Each option affects capital allocation, regulatory planning and the timing of market entry.

This is not only a question for the largest pharmaceutical companies. Smaller biotechs and specialty manufacturers may face the same choice earlier in their development cycle because investors and strategic partners want to know where production will occur and how resilient the supply chain will be.

The larger point is that drug pricing policy is beginning to influence industrial policy. Decisions about reimbursement and market access can affect where companies build, where they hire and where they place their next dollar of investment.

For European life-sciences companies looking toward the United States, manufacturing strategy can no longer be separated from policy strategy.

AI + Healthcare, Part 2: What Happens When the Product Keeps Changing After Approval?

The harder regulatory question may begin after FDA clearance or approval.

A medical device, diagnostic tool or clinical software platform may reach the market based on one version of its technology. The company then uses AI to improve performance, identify new patterns, reduce false positives or expand the product’s usefulness.

That creates a new practical question for leadership: when is an update still part of the approved product, and when has the company created something that needs another regulatory review?

A conventional medical product usually stays recognizable after approval. Its manufacturer may improve the design, but providers, payers and regulators can still identify the product they evaluated and compare the changes against the earlier version.

AI-enabled software can change things more quietly. A new training set, algorithm or software release may alter the product’s recommendations without changing its outward appearance. The company’s process for managing those changes therefore should become part of its regulatory strategy.

For example, an update that fixes a technical problem may raise different questions from one that changes the product’s intended use, clinical claims, risk profile or method of operation. A diagnostic tool that becomes capable of identifying a different condition, guiding a new treatment decision or serving a broader patient population may require more than ordinary maintenance.

Executives should establish those boundaries before the product reaches the market. Waiting until an engineering team has completed a major update can leave the company trying to answer regulatory questions after the commercial decision has already been made.

Approval does not end the regulatory work

AI development often follows a continuous cycle. Teams release improvements in response to new data, customer feedback and performance testing. FDA review, however, is based on defined submissions and defined evidence.

A company needs a practical plan for what happens next. It should know which changes can be handled through an established change-control process, which require additional validation and which may require a new submission. It should also be able to show how the updated product performs across the populations and care settings where it will be used.

This does not require companies to abandon rapid development. It requires technical, clinical and regulatory teams to make decisions together before an update is released.

Payment and adoption create a second gate

FDA authorization allows a product to be marketed under the applicable rules. It does not guarantee coverage, payment or adoption.

An AI update may improve accuracy or expand the number of patients who can benefit. A payer may still ask whether the change improves outcomes, lowers total cost or simply produces a more sophisticated recommendation.

Hospitals may ask whether the update changes workflow, documentation, staffing or liability. Health plans may ask whether the revised product fits within an existing coverage category or requires new evidence.

A company that treats reimbursement as a post-approval issue may discover that its commercial plan has not kept pace with its regulatory progress.

Responsibility follows the update

Leadership also needs a clear answer to a basic question: who is responsible when the product changes?

That answer depends on how the company tests and validates each release, notifies providers and customers, maintains version records and manages human review. 

It also depends on cybersecurity, data governance and the contracts that allocate responsibility among the developer, provider and health system.

If the system produces a different result after receiving new data, the company should be able to explain what changed, why it changed and how the revised performance was evaluated. 

That is a business requirement as much as a legal one.

The investment question

Investors may see continuous AI improvement as a competitive advantage. They may also ask whether the company has the systems needed to manage continuing FDA, reimbursement, quality and liability obligations.

A company that can show disciplined product governance may be better positioned than one that treats every update as a software release with no regulatory consequences. The quality of that governance can affect launch timing, contracting, payer discussions and investor confidence.

The central issue is not whether AI should continue improving after approval. It should.

The issue is whether the company has built a process that allows improvement without losing track of authorization, evidence, payment and accountability.

FDA approval marks an important milestone. For an AI-enabled product, it may also mark the beginning of a more demanding operating phase.

The companies most likely to succeed will connect engineering, regulatory, clinical, reimbursement and legal decisions before an update reaches the market.

That is the real test for healthcare AI should not be simply whether the product can learn, but whether the company can govern what it learns.

This is the second article in a series examining artificial intelligence through healthcare, regulation, reimbursement, capital and the institutions that determine whether innovation reaches patients.

Lanton Strategies International advises healthcare and life-sciences companies on U.S. market entry, policy, reimbursement, regulatory strategy and commercial risk. Lanton, Lanton & Sosa Law PLLC provides legal counsel to regulated healthcare organizations, associations and businesses.

This article is provided for general educational and informational purposes only. It is not legal advice and does not create an attorney-client relationship. Readers should consult qualified counsel about their specific circumstances.