Why Most Favored Nation pricing is becoming a political imperative

President Trump’s July 31st letter regarding Most-Favored-Nation Prescription Drug Pricing (MFN) introduces several notable escalations and expansions:

1. Moved from intent to enforcement – Sets a 60-day deadline on manufacturers to confirm their approach, broadens reach, and sets public expectation for action.
2. Expansion of MFN is significant – no longer just about Part B – Outlines a significant expansion, beyond office or outpatient administered drugs, to include Medicaid and all new launches bringing in Part D, pharmacy-supplied medicines.
3. All launch prices are on the table – New launch Most Favored Nation drug pricing now covers Medicare, Medicaid, and commercial pricing.
4. Direct-to-consumer (DTC) to bypass the middleman – Delivering savings to the patient sounds good in theory, but the devil is in the details. How will DTC be covered, and how will it be set against max out-of-pocket limits?
5. Introduces potential pricing parity clauses or informal enforcement under trade and procurement tools but leaves room for policy negotiation.

Start the assessment →  MFN exposure assessment

What are your considerations?

Understand MFN’s broad and aggressive drug pricing scope: The 2025 MFN policy extends to Medicaid, new drugs, and commercial payers, forcing drug prices in the U.S. to match those in comparable developed countries. This could reduce revenue and disrupt existing pricing and U.S. rebate systems.

Global Strategy Adjustments:

• Pricing: Understand global launch pricing scenarios to maximise prices in ex-U.S. markets that would support pricing in the U.S. Develop scenarios in Europe, Canada, Japan, and other markets that may need upward pressure or confidential rebate arrangements to protect global revenues and U.S. market access.
• Launch sequencing: This may require prioritizing the U.S. or managing delayed launches in Organization for Economic Co-operation and Development (OECD) referenced countries.

Global and U.S. Strategy Adjustments

• Optimizing and investing in launch to drive momentum: Vital to overcome potential revenue losses in U.S. and potential launch delays in developed markets.

U.S. Strategy Adjustments

• Prepare for direct-to-consumer distribution channels: The MFN drug pricing policy supports DTC purchases at MFN prices, bypassing intermediaries. This may affect out-of-pocket costs and insurance interplay, and companies should anticipate compliance and operational complexities in multi-channel access strategies.
• Rebate and contract model overhaul: MFN may compress rebates traditionally negotiated with PBMs and commercial insurers. Brands should reevaluate rebate strategies as overall list prices are pressured downward and rebate structures face legal and compliance challenges. These changes may also inadvertently encourage more 340B participation due to the altered incentives.

How Can Acumetis Help?

This is a pivotal moment in your business and access planning. Conventional thinking may not suffice. Acumetis brings together deep industry expertise, stakeholder insights, and analytical tools to help organizations understand their options and navigate an evolving policy and access landscape.

Evidence generation and roadmap creation

The traditional U.S. pricing and access environment is evolving rapidly. As a result, establishing and communicating the value of your asset to maximize its commercial potential has never been more important. Acumetis combines expertise in health economics and outcomes research, market access, and stakeholder engagement with insights from payers, providers, and healthcare decision-makers to help manufacturers generate the evidence, value strategy, and roadmaps needed to succeed in a time of unprecedented change.

Direct-to-patient and innovative access models

As manufacturers explore new approaches to improving patient access and engagement, direct-to-patient and other innovative access models continue to gain momentum. Acumetis has helped organizations assess, design, and evaluate these models, providing strategic guidance on commercialization, patient experience, operational requirements, and long-term sustainability.