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From Operational Access to Strategic Advantage: How MFN Pricing is Reshaping Managed Access Programs

Dr Romina Oxborough
Dr Romina Oxborough

One of the most significant consequences of the Trump administration’s Most-Favored Nation policy is the growing recognition that patient access programs play a strategic role within the broader pharmaceutical access ecosystem. Every decision regarding access now has greater potential implications for pricing strategy, launch sequencing, reimbursement negotiations and international reference pricing exposure.

A delayed commercial launch may increase demand for managed access. A managed access program may generate real-world evidence that supports reimbursement. A reimbursement decision in one market may influence pricing negotiations elsewhere. These activities are becoming increasingly interconnected, creating opportunities for more integrated and effective access strategies.

As a result, pharmaceutical companies have an opportunity to rethink the role of Managed Access Programs. Rather than serving purely as a mechanism for supplying treatment prior to commercial availability, MAPs are becoming an integral component of broader global access strategies.

This evolution creates an opportunity for organisations to align multiple priorities more effectively:

  • ensuring patients receive timely access to treatment;
  • protecting pricing and reimbursement strategies;
  • maintaining regulatory and compliance standards;
  • generating meaningful real-world evidence; and
  • supporting long-term commercial objectives.

Successfully leveraging these competing demands requires more than operational execution. It requires a strategic approach to access planning that considers the entire product lifecycle and the interdependencies between patient access, pricing and market access. This is where specialist managed access expertise has become vital.

At Maprium, we are seeing growing recognition that access programs should not be designed in isolation from broader commercial and market access considerations. As global pricing pressures intensify and launch strategies become more complex, organisations benefit from partners who understand not only how to deliver access programs efficiently, but also how to align them with evolving global access objectives.

Looking Ahead

One year after the introduction of MFN pricing, its most significant impact may not be on drug prices themselves but on how patients access medicines.

If international reference pricing starts to influence launch sequencing and commercial decision-making, demand for Managed Access Programs is likely to increase. At the same time, manufacturers will face growing pressure to ensure those programs align with broader commercial and pricing objectives.

For pharmaceutical companies, this creates both a challenge and an opportunity.

The challenge is maintaining patient access while navigating increasing pricing scrutiny and commercial complexity.

The opportunity is to use Managed Access Programs more strategically—to support patients, generate evidence, inform market access planning and bridge access gaps created by evolving pricing environments. The organisations best positioned for this future will be those that recognise patient access, market access and pricing strategy as complementary components of a unified global access cross-functional discipline.

At Maprium, we believe Managed Access Programs are becoming a critical strategic asset within the pharmaceutical access ecosystem. As healthcare systems seek greater affordability and manufacturers adapt to new pricing realities, the ability to design and execute effective global access programs will become increasingly important, as will the ability to use technology to do this.

The future of managed access is unlikely to be defined by whether these programs exist. Instead, it will be defined by how effectively they are integrated into broader global access strategies and how this cross-functional delivery is managed. Organisations will need solutions like Maprium to ensure transparency, visibility and control and to connect access activities with evidence generation within a single framework.

In a world increasingly shaped by international reference pricing, the companies that succeed will be those that treat patient access not as an operational necessity, but as a strategic capability that supports patients, informs market access, strengthens evidence generation and contributes to long-term commercial success.

Sources and further reading

  1. RAND Corporation. Prescription Drug Prices in the U.S. Are 2.78 Times Those in Other Countries. RAND Health Care Research Report, February 2024. Available at: https://www.rand.org/news/press/2024/02/01.html
  2. Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services. Comparing Prescription Drugs in the U.S. and Other Countries. January 2024. Available at: https://aspe.hhs.gov/reports/comparing-prescription-drugs
  3. U.S. Department of Health and Human Services (HHS). CMS and HHS Set Most-Favored-Nation Pricing Targets to End Global Freeloading on American Pharmaceutical Innovation. May 2025. Available at: https://www.hhs.gov/press-room/cms-mfn-lower-us-drug-prices.html
  4. Matcha G. The Global Risks of America's "Most-Favored-Nation" Drug Pricing Policy. Petrie-Flom Center, Harvard Law School. May 2025. Available at: https://petrieflom.law.harvard.edu/2025/05/22/the-global-risks-of-americas-most-favored-nation-drug-pricing-policy/
  5. Yadav P, Singh P. Executive Order to Lower U.S. Drug Prices Could Hurt the Poorest Countries. Think Global Health, Council on Foreign Relations. May 2025. Available at: https://www.thinkglobalhealth.org/article/executive-order-lower-us-drug-prices-could-hurt-poorest-countries
  6. Certara. International Reference Pricing: Global Implications and Pharma Strategy. October 2025. Available at: https://www.certara.com/blog/u-s-international-reference-pricing-global-implications-and-pharma-strategy/
  7. Rand LZ, Conti RM. International Reference Pricing for Prescription Drugs in the United States. Journal of Managed Care & Specialty Pharmacy. 2021;27(6):839-842. Available via PubMed: https://pubmed.ncbi.nlm.nih.gov/33840424/
  8. Brookings Institution. International Reference Pricing for Prescription Drugs. July 2025. Available at: https://www.brookings.edu/articles/international-reference-pricing-for-prescription-drugs/
  9. Office of Health Economics (OHE). The Trump Administration's US Drug Pricing Proposal: What Will Happen Next? June 2025. Available at: https://www.ohe.org/insights/the-trump-administrations-us-drug-pricing-proposal-what-will-happen-next/
  10. ISPOR. International Reference Pricing Comes to America: The MFN Policies Explained. Available at: https://www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/preventive-medicine/international-reference-pricing-comes-to-america--the-mfn-policies-explained

 

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