{"id":34554,"date":"2025-06-05T13:00:56","date_gmt":"2025-06-05T17:00:56","guid":{"rendered":"https:\/\/advisory.avalerehealth.com\/?p=34554"},"modified":"2025-06-05T14:57:05","modified_gmt":"2025-06-05T18:57:05","slug":"mfn-eo-raises-a-range-of-potential-options-for-dtc-implementation","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/mfn-eo-raises-a-range-of-potential-options-for-dtc-implementation","title":{"rendered":"MFN EO Raises A Range of Potential Options for DTC Implementation"},"content":{"rendered":"

On May 12, President Trump signed an Executive Order <\/a>(EO) that directs drug manufacturers to reduce US drug prices to align with those paid in economically comparable countries, a concept known as most favored nation (MFN) pricing<\/a>. The EO outlines a series of near-term steps the federal government may take to make manufacturers lower their US drug prices. One of these steps is implementing a direct-to-consumer (DTC) purchasing program to enable manufacturers to make MFN pricing available to consumers.<\/p>\n

The EO provides limited detail on how a DTC program would be structured and operationalized or what the role of government would be. Additionally, there is a fundamental question of whether the goal is to establish a DTC channel that affects the physical distribution model of a product, enables patients to directly benefit from MFN pricing, or a combination of the two. There is also uncertainty on whether it applies to medical and pharmacy benefit products and the subsequent operationalization, channel and reimbursement implications. Avalere Health has identified a range of potential approaches for setting up a DTC program in the context of MFN \u2013 ranging from incremental in nature and building on existing market models to the establishment of a new government-facilitated purchasing channel.<\/p>\n

Below, we outline the spectrum of potential approaches for structuring a DTC program to facilitate MFN access and pricing. Implementation considerations and potential policy and market access pathways for these approaches will likely vary based on drug-specific factors (retail vs. specialty, pharmacy benefit vs. physician administered) and by market segment (commercial, Medicare Parts B and D, Medicaid).<\/p>\n

Figure 1. Potential Approaches for Structuring a Direct-to-Consumer Program to Facilitate MFN Access and Pricing\u00a0<\/strong><\/p>\n

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Next Steps<\/b><\/p>\n

Biopharmaceutical companies and payers face key decisions in the upcoming months, including deciding whether to participate in a voluntary MFN model, developing and executing policy and access strategies to shape these changes, and evolving their business and portfolio strategies to reflect new market realities.<\/p>\n

Avalere Health\u2019s seasoned experts in market access, US and global pricing strategy, and federal and state policy support organizations with a range of tailored activities, including:<\/p>\n