Most Favored Nation, Direct-to-Consumer Strategies Reshape US Pharma Landscape, Challenging Traditional Care

On November 4, 2025, policy and economics experts convened for the third installment of a webinar series discussing the Most Favored Nation (MFN) Drug Policy Executive Order. Presented by MJH Life Sciences in partnership with a variety of its brands, including Drug Topics, the final part of the webinar series focuses on helping all stakeholders involved understand the potential implications of the groundbreaking MFN drug policy.

Moderated by Ron Lanton, Esq, senior partner at Lanton Law, the discussion assessed MFN’s viability as a long-term reform mechanism, the economic spillovers of policy threats, and the impact of direct-to-consumer (DTC) channels on the established pharmaceutical ecosystem, particularly concerning community pharmacy and patient access.

Joining Lanton were 3 other panelists: Lindsay Greenleaf, JD, MBA, head of policy at AbbVie Health; Stacie Dusetzina, PhD, professor of health policy at Vanderbilt University Medical Center; and Neal Masia, PhD, economist and CEO of Entity Risk.

“MFN as a concept is certainly here to stay, especially during the Trump administration, [and] if we were to have another Republican president come on the heels of President Trump,” Greenleaf said. “Where things may get a little different is if Trump is followed by a Democrat in the White House. Democrats are a little less focused on this idea of international fairness [and] who's funding this American-fueled innovation.”

The Policy Pressure Cooker: MFN as a Negotiating Tactic

Currently, the focus of MFN remains on administrative authority under the Trump administration, especially through the Center for Medicare & Medicaid Innovation (CMMI) demonstration models.

Two proposed CMMI rules are currently pending final review:

• GLOBE (Global Benchmark for Efficient Drug Pricing Model), which is speculated to be related to Medicare Part B.
• GUARD (Guarding Us Medicare Against Rising Drug Cost Model), which is rumored to be related to Medicare Part D.

CMMI possesses broad authority, including the power to waive Title 18 of the Social Security Act for demonstration projects, affecting many Medicare beneficiaries for potentially long periods. The mere existence of these powerful, looming proposals serves as a significant leverage point.

Greenleaf explained that if manufacturers provide a steady stream of manufacturer announcements regarding voluntary agreements, the formal CMMI proposals like GLOBE and GUARD might not be released at all. Masia agreed, stating, “The monster in the horror movie is always scarier when it's hidden.” He suggested the threat of MFN, rather than its formal implementation, is the primary driver of current policy shifts.

Dusetzina addressed the implementation of tariffs on foreign-manufactured branded drugs, noting that the threat has successfully brought companies to the table for pricing concessions. However, if tariffs were broadly implemented, the US customer would typically end up picking up the tab on that through increased health insurance premiums and higher cost sharing.

Impact on Community Pharmacy and Patient Safety

A major consequence of the DTC model is the potential disruption to the continuity of care by bypassing the pharmacist, which raises concerns about safety checks and monitoring.

“You do have to acknowledge you're cutting the pharmacist out of this scenario and out of this dialog with the patient,” Greenleaf said. “You are increasing the risk of some bad things that can happen, things like drug interactions."

Greenleaf added that it can increase the risk of negative outcomes, such as drug interactions, because the patient may lack the level of monitoring provided by a pharmacist. She suggested that drugs requiring intensive monitoring or complex safety checks might not be the right drugs for a program like this and might see limits on shifting to a DTC platform.

READ MORE: The Most Favored Nation Drug Policy’s Impact on Access, Pharmaceutical Innovation

The traditional cash-pay DTC model generally avoids issues related to the Anti-Kickback Statute (AKS), which prohibits inducing federal business, such as Medicare and Medicaid. However, Greenleaf suggested that manufacturers are exploring models where the pharmacy might still be involved (e.g., DTC programs where patients pick up prescriptions at the pharmacy counter) to maintain professional roles while bypassing pharmacy benefit manager functions.

Dusetzina added that reliance on cash-pay DTC models carries significant financial risks for patients who have health insurance. Employers, seeing cash-pay options available for certain drugs, such as glucagon-like peptide-1s for weight loss, may roll back coverage on products under the benefit. Crucially, DTC spending may not count toward a patient’s deductible or out-of-pocket maximums. Dusetzina also emphasized that if patients use a cash-pay DTC option, they might face greater total health care costs later in the year because they haven't started reaching thresholds for better insurance coverage.

“In general, it's probably not a great deal for most people who have health insurance because at some point they're going to meet their out-of-pocket maximums, or they're going to have met their deductibles, and their costs for the subsequent bills are going to be less,” Dusetzina said. “People don't really think about health insurance in those ways.”

Conclusion

Greenleaf recommended that manufacturers invest heavily in policy analytics. She noted the frantic pace of rumors and proposals, requiring companies to be ready to answer complex questions about their portfolios, launch planning, and potential offers within minutes. Dusetzina’s key advice was to “pay attention to the details and don't feel like you have to be the first one out of the gate with a response,” emphasizing that specific policy details matter significantly more than initial announcements.

Masia stressed the critical need to explain a drug’s value, not just to payers but to patients in language they can understand, and to be really clear about how they can access the drug.

“The reality is we're not currently in a stable policy framework for that. It's just not, and there's nothing to really hang your hat on because we're making individual deals right now, one at a time, and every company has its own little strengths and weaknesses,” Masia said.

To see the full video of the MFN drug policy roundtable, visit here.

READ MORE: Pharmacy Industry Leaders Gather to Discuss Most Favored Nation Drug Policy

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