Deal-Driven Policy, Direct-to-Patient Models, and State Momentum: Preparing for 2026
Federal pricing signals, emerging direct-to-patient models, and accelerating state policy activity are reshaping access planning for 2026. Here’s how manufacturers can prepare.
Understanding and meeting statutory and regulatory requirements has long been the foundation of pharmaceutical policy planning. Today, the challenge is anticipating how pricing expectations, data pathways, and state actions intersect with federal rulemaking and emerging distribution models. Forward planning now requires preparing for multiple scenarios, monitoring behavioral policy signals, and ensuring cross-functional readiness across pricing, market access, and compliance.
That theme anchored Magnolia Market Access’ October policy webinar on Federal and State Policy Updates and 2026 Planning. Legal, actuarial, and policy experts, including Chris Schott, Partner at Latham and Watkins, Greg Warren, Partner at Axene Health Partners, and Tracy Baroni Allmon, Vice President of Health Policy at Magnolia Market Access, joined Managing Partner Amanda Forys to discuss how manufacturers can position themselves for stability and predictability in an evolving environment. Their discussion highlighted practical steps for access leaders: build scenario-based pricing plans, assess direct-to-patient (DTP) readiness, strengthen state policy monitoring and engagement, and coordinate assumptions across internal teams.
Federal Policy Signals and Pricing Behavior
Chris Schott, Partner at Latham and Watkins, described a departure from the traditional rulemaking environment toward one where federal signals and expectations can influence decisions before regulations are finalized.
Regulatory processes at OMB and CMS continue, but recent pricing decisions illustrate that federal expectations and tariff discussions can influence company actions even before policy is finalized. Planning models therefore benefit from incorporating multiple policy scenarios and timelines.
“This industry has operated under statutes and rules. That is why this moment is so unusual.”
— Chris Schott, Partner, Latham and Watkins
DTP distribution continues to gain attention as an affordability pathway. At the same time, it requires careful planning to ensure patient safety, data integration, and coordination with prescribers and payers.
Tracy Baroni Allmon, Vice President of Health Policy at Magnolia Market Access, emphasized the operational rigor that accompanies new distribution channels.
“A new channel means new responsibilities and new risk.”
— Tracy Baroni-Allmon, VP, Health Policy, Magnolia Market Access
Traditional pharmacy benefit flows support safety checks, benefit administration, and claims visibility for clinical and non-clinical use. As DTP models evolve, manufacturers will need to ensure those functions remain intact.
Tariff-Related Pricing Signals
Tariffs, historically tied to trade and supply chain policy, have begun influencing pharmaceutical pricing actions in certain instances. When tariff signals factor into pricing considerations, manufacturers can benefit from flexible pricing frameworks that adapt as policy conversations evolve.
State Policy Acceleration and Diffusion
State legislatures continue to advance policy activity related to PBMs, affordability, and 340B. These efforts often spread quickly once early models withstand legal challenge.
Greg Warren, Partner at Axene Health Partners, noted the pattern of state policy adoption.
Manufacturers benefit from state-level monitoring and operational preparedness, particularly across contracting, pharmacy distribution, and patient access services.
“Once one state passes a bill that survives challenge, others copy and paste it.”
— Greg Warren, Partner, Axene Health Partners
Constructive Pathways and Planning Alignment
The panel also discussed policy options that support patient affordability while maintaining system stability, including targeted reimbursement strategies, value-based approaches, and enhanced data pathways.
Amanda Forys, Managing Partner and Health Policy Lead at Magnolia Market Access, emphasized coordinated planning across internal functions.
“There are levers to reduce costs without destabilizing the system.”
— Amanda Forys, Managing Partner, Magnolia Market Access
Cross-functional planning helps ensure manufacturers are prepared to adjust as policies develop.
Key Takeaway
Policy direction today is shaped not only by published rules, but also by how federal actions influence decisions before rules are finalized. DTP models bring affordability along with operational responsibility. State momentum continues to build and often moves quickly across jurisdictions.
Organizations that prepare for multiple outcomes, establish shared policy priorities and assumptions internally, and integrate policy insight into commercialization decisions will be well positioned to support patient access and strategic objectives.
Magnolia Market Access partners with biopharma organizations to turn policy signals into clear access strategy and planning frameworks.