BOSTON, April 16, 2026 /PRNewswire/ — The Digital Medicine Society (DiMe) today announced the launch of a new pre-competitive initiative, Optimizing Direct-to-Patient (DTP) Strategies for Pharma, focused on establishing the operational, regulatory, and evidence-based foundation required to scale DTP models responsibly across healthcare.

The initiative brings together founding partners across the healthcare ecosystem to realize a critical and timely opportunity for the industry at a moment of significant downward pressure on drug prices: expanding direct access to therapies in ways that are safe, compliant, and worthy of patient trust.

A rapidly evolving market, and the opportunity to build it right

Direct-to-patient (DTP) models are already a meaningful part of how patients access care, particularly in high-demand areas like GLP-1 therapies, where cash-pay pathways have expanded rapidly in response to access constraints, pricing complexity, and unmet demand.

Recent federal discussions around drug pricing and access have sharpened attention on cash-pay pathways. At a STAT event in March, CMS official Chris Klomp clarified that TrumpRx is a cash-pay model not intended for most Americans with insurance, underscoring both the policy interest in direct channels and the opportunity to define how these models can expand access more broadly.

At the same time, the combination of virtual prescribing, digital pharmacies, and direct distribution models is making it easier for patients to access care while introducing new questions about oversight, consistency, and accountability. Recent scrutiny of fast-scaling direct-to-patient models — including reporting on misleading clinical marketing and affiliate-driven growth practices — has highlighted the importance of establishing clear standards for marketing, clinical transparency, and partner alignment from the outset.

The pathways for supporting DTP models exist and patient demand is clear. The opportunity now is to establish systems that ensure these models operate safely, effectively, equitably, and with confidence. Done well, DTP models have the potential to expand access to the treatments patients need at prices they can afford, while strengthening trust in how care is delivered.

This new initiative is designed to accelerate that work by building the infrastructure required for direct-to-patient models to scale in a way that delivers on both access and trust.

“Direct-to-patient models are already reshaping how patients access care, particularly in therapeutic areas where demand has outpaced the capacity of traditional brick-and-mortar approaches,” said Jennifer Goldsack, CEO of DiMe. “Now, we need the infrastructure to ensure these models operate safely, consistently, and in a way that earns trust. We are proud to bring this community together to help build a pathway that expands access to the treatments patients need at prices they can afford, while maintaining the confidence of patients, clinicians, and regulators.”

Building the foundation for trusted direct-to-patient care

DiMe and its partners will co-create a practical, scalable blueprint for DTP models, grounded in real-world execution and aligned with evolving policy and regulatory expectations, with the explicit goal of ensuring these models operate in ways that earn trust as they scale.

The initiative will map the market, regulatory, and policy landscape and translate it into clear, actionable guidance to support teams operationalizing DTP models. It will also define how to measure patient access and affordability, enabling more transparent and equitable approaches to care.

To support disciplined adoption, the work will establish a structured approach to assessing the appropriateness of DTP models, grounded in regulatory readiness, patient benefit, and commercial viability.

Finally, the project will surface real-world examples from across the ecosystem, highlighting both successful and cautionary approaches to scaling DTP models, with a focus on what drives access, affordability, and trust in practice.

A coordinated, cross-sector effort

This initiative is designed to align stakeholders across clinical care, prescribing, fulfillment, patient services, and patient engagement to ensure that direct-to-patient models function as trustworthy, cohesive systems.

“Direct-to-patient models are now a real part of how patients are accessing care,” said Michelle Davey, CEO of Wheel. “Consumers expect faster, simpler ways to get treatment, and that shift isn’t slowing down. But building for access is different from building for the full patient journey. To do that well, you need clear standards, clinical independence, and accountability from the start. That’s what will define which models actually last, and this initiative is an important step in getting there.”

“A well-designed DTP program transforms the prescription access experience from a transaction into a relationship. This requires building a frictionless experience that gives patients what they want: transparent, affordable pricing with coverage support, multiple access pathways, and a clear path forward to start and stay on therapy on their terms. Pharmaceutical manufacturers that do this well will see the impact where it matters most: patient starts, adherence, and long-term therapy outcomes.” – Josh Zeidman, SVP Business Development, PHIL Inc.

Leading pharma organizations will be joined by fellow founding partners, including:

• Coalesce Health
• DistributeRx
• Fullspan Health
• Health Advances
• Phil, Inc.
• S3 Connected Health
• Welldoc
• Wheel
• Ypsomed

Together, these partners will help define how DTP models can scale in a way that improves access while maintaining trust.

About the Digital Medicine Society (DiMe)

The Digital Medicine Society (DiMe) is a global non-profit and the professional home for digital medicine. DiMe brings together diverse perspectives to advance the safe, effective, and equitable use of digital technologies to redefine healthcare and improve lives.

Media Contact

press@dimesociety.org

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SOURCE Digital Medicine Society (DiMe)