On July 31, 2025, the White House escalated U.S. drug pricing pressure by sending letters to 17 pharmaceutical CEOs demanding concrete steps to align U.S. prices with “most favored nation” (MFN) levels.
At the same time, affordability pressure is rising from the bottom up. Patient out-of-pocket spending reached $98 billion in 2024, up nearly 25% in five years, as overall net medicine spending grew 11.4% to $487 billion.
The broader message is clear: traditional gross-to-net models are under strain, and the industry is expected to find alternatives.
A white paper from Triangle Insights Group outlines key considerations for Direct-to-Patient models, how the channel has evolved, the opportunities and risks, and practical steps to begin evaluating, piloting, and scaling without compromising gross-to-net performance.
A Brief History of Pharma’s Direct-to-Patient Evolution
Pharma’s journey to DTP sales tells a compelling story of innovation borne from necessity.
In the early 2000s, patients with complex conditions like multiple sclerosis needed personalized care and detailed guidance beyond what the health care system provided. Manufacturers responded by creating patient-centered support programs featuring home delivery and adherence coaching, fundamentally improving patient experiences.
In the late 2010s, healthcare’s digital evolution reshaped patient expectations around the prescription journey. Telehealth startups successfully introduced cash-pay models to bypass traditional insurance channels entirely. With the advent of ultra-rare and gene therapies, pharma prioritized end-to-end direct engagement with patients throughout their journeys as well.
Today, however, the pharmaceutical industry faces a new challenge: increasing patient affordability. In response, major players are increasingly adopting DTP models to provide end-to-end improvements in the patient experience across a broader portfolio of products. This strategic shift among leading manufacturers toward DTP highlights that traditional distribution models need to evolve to meet today’s market pressures and patient expectations.
Direct-to-Patient: Promise and Pitfalls
As more manufacturers explore/expand DTP models, it is critical to understand the opportunities and risks DTP presents.
Selected Opportunities:
- Patient/Margin Economics: Cash-pay models help reclaim margins ceded to intermediaries while offering patients clearer, and often lower, OOP costs.
- Patient Engagement: Manufacturer control over DTP can reduce friction in patient and prescription journeys.
- Real-time Data: DTP platforms enable manufacturers to develop marketing and patient services strategies around a self-contained data set.
Selected Risks:
- Pricing Challenges: If not carefully structured around a comprehensive set of uninsured and underinsured patient use cases, cash-pay programs in DTP can trigger unfavorable “Best Price” implications within Medicaid and 340B channels.
- Payer Backlash: Payers may view DTP as channel leakage and respond with additional formulary exclusions and restrictions, reducing patient choice within traditional channels while prioritizing competitors that do not pursue DTP.
- Channel Disruption: DTP may disrupt relationships with specialty pharmacies, wholesalers, and large provider networks, many of whom offer ancillary patient support services that manufacturers must absorb.
Making DTP Work for Your Patients and Brand
Introducing a DTP channel is a significant strategic decision and must begin with key questions for your brand (e.g., “what are we solving for in the moments that matter to our patients?” and “how does DTP solve for it?”).
Begin by identifying the strategic need for DTP solutions with regards to pricing, access, fulfillment, persistence, and benchmarking.
After identifying the strategic need, clarify whether/how to pursue DTP for your brand:
- Validate Product-Channel Fit: Conduct a multi-factor feasibility assessment before pursuing DTP.
- Anticipate Product-Model Fit: Brand-owned, marketplace, or hub-anchored DTP models work best in different scenarios.
- Lead with Clarity for Patients: Keep the program simple, trustworthy, and brand-centric.
- Set Clear Guardrails: Design your program to mitigate Best Price/340B implications and relationships with channel partners. Be clear that cash purchases may not count toward insurance benefits.
- Measure and Course Correct: Track website traffic and conversion to script, time to first dose ± persistence, brand volume/margin (DTP + non-DTP channels), and compliance.
Get the Full DTP Playbook: To bridge strategy and execution, we outline three steps to evaluate, pilot, and scale DTP in the full white paper.
Our Triangle Insights Group Recommendation
Direct-to-patient is no longer theoretical. It is already reshaping patient journeys in select categories and is now explicitly contemplated by federal policy. The July 31 letters signal that manufacturers must deliver transparent affordability while reducing reliance on opaque rebate structures or face potential regulatory action.
DTP will not be the primary solution for every product or organization. But when applied thoughtfully, it can expand access, accelerate time to therapy, strengthen patient connection, and reclaim value otherwise ceded to intermediaries. A disciplined test-and-learn approach offers a practical path forward.
Our recommendation: put DTP on your brand’s agenda to de-risk the path, protect gross-to-net, and demonstrate value early.
Triangle Insights Group can determine if, when, and how DTP makes sense for your brand. Valeris can help build, operate, and scale your pilot with compliance at its core.