Blog | Events | S3 Connected Health

Setting a New Benchmark for Pharma’s Direct‑to‑Patient Shift

Written by John Mulcahy | May 25, 2026

Direct-to-patient (DTP) platforms are quickly becoming a key strategic necessity in pharma. This article looks at what setting the benchmark for a DTP model involves and how companies can design and evolve leading DTP services. The recent surge in DTP launches shows a bigger industry change, as manufacturers invest in digital 'front doors' that connect directly with patients and guide them through a smooth, start-to-finish experience.

The best DTP platforms bring together disease and treatment education, care navigation, telehealth diagnosis, e-prescribing, flexible access for both insured and self-pay patients, therapy fulfillment, and ongoing disease management support. Provided in a seamless experience, these provide a clear shift from old, fragmented models to a more patient-focused, digital system. This approach helps pharma companies get closer to patients and have more impact throughout the treatment process.

 

Rapid expansion and evolution of DTP programs

Over the past two years, a wave of direct-to-patient (DTP) launches has reshaped the pharmaceutical industry’s digital landscape. Early movers like Eli Lilly’s LillyDirect in early 2024 quickly gained momentum. Pfizer introduced PfizerForAll later that year, and Novo Nordisk followed with NovoCare in early 2025. This wave has since expanded, with major players including AstraZeneca, Boehringer Ingelheim, Amgen, and Novartis launching their own DTP platforms throughout late 2025.

Click to zoom in and explore the details

 

The market is now iterating quickly, with DTP programs evolving rapidly to meet patient, provider, and payer expectations. Therapies tied to lifestyle improvement — such as weight loss, mental health, sexual health, and hair loss — have emerged as strong early fits for this model.

Chronic conditions that require ongoing management and regular refills are also well‑suited to DTP. Therapies for high blood pressure, diabetes, and asthma, in particular, can benefit from a robust, well‑designed DTP program that streamlines access and supports long‑term adherence.

 

The move to DTP is being driven by two major forces

1. The success of early DTP programs

Eli Lilly’s pioneering LillyDirect service has shown how a comprehensive DTP platform can overcome access, pricing, fulfillment, and compliance barriers to deliver high-volume weight-loss, diabetes, and migraine therapies directly to patients. It streamlines prescribing bottlenecks, reduces prior-authorization friction, and helps patients navigate inconsistent insurance coverage. By October ’25, LillyDirect accounted for more than 35% of all Zepbound prescriptions.

 

2. The May 2025 White House executive order

The May 2025 most-favored-nation (MFN) executive order, introduced under the Trump administration, is designed to benchmark US drug prices against those in other developed countries, effectively lowering the prices manufacturers can charge and reducing pharma’s traditional pricing power. However, the executive order opens a pathway for pharmaceutical companies to sell directly to patients. By enabling direct-to-patient distribution models, manufacturers can build patient proximity, gain greater control over patient access and experience, and offset some margin pressure by reducing reliance on middlemen.

 

Strategic implications of DTP

With the right strategy and execution, DTP programs can enable pharma to effectively compete in the new realities in the US market, offsetting reduced prices by increasing prescription volume. Beyond volume, DTP provides pharma with new strategic assets:

  • Direct engagement with patients, payers (including self‑insured employers), and providers
  • Greater proximity to the patient journey; a clearer view of real‑world disease progression
  • Access to proprietary data sets and insights generated through these interactions
  • Enter a manufacturer’s DTP program
  • Have a remote or in‑person consultation with an independent clinician
  • Pay cash or use insurance
  • Receive an e‑prescription
  • Have medicines shipped within days
  • Access ongoing support from therapy initiation through long‑term disease management

 

These enable pharma to iterate and improve their offerings for US patients. Access to proprietary data insights, and the predictive analytics and digital twins trained from this data become the basis for future competitive differentiation.

 

What today’s DTP experience enables

For the first time, patients can move through a fully integrated, end‑to‑end digital care pathway within a pharma‑run DTP platform:

This represents a step‑change in patient proximity and service integration compared to traditional distribution channels.

 

Wide performance variability

Despite the momentum, not all programs have succeeded. Execution quality, clinical workflow design, compliance architecture, and patient experience are emerging as the key differentiators.

As DTP programs remove long‑standing system‑level frictions, they must simultaneously navigate a complex and overlapping compliance landscape. Each DTP service operates at the intersection of multiple regulatory regimes, including anti‑kickback rules, independent prescribing and anti‑steering safeguards, FDA promotion and fair‑balance requirements, HIPAA and emerging consumer health‑data laws, cross‑state telehealth licensure, informed‑consent standards, and online prescribing rules.

While the Department of Health and Human Services and the Office of Inspector General are making compliance more workable — most notably through OIG’s January 2026 safeguards, which make pharma cash‑pay DTP programs for non‑controlled drugs more feasible. Manufacturers still bear significant responsibility. Pharma must ensure patients are not inappropriately steered, prescriber independence is protected, cross‑state telehealth requirements are respected, and pharmacy fulfillment workflows remain fully compliant as programs scale.

 

Building the new benchmark: The core capabilities

Delivering a high-performing DTP platform requires a far more comprehensive approach — one that extends well beyond the minimal features found in basic programs. This model can be broken down into five core capability areas, each containing a set of considerations and optional features.

While not every feature will be necessary for every pharma company, those that hope to remain competitive will need to carefully evaluate these capabilities, determine which are essential for their therapeutic areas and patient populations, and define the scope of their DTP program accordingly.

Below, you can download an infographic with the key component areas and read a brief explanation of each core area.

 

Disease and treatment awareness

An effective DTP platform begins with comprehensive disease and treatment awareness. Above-brand education enables patients to understand their condition and available treatment options. Accelerating diagnosis is a key objective, achieved through personalized, adaptive, and multilingual symptom-education tools, and digital self-assessments with symptom checkers. These elements help patients recognize symptoms sooner and access care more quickly. Algorithmic identification of high-risk patients via EHR-embedded prompts within clinician workflows and data mining to identify high-risk patients, assisting provider care teams to identify patients who may benefit from treatment.

 

Care navigation, telehealth, and diagnosis

Care navigation and telehealth services guide patients from awareness to diagnosis and treatment initiation. This includes telehealth or in-person consultations with independent clinicians who assess symptoms and issue e-prescriptions as needed. Curated provider networks ensure a consistent, high-quality clinical experience, and integrated diagnostics to support accurate and timely diagnosis. Electronic prescribing (eRx) streamlines treatment initiation, while personalized care plans provide clear, tailored guidance. Together, these components reduce barriers and accelerate therapy initiation.

 

Access and affordability

A leading DTP platform simplifies the financial aspects of patient care. It provides clear information on reimbursement status, prior-authorization requirements, insurance coverage, and benefit eligibility. Rapid prior authorization and real-time benefit verification minimize delays. Cash-pay and self-pay options offer alternatives for patients without coverage, while cost transparency enables understanding of out-of-pocket expenses and access to affordability programs, financial assistance, or copay support. Reducing financial barriers directly improves treatment uptake and adherence.

 

Fulfillment

Reliable and flexible fulfillment is critical to a strong DTP experience. Patients should have options to receive their medication in the way that best suits their needs, lifestyle, and clinical circumstances such as home delivery, pharmacy pick-up, or fulfillment-dispensing pharmacies. An effective fulfillment model also maintains continuity of medication possession and reduces the risk of treatment interruptions.

 

Disease management and treatment support

The final capability supports patients throughout their treatment journey. This includes treatment initiation, onboarding, disease-specific education, and ongoing management. Personalized care plans aligned with clinical governance help patients use their therapy effectively, while support for co-morbidities addresses broader health factors. Integration with patient support programs (PSPs) provides nurse-led support for patients experiencing challenges. Advanced programs may offer adherence and persistence tools, digital companions, connected drug-delivery devices, and digital therapeutics to support specific aspects of care. Together, these features create a comprehensive support system that improves outcomes and enhances the patient experience.

 

The role of platforms, devices, and connected health

A DTP program must address five core design challenges, which ultimately determine the selection and implementation of platforms, devices, and connected health tools.

  • Deliver an experience that meaningfully reduces friction for patients and payers. Key moments such as onboarding, access, reimbursement, and ongoing care determine engagement. Well-designed touchpoints simplify processes, reduce drop-off, and build trust.
  • The experience must be clinically grounded. It should reflect actual care pathways, support disease management, and align with existing PSPs. Convenience alone is insufficient; the experience must reinforce appropriate clinical behaviors and outcomes.
  • The entire service must remain compliant, covering both standard workflows and edge cases. These scenarios reflect real patient journeys, and any unaddressed gap can introduce regulatory risk. Effective DTP design addresses these gaps from the outset.
  • The program should deliver strategic value. Enhanced access, stronger adherence, improved data visibility, and differentiated services that improve competitive position in the new US market reality are key reasons companies invest in DTP.
  • Speed is essential. The ability to launch quickly, iterate, and scale determines whether a program meets current market expectations or falls behind.
  • A clear overarching design is essential. It defines the patient experience, identifies key friction points, and aligns them with a coherent clinical pathway. Without this structure, the experience becomes fragmented and inconsistent.
  • Integration with thirdparty partners is also critical. Across the patient journey, specialized providers — telehealth, benefits verification, self-pay, fulfillment — already offer mature, compliant solutions. They’re built to handle complexity, including edge cases. Leveraging them accelerates timelines and strengthens compliance, though it does introduce service fees.
  • A strong technology platform underpins all aspects of the program. It enables a compelling user experience, supports a unified data model, and serves as the integration layer across multiple partners. It also allows teams to innovate quickly while ensuring compliance.

 

 

Addressing these challenges requires several foundational elements

Together, platforms, devices, and connected health tools form the infrastructure that enables DTP programs to balance experience, clinical relevance, compliance, strategic value, and speed.