LillyDirect launched in January, 2024, 18 months before TrumpRx was announced, because insurance was suppressing demand for products patients were already willing to pay for out of pocket. The platform was a commercial solution, not a compliance gesture.

DTP is scaling rapidly, with one pharma executive noting: "I would say [we’re at the] tip of the iceberg... a lot more people, including older adults, are now comfortable going through these types of channels to get treatment. The next three years [will see] continued growth and new starts on GLP-1s in particular."

The question that matters now is a different but critical one: Is the DTP ecosystem being designed with patient safety at its core? As distribution capabilities rapidly expand, clinical infrastructure is struggling to keep pace. Based on the recently completed research collected from Alvarez & Marsal, that gap is growing and if left unaddressed, it could evolve into a patient harm story.

The privacy premium is real, and it’s creating a care gap

Pharma discovered and is now building entire distribution channels around the idea that patients will pay out of pocket for privacy. This is especially true in stigmatized categories such as weight management, HIV prevention, hormonal therapy, sexual dysfunction, and mental health where patients want to avoid the social exposure of a pharmacy counter, an insurance paper trail, or a conversation at a doctor's office.

Our patient survey found that stigma increases the perceived value of a private, low-friction care experience, helping explain the rapid growth of DTP models in these categories.

But when privacy becomes the organizing principle of the care model, the industry must ask what clinical safeguards may be lost along the way. One of those safeguards is the clinical oversight that traditionally comes from an ongoing relationship with healthcare providers.

When DTP platforms replace rather than supplement that relationship, important safety signals can be missed. The most significant risk is the creation of an electronic health record (EHR) blind spot.

The EHR blind spot

Prescriptions fulfilled through first-generation DTP platforms do not flow back to the patient's primary care physician or appear in the EHR, creating a critical gap in care coordination.

A GLP-1 patient self-managing a dose reduction may not disclose that to their endocrinologist. A patient on HIV PrEP obtained through a DTP platform may not have that listed when a cardiologist reviews their medication list before prescribing.

Drug-drug interactions, adverse event management, and care coordination all depend on a complete medication record. DTP, as currently designed, is fragmenting that record at scale.

What first-generation platforms got wrong and how to fix it

The early platforms proved something important, patients want this channel, yet they did not prove the model is clinically safe. Platforms built the distribution infrastructure first, but not the mechanisms for ensuring that DTP prescriptions are visible in the patient's broader medical record.

When reflecting on lessons learned from the first generation of DTP platforms, one pharma executive said: “Consider what experience you want to deliver and then build the infrastructure operationally around that. A lot of brands gave these critical roles of building the platform to people as a secondary or tertiary part of their job without considering how to build a feedback loop to improve the experience."

The near-term fix is not complicated in concept, even if it is in execution. In the near-term, platforms should make it easy for patients to share prescription information with their primary care physician through downloadable summaries, one-click notifications, or pre-populated messages.

Over time, DTP platforms should move toward direct EHR integration via FHIR APIs, so prescriptions automatically appear in the patient's medical record. This technology already exists in other parts of digital health. The integration gap in DTP is not driven by complexity. It is that no one has required it yet or made a commercial case that it matters enough to prioritize.

The commercial case for getting this right

Pharma shouldn’t need a regulatory mandate to build clinical safety infrastructure into DTP platforms. It should want to, because the alternative is a harmful event that will define the policy response to the entire channel.

As the DTP market consolidates around a small number of platforms, competitive advantage will come from combining convenience and privacy with clinical accountability, including independent prescribing, strong data governance, and seamless EHR integration.

Our framework identified thirty indications that meet the structural prerequisites for DTP investment. The five clusters where the case is strongest, metabolic and GI conditions, men's and women's health, psychiatry and neurology, pain, and dermatology, share a common profile: chronic conditions, high stigma, patients with demonstrated willingness to pay for privacy, and high-deductible insurance coverage that was already pushing them toward out-of-pocket alternatives.

They also represent the patients most likely to be managing multiple conditions, on complex medication regimens, and harmed by a prescription that doesn’t exist in their medical record.

What needs to happen now?

The industry does not need to wait for regulation to act. Platforms can begin closing the care gap today by adding a patient-facing prompt to share prescription information with a primary care provider at the point of fulfillment, while working toward deeper EHR integration over time. That is a product decision, not a policy decision, and it can be made today.

The medium-term goal should be direct EHR notification with patient consent. The long-term goal should be full FHIR integration.

DTP is a durable channel. The patient demand behind it is structural. The clinical safety infrastructure to support it should be too.