Reimagining Patient Access: Building Direct-to-Consumer Models for a New Regulatory Era

Today’s guest post comes from Jordan Armstrong, VP of Business Development at AssistRx.

Jordan examines the growing role of direct-to-consumer (DTC) access models in the pharmaceutical sector. He discusses recent regulatory developments, the potential benefits and risks for manufacturers, and key considerations for building sustainable DTC programs.

To learn more, register for AssistRx's October 21st webinar: The New Patient Support Program: Why Regulatory Shifts Require a Higher Caliber of Program Sophistication and How to Do It.

Read on for Jordan’s insights.

Reimagining Patient Access: Building Direct-to-Consumer Models for a New Regulatory Era
By Jordan Armstrong, VP, Business Development, AssistRx

July 31, 2025, marked a seismic event for the pharmaceutical space. President Trump sent letters to 17 major life sciences organizations outlining steps to make Most Favored Nation (MFN) pricing available to consumers, including a directive to participate in direct-to-consumer (DTC) or direct-to-business (DTB) distribution models. This follows the May 2025 executive order, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” which directed the Department of Health and Human Services to establish an MFN target for prices charged to Medicare and Medicaid.

Earlier this week, the administration announced TrumpRx.gov, a website that will take consumers to pharmaceutical companies’ DTC websites to fulfill orders. The website is part of a broader initiative to bring prices more in line with other developed countries. Already exploring DTC models to improve access and the patient experience, these developments further drive life sciences organizations to pursue DTC models.

AssistRx successfully supports several life sciences organizations’ DTC programs. Our team understands when it makes sense to implement a DTC model, the model’s advantages and disadvantages, and considerations for best-in-class implementation and ongoing delivery:

DTC Model Success Factors:

• Product Type: High-volume products, either high-touch or low-touch, are well-supported by DTC models—especially those with coverage hurdles. In these instances, the ease of DTC models helps differentiate the product from its competition, and selling the product at cash may be the best option for the manufacturer—and the patient.


• Patient Population: DTC models require patients to be proactive care seekers and understand the value of taking on financial responsibility. They may need to be comfortable with telehealth, a significant component of DTC models.


• Internal Buy-in and Organizational Risk Tolerance: Organizations considering DTC models must ensure they have the right internal and external resources in place. These models require significant planning, cross-functional collaboration, budget allocation, vendor management and dedicated monitoring of market and regulatory dynamics.

Benefits of DTC Models

In addition to market and regulatory factors, DTC models also enable life sciences organizations to delight patients and HCPs with scalable PSPs that deliver:

• Branded, Comprehensive Experiences: DTC digital ecosystems empower patients to self-serve, accessing disease state education, telehealth appointments, PSP services and even pharmacy fulfillment—all in one branded experience.


• GTN Mitigation: DTC models mitigate the gross-to-net (GTN) squeeze by cutting out channel intermediaries, as well as enabling cash pay access to patients facing coverage challenges.


• Data and Insights: Patient visibility is typically lost when products are sent to retail. Life sciences organizations that adopt DTC models for their products gain greater patient-level data, which can then be used to deliver more personalized and meaningful engagement, as well as actionable insights to power program performance.

Risks of DTC Models

While DTC models offer many advantages to life sciences organizations and patients, they present new and evolving risks that manufacturers need to navigate:

• Legislative and Judicial Activity: Recently, DTC models have come under scrutiny from both U.S. senators and state courts. A recent Senate investigation sought to uncover whether DTC models steer patients toward medications that increase spending for federal healthcare programs.


• Regulatory Uncertainty: Under the law, drug advertisements must provide a “fair balance” of information about the drug’s benefits and risks. However, the bar for “fair and balanced” drug advertising remains unclear.


• Stakeholder conflict: Cutting out channel intermediaries, as well as payers, PBMs, pharmacies and HCPs can strain relationships with life sciences organizations. There is a risk that HCP groups may file lawsuits against life sciences organizations implementing a DTC model to safeguard their practices.


• Telemedicine compliance: DTC models that include a telehealth component need to monitor federal and state law compliance requirements for telehealth providers and their prescribers.

Considerations When Implementing DTC Models

We’ve developed several key considerations to support life sciences organizations in improving DTC program operationalization and ongoing management while maintaining compliance:

• Build with a Patient-Centric Approach: Meet your patients, HCPs and pharmacies where they are, such as your existing website, an HCP portal, the pharmacy counter and even the fax. AssistRx solutions integrate easily into your access channels to empower your customers with self-serve access, affordability and adherence tools.


• Create a Seamless Experience: Work with a partner that has interoperable, real-time technology and wraparound services. Our partners choose us to support their DTC programs because of our tech-first therapy initiation and fulfillment solutions like CoAssist Pharmacy. Intaking the prescription from the EHR, CoAssist automatically triggers our Advanced eServices—eConsent, Advanced Benefit Verification, Advanced Prior Authorization, eCopay/ePAP and more—at the point of prescription from within the EHR and routes the prescription for dispense based on the patient’s best affordability option.


• Stay Proactive: Ensure your DTC program partner performs proactive regulatory and compliance monitoring across the FDA, DEA, state pharmacy boards and evolving data privacy laws—and provides you with proactive guidance to maintain compliance.


• Continuously Improve: Select a partner that is willing and able to integrate with stakeholders across your DTC ecosystem to deliver comprehensive program visibility. The right partner will serve up timely, relevant and actionable data to improve patient and HCP experiences and optimize program performance.

In this rapidly evolving market, life sciences organizations need a partner with the technology, expertise and experience needed to stand up a successful DTC model. Learn more about the latest regulatory and payer shifts and how they’re impacting PSPs by registering for our free October 21st webinar, The New Patient Support Program: Why Regulatory Shifts Require a Higher Caliber of Program Sophistication and How to Do It.

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