Direct-to-Consumer Models: Why They’re Expanding and Where They Deliver the Most Impact

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

Jordan discusses the uptick in direct-to-consumer (DTC) models for life sciences organizations looking to navigate market challenges and improve patient access. He goes on to describe some potential risks and complexities associated with these models.

To learn about AssistRx’s technology solutions designed to simplify the patient experience and reduce channel costs, meet with AssistRx at the Drug Channels Leadership Forum, Informa Connect’s Access USA, and/or the Asembia Summit.

Read on for Jordan’s insights.

Direct-to-Consumer Models: Why They’re Expanding and Where They Deliver the Most Impact
By Jordan Armstrong, Vice President of Business Development, AssistRx

Since the beginning of 2024, four major life sciences organizations have announced their adoption of direct-to-consumer (DTC) models for their patient support programs (PSPs)—including one organization as recently as last week. This trend is a response to consumer demand to bypass physician visits or brick-and-mortar pharmacy trips and to use self-serve tools to access medications, as well as manufacturer attraction to simplified patient access and better patient experiences. Continued growth of DTC is expected, especially in “lifestyle” products like weight-loss, sexual health and hair loss medications.

Several other market challenges are driving life sciences organizations’ interest in DTC:

• Payer activity: Frequent payer policy changes, use of specialty carveouts and copay accumulators and maximizers, and increasing prior authorization (PA) requirements have made it difficult to predict patient coverage. For some products, access challenges are so unpredictable that it’s less costly for the manufacturer to sell the product at cash with the assumption that the patient has already been denied access.

• Cost of channel intermediaries: The gross-to-net squeeze is getting ever tighter. Life sciences organizations need to budget for higher distribution service agreement (DSA) fees, higher rebates and other costs to get their products from the manufacturing facility to the patient’s hands. For some life sciences organizations with low-WAC products, a DTC model is more cost effective.

• Looming patent cliff: The market will soon face a significant wave of patent expirations (or losses of exclusivity) for major blockbuster products. Once generics hit the market, products can be disadvantaged by the PBM or pharmacy through a less favorable coverage profile or switching at the pharmacy counter. The ease of DTC models helps life sciences organizations differentiate their product to retain market share and reduce switching.

• Loss of data: For prescriptions sent to retail pharmacies, life sciences organizations lose visibility into the patient journey. Unless the patient is enrolled in a copay program or other support program, it’s difficult to know whether patients are abandoning the script or refilling.

While DTC models can meet patient demand to bypass in-person visits to doctor offices and pharmacies and meet market challenges by cutting middleman costs, DTC models also present hurdles and risks:

• Complexity of standing up a DTC model: DTC models require months of planning, buy-in from internal partners, substantial budget allocation, robust alignment among vendor partners and close delivery monitoring to ensure actual delivery matches the model and vendor(s) access and affordability promises.

• Telemedicine compliance: Providing telemedicine services requires providers and their prescribers to maintain compliance with federal and state law, including professional board regulations.

• Evolving privacy, data protection, HIPAA and security requirements: Some life sciences organizations may be averse to navigating the complex laws and regulatory requirements surrounding these arrangements, such as anti-kickback laws, regulations surrounding secure e-prescription transmission and patient privacy concerns.

DTC Alternatives: What Model Best Supports Your Patient and Program Needs

DTC models require a broad range of capabilities core to PSP providers, including real-time and automated e-benefit verification (e-BV), e-PA and e-appeal, e-copay eligibility and processing, as well as e-prescription routing and dispensing. However, standing up a DTC model with these services may be too implementation-intensive, unattainable by certain PSP vendors, or the life sciences organization may be too risk-adverse.

There are models that can support lower WAC products and/or products approaching LOE—while maintaining visibility into the patient journey and powering real-time, automated access and affordability e-services and fulfillment.

CoAssist, a true tech-first patient access and fulfillment offering that facilitates a digital hub model, automatically triggers real-time Advanced eServices like eConsent, eEnrollment, Advanced Benefit Verification, Advanced Prior Authorization and eCopay at the point of prescription from within the EHR. CoAssist enables efficiency while maintaining the HCP’s established workflow. Additionally, CoAssist Pharmacy and its selective pharmacy network of commercial and non-commercial pharmacies drive access an ideal best affordability option for the patient based on their coverage for the product—while upholding the clinical decision.

Advanced Access Anywhere is similar but triggers these same Advanced eServices at the pharmacy claim, making it an ideal solution for products distributed through retail. This solution meets HCPs and pharmacies in their workflow and patients in their lifeflow. HCPs simply ePrescribe to a pharmacy, the pharmacy submits the claim and the patient receives their medication—all in seconds with Advanced eServices running in the background. Additionally, through its 61k+ nationwide pharmacy network, AAA facilitates patient visibility usually lost in the retail channel.

These tech-first alternatives not only meet patient demand for simplified experiences obtaining their medications, but also automate BVs and PAs to overcome payer hurdles, reduce channel costs, account for switching at the pharmacy counter and deliver visibility into the patient journey—all without substantial compliance/privacy risk and implementation lift.

Meet with our team at Drug Channels Leadership Forum, Informa Connect’s Access USA and/or Asembia Summit to continue the conversation on DTC models, digital hubs and our innovative solutions to advance your PSP.

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