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2025 年 4 月 11 日

Accessing affordable healthcare is one of the biggest challenges U.S. patients face. Historically, the pharmaceutical industry has relied on traditional distribution models, but this has often left patients navigating high out-of-pocket costs and fragmented access to medications. Enter direct-to-patient sales programs—a modern solution redefining how patients can access medications.

But what exactly are direct-to-patient sales programs? How do they compare to other patient affordability initiatives? And can they address the growing demand for convenient, transparent, and affordable healthcare? This post examines the nuances of direct-to-patient sales and their role in transforming patient access to essential therapies.

From market access leaders to pharmaceutical executives, here’s everything you need to know about the evolution of direct-to-patient programs.

What are direct-to-patient sales programs?

Direct-to-patient (DTP) sales programs allow pharmaceutical companies to sell medications directly to patients, bypassing traditional intermediaries such as wholesalers, retailers, and payers e.g., health insurance plans or integrated delivery networks. While the concept is not entirely new, its adoption gained significant momentum during the COVID-19 pandemic, as companies sought remote healthcare solutions to improve access and reduce barriers.

A notable example involves a leading pharma company developing biologic therapies for patients with rheumatoid arthritis. By creating an online platform, the company allowed patients to order medications directly from the manufacturer after receiving their prescription. The program provided the drugs at a patient-friendly price point, shipped medications to patients’ homes, and included educational resources to support medication adherence.

This reimagined sales model bridges the gap between affordability and convenience, empowering patients in ways traditional systems have struggled to achieve.

Why direct-to-patient sales matter

The primary goal of direct-to-patient sales programs is to empower patients by improving access and affordability.

For patients requiring high-cost therapies for rare or chronic conditions, affordability often feels out of reach. Traditional patient affordability programs—such as short-term co-pay and bridge programs—only partially address these concerns. The rise of payer co-pay accumulators and maximizer programs are also undermining traditional affordability programs. By contrast, DTP programs are designed to reduce friction throughout the process of obtaining medications.

Additionally, direct-to-patient sales are particularly beneficial for Medicare patients, who are often ineligible for traditional financial assistance due to regulatory constraints. The direct channel ensures patients can access therapies without the usual bottlenecks, enhancing medication adherence and streamlining the experience.

Comparing direct-to-patient sales to other patient affordability programs

How do direct-to-patient initiatives stack up against other affordability programs? Below is a comparison of key strategies pharmaceutical companies commonly employ:

1. Co-Pay Assistance Programs
These initiatives help reduce out-of-pocket costs at pharmacies by subsidizing the co-pay amount. They are effective at lowering upfront costs for eligible patients but may not address other barriers, such as ongoing affordability or coverage hurdles. Also, such programs are restricted only to patients with commercial insurance plans due to regulatory restrictions (e.g., can’t support patients on Medicare, Medicaid, or other government provided health plans).

2. Bridge Programs
Bridge programs offer patients temporary access to medications while awaiting insurance approval or during transitional periods between coverage plans. While effective in closing short-term treatment gaps, these programs are primarily designed for temporary use and don’t provide a sustainable affordability solution.

3. Free Trials
Free trials allow patients to try medications before committing financially. These programs can increase patient access but might result in potential gaps in treatment once the trial period ends.

The Direct-to-Patient Edge
Compared to these programs, direct-to-patient sales provide a comprehensive, patient-centered solution:

  • Enhanced patient access through direct shipping, reducing geographical or logistical barriers
  • Wider reach to support access for any patient regardless of their healthcare coverage
  • Greater affordabiltiy via streamlined pricing mechanisms
  • Improved adherence due to stable access to care despite any changes in their coverage and enhanced convenience of home delivery

Unlike other solutions that focus on partial affordability or access gaps for a limited population of patients, direct-to-patient programs deliver on both fronts for potentially all patients while building long-term trust and loyalty among patients.

Pros and cons of direct-to-patient sales programs

优势

Improved Access
Transform patient experiences by ensuring medications reach even rural or underserved areas where pharmacies may be scarce.

Convenience
By having medications delivered directly, patients can avoid multiple touchpoints, leading to greater satisfaction and higher adherence rates.

Streamlined Costs
Removing certain intermediaries can lead to more predictable pricing, potentially lowering costs for patients purchasing directly.

劣势

Regulatory Hurdles
Pharmaceutical companies must ensure their DTP models comply with evolving regulations on drug safety, marketing ethics, and patient privacy.

Technological Gaps
Not all patients have access to or familiarity with online platforms. This can exclude older demographics or those in areas with unreliable internet.

Figure 1: While direct-to-patient sales offer significant benefits for improving patient affordability and access, they also come with challenges.

Of course there are some challenges in launching a DTP program but with proper planning and strategic collaboration, pharmaceutical companies can ensure DTP programs remain both compliant with evolving regulations while enhancing patient access.

Direct-to-patient sales as a path forward

Direct-to-patient sales programs represent a bold and necessary evolution in the pharmaceutical industry’s approach to patient access. By situating patients at the center of the distribution model, these programs offer a practical response to pressing affordability challenges, particularly for high-cost therapies like biologics and for therapies that manage chronic conditions, which necessitates predictable access to medications.

At their core, DTP programs demonstrate how innovation can align with patient needs to deliver a more accessible, affordable, and personalized healthcare experience.

Learn more about Value & Access services

Curious about whether a DTP model could fit your market access and patient services strategy goals? Speak to Certara today and take the next step toward reshaping patient affordability and access.

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Joshua Berus, PhD

Associate Director, US Access Strategy

Joshua Berus has a background in biomedical science and broad experience in market access, brand strategy, and patient services. He has experience leveraging both primary and secondary, qualitative and quantitative data to analyze market dynamics and generate strategic insights across multiple therapeutic areas at various stages of commercial development.

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