WEP Insights

Home Health in Expanded Access Programs: A Design Strategy, not a Rescue Solution

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Gabby Sorenson

Executive Director, Clinical Nursing & EAP Project Management

Gabby has 8 years of experience in Project Management and Clinical Monitoring within the clinical research industry. As Associate Director of the Clinical Monitoring group at WEP, she’s passionate about optimizing operations, streamlining processes, and driving strategic initiatives to improve efficiency and team performance.

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For years, home health care in Expanded Access Programs (EAPs) was viewed as a patient convenience. Something to consider when a patient lived far from a treatment site, but not a core component of program design.

Today’s Expanded Access Programs often support patients for years, creating an opportunity for Sponsors and Healthcare Providers (HCPs) to think differently about how care is delivered over the long term.

As programs expand geographically and remain active for longer periods, Sponsors face a growing operational reality:

  • Sites are absorbing additional visit volume on top of already demanding workloads.
  • Patients may travel significant distances for routine assessments, monitoring, and drug administration.
  • Travel reimbursement, site fees, and administrative costs continue to accumulate throughout the life of the program.
  • Access may become constrained for patients who do not live near participating sites.

In many cases, the patients enrolled in EAPs are also those least able to tolerate extensive travel. They may be managing rare diseases, chronic conditions, or advanced illnesses where every additional trip represents a physical, emotional, and financial burden.

The result is a program model that can become increasingly expensive, difficult to scale, and burdensome for both sites and patients.

The Solution: Build Home Health into Program Design From Day One

Having the opportunity to lead both Expanded Access and Clinical Nursing Project Management teams has allowed me to see firsthand how home health can transform program operations when it’s incorporated early rather than introduced as a reactive solution.

When designed appropriately, home health shifts many routine, protocol-approved activities closer to the patient while still maintaining the appropriate level of oversight.

That approach delivers value across multiple dimensions:

✅ Reduced Patient Burden: Patients spend less time traveling and more time focusing on their health. Care is delivered where patients are most comfortable, making participation significantly easier.

✅ Expanded Patient Access: Geographic proximity to a site becomes less of a barrier. Sponsors can potentially support patients in regions where opening a new site would not be operationally or financially feasible.

✅ Improved Cost Efficiency: When considering travel expenses, site fees, resource utilization, and ongoing operational demands, home-based care can often be a more economical approach than repeated site-based visits.

Why Sponsors Should Consider Home Health During Program Design

One of the biggest mistakes I see is treating home health as a solution to a problem that has already occurred.

  • A patient struggles with travel.
  • A site becomes overloaded.
  • Interest in the program expands beyond the geography of existing sites, but Sponsors need a scalable way to reach patients without activating additional locations.

By that point, the program is adapting to operational challenges rather than preventing them.

The most successful EAPs are the ones where Sponsors and service providers align early and intentionally evaluate where decentralized care and home health can be integrated into the care pathway from the start.

Bottom Line

Expanded Access Programs are ultimately about helping patients gain access to therapies when few options remain.

Access is not just about making treatment available. It’s about making treatment feasible. When Sponsors incorporate home health into program design early, they create opportunities to reduce patient burden, preserve site capacity, expand geographic reach, and build a more sustainable program for the long term.

The most successful EAPs aren’t simply asking, “How do we get treatment to patients?” They’re asking, “How do we deliver that access in a way that works for patients, sites, and Sponsors alike?”

Let's Connect

I’d welcome the opportunity to discuss how Sponsors can incorporate home health and decentralized care strategies into EAPs from the outset.

📧 [email protected]

📅 Book time with me to discuss EAP strategy, clinical nursing, decentralized care, and patient access solutions.