Beyond The Drive-Thru: Ensuring Patient Access Across Specialty Distribution Systems and Non-Formulary Coverage

An increasing number of medications are now distributed through specialty distribution models. While these models are established for good reason, how does this translate to patient care when patients are asked to engage in behavior outside their routine of simply picking up a prescription from their usual retail pharmacy?

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What are the effects of limited drug distribution models on patient access and health care delivery?

Specialty distribution models, including limited drug distribution (LDD) systems, aim to ensure that medications requiring specialized handling and administration reach patients safely and effectively. These models prioritize a patient-centric approach for support and risk management. Reporting obligations ensure timely access to medication, onboarding education, and tailored care management, particularly for medications with added risk potential. For patients receiving oncology care, who are already managing a complex mix of treatment appointments, prescriptions, and medical visits, assistance in navigating the LDD approach can be very beneficial, if not essential. More frequently, medications are distributed through a limited network that is set up and designed to ensure proper management of medications, thereby limiting access within traditional retail pharmacies.

Insurance and Complications to Accessing Specialty Medications

For many patients, insurance plan design and coverage also introduce additional obstacles for drugs that require varying types of distribution or are not commonly included in standard formulary lists. This can be a confusing step for patients who are unfamiliar with navigating more complex prescription fills beyond simply going to a retail pharmacy near them.

These challenges often apply to orphan drugs, which are, by definition, intended to support limited patient populations. However, given that the specific presentation of a variety of cancers falls under the threshold for orphan drug designation—impacting 200,000 or fewer annually—there is an unintended consequence when the FDA approves cancer treatments as orphan drugs. For instance, a drug may first be approved for a rare cancer, affecting only 20,000 patients annually and carrying orphan drug status even if its use expands to be a standard of care for other cancers following FDA approval, becoming clinically validated and guideline supported. This poses challenges in many insurance policies, which may exclude orphan drug coverage.¹

When patients face added steps like prior authorization, having to work to gain coverage of a unique drug, or being required to navigate the financial implications of non-formulary medications, the process becomes complicated and frustrating, especially as the likelihood increases of being unable to get the care they need.

How can medically integrated models help patients ensure access to critical medications in a timely manner?

Medically integrated pharmacies (MIP) are an emerging option in accessing some limited distribution drugs, providing a more personalized approach that allows for access to electronic medical records and direct communication between the care team.

Collaborating with pharmacy staff experienced in insurance plan designs for high-cost specialty medications—including navigating appeals, working directly with insurers to secure coverage, leveraging alternative resources, and coordinating with manufacturers—can be instrumental in ensuring patient access to essential therapies, and MIP pharmacies do this regularly on behalf of patients.

Integrating Pharmacy Staff to Streamline Coordination

MIPs are uniquely positioned to streamline the process of accessing LDD systems. By embedding pharmacy services into the care team, MIPs create a seamless approach to managing high-cost specialty medications. These teams provide expertise in navigating insurance plans, managing appeals, securing coverage, and collaborating with manufacturers to ensure access. Many practices also integrate financial counseling and advocacy as standard services, demonstrating a commitment to supporting patients even when prescriptions are filled externally due to LDD restrictions. This holistic advocacy fosters trust and reassures patients that their care team is fully invested in addressing their needs during a challenging time.

Proactively Collaborating With Drug Manufacturers for Access to LDD and Support Programs

Effective collaboration with drug manufacturers can enhance access to LDDs while meeting operational, staffing, and training requirements. By working closely with manufacturers, MIPs facilitate access to patient assistance programs and other resources designed to reduce barriers to care. For many patients, a cancer diagnosis marks their first encounter with the complexities of specialty medications and associated costs. The pharmacy team’s expertise and proactive guidance can help patients navigate these challenges, alleviate concerns, and empower solutions aligned to treatment plans.

Develop Integrated Pharmacy Communication and Care Plans

An integrated pharmacy model minimizes the risk of patients being lost during the follow-up process by embedding pharmacy staff as a core part of the care team. This closed-loop system ensures consistent communication between providers, pharmacists, and patients, enabling timely interventions and adjustments to therapy. With regular check-ins and ongoing engagement, MIP teams can identify potential gaps in therapy, mitigate medication delays, and reduce waste—improving both patient outcomes and resource utilization.

The incorporation of the medically integrated model into oncology care fosters better patient understanding, trust, and engagement. These efforts translate to more positive clinical outcomes and less overall costs, reinforcing the ultimate goal of delivering comprehensive patient-centered care.

REFERENCE

1. FDA. Medical products for rare diseases and conditions. Last Updated October 1, 2024. Accessed March 18, 2025. https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions