BeOne Medicines

The promise of modern oncology lies in precision—precision medicine, precision diagnostics, and increasingly, precision therapeutic decision-making. Yet, within the U.S. healthcare system, a misalignment persists that undermines this progress: the use of step edits in oncology by pharmacy benefit managers (PBMs) and payers.

As a pharmacist and leader who has practiced both in retail and health system specialty pharmacy, I have witnessed the impact of step edits from multiple vantage points. Early in my career, I was consistently confronted with a troubling reality: the medication a provider prescribed was not always the medication a patient could access. Instead, coverage decisions were frequently dictated by PBM formularies—often requiring patients to “fail first” on preferred therapies before receiving the treatment their provider originally selected.

At the time, my role was reactive. Like many pharmacists, I worked within the system—helping patients navigate prior authorizations, identifying alternatives, and doing everything possible to avoid therapy delays. However, I had little visibility into the broader forces shaping these barriers.

That perspective changed significantly when I transitioned into a leadership role, building and scaling a top 10 academic medical center (AMC) specialty pharmacy. It was there that the systemic influence of PBMs—and the implications of vertical integration across insurers, PBMs, and specialty pharmacies—became unmistakably clear.

Rather than enabling patient-centered care, these structures often introduced administrative and financial barriers that delayed access to life-saving therapies. Nowhere was this more evident than oncology.

The Oncology Exception That Isn’t

Oncology is designated as a protected therapeutic class under Medicare Part D, reflecting the critical nature of timely and appropriate treatment. Yet, in practice, step edits and utilization management strategies continue to affect oncology patients—particularly within the commercial and managed care landscapes.

Cancer is not a condition that affords patients the luxury of time. Unlike chronic conditions where step therapy may be clinically appropriate in certain scenarios, oncology treatment decisions are often urgent, highly individualized, and based on rapidly evolving evidence. Many patients are diagnosed at advanced stages or with rare malignancies, where first-line therapy is not only the standard of care—but potentially their best and only chance for survival.

Requiring these patients to “try and fail” on alternative therapies—driven not by clinical evidence but by formulary preference—introduces unnecessary risk which can lead to disease progression, diminished quality of life and in some cases, irreversible harm.

OOLD: A Patient-Centered Response to Step Edits

In response to these challenges, a new model is emerging within the specialty pharmacy ecosystem: Optimized Oncology Limited Distribution (OOLD). OOLD represents the NCODA (Network for Collaborative Oncology Development) preferred model, where PBM affiliated mail order pharmacies are excluded from dispensing an oncolytic, and MIPs (medically integrated pharmacy) and non-PBM affiliated pharmacies can dispense.

The OOLD model represents a more intentional approach to limited distribution—one that enables coordinated, in-practice care and supports timely, patient centered treatment designed specifically to support oncology patients and preserve the integrity of provider-directed care. Rather than focusing solely on product control, OOLD models prioritize:

• Alignment with centers of excellence and oncology clinics

• Integration with health system specialty pharmacies embedded in care teams

• Faster access to therapy by minimizing administrative friction

• Enhanced clinical coordination and patient support services

At its core, OOLD is about ensuring that the right patient gets the right therapy—without unnecessary delay or payer-driven detours.

While not a complete solution to payer-imposed step therapy, OOLD introduces a structural advantage—it aligns the distribution channel with the clinical pathway, rather than working against it.

How Manufacturers Are Leaning Into OOLD

Recognizing both the clinical and strategic importance of oncology access, manufacturers are increasingly embracing OOLD principles as part of their distribution and access strategies. Key approaches include:

1. Prioritizing Integrated Health System Specialty Pharmacies

Manufacturers are partnering more intentionally with health system–owned specialty pharmacies that are embedded within oncology clinics, enabling tighter care coordination and faster therapy initiation.

2. Designing Distribution Around Clinical Pathways

Rather than broad or traditional limited distribution networks, OOLD models are being structured to align with how oncology care is actually delivered—supporting first-line therapy decisions and minimizing disruption.

3. Strengthening Hub and Access Support Services

Manufacturers are investing in hub services that proactively address prior authorizations, benefits verification and financial assistance—helping patients navigate (or avoid) step edit barriers.

4. Using Data to Demonstrate Value

There is increasing emphasis on capturing real-world evidence and outcomes data from OOLD-aligned channels to reinforce the value of timely, provider-directed therapy.

5. Engaging in Policy and Market-Shaping Conversations

Manufacturers are becoming more active in discussions around step therapy reform, PBM practices and access barriers—recognizing that distribution strategy alone cannot fully solve systemic misalignment.

From Mitigation to Advocacy

In my role as a pharmacy director, I recognized that while I could not immediately dismantle these systemic barriers, I could build an infrastructure to mitigate their impact. I established a model that embedded pharmacy technician liaisons directly within specialty clinics, including oncology.

These liaisons became essential partners in care—proactively identifying step edit requirements, coordinating prior authorizations, drafting appeal letters and facilitating peer-to-peer reviews between providers and payers. This model significantly reduced delays and improved access, but it also highlighted a fundamental truth: the system requires extraordinary effort to overcome barriers that should not exist in the first place.

While mitigation strategies are necessary in today’s environment, they are not a substitute for meaningful reform.

Call for Policy Change

It is time to reevaluate the role of step edits in oncology care.

Clinical decision-making should rest with the provider—guided by evidence, patient-specific factors and the urgency of the disease—not by payer-driven algorithms designed to manage cost. While cost containment is an important consideration in healthcare, it should never supersede timely access to appropriate cancer treatment.

There is a strong case for prohibiting step edits in oncology altogether. At a minimum, policies should ensure that:

• Step therapy protocols do not apply to oncology treatments where delays or substitution could compromise outcomes

• Exceptions and appeals processes are streamlined and expedited for cancer patients

• Greater transparency exists around formulary decision-making and the role of financial incentives

• Providers retain autonomy in selecting first-line therapies based on clinical judgment

• Innovative access models, such as OOLD, are not undermined by payer-imposed channel or utilization restrictions

Putting Patients First

The oncology patient population represents some of the most vulnerable individuals in our healthcare system. They are navigating complex diagnoses, emotional distress and often significant financial burden. They should not also have to navigate avoidable administrative barriers to access the treatment their oncologist has determined is best.

As pharmacists and healthcare leaders, we have a responsibility to advocate for systems that prioritize patients over process and outcomes over optimization. Step edits—and the need for models like OOLD to work around them—highlight just how far we still must go.

It is time to move beyond mitigation—and toward reform.