Protecting Patient-Centered Oncology Care from Harmful Step Edits

The right therapy, the right time, the right patient – selected by the physician.

NCODA’s mission is to advance patient-centered, medically integrated oncology care. At its core is a simple principle: people with cancer deserve timely access to the most appropriate, evidence-based therapies, guided by the clinical expertise of their oncology care team and informed by each patient’s unique disease characteristics and personal circumstances.

NCODA strongly opposes step therapy policies in oncology, as they delay appropriate treatment, increase the risk of avoidable complications and drug waste, and undermine the cost-avoidance benefits achieved through medically integrated oncology care. While we recognize the need for responsible healthcare spending and collaboration among payers, oncologists, manufacturers, and policymakers, cancer care requires flexibility, nuance, and trust in clinical expertise.

NCODA calls for:

• Meaningful oncology-specific exemptions from step therapy requirements
• Transparent, clinically grounded criteria when utilization management is applied
• Timely, streamlined exception and appeals processes that prioritize patient safety (including rapid review pathways when delay risks harm)
• Collaboration with oncology clinicians and patient advocates in policy design
• Recognition of medically integrated oncology practices as partners in value-based care

Patient-centered care is not achieved through rigid algorithms, but through thoughtful collaboration and respect for the complexity of cancer treatment.

In 2025, NCODA published a Perspective addressing growing concerns around step therapy and its implications for oncology care. Since that time, the use of step edits has continued to expand across payers and care settings. While step therapy is often positioned as a cost-management tool by insurers, its routine application in oncology raises serious concerns about safety, equity, clinical autonomy, and outcomes.

NCODA recognizes the complexity of healthcare economics and the importance of stewardship of limited resources. However, policies that delay or restrict access to the right cancer therapy at the right time undermine both patient outcomes and the long-term value of care.

Our goal is to elevate the conversation around step therapy in oncology by increasing visibility to its real-world impact and encouraging thoughtful, patient-centered policies grounded in clinical evidence, patient needs, and shared accountability.

The Unique Nature of Oncology Care

Cancer care presents unique clinical and timing considerations that distinguish it from many other areas of medicine. Oncology treatment decisions are rarely interchangeable, rarely straightforward, and rarely forgiving of delay. Advances in precision medicine have transformed cancer treatment from a one-size-fits-all approach to one that is increasingly driven by tumor biology, biomarkers, genetic mutations, disease stage, prior treatment response, and patient-specific factors.

In this context, step therapy, which requires patients to try and fail one or more insurer-preferred therapies before accessing the therapy selected by their oncologist, is particularly problematic. Unlike many chronic disease medications, cancer therapies are often not therapeutically equivalent substitutes. A “fail-first” or “intolerance” requirement can mean knowingly exposing patients to treatments that are less likely to work, and more likely to cause harm, or both.

Timing matters in cancer. Delays in initiating the most appropriate therapy, and interruptions in treatment sequencing, can allow disease progression, reduce the likelihood of response, and narrow future treatment options. Even short interruptions or detours in care can have lifelong consequences.

Disruption of Continuity and Personalized Medicine

One of the most significant harms of step edits in oncology is the disruption of continuity of care. Patients begin their cancer journey at a moment of profound vulnerability, relying on their care team for clarity, trust, and guidance. When a payer-mandated step edit overrides a carefully constructed treatment plan by a healthcare provider, that trust is strained.

Step therapy policies also ignore the reality of personalized medicine and undermine clinical judgement. Treatment decisions are complex, based on clinical trial data tied to specific patient populations. Step edits often apply blunt rules to nuanced clinical situations, forcing patients into standardized pathways that do not reflect their individual disease and can have serious consequences on health outcomes.

By treating patients as members of a generalized group rather than as individuals, step edits undermine the very progress oncology has made over the past two decades.

Risk of Disease Progression and Increased Toxicity

Requiring patients to try suboptimal therapies first is not a benign exercise. For many cancers, progression during an ineffective line of therapy can mean loss of performance status, increased symptom burden, and reduced eligibility for future treatments or clinical trials.

Step edits may force patients onto older therapies or regimens with higher toxicity profiles. Increased adverse effects can lead to emergency department visits, hospitalizations, treatment interruptions, and diminished quality of life. These downstream consequences are not only harmful to patients — they also increase the total cost of care.

Emotional and Psychological Impact on Patients

A cancer diagnosis already carries immense emotional weight. Patients face fear, uncertainty, and loss of control. Being told that the treatment recommended by their oncologist is delayed or denied — not due to medical reasoning, but because of an administrative requirement — adds another layer of distress.

The message patients often hear is not “this is the best care for you,” but rather “you must wait” or “you must try something else first.” This uncertainty erodes confidence in the healthcare system and exacerbates anxiety at a time when emotional support is critical.

Administrative Burden and Clinician Burnout

Step therapy policies place a significant administrative burden on oncology practices. Prior authorizations, appeals, peer-to-peer reviews, and repeated documentation requirements divert time and resources away from direct patient care.

Over time, this burden contributes to staff burnout and practice strain. In some cases, the complexity and time required to appeal a step edit may discourage pursuit of the optimal therapy altogether — resulting in patients receiving treatments that neither the physician nor the patient believes are best.

This shift of decision-making authority away from oncologists undermines shared decision-making and devalues clinical expertise.

Questioning the Cost Narrative

While step therapy is often justified as a cost-containment strategy, the financial reality in oncology is far more complex. Delays in accessing the most appropriate therapy can result in disease progression, additional lines of treatment, increased toxicity, and hospitalizations, all of which drive higher total costs of care.

Step edits can increase drug waste. When patients are required to initiate therapies that are unlikely to be effective, partially administered regimens, unused medications, and treatment changes due to progression or toxicity contribute to avoidable financial waste. These inefficiencies stand in contrast to the cost-avoidance benefits achieved through medically integrated oncology practices, where close coordination of care, real-time clinical oversight, and adherence help optimize therapy selection and minimize unnecessary utilization.

Short-term cost shifting should not be mistaken for sustainable, long-term value. True value in oncology is achieved by ensuring the right therapy is delivered at the right time, reducing avoidable complications, minimizing waste, and supporting sustainable, patient-centered care delivery.

Advancing a Better Path Forward

As the oncology landscape continues to evolve, policies must evolve with it. Cancer care demands precision, timeliness, and trust in clinical expertise. Administrative mechanisms that delay or redirect evidence-based treatment decisions do not reflect the complexity of modern oncology or the shared goal of improving outcomes while stewarding resources responsibly.

Patients with cancer deserve more than administrative complexity. They deserve care that is timely, individualized, and grounded in clinical evidence. Step therapy, as currently applied in oncology, too often falls short of that standard.

NCODA remains committed to being a leading, constructive voice in this conversation. By shining a light on the real-world impact of step edits and advocating for policies aligned with patient needs, we can move toward a healthcare system that balances cost considerations with compassion, precision, and outcomes.

Delivering the right cancer therapy, at the right time, for the right patient, is not only good medicine, it is sound health policy.

As step edit policies continue to evolve, NCODA will remain actively engaged in leading education and advocacy efforts that prioritize clinical integrity and patient outcomes. Our commitment to addressing these challenges alongside our members and partners is ongoing. Please reach out to contact@ncoda.org for further information or to further discuss this important issue.