Josh and Matt aim to raise awareness about the negative effects of insurer-imposed policies such as therapeutic substitution and step therapy. They argue that physicians have a deeper understanding of disease states and individual patient biology than insurance companies and pharmacy benefit managers (PBMs). To ensure the best outcomes, they contend that doctors—not insurers—should determine each patient’s optimal treatment plan.
Learn about BeOne Medicines, a global oncology company.
Read on for Josh and Matt’s insights.
The Hidden Burdens of Cancer Care: When Insurers Override Doctors
By Josh Schwartz, Vice President, Medical Affairs, North America, BeOne Medicines and Matt Shaulis, General Manager, North America, BeOne Medicines
Patients and healthcare providers are forced to navigate unnecessary barriers that make delivering and receiving care harder than it should be. These hidden burdens take many forms: insurance-driven therapeutic substitution, prior authorizations and formulary restrictions, financial concerns, care navigation, information gaps, mental health challenges, and more. And of all these obstacles, none is more damaging than healthcare insurers inserting themselves into treatment decisions, undermining outcomes, disrupting care, and weakening the patient-provider relationship.
Who’s Really in Charge of Cancer Care: Insurers or Physicians?
Across the country, health insurers and pharmacy benefit managers (PBMs) are forcing one-size-fits-all protocols in cancer care—delaying access to treatment, and dictating choices based on their financial bottom line, not patient clinical need. These policies undercut physician preference and compound the emotional toll at a time when patients most need stability.
One of the clearest ways this plays out is through therapeutic substitution and step therapy—insurer-imposed rules designed to protect profits that interfere with the treatment plan chosen by a physician and patient. These policies often require patients to “fail” or prove intolerability on a different drug or formulary alternative before gaining approval for the treatment originally prescribed, even when the substitute doesn’t align with clinical judgment.
Insurers are overriding physician preference and dictating care based on their profits—a direct intrusion into the doctor-patient relationship. These barriers have become increasingly common, part of a broader arsenal of utilization and financial management tools including prior authorizations, formulary restrictions and more. The names may differ, but the outcome is the same: delayed care and eroded trust.
The data support this. Drug denials by private insurers are up 25% since 2016, creating access barriers across cancer and other chronic conditions. Further, a 2023 analysis of coverage policies found that commercial health plans’ use of restrictions on oncology drugs nearly doubled—from 17.6% to 33.5% between 2017 and 2021.
Therapeutic Substitution in Blood Cancer
Take chronic lymphocytic leukemia (CLL), a slow-growing, life-threatening blood cancer that accounts for nearly one-third of all new leukemia cases in adults each year. Patients often require multiple lines of therapy over time, and National Comprehensive Cancer Network (NCCN) Guidelines identify covalent BTK inhibitors (zanubrutinib, acalabrutinib, ibrutinib) as preferred treatments. Yet in certain Medicare Part D plans managed by insurers like UnitedHealthcare, Aetna and their PBMs, patients must first demonstrate intolerance on one BTKi before accessing the one originally prescribed by their doctor.
In CLL, where every patient’s disease biology treatment needs are unique, individualized care is critical. Therapeutic substitution practices that restrict parity access in the BTKi class undermine evidence-based treatment and compromise patient outcomes. These barriers are contrary to the intent of Medicare’s protected class policy, designed to ensure patients with cancer have timely access to the full range of appropriate therapies.
The consequences of these policies fall hardest on patients. They can cause potential harm by leading to disease progression and creating treatment gaps that disrupt care at critical moments. They also place a heavy strain on providers, pulling time and resources away from care, especially in community oncology practices.
The bottom line is treatment decisions should be driven by physician expertise and treatment guidelines, not by insurers’ bottom lines.
What’s at Stake: Shared Decision-Making and Quality Care
When patients cannot access the treatments their doctor recommends, they may lose an important window to ensure the best outcome. Shared decision-making only works when patients and clinicians can chart a path forward together—without being overruled by payer-imposed utilization management.
In many cases, patients don’t even realize their treatment plan has been altered behind the scenes, and sometimes their doctors do not either, until it’s too late. Insurers often force therapeutic substitution on the backend through pharmacies, leaving physicians and staff to absorb the disruption.
A Call to Action: Putting Patients and Doctors Back in Charge
These hidden burdens created by insurers are widespread but solvable. Cancer does not wait, and neither should we. We need a system that meets patients with speed and support.
We must confront these hidden burdens head-on. That means greater public transparency, accountability, and meaningful reform in insurance and PBM decision-making—including passage of current PBM reform legislation before Congress. It also requires stronger support for community practices, which often shoulder the work of navigating affordability, access, and mental health care without the infrastructure larger systems rely on.
Without change, these burdens will keep draining patients and providers. It’s time to lift them—to restore trust, protect clinical autonomy, and put patients and doctors back in charge of cancer care.
Learn about BeOne Medicines, a global oncology company that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
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