In pursuit of strategies to decrease ever-spiraling healthcare costs in the US, commercial and government payers are increasingly turning to step therapy as a common cost-control tactic for expensive cancer drugs.
Step therapy is a cost-containment strategy based on the premise that lower-cost drug therapies should be tried first before patients can access more expensive (typically newer) drugs indicated for the same disease or symptom. Medicare.gov describes step therapy as a type of prior authorization:
In most cases, you must first try a certain less expensive drug on the plan’s formulary that’s been proven effective for most people with your condition before you can move up a “step” to a more expensive drug. For instance, some plans may require you first try a generic drug (if available), then a less expensive brand-name drug on their drug list before you can get a similar, more expensive, brand-name drug covered.
While commercial payers have increasingly adopted step therapy as a cost-control measure, until recently, Medicare and Medicare Advantage (MA) plans were prohibited from doing so. But recent regulatory actions have reversed that policy, and in August 2018, CMS reversed its policy prohibiting the use of step therapy in MA plans, a rule that became effective January 1, 2019. This has a potentially significant impact on Medicare patients, as more than 20 million Medicare beneficiaries (34 percent) were enrolled in MA plans in 2018.
Although cost containment is necessary in today’s healthcare system, the increased use of step therapy for cancer drugs is raising concern among oncologists and patients. Prior authorization processes can be a significant administrative burden on practices, hospitals, and health systems. Clinicians may appeal an insurer’s step therapy decision, but appeals processes are time-consuming and require documentation to support a provider’s therapeutic choice. If a payer-mandated step therapy leads to poor outcomes, patient care can suffer.
To help providers better understand how to manage step therapy within their patient treatment and prescribing practices, ACCC has produced a four-part lecture series entitled, “Perspectives on Step Therapy in Oncology.” The series, in which a panel of clinicians review patient care scenarios, aims to increase awareness about the implications of step therapy for oncology practice. The panelists include:
The Price of Failure
In the first two videos in the series, the four-person clinician panel responds to patient case studies and discusses the effects of step therapy on cancer care.
The first video reviews a real-life case study in which a physician prescribed an antiemetic to a patient undergoing cancer treatment. The patient’s insurance company has a step therapy requirement for the prescribed drug, requiring patients to first “fail” a less-expensive treatment option before reimbursing for the more costly, originally prescribed drug. The patient subsequently received the less expensive drug first, and, after one course of treatment, she was taken to the emergency room with renal failure resulting from severe nausea and vomiting.
Reviewing this scenario, the panelists noted that—in addition to the patient’s pain and suffering caused by the ineffectiveness of the first step drug—the cost of the patient’s lengthy hospital stay defeated the aim of step therapy to lower drug costs. Asked one panelist, “Are we actually preventing waste, or are we in essence increasing our healthcare costs?”
Other panelists agreed that a “fail first” methodology can have potentially devastating implications for patients with cancer if step therapy is treated as a “one-size-fits-all” approach. Time is of the essence in oncology, noted the clinicians on the panel. When a provider wants to prescribe a patient a drug that requires a “fail first” alternative, the process of working through multiple medications and communicating results to insurance companies can be lengthy and onerous. Physicians naturally want their patients to have access to the therapies they believe are most suited to their needs.
The panelists also agreed that guidelines and algorithms can be appropriate in medicine as a means to regulate out-of-control healthcare costs. At times, sound clinical evidence and standards guide payers’ decision-making processes, and a lower-cost agent may be appropriate. But such cost-saving measures should not interfere with clinicians’ ability to provide personalized care for their patients. As innovative new treatment options have become available to patients, noted the panelists, the pace of cancer care has accelerated, and insurers’ reimbursement policies need to keep up.
Advocating for Patients
In the second video, the panel considers a hypothetical case study that involves a 62-year-old patient with metastatic colorectal cancer. The patient has “failed” first-line step therapy and has moved on to second-line therapy. The patient’s physician prescribes a prophylactic supportive care therapy for potential neutropenia. Because the patient hasn’t yet become neutropenic, the insurer’s step-policy requirements prevent the patient from accessing the supportive care drug for neutropenia. In this case, the panelists suggest this would be an appropriate decision from the insurer based on the fact that the patient hadn’t yet developed the condition. However, it is essential to communicate to a patient why a specific drug may be denied and explain that the medication will be covered if found necessary.
A conflict arises when a prescribing clinician has insight into a patient’s medical history and determines it is likely that the patient will develop neutropenia when they take a certain drug. In that case, the panelists agreed that the physician should appeal. In a community oncology setting, a nurse or nurse practitioner would typically file an appeal with the insurance company through an online portal, or, more often, through multiple phone calls.
The appeals process can be inefficient and lengthy, panelists agreed. Often, insurers require a “peer-to-peer” review before they make an appeal decision, which may take weeks. This can create anxiety for patients, said the panelists, and it can be burdensome for an oncology practice’s employees, who must make repeated calls and update patients on the status of their appeals. The appeals process is time- and resource-intensive and consumes hours of unreimbursed staff time.
For many cancers, treatment is complex and nuanced. In some instances, anticancer regimens involve combination therapies of two, three, or even four oncolytic drugs. This makes a linear drug approval process—such as step therapy—all the more challenging, the panelists noted.
The conversation ended on a positive note, with panelists expressing optimism that, as biosimilars become increasingly available, there will be better alignment of cost savings. Watch our Lecture Series for additional insights into the potential impact of step therapy as a cost containment strategy for oncology care.
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Disclosure: Dr. Fonseca is a consultant with Amgen, BMS, Celgene, Takeda, Bayer, Janssen, AbbVie, Pharmacyclics, Merck, Sanofi, Kite, and Juno; has served on the scientific advisory board for Adaptive Biotechnologies; and Mayo Clinic holds the patent in his name for the prognostication of MM based on genetic categorization of the disease.