As healthcare costs in the United States continue to skyrocket, payers are increasingly using step therapy as a cost-containment strategy for newer, more expensive drugs.

To help oncologists and their care teams better understand how to manage the step therapy model within their practices, ACCC has produced a four-part video lecture series entitled, “Perspectives on Step Therapy in Oncology.” The series aims to increase awareness about the concept of step therapy and its implications for oncology practice. Read about the first two video lectures here.

In the final two lectures in the series, a clinical panel discusses the unique challenges of step therapy in a cancer care practice. Included on the panel are:

• Kristina Rua, RN, BSN, OCN, ONN-CG, Director of Oncology Navigation at Sarah Cannon in Fort Lauderdale, Fla.
• Jacob K. Kettle, PharmD, BCOP, Oncology Clinical Pharmacy Specialist at University of Missouri Health Care in Columbia, Mo.
• Lee S. Schwartzberg, MD, FACP, Executive Director at The West Cancer Center, Memphis, Tenn.
• Rafael Fonseca, MD, Getz Family Professor of Cancer & Professor of Medicine at the Mayo Clinic in Phoenix, Ariz.

The Shifting Landscape of Oncology Care

Step therapy is a cost-containment strategy based on the premise that lower-cost drug therapies should be tried before patients can access more expensive (typically newer) drugs indicated for the same disease or symptom.

“Step therapy is different from prior authorization in that the latter is sort of an open conversation about ‘I want this drug. I want to get it approved,’” explains Dr. Fonseca in the third video of the series. “Step therapy from the get-go considers the steps that are necessary for you to get to a second therapy. It’s arguably a decision that is made by the payer.”

The panel agreed that while the step therapy model has been effective in other areas of therapeutics, it poses unique challenges in oncology.

“We are in a very dynamic period in time where oncology is rapidly shifting, and it is a very daunting challenge when we start to apply those concepts that have been effective maybe in hypertension or antibiotics—some disease states that, by comparison, are relatively static, applying that to our world of oncology, which is rapidly shifting and changing,” says Dr. Kettle.

For example, Kristina Rua explains that, in nursing, it’s understood that you begin with a lower-cost drug to treat hypertension. If the hypertension isn’t controlled, or the medication “fails,” the provider proceeds to the next step, or the next medication, in order to get to the desired outcome for the patient. In oncology, it’s different. For a patient with ovarian cancer, if “medication A” doesn’t work, that means the disease has progressed, says Rua.

Panelists expressed concern that step therapy can cause delays in treatment in the event that a provider must appeal a denial by the insurer for a treatment that is not in alignment with the step therapy protocol.  

“That’s really the fundamental problem with step therapy for therapeutics in cancer: the severity of the disease,” says Dr. Schwartzberg. “The fact that the first thing you learn in training in medical oncology is that your best shot for treating an advanced cancer is the first shot. You don’t have the luxury to fail, because failing there can mean life-threatening consequences or death. Our principle when we learn how to treat patients is ‘use the best therapy.’”

“This is a very complex thing,” adds Dr. Fonseca. “Of course, all of us want to have our patients get the right therapy when they need it. And we recognize there are limited resources and there needs to be some responsible stewardship of how we all practice medicine. But at the same time it is critically important patients get timely access to their medications, because often they won’t have time to come back and try this two or six months down the line.”

The clinicians on the panel agreed that it can be challenging for everyone—both payers and providers—to keep up with the rapidly shifting landscape of oncology care. But they agreed that comorbidities, prior history, and access all must be taken into consideration when it comes to selecting the best therapy for a patient.

“To make the waters even muddier, different states have different bills that have been passed to protect their constituents,” says Rua. “Currently there are 19 states that have made amendments to the actual CMS step policy.” The panelists agreed that a federal policy setting a length of time for appeals decisions across all insurers would be beneficial.

Educating Patients About Step Therapy

In another video, the panel reviewed a hypothetical case in which a patient has a particular disease, and his care team has decided to offer a specific therapy. Everything is set in motion, but the insurer’s step therapy policy mandates a different approach to the patient’s treatment.

“As a nurse navigator, a lot of times we get the backlash of all of this,” says Rua. “The patients don’t necessarily communicate their angst, disappointment, and fears to their physicians, so it’s really important to educate the patient in a way that doesn’t detract from the decision that’s been made.”

The focus on a patient’s mental health and the psychosocial aspects of care are crucial during this time, agreed the panelists. Education can help the patient understand why a medication was denied and that there are alternative yet effective options that will get them clinically appropriate care.

But Rua says the situation still inevitably creates anxiety, affecting the patient’s overall care and experience. “It puts a negative strain on the physician-patient relationship,” says Rua. “Because they had seen their physicians as the end-all-be-all, and now they are no longer allowed or capable of getting what they’re prescribed. The stress that it adds to the relationship is detrimental. It undermines that relationship, and it undermines the physician.”

“Patients often feel guilty,” adds Dr. Schwartzberg. “When you propose a therapy to them, and they can’t get it, they feel they picked the wrong insurance plan. And they say, ‘Oh, I had the option to pick A or B, and I took the one with the lower deductible, and now look how it’s coming back to hurt me.’”

“One of the ways that providers can frame the discussion, especially early on in the relationship, is to not be as prescriptive at the beginning and say, ‘There are several excellent ways to treat your cancer, and this is the one I’m picking,’” adds Dr. Schwartzberg.

The panelists agreed that in order to deliver the best care possible, they must serve as advocates for their patients and remain flexible, transparent, and supportive.

“We have a process of communicating with the payer who’s made the step therapy decision,” says Dr. Schwartzberg, “and we can be successful with that, assuming we can have the information and make a compelling argument. . . .In most cases, we’ve been successful if we have a compelling story about why one therapy might be better than another.” 

Watch ACCC’s video lecture series for more insights on the potential impact of step therapy as a cost-containment strategy for oncology.  

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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.