Advocacy in Action: Putting Guardrails Around Step Therapy

By Matt Devino, MPH

Step therapy is a method of prior authorization used by health insurance plans and pharmacy benefit managers (PBMs) to control prescription drug use and contain costs. Also known as “fail first” therapy, this approach requires patients to try (and “fail”) one or more lower-cost medications before the insurance plan will cover the drug originally prescribed by a patient’s physician.  

As a utilization management tool, “fail first” requirements are particularly problematic and misaligned with the evolution of modern cancer care, which is informed by a growing understanding of cancer biology and disease-specific treatments increasingly driven by therapies directed at actionable molecular biomarkers. For many types of cancers, interchangeable treatment options do not exist.  

The delivery of the right treatment to the right patient at the right time is a hallmark of quality care. Step therapy applied to oncology can needlessly and dangerously derail a patient's care. Finding balance in step therapy so patient well-being comes first, exemption and appeals processes are timely and transparent, and duplicative administrative hurdles are eliminated are important guardrails toward improving access equilibrium for patients and providers. Learn more about step therapy challenges in oncology here.  

On Capitol Hill 

In February 2021, Senator Lisa Murkowski (R-AK) introduced S. 464, the Safe Step Act. This bipartisan legislation would establish guardrails around group health insurance plans’ step therapy protocols. The Safe Step Act includes some important protections for patients with cancer, including addressing circumstances in which patients may be exempt from a step therapy protocol and requiring insurance plans to respond “no later than 72 hours after receiving an initial exception request.”  

For patients with cancer whose treatment plans may be held up by prior authorizations, establishing a 72-hour response window for health plans will help reduce unnecessary delays in care and mitigate the added anxiety associated with uncertain wait times for an insurer’s coverage decision. Other key protections include a transparent appeals process and protecting patients who have a change in insurance from the unnecessary repetition of step therapy protocols. 

During ACCC’s 2021 Virtual Capitol Hill Day, ACCC members urged their legislators to support S. 464. Learn more here.   

State Action in Arizona 

Nearly 30 states have passed step therapy legislation. Right now, advocates from The Arizona Clinical Oncology Society are urging support for the bill, “Insurance; Prescription Drugs; Step Therapy” (SB1270), introduced by Arizona State Sen. Nancy Barto. The legislation would create a time-sensitive step therapy protocol exemption process that would help protect cancer patients from delays in care. The bill passed Arizona’s state senate in early March and is now under consideration in the house. The Arizona Clinical Oncology Society and the Association for Clinical Oncology have issued a joint letter of support for the legislation. 

Arizona hematologist/oncologist Raju Vaddepally, MD, a director-at-Large for The Arizona Clinical Oncology Society, explains that this legislation will address a critical issue for patients with cancer and their physicians: Time. Step therapy protocol typically includes administrative requirements that frustrate patients and providers alike, who often are forced to wait weeks for the insurer’s coverage decision. When a therapy is denied, there is another wait for the alternative drug to arrive. “So, you can see how long the patient has to wait sometimes, and unfortunately cancer doesn’t wait for anyone,” says Dr. Vaddepally.  

Delaying the start of treatment can increase patient anxiety, during which time patients may become sicker. “In terms of timing, it is essential that we start patients at the right time in the right [ECOG] status, otherwise we may lose them,” says Dr. Vaddepally. SB1270 would require health plans to respond to physician requests within a set timeframe (usually 48 to 72 hours), a critical protection for patients.  

A Physician's Perspective

Dr. Vaddepally cares for patients at Yuma Regional Medical Center Cancer Center, a facility that sees a large proportion of underserved, underinsured, and uninsured patients of a diversity of ethnicities. He believes that insurers also have an obligation to patients with cancer to, “look at things from a different lens. It’s not just cutting costs at every corner. There are times you have to give a [more expensive] drug. And patients deserve not to have to wait several weeks for a response [on drug approval].” 

In his practice, Dr. Vaddepally is also seeing a similar trend in more required prior authorizations for imaging, which has been quite challenging for day-to-day practice and operations. 

While step therapy may be a viable utilization containment tool for some health conditions for which there are multiple equally effective drugs available, for cancer and a number of other chronic diseases, this is not the case. In the current environment, step therapy only increases costs—for hospitals, physicians, and patients—both in dollars spent and morale. 

“We are really having a lot of struggles with insurance companies. We have a separate and dedicated department that works on getting drugs authorized,” says Dr. Vaddepally. “In spite of having additional personnel, it’s a full-time job to obtain financial authorizations for these drugs and imaging tests—even then we don’t clear all the hoops that insurers put us through.” 

Dr. Vaddepally’s perspective as a clinician is familiar to many providers. To obtain prior authorization, first the nurse or patient navigator gathers all the necessary documentation and provides this to the insurance plan. The documentation typically includes an explanation of the patient history, current status, and why the specific requested drug (or imaging) is necessary. Despite providing this, many times the insurer (or PBM) will require physicians to speak directly with insurers or PBMs before they agree to approve the drugs, a process known as a “peer to peer,” which takes clinicians away from providing patient care. Even reaching the insurance company’s peer review physician can be a struggle. “Then they ask the same information, and we have to explain all the same things [that have already been provided],” explains Dr. Vaddepally. Even when the peer reviewer approves the treatment, the practice will often later receive a notice saying the drug has been denied.  

“It doesn’t make sense,” Dr. Vaddepally says. “Most days we go from 8 am to 5 pm seeing patients back-to-back. We only have so much time. We have to document our patients’ findings and notes, and then we have emails, phone calls, messages. Healthcare has gotten more complicated than almost any other industry right now.” 

In addition to advocacy support from ASCO and ACCC, The Arizona Clinical Oncology Society has joined state-wide coalitions, such as Arizonans for Step Therapy Reform, that elevate the voices of diverse patient populations impacted by step therapy, including the advocates from the American College of Rheumatology, the American Cancer Society Cancer Action Network, the American Liver Foundation, the Arizona Medical Association.  

Although participating in advocacy activities was a new experience for Dr. Vaddepally, the timing was right, he says: “When I started my career as a community oncologist, the first thing I did was join The Arizona Clinical Oncology Society. Once I started noticing the real-time struggles patients go through, I thought, well, I’m perfectly matched [for advocacy] right now being a part of the state oncology society. This is the right opportunity.”  

Delivering the best care possible to patients with cancer requires constant learning that extends beyond keeping up to date on the latest research and clinical advances, says Dr. Vaddepally. “I learn every day about the social paradigm in the community. . . . I’m opening a dialogue with patients.” Many of his patients have no health insurance coverage. They struggle to find money for gas, transportation, food—even shelter. “We need to know the patient’s education, their financial status, social circumstances, demographics, and how we can help them. As a clinician when I’m speaking to them, they are not going to ask me [about help with affording care]; I have to open that Pandora’s Box for them and make them feel comfortable talking about these important logistical issues.” 

Dr. Vaddepally says advocating for patients through The Arizona Clinical Oncology Society and caring for patients at the bedside is very rewarding: “I like what I do.”