What is Step Therapy and What Does It Mean for Patients?

May 21, 2019

Medical doctors have years of training and expertise in their chosen field. And yet, when it comes to prescribing a medication, they often have to jump through hoops before their patients can get the medicine they recommended. One of those hoops is called a “fail first” or “step therapy” policy.

What is step therapy?

Step therapy is when an insurance company or pharmacy benefit manager (PBM) requires a patient to try certain medications, which may be lower cost to them, without success before agreeing to cover a particular medication that the patient’s doctor prescribed. In other words, the insurance company may deny a drug that a doctor has chosen to prescribe in an effort to control their costs.^[1]

How does it work?

As an example, a physician prescribes a medication for a patient's condition. That medication is on the drug formulary, but the insurance company requires the patient to first try—and fail—medications the insurance company "prefers." When this happens, the physician must then prove to the insurance company or PBM that those drugs didn’t work in the past, in order for the patient to get coverage for the medication that the physician had originally prescribed.

The process can take weeks or even months. And if a patient switches to a new insurer, they may have to go through this process again, depending on the drug formulary and the insurance plan.

What does it mean for patients and physicians?

This practice can present challenges for patients, many of whom have serious illnesses and cannot afford to delay getting the treatments they need. In 2017, the American Medical Association surveyed 1,000 U.S. physicians about prior authorization—requiring a doctor to state that a drug is medically necessary for the patient—[2]and 92% indicated that prior authorization procedures can result in delays in care for patients as they go through the required steps.

15% of physicians said the process “always” results in delays to necessary care

39% said it “often” results in delays to necessary care

38% said it “sometimes” results in delays to necessary care

6% said it “rarely” results in delays to necessary care

1% said it “never” results in delays to necessary care

Further, the AMA survey found that the process can lead to patients abandoning treatment. 78% of physicians polled reported that they’d seen patients give up on the recommended course of action.^[3]

Fail-first policies can also be burdensome to physicians. Eighty-four percent of those polled by the AMA said the burden was “high or extremely high” on physicians and staff in their practice.^[4] And 51% noted that the burden has “increased significantly” in the past five years.^[5]

In 2018, the AMA and nearly 100 medical groups opposed allowing Medicare Advantage plans to use step therapy for Part B drugs beginning in 2019, stating in a letter[6] that “delays in getting appropriate treatments can mean prolonged symptomatic periods and irreversible damage” for patients with particular diseases like UC, and for those with cancer, “selecting the proper personalized treatment as quickly as possible can be critical to survival.”

What can patients do?

A number of states are stepping up to make a difference. In recent years, 19 states have passed laws that allow insurers and PBMs to continue to use step therapy, but add important patient protections that ensure it is used safely and appropriately.^[7] For example, some state laws ensure that patients can be exempted from step therapy requirements when medically appropriate. Some states also limit the amount of time that insurance companies or PBMs can wait before approving or denying an exemption request.

Patients can find out if their state has a policy that helps establish rules and limits for step therapy and educate themselves about what it covers. If their state doesn't have such a policy, they can reach out to elected officials and voice their support for responsible step therapy practices that put patients first.