Step Therapy: What Patients Need to Know

September 11, 2020
Doctor writing on clipboard

In 2018, the U.S. spent $3.6 trillion, or approximately 17.7% of gross domestic product, on health care (Centers for Medicare & Medicaid Services, 2019). UM techniques take several different forms, all aimed at managing health care costs by influencing patient care decision-making through case-by-case assessments of the appropriateness of care (Institute of Medicine Committee on Utilization Management by Third Parties, 1989). When implemented appropriately, these techniques can enhance the patient experience. However, UM practices can also negatively impact patient access to care as well as contribute to provider burden (American Medical Association, 2018). This blog focuses on one type of utilization management called step therapy.

What is Step Therapy?

Step therapy, also referred to as “Fail First or “Try and Fail,” is a policy where a patient is required to try an alternative product (medicine, therapy or service) to the one that the doctor prescribes. Only if that less expensive product does not work well (the patient does not respond to it, the patient experiences complications, etc.) will the insurance company cover the originally prescribed drug. In other words, products are placed on steps (otherwise known as tiers) and a patient must start with the lower cost step and proceed up through the higher cost steps.

How Does Step Therapy Impact Patients?

When step therapy policies are put in place, patients may have to start taking a therapy that is different than what their doctor originally prescribed. This can cause delays in treatment, increased distress, and unexpected costs (Cancer Support Community, 2016). The Cancer Support Community (CSC) has found that over 32% of patients reported starting the medication required by the insurance company instead of taking the medication originally prescribed to them, while 16% reported a delay in treatment by deciding not to take the medication and waiting until an exception was granted. Most alarmingly, 8.5% of patients surveyed decided not to start any medication (Cancer Support Community, 2016)

How Does Step Therapy Impact Providers?

Step therapy is not only a barrier to high quality patient care, but it can also burden providers. Step therapy is a time-consuming process that affects patient-healthcare provider decision-making as it shifts the clinical decision-making away from physicians (Chung, MacEwan, & Goldman, 2016). The administrative burden associated with step therapy, including the time spent contacting insurance companies regarding coverage, detracts from time that could be spent on patient-centered health care (Chung, MacEwan, & Goldman, 2016).

Advocacy Opportunities

At the CPI, we advocate for access to affordable, comprehensive cancer care. As such, we oppose step therapy policies for individuals being treated for cancer, and support the following:

  • Treatment that is based on clinical guidelines and shared decision making, not solely cost to health plans
  • Safeguards to protect patients from the harmful impacts step therapy policies
  • A transparent exceptions and appeals process for prescribing health care providers and patients
  • An exception and appeal timeline of 24 hours for emergency cases and 72 hours for nonemergency cases
  • Established policies for when the prescribing health care provider can override step therapy when medically appropriate for a patient

The outlined ways in which step therapy can negatively impact access to treatment is a perfect example of why it is important for all health care stakeholders - including health care systems, health insurance companies, pharmacy benefit managers, employers, and members of the health care team – to come together to advocate for policies that protect patients from harmful step therapy policies. Federal and state policy activities provide additional opportunities for step therapy advocacy engagement, including streamlining the step therapy process, providing clear timelines, and increasing transparency.

Step Therapy Policy Advocacy:

More than twenty states have enacted legislation on step therapy mandates. Learn more about legislation by state at

Congress is also taking action through a federal effort focused on increasing access to treatments by curbing step therapy practices. H.R. 2279/S. 2546, also known as the Safe Step Act, aims to enact a review process that ensures step therapy protocols are based on sound clinical guidelines. The bill outlines a clear and convenient step therapy exception process and establishes a timeline that health insurers must meet when receiving an exception request.

The Impact of COVID-19

Amid the COVID-19 pandemic, many patient organizations have advocated to lift step therapy and other UM techniques that affect access to timely care and services. Certain actions have been taken to ensure patients can access medically necessary treatments during this uncertain time. For example, at the onset of the pandemic, California required all health insurers in the state to streamline or eliminate step therapy processes. Some insurance providers have streamlined or suspended prior authorization requirements for many services in an effort to reduce health care provider burden. Additionally, many insurance providers have waived prior authorization and step therapy requirements related to the testing and treatment of COVID-19. CSC continues to advocate for the lifting of UM techniques (such as step therapy) that prevent access to timely care and services during the pandemic.

What Can You Do?

Many states have yet to enact legislation to streamline the step therapy process and protect patient access to care. Using your voice to help policymakers understand what is important to people affected by cancer is one way to take action regarding step therapy. You can engage with elected officials by phone, email, or social media to share your concerns about step therapy. For example, you can urge your state’s members of Congress to support the Safe Step Act. Check out our Advocacy Tools to learn more about contacting your elected officials.

Another way to get involved is by sharing your story. If you have been personally impacted by step therapy, sharing your story can help policy makers understand the importance of amending existing step therapy processes. You can make your voice heard through our Share Your Story tool. Additionally, by signing up for the Grassroots Network, you can receive regular updates about policies that could impact cancer patients and their families, and make your voice heard with decision makers at every level.

Missed our blog on Prior Authorization? Read it here!


American Medical Association. (2018). 2017 AMA Prior Authorization Physician Survey.

Cancer Support Community. (2016). Access to care in cancer 2016: Barriers and challenges. Washington, DC: Author.

Chung, A, MacEwan, J, Goldman, DP. Does A ‘One-Size-Fits-All’ Formulary Policy Make Sense? Health Affairs Blog. 2016. doi: 10.1377/hblog20160602.055116

Institute of Medicine Committee on Utilization Management by Third Parties. (1989). Controlling costs and changing patient care?: The role of utilization management. National Academies Press: Washington, DC.

U.S. Centers for Medicare & Medicaid Services. (2019). NHE Fact Sheet. Retrieved from