What Is Step Therapy? And Why It Might Delay Your Medication

Navigating the healthcare system to get the care you or a loved one needs can be challenging. Just when you think you’ve cleared the hardest parts — finding the right provider, getting an accurate diagnosis, and choosing a treatment plan — your insurance company can throw in a surprise roadblock by denying coverage for a prescribed medication. One possible reason? A policy called step therapy.

Step therapy is a requirement that makes people try a lower-cost or insurance-preferred medication before their insurer will consider covering the specific one their clinician prescribed. If the first medication doesn’t work, the insurer may then approve a higher-tier option. Sometimes, patients have to try and “fail” multiple medications before getting access to the one initially recommended.

In some instances, it’s possible to bypass step therapy requirements by requesting an exception or making an appeal — but the keyword is possible. Patients caught in the crosshairs may be kept on edge for weeks to months, anxious about whether they’ll be able to get their treatment.

“It’s just a non-transparent, confusing process where you’re praying every day that your med gets approved while you get worse,” says Dayna Pham, who became a patient advocate after struggling to get insurance coverage for the psoriatic arthritis treatment her rheumatologist prescribed.

Prescribers are also frustrated.

“Basically, medical care at this point is subject to insurance policies,” says Jenna Kopp, APRN, director of clinical operations at Midwest Gastrointestinal Associates in Nebraska. “Even though we have so many more medications to choose from today, we don’t really,” she says, pointing out that she sees patients every day who are impacted by step therapy. So much of the “choice” is dictated by the insurer’s order of step therapy rather than what is guideline-driven treatment, she explains.

Whether you’re currently facing step therapy challenges or not, it’s helpful to understand how step therapy can affect your access to prescription medications.

What Is Step Therapy and Why Does It Exist?

Step therapy is primarily a cost-management tool, says James D. Chambers, Ph.D., MPharm,, an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. The idea, he explains, is to control prescription drug costs by preventing the overuse of high-cost medications and promoting lower-cost, clinically appropriate options instead.

Both public and private insurance plans use step therapy protocols to guide prescribers in selecting therapies that are both evidence-based and cost-effective. This is according to a pharmacist with experience working for Pharmacy Benefit Managers (PBMs), who is currently employed by Navitus but was not authorized to speak on the company’s behalf. Specific step therapy rules, notes this pharmacist, can vary by insurance policy and apply only to certain medications, medical devices, procedures, or services.

In a 2023 Morning Consult poll of 2,202 adults sponsored by the Patient Access Network Foundation, one in six people said they’ve been affected by “fail first” insurance policies when trying to access coverage for a medication their clinician prescribed for them. But you may be affected by step therapy and not even realize it, says Jennifer Drum, PharmD, a clinical consultation pharmacist. She says many patients she encounters aren’t aware that their treatment is being guided by step therapy; they just know whether a medication is covered or not.

High-cost medications are often subject to added restrictions when lower-cost or generic alternatives exist for the same condition, explains the Navitus pharmacist. But it’s not just the drug’s listing price that matters. Health plans or PBMs tend to favor drugs whose manufacturers offer them larger discounts or rebates compared to competing drugs in the same category. Even drugs listed as “preferred” on a formulary can carry step therapy requirements, meaning patients may still have to try and fail other treatments first.

“Health plans are increasingly using step therapy during prior authorizations [the process insurers use to determine whether a treatment will be covered] to limit access to more medications,” notes Dr. Chambers.

“Health plans are increasingly using step therapy during prior authorizations [the process insurers use to determine whether a treatment will be covered] to limit access to more medications.”

In fact, a 2021 study co-authored by Dr. Chambers found that nearly 40% of drug coverage policies across 17 major U.S. commercial health plans included step therapy protocols. By steering patients towards formulary medications that have lower negotiated prices, insurers and PBMs can control their drug spending costs.

Prescription drugs represent a major cost for insurers, which is why medication coverage is closely managed. In 2024, these drugs made up more than 10% of total healthcare spending. To keep premiums [and out-of-pocket costs] affordable, insurers often place restrictions on high-cost medications, Dr. Chambers explains. While step therapy reforms can offer important protections for patients, he notes, they don’t eliminate the practice altogether.

For example, biologics, which account for nine of the 10 most expensive medications and comprise nearly a third of newly approved drugs in 2024, are a major target of many step therapy protocols. These specialty medications are used to treat the chronic health conditions most often affected by step therapy protocols, including chronic migraine, multiple sclerosis (MS), rheumatoid arthritis, and inflammatory bowel disease (IBD), like Crohn’s disease and ulcerative colitis.

Drug policy experts say step therapy protocols are a symptom of our failure to address high drug pricing at the societal level. As a result, patients and providers are often caught in the middle, struggling through a complicated maze to access necessary treatments.

How Step Therapy Can Delay or Derail Effective Treatment

When there’s a mismatch between step therapy protocols and current treatment recommendations, that’s where problems arise, says Dr. Chambers, who consistently finds wide variation between the two in his research. While about a third of insurance plans align with guidelines, concerningly, more than half are “more stringent,” meaning patients in these plans may have trouble accessing needed medication.

“The science by which insurance companies are making their algorithms for step therapy is usually outdated,” says Jonah B. Essers, M.D., MPH, a pediatric gastroenterologist at Swedish Health Services in Seattle. What’s more, he says that the algorithms insurance companies use aren’t peer-reviewed and litigated in the same way recommendations from governing bodies, such as the American College of Gastroenterology, are.

In general, treatment guidelines are meant to be individualized, as not every recommendation within them is supported by equally strong evidence, says Charlene Hope, PharmD, chief pharmacy quality and safety officer at UChicago Medicine. And sometimes, there aren’t any official guidelines, adds Dr. Chambers.

Despite what Dr. Chambers and medical providers may think, there is a deeply detailed process for how step therapy guidelines are developed at Navitus. According to sources, payors collaborate with the P&T committee, the drug information team, and medical directors. Medicare, Medicaid, and state requirements are factored in, and treatments are evaluated based on cost and outcomes to determine the best options for coverage.

Navitus is a small PBM, and differs from many others in the industry: It operates on a transparent pricing model. And while some PBMs may follow responsible practices, Dr. Chambers advocates for broader transparency overall to ensure step therapy decisions don’t prioritize cost savings over sound clinical judgment. “It’s important that the public can see their justification for prioritizing some medications over others,” he says, “to show it’s based on a drug’s safety and efficacy profile and not ‘negotiated discounts obtained in backroom dealings.’”

Even when step therapy protocols match treatment guidelines, both Dr. Essers and Kopp note that the fields of care they specialize in are changing so rapidly that the guidelines themselves are often not up to date. For example, Kopp notes that newly approved drugs may take a year or more to become incorporated into the guidelines.

Additionally, inconsistent step therapy protocols lead to unequal care, says Dr. Chambers. “Patients in different health plans have very different access to the same therapies,” he explains. This can also lead to problems if someone changes insurance plans.

In some cases, an individual may no longer qualify for a medication they’re currently taking and instead be required to start the step-up process over again. Other times, switches may occur because your insurance plan’s formulary changes and the steps in step therapy are reordered, says Dr. Drum. With biologics, “it takes three to six months to see the full therapeutic effect and benefit,” she says, which is why extra steps can make finding an effective treatment a lengthy process.

According to Dr. Essers, step therapy rules can be especially complicated when it comes to the individualized treatment approaches that are important with children. “Almost every drug we use with a child is ‘off label,’ meaning that there isn’t an FDA indication for it,” he adds,

The challenge arises when families and providers settle on a plan — only to have the insurance company reject it. Some step therapy protocols classify the use of an off-label medication as “experimental,” Dr. Essers says, even when there’s strong evidence that it’s safe and effective, and no better alternatives are available.

Another difficulty with step therapy is that it’s nearly impossible to anticipate which medication will be covered. “There is no uniformity whatsoever. Every single metric is different: appeal process, time to appeal, type of documentation, time limit for each drug,” explains Dr. Essers

According to Dr. Hope, what really puts patients at risk is the inherent complexity of insurance mandates like step therapy. The administrative burdens and extra documentation may prevent timely access to needed medications, she explains. For patients with language or health literacy barriers, this can make it even harder to get a drug approved, she adds. “Insurance plans are just so complex to navigate.”

Pham learned firsthand just how complex the process can be. “Naively, I thought having the knowledge and resources as a medical student would have made it digestible,” she explains. Despite having debilitating back pain and barely being able to sleep and function, Pham faced repeated insurance denials for the medication prescribed to her. While waiting for access, she struggled to stay afloat with her studies as her condition worsened, raising the risk of lasting joint and heart damage. Unsurprisingly, her mental health suffered too.

Delays in Care, Declines in Health

Completing additional treatment steps can result in more office visits. According to one study, step therapy led to an average of 1.4 extra appointments, which, as Pham points out, could mean waiting many months just to be seen. Online forums like Reddit are full of people looking for advice and sharing their frustrations. In one discussion, a user named Ciderenthusiast describes the exhausting process of seeking treatment for severe migraines: “Get my doctor to do a PA, deal with more info needed requests, get a denial, doctor appeal, my appeal, wait for appointment, 6 week fake med trial, follow up appointment, and another appeal.” The title of the thread asked, “Why isn’t step therapy illegal?”

Survey research also shows that even when people eventually obtain needed treatment, the delays alone can cause new or worsening anxiety, especially when early or aggressive treatment is needed, such as in Pham’s case.

Kopp, who treats patients with inflammatory bowel disease (IBD), shares similar findings based on her nearly three decades of experience. If inflammation is prevented, these patients not only see their conditions improve, but so does their mental health, social aspects of life, and ability to work. Unfortunately, she says, patients are sometimes relegated to starting on corticosteroids, like prednisone, rather than biologic treatments, which are widely recognized as first-choice treatments. Delaying optimal treatment or forcing patients to use less effective options can lead to their disease progressing and becoming harder to treat, she explains.

The over-reliance on oral corticosteroids in some step therapy plans is especially concerning, Kopp says, given the possible damage that can occur with their long-term use. When used chronically, biologics are safer for many systemic autoimmune diseases and work better because they actually treat the disease rather than just the symptoms.

Similar situations can be found with other conditions. A 2023 review of treatments for overactive bladder found step therapy led to increased use of older medications that cause anticholinergic side effects, such as dry mouth, blurred vision, and constipation. In older adults, the American Geriatrics Society recommends avoiding this group of medications altogether due to the increased risk of falls and cognitive dysfunction. The review also found that many patients don’t return for next-step medical visits. So if they don’t have early access to treatments most likely to work and be tolerated, they may never get them.

“It doesn’t matter how good the medication is if I can’t get it to my patient,” Kopp says.

State and Federal Efforts to Reform Step Therapy

Across the country, efforts to reform step therapy have been mounting. Many states have already passed laws of their own (at least 37 states so far). Requirements differ by state, but most passed reforms require insurers to allow exemptions if a medication is likely to be ineffective or may cause harmful side effects. Some states also set deadlines for insurers to respond to exemption requests, with stricter timelines in urgent cases.

Illinois is the only state to have passed an outright step therapy ban, including for Medicaid, beginning in 2026. According to Illinois State Senator Laura Fine, a ban is necessary because step therapy reforms have had minimal impact. But even with a full ban, she notes that getting insurance companies to actually follow the law will still be a challenge.

Importantly, step therapy laws don’t apply to Medicare plans and, in most cases, also exclude Medicaid. Another limitation to consider with any of these state-level reforms is that they don’t apply to the majority of group health plans, since an estimated 65% of employer plans are regulated at the federal level. These plans — known as self-funded plans and typically offered by large employers — fall under the Employee Retirement Income Security Act (ERISA). To extend step therapy reforms to them, ERISA would need to be amended at the federal level.

To address this gap, a bill known as the Safe Step Act (SSA) was introduced in the U.S. House in 2019 by two physician lawmakers, Representatives Raul Ruiz (D-CA) and Brad Wenstrup (R-OH). This doctor duo paired up on the issue out of concern that step therapy undermines the doctor-patient relationship, which Rep. Ruiz describes as “a critical component of quality of care.” He points out that “it is not safe or fair for patients to be forced to use medications that don’t work for them.” Rep. Wenstrup also notes that step therapy “places additional financial burdens on our health care system as a whole.”

Although the SSA bill successfully passed through the Senate HELP committee and has broad bipartisan support — with 235 House and 48 Senate members backing it — progress has stalled, and some experts doubt it’ll be signed into law any time soon. Still, insurers have taken notice. More than 50 have just signed a pledge to voluntarily reduce barriers and delays in drug coverage approvals. However, similar non-binding promises in the past haven’t fallen short, so physician groups are waiting to see if insurers will actually follow through this time

Is Step Therapy Ever Helpful?

When treatment isn’t urgent or in situations when qualifying for a drug is borderline, Dr. Hope says that going through a step therapy process may make sense. However, she notes it really depends on the drug and disease state. With IBD, for example, she wouldn’t see a need or benefit of step therapy since it could delay or prevent treatment that will achieve the best outcomes.

Dr. Chambers agrees that, in some cases, step therapy can help ensure you’re prescribed the most cost-effective medication for your condition. He points out that a more expensive drug isn’t necessarily better or safer. If a simpler medication is effective and safe for you, trying it first can make sense. Step therapy, he notes, may also help prevent overtreatment.

Step therapy rules are not only put in place due to cost control, “but are implemented for safety,” the Navitus source explains. For example, a high-risk medication may be restricted if safer options are available. The stepwise approach can help ensure that medications are prescribed according to their FDA-approved indication, standard-of-care guidelines, and evidence-based support for off-label uses.

Keep in mind, each insurer or PBM develops its own step therapy protocols, and how they balance cost control with ensuring clinically appropriate care can vary. The only rule of step therapy is that there’s no single rule.

In the short term, step therapy lowers spending on the medications it targets, but this doesn’t mean it helps control healthcare spending overall. For example, Kopp points out that treatment delays and poorly managed care can increase complications of IBD and lead to patients needing more healthcare services in the long run.

What You Can Do

All of the same things you would typically do when seeking healthcare and considering medication treatment can also help if you are impacted by step therapy:

• Find a clinician experienced in treating your type of condition.
• Understand your diagnosis or condition and check that it’s accurately listed in your electronic health record.
• Share your full medical, allergy, and family history with your provider. If information is transferred from another medical office, verify that the new practice has received your complete records.
• Provide your medical team with a list of all your medications and supplements.
• Describe your condition in detail: When did it start? What are your symptoms? How is it impacting your life? What treatments have you tried? Make sure to include drug names, doses, dates, and outcomes of any past treatments.
• Know all of your treatment options. Ask if step therapy is limiting your options, and if so, how.
• Ask if a wait-and-see approach is an option.
• Find out what lifestyle changes might be beneficial.
• Ask how urgent it is that you start treatment. Find out if there are any short-term or “bridge” therapies you can take for symptom relief while you’re waiting to see if your medication will be approved.
• Discuss your own risks, benefits, and preferences to determine the best approach.
• Learn about your medication before starting it, so you know how to take it safely, what to watch out for, and what to expect. Ask about drug or food interactions.
• Ask how you will obtain your medication and how coverage will be determined. Know who to contact to check on the status.
• Complete any pretreatment laboratory or other testing on time.

Missing information is a common reason for insurance denials, explains Dr. Hope. She recommends getting to know your pharmacist, as they can help review your medication list to make sure it’s updated and accurate. Specialty pharmacists, who dispense complex, costly medications referred to as specialty drugs, may also be available to answer questions.

If you receive a denial from your insurance company, discuss appealing the decision with your doctor or prescriber. Ask them to write a letter of support to your insurer to explain why the prescribed medication is a necessity. Keep detailed records of any communication you have with your insurance company.

The appeals process depends on what type of plan you have. It’s recommend patients read the appeal instructions included in the denial letter closely. Pay close attention to documents requested and the deadline for submitting an appeal. All of these steps are outlined in the denial letter sent to the patient and doctor’s office, and highlighted several potential next steps, depending on insurance plans:

• Request a second-level internal review by a Grievance and Appeals team. “A peer-to-peer review may allow your provider to have a one-on-one phone call with the pharmacist who reviewed the original coverage determination.”
• Seek an external review from an independent review organization.
• Pursue further action, such as a court hearing for attorney, council, or judicial review.

After Pham’s insurance appeal was denied, she eventually obtained coverage for the medication her rheumatologist recommended with the help of a patient access support program (PASP) run by the medication’s manufacturer. The program staff worked directly with her insurance company to achieve coverage, she explained.

Kopp created a whole infrastructure within her organization to manage the prior authorization process, but she notes that many medical offices don’t have the resources to do that. If you’re having difficulty affording a medication prescribed to you, a PAP may be another option to consider after talking with your clinician. While Pham is thankful the PASP helped her get her medication approved, she points out that these programs are “a small bandage on a much larger problem” within our broken healthcare system.

Just remember, an insurance claim denial doesn’t have to be the final word. Each decision in the appeals process is made independently, so a denial at one level doesn’t mean the same outcome at the next. Staying persistent can help you obtain the medication you need.