When your doctor prescribes a medication, you expect to get it. But for millions of Americans, that’s not how it works. Instead, your insurance company might force you to try cheaper, generic drugs first-even if your doctor says they won’t work for you. This is called step therapy, and it’s one of the most common-and controversial-rules in health insurance today.
Step therapy, also known as a "fail-first" policy, means you can’t get the medication your doctor ordered until you’ve tried and failed one or more lower-cost alternatives. These alternatives are almost always generics. The idea? Save money by avoiding expensive brand-name drugs unless absolutely necessary. But for many patients, this system doesn’t save time or money-it delays care, worsens symptoms, and sometimes causes permanent damage.
How Step Therapy Actually Works
Insurance plans organize drugs into tiers. Step therapy kicks in when your prescribed drug is in a higher tier. For example, if your rheumatologist prescribes a biologic for rheumatoid arthritis, your insurer might require you to try three different NSAIDs first. Each one must be tried, taken as directed, and documented as ineffective before you can move to the next step.
According to a 2021 analysis by the National Institutes of Health, about 40% of all prescription drug plans in the U.S. use step therapy. That number has climbed 15% since 2018. Most employer-sponsored plans, Medicaid managed care, and individual market plans include it. Even Medicare Part D plans use it for certain specialty drugs.
The process isn’t random. Insurers follow strict protocols. Aetna, Blue Cross Blue Shield of Michigan, and other major insurers publish their step therapy lists online. For asthma, they might require you to try albuterol inhalers before moving to combination inhalers. For depression, you might need to try two SSRIs before getting access to SNRIs. The list is long, and the rules vary wildly between plans.
Why Insurers Use Step Therapy
Insurers don’t use step therapy to make life harder. They use it because drug prices are skyrocketing. A single course of a new biologic can cost $30,000 a year. A generic version? Maybe $300. That’s a 99% difference.
According to the Congressional Budget Office, step therapy can reduce pharmaceutical spending by 5% to 15%, depending on the condition. For insurers, that’s a big win. It’s also why the practice has grown so fast. In 2023, industry analysts at Avalere Health projected that by 2025, step therapy will apply to 55% of all specialty drug prescriptions-up from 40% today.
But here’s the catch: insurers aren’t paying the bills. You are. If you end up in the emergency room because your arthritis got worse while waiting for approval, your hospital bill doesn’t come from the insurer’s bottom line. It comes from your deductible, your copay, or your credit score.
When Step Therapy Goes Wrong
Patients don’t just lose time-they lose function, mobility, and sometimes their health.
One Reddit user, "ChronicPainWarrior," shared their story in March 2023: they were required to fail three different NSAIDs over six months before getting approval for a biologic for rheumatoid arthritis. During that time, their joint damage progressed. By the time they got the right drug, their fingers were permanently deformed.
The Arthritis Foundation’s 2022 survey found that 68% of patients experienced negative health outcomes due to step therapy. Of those, 42% reported disease progression during the required drug trials. That’s not an outlier. A 2022 report from Step Therapy Awareness found that 28% of patients stopped taking their medication altogether because the paperwork was too overwhelming.
And it’s not just arthritis. Patients with multiple sclerosis, psoriasis, Crohn’s disease, and depression report the same delays. The American College of Rheumatology says step therapy is dangerous because it assumes all patients respond the same way. They don’t. One person’s ineffective drug is another’s lifesaver.
Exceptions: The Loophole That Might Save You
There’s a way out: the step therapy exception.
Under federal law and in 29 states, insurers must allow exceptions if certain conditions are met. The Safe Step Act, reintroduced in Congress in 2021, outlines five clear cases where insurers must approve your drug immediately:
- You’ve already tried the required drug and it didn’t work.
- The required drug could cause serious harm.
- The required drug is contraindicated due to another condition you have.
- Delaying treatment would prevent you from doing basic daily tasks.
- You’re already stable on the drug you’re on and switching would risk your health.
But getting an exception isn’t easy. Your doctor has to submit medical records, lab results, and a letter explaining why the step therapy drug won’t work. Many practices report spending 18.3 hours per week just on paperwork related to prior authorization and step therapy.
Blue Cross Blue Shield of Michigan says they review exceptions in 72 business hours. For urgent cases, it’s 24 hours. But that’s not always what happens. Real patients report waits of four to eight weeks. That’s longer than a flu season.
What Happens When You Switch Plans?
Here’s the cruel twist: if you change jobs, get new insurance, or switch from Medicare Advantage to Original Medicare, you might have to start step therapy all over again-even if you’ve been on the same drug for five years.
Healthinsurance.org reports that patients often face treatment interruptions when switching plans. One woman with lupus had to stop her medication for three months after changing employers. Her kidneys started failing. She had to be hospitalized. Her new insurer eventually approved the drug-but only after she submitted proof from her old doctor, her ER records, and three separate appeals.
Self-insured employer plans, which cover 61% of Americans, aren’t even required to follow state exception rules. That means if your employer self-insures, you have fewer protections-and more risk.
What You Can Do
If you’re stuck in step therapy, here’s what actually works:
- Ask your doctor to file an exception immediately. Don’t wait. The sooner you start, the sooner you might get approved.
- Get copies of all your medical records. Insurance companies require proof you’ve tried other drugs. If you’ve been on the same medication for years, your old prescriptions are your best evidence.
- Call your insurer. Ask for the name of the case manager assigned to your file. Call them weekly. Politely, but persistently.
- Check if your drug manufacturer offers a patient assistance program. 78% of major drugmakers provide co-pay cards or free trials that can bypass step therapy.
- Know your state’s laws. If you live in a state with step therapy protections, you have more rights. Visit StepTherapy.com for a state-by-state guide.
And if you’re on a generic drug that works? That’s great. Step therapy isn’t always bad. A 2023 GoodRx survey found that 17% of patients ended up doing better on the required generic than they did on the brand-name drug. But that shouldn’t be the exception. It should be the rule.
The Bigger Picture
Step therapy exists because drug prices are out of control. But instead of fixing the root problem, insurers shifted the burden to patients. They turned doctors into clerks and patients into bureaucrats.
There’s no easy fix. But pressure is building. In 2023, 14 more states introduced new step therapy laws. Eight strengthened existing ones. The Safe Step Act is still alive in Congress. If it passes, it could force self-insured plans to follow the same rules as everyone else.
Until then, if you’re caught in the system, you’re not alone. And you’re not powerless. Know your rights. Document everything. Push back. And don’t let an insurance form decide what treatment you need.
