What fail-first protocols are, how they work, and how to get around them — including state override laws and the appeal process.
Step therapy is a prior authorization protocol that requires patients to try and fail on one or more less expensive medications before an insurer will approve coverage for the drug their doctor actually wants them to take. The insurer sets the sequence — your doctor does not.
Step therapy is used most commonly for brand-name drugs when a generic exists, specialty medications for chronic conditions like rheumatoid arthritis, Crohn's disease, and multiple sclerosis, mental health and psychiatric medications, and pain management medications.
Step therapy protocols are set by PBMs and insurers, not by your doctor, not by clinical evidence, and not by the FDA. The sequence is built into the insurer's formulary and prior authorization system. The preferred first-step drug is often the one that generates the highest rebate for the PBM — not the one most likely to work for you.
For many conditions, step therapy is more than an inconvenience. For a patient with rheumatoid arthritis whose disease has been controlled by a specific biologic, being forced to step down to an alternative can mean weeks or months of disease flare, joint damage, or hospitalization. For a patient with a psychiatric condition that has responded to a specific medication, switching can mean destabilization that is very difficult to reverse.
A step therapy override allows your doctor to prescribe the medication they consider most appropriate without requiring you to fail on the insurer's preferred sequence. Override grounds typically include:
