Step Therapy
A cost management practice where Medicare Part D or Medicare Advantage plans require patients to try lower-cost drug alternatives before approving coverage of a more expensive prescribed medication.
Step therapy (also called "fail first") requires a patient to try one or more lower-cost drugs in the same therapeutic class before the plan will cover the originally prescribed medication. For example, if a physician prescribes a newer biologic for rheumatoid arthritis, the plan may require the patient to first try two older DMARDs for 3–6 months each before approving the biologic — even if the physician believes the biologic is the appropriate first choice.
CMS expanded MA plans' authority to use step therapy for Medicare Part B drugs (physician-administered biologics and infused medications) beginning in 2019. Part D step therapy is separately governed by plan formulary design standards. Step therapy is most prevalent for specialty drugs, psychotropic medications, pain medications, and biologics.
Exceptions to step therapy are available when the plan requires it as a condition of coverage. A physician can request a formulary exception or PA exception demonstrating that the required "step" drugs are contraindicated, previously failed (prior history), or will cause clinical harm. Immediate approval is appropriate when step therapy would result in a clinically significant adverse event, significant deterioration, or is a biological medication with immunogenicity concerns.
Real-World Example
A physician prescribed Humira for a newly diagnosed Crohn's patient; the MA plan's step therapy protocol required a 3-month trial of azathioprine first. The physician submitted a step therapy exception documenting the patient's elevated liver enzymes that contraindicated azathioprine, and the plan approved Humira without the step.