OBJECTIVES: Step therapy protocols require patients to first fail an alternative cheaper treatment before gaining access to a more expensive drug. Health plans use step therapy protocols to optimize prescribing, but there is a risk that their inappropriate application can impede patients’ access to much needed treatments. We assessed a set of US commercial health plans’ use of step therapy protocols in their specialty drug coverage decisions.

METHODS: We used the Tufts Medical Center Specialty Drug and Evidence Coverage (SPEC) database, which includes information on how 17 large US commercial health plans cover specialty drugs. We analyzed coverage decisions in force in December 2019 (n=7,380). We determined how frequently plans in SPEC applied step therapy protocols in their coverage decisions, the number of drugs plans required their enrollees to step through, and the diseases for which plans applied step therapy protocols most often.

RESULTS: Overall, health plans applied step therapy protocols in 38.9% (2,872/7,380) of coverage decisions. Plans applied step therapy protocols with different frequencies (from 20.6% to 57.5% of decisions), with one plan applying step therapy protocols in more than half of their decisions. On average, plans required patients to step through 1.5 (SD: 0.8) prior therapies. This number varied between 1.2 and 1.8 steps across plans. Health plans most often applied step therapy protocols in coverage decisions for drugs indicated for ulcerative colitis, chronic migraine, Crohn’s disease, psoriasis, and rheumatoid arthritis.

CONCLUSION: US commercial health plans commonly impose step therapy protocols in their specialty drug coverage decisions, with study plans doing so in at least one fifth of their decisions. Plans vary with respect to the number of alternative drugs they require patients to step through before accessing the prescribed drug. Health plans often imposed step therapy protocols in decisions for various autoimmune diseases and for chronic migraine.