Study: Health Plans Use Restrictive Step Therapy Protocols

Half of the step therapy protocols for specialty drugs evaluated by investigators go beyond what is suggested in treatment guidelines.

Among the largest U.S. commercial plans, step therapy was applied to one-third of specialty drug coverage policies and half of those protocols were more stringent than treatment guidelines recommended by clinical organizations, according to a study published in the November 2021 issue of Health Affairs.

Cost savings generated by step-therapy protocols may be offset by additional costs associated with therapy that ends up being ineffective and may have a negative impact on patient outcomes, said investigators, led by Kelly L. Lenahan, associate director at ISPOR— the Professional Society for Health Economics and Outcomes Research. She was research associate in the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, when the majority of this research was conducted.

“Large deviations from the treatment algorithms recommended by national clinical organizations may indicate that a plan’s step therapy requirements present an undue burden on both the patient and the prescribing clinician administering the protocol,” the investigators wrote.

Investigators looked at how large health plans apply step therapy for specialty drugs in 10 diseases in which step protocols are often required: chronic migraine, Crohn’s disease, psoriasis, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathy arthritis, multiple sclerosis, and hepatitis C.

They used Tufts Medical Center’s Specialty Drug Evidence and Coverage (SPEC) Database, which includes information on how 17 of the 20 largest commercial health plans in the United States cover specialty drugs. These plans represent 150 million covered lives.

Investigators compared plans’ step therapy programs with treatment algorithms recommended by clinical organizations and with clinical trials used to support FDA approval.

Investigators found that the included health plans applied step therapy protocols in 38.9% of their coverage policies, and on average included 1.5 steps.

Of the 1,057 coverage policies for the 10 diseases where step therapies studied by investigators, 34.1% were consistent with clinical guidelines, 55.6% were more stringent, 6.1% were less stringent, and 4.2% required patients to use drugs different from those in the treatment guidelines.

Across the 10 diseases evaluated, plans were more consistent with treatment protocols for some diseases and less consistent for others. For example, plans’ protocols for drugs indicated for Crohn’s disease were consistent with clinical guidelines 67.8% of the time.

But health plans’ protocols for psoriasis were more stringent than the treatment guidelines 99.4% of the time. Plans’ protocols for psoriatic arthritis, hepatitis C, and multiple sclerosis were more stringent than the guidelines 50% of the time or more.

“These differences raise questions and concerns about potentially overly restrictive step therapy protocols; the burden protocols place on patients; potential delays in provision of and discontinuities in effective drug therapy; and potential differences in patients’ access to specialty drugs, across plans, for the treatment of the same clinical conditions,” investigators wrote.