Study finds significant variation in how payers are using step therapy

Insurers' use of step therapy for specialty drugs varies widely, according to a new study.

The analysis, led by researchers at Tufts University and published in Health Affairs, tracked the application of step therapy protocols across 17 payers. Across those insurers, 38.9% of coverage policies deployed some kind of step therapy protocol.

Step therapy is a common payer or pharmacy benefit manager policy that is controversial among patient advocates and providers. In such a program, members try less expensive drug options before "stepping up" to pricier therapies if necessary.

Insurers deploy step therapy as a key tool to manage drug costs.

On average, insurers required 1.5 steps in their protocols, with 66.6% of policies requiring a single step. Of the remaining policies, 22.7% required two steps, 7.6% were three steps and 3.1% included four or more steps, according to the study.

RELATED: Industry Voices—How the Trump administration’s step therapy policy changes will affect Medicare Advantage plans

Plans were most likely to deploy step therapy across 10 conditions, the study found: chronic migraine, Crohn’s disease, psoriasis, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathy arthritis, multiple sclerosis and hepatitis C.

Across these conditions, step therapy protocols were deployed in 77.3% of policies, the researchers found.

In addition, the researchers found that in more than half of cases (55.6%) insurers applied step therapy protocols for these diseases that were more stringent than clinical guidelines. In 34.1% of cases, these protocols matched clinical guidelines.

In 4.2% of cases, patients were expected to "step-through" drugs that were different from those in treatment guidelines.

The variance in how payers approach step therapy has significant implications for members, the researchers said.

"Inconsistency across plans also has the potential to negatively affect a patient who moves from one health plan to another if that person is taking a drug for which the two plans employ different step therapy protocols," they wrote in the report. "The difference could mean loss of eligibility for the drug under the new plan and could require completion of the new plan’s step therapy protocol to regain access."

The researchers argue that the findings should bolster calls for a legislative intervention that ensures payers are appropriately deploying step therapy protocols.