Step therapy protocols are defined in the Code of Virginia (Code) as “a protocol setting the sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered under a health benefit plan."(*1) In practice, these protocols generally require patients to try a clinically appropriate, lower cost alternative prior to health plan approval of a more expensive alternative.

Pursuant to Chapter 256 of the 2025 Virginia Acts of Assembly, the Bureau of Insurance (Bureau) of the State Corporation Commission (Commission) studied the step therapy protocols by conducting a data call of comprehensive health insurance carriers in Virginia. The study covered the three-year period from 2023 through 2025. Carriers reported on the total number of step therapy protocols in place, how those protocols have changed over time, and the results of requests for exceptions to these protocols. Carriers also reported on their use of step therapy protocols within various clinical specialties.

Based on the data reported, the Bureau found that carriers were using a large number of step therapy protocols, though the number of protocols varied considerably among carriers. The Bureau also found that carriers had received more than 100,000 requests for exceptions to their step therapy protocols and approved close to 70 percent of these requests. Fewer than 1 in 20 exception requests that were denied (33,722) were appealed (1,473), but of those that were appealed, nearly half (750) were reversed.

Finally, within clinical specialties, the Bureau found that endocrinology, psychiatry, and dermatology had the highest number of step therapy protocols in place. Step therapy protocol exception requests were denied at a rate of approximately 31 percent across all surveyed specialties, though some specialties had rates of denial that were substantially higher.

The Bureau has no recommendations based on the data received.
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(*1) § 38.2-3407.9:05 of the Code of Virginia.