US commercial health plan use of corticosteroids in step therapy protocols: Frequency and clinical appropriateness.

Abstract

Background: Commercial health plans may include corticosteroids in step therapy protocols for specialty drugs as part of use management. However, alignment with regulatory and clinical guidance is not well characterized.

Objective: To assess how corticosteroids are incorporated into plan-imposed step therapy protocols and evaluate alignment with US Food and Drug Administration (FDA) labeling, clinical guidelines, and pivotal trials.

Methods: We analyzed coverage policies from 18 large US commercial health plans in the Tufts Medical Center Specialty Drug Evidence and Coverage Database, reflecting policies active as of August 2024. We identified drug-indication pairs for which at least 1 plan included corticosteroids in step therapy. For each drug-indication pair, we reviewed FDA labeling to determine whether prior corticosteroid failure was consistent with FDA-recommended use. When corticosteroid use was not specified by FDA labels, we examined pivotal clinical trials and clinical guidelines to assess support for corticosteroid use in step therapy. We also examined how health plans operationalized corticosteroid use (eg, systemic vs local use, single vs multiple steps, etc).

Results: We identified 201 specialty drug-indication pairs and 2,767 corresponding coverage policies for which at least 1 plan included corticosteroids in step therapy. Of these drug-indication pairs, 33 (16.4%) had an FDA label indication recommending prior corticosteroids use, whereas 168 (83.6%) did not. Among 2,210 coverage policies for the 168 pairs without FDA label-indicated prior corticosteroid use, 952 (43.1%) included corticosteroids in step therapy protocols. In 21% (200/952) of these policies, corticosteroid use was a mandatory step, whereas the remaining 79% (752/952) allowed patients to meet the requirement by failing alternative agents (eg, immunomodulators). In total, 63.8% (607/952) specified the use of corticosteroids to be systemic. Few protocols defined dosage requirements (7.9%, 75/952) or treatment failure criteria (3.8%, 36/952). Among policies in which FDA labeling did not specify prior corticosteroid use, plans were significantly more likely to include corticosteroids in step therapy when corticosteroid use was an eligibility criterion in pivotal clinical trials (χ² [1, N = 2,198] = 31.2; P < .001) or strongly recommended in clinical guidelines (χ² [1, N = 1,434] = 128.0; P < .001). Inclusion also varied across plans, ranging from 15% to 74% of policies without FDA label-indicated corticosteroid use.

Conclusions: Commercial health plans frequently include corticosteroids in step therapy, including when not specified in FDA labeling. Substantial variation in implementation highlights opportunities to improve transparency and consistency.