(208) US Commercial health plan use of corticosteroids in step therapy protocols

Background: : Health plans often impose step therapy protocols requiring patients to try and fail alternative therapies before accessing to higher-cost specialty drugs. Corticosteroids (CS), due to their wide availability and low cost, are commonly used in these protocols. While short-term CS use can reduce inflammation, chronic systemic use may lead to serious clinical side effects. Requiring CS failure before specialty drug access may delay initiation of more effective therapies and cause patient harm.

Objective: : To estimate how often commercial health plans include CS in step therapy protocols and describe the nature of CS failure requirements and variation across plans.

Methods: : We analyzed data from the Tufts Medical Center Specialty Drug Evidence and Coverage Database, which tracks coverage decisions for 18 large US commercial health plans. We identified drug-indication pairs for which at least one plan included CS in step therapy. For each, we reviewed coverage decisions to determine whether CS failure was included, CS failure criteria, and categorized specifics of CS failure requirement by characteristics such as route of administration of CS (systemic vs. local use).

Results: : As of August 2024, we identified 201 drug-indication pairs for which at least one plan CS in step therapy. Of these drug-indication pairs, 33 (16.4%) had an FDA label indication recommending prior CS use, while 168 (83.6%) did not. Among 557 coverage decisions involving drug-indication pairs with FDA-indicated prior CS use, 76.5% required CS failure - typically featuring the use of systemic CS (78.4% of decisions with CS failure requirement). For the 2,210 decisions for drug-indication pairs lacking FDA-indicated prior CS use, 43.1% still included CS in step therapy. In these, 63.8% specified systemic CS use and 48.4% required additional steps beyond CS. Use of CS in step therapy varied widely across plans, ranging from 15% to 74% of relevant decisions. Examples of drug-indication pairs most likely to include CS steps beyond FDA label recommendations included deflazacort for Duchenne Muscular Dystrophy (100% of coverage decisions), adalimumab for Uveitis (93.3%), and apremilast for Behcet's disease (85.7%).

Conclusions: : Commercial plans frequently include CS failure, often beyond the FDA-label. Substantial variation across plans highlights inconsistencies in application of CS failure criteria. Further research should examine the clinical appropriateness and patient impact of CS failure requirements.

Sponsorship:: argenx, inc