A Cost Utility Analysis of Zuranolone in the Treatment of Major Depressive Disorder

OBJECTIVES: Zuranolone is a neuroactive steroid in development for major depressive disorder (MDD). While it is promising for the short 14-day treatment period required in MDD patients, no analysis has been conducted. This research aims to determine the cost-effectiveness of zuranolone compared to mirtazapine, a tetracyclic atypical antidepressant, in the treatment of patients with severe MDD.

METHODS: We developed a cohort-based decision tree and Markov model to project the costs and quality-adjusted life years (QALYs) of zuranolone and mirtazapine in a simulated cohort of patients with severe MDD. The model adopted a US healthcare perspective over a one-year time horizon based off the phase 3 placebo-controlled MOUNTAIN trial that evaluated zuranolone in patients with severe MDD. Zuranolone drug costs were based off wholesale acquisition costs of a 14-day course treatment for postpartum depression. Efficacy parameters for each intervention were generated by pooling trial results comparing either treatment to placebo. Direct costs were extracted from prior literature and further categorized into drug cost, outpatient, inpatient, emergency room, and counseling costs. No discounting was applied given the short time horizon. Sensitivity and probabilistic sensitivity analyses were conducted for each parameter.

RESULTS: In our model, the one-year costs and QALYs of zuranolone were $22,901.57 and 0.56 per patient and $9,715.49 and 0.52 per patient for mirtazapine, for an ICER of $302,733.80. Results were most sensitive to drug cost, relative risk of remission, and remission health-state utility. In sensitivity analyses, zuranolone was the preferred treatment in 15% of the total draws under a willingness to pay threshold of $150,000.

CONCLUSIONS: Our model suggests that zuranolone is not cost effective compared to mirtazapine in the treatment of patients with severe MDD. However, limited clinical head-to-head comparison data and cost data specific to MDD necessitate further economic evaluation studies in the future as they become readily available.