Understanding Profiles of Patients with Treatment-resistant Depression by Stringency of Health Plan Prior Authorization Criteria for Approval of Esketamine

This work was sponsored by Janssen Scientific Affairs, LLC BACKGROUND: This study characterized patients with treatment-resistant depression (TRD) initiated on esketamine and covered through United States (US) health plans with varying stringency defined based on prior authorization (PA) criteria for esketamine approval. METHODS: Adults with evidence of TRD (≥2 antidepressant courses of adequate dose and duration) before esketamine initiation (index date) were selected from a de-identified US insurance claims database. Patients were stratified into cohorts based on their health plan’s PA criteria for esketamine, obtained from Managed Markets Insight & Technology data: (1) stringent, with PA criteria above label; (2) non-stringent, with PA criteria to label. Treatment history was described by cohort before the index date, during the major depressive episode (MDE) in which the evidence of TRD and esketamine initiation occurred. RESULTS: 168 patients were included in the stringent cohort (mean age: 45.3 years, 63.1% female) and 400 patients in the non-stringent cohort (mean age: 44.8 years, 69.5% female). During the MDE before esketamine initiation, the stringent cohort completed a mean of 3.9 antidepressant treatment courses; 94.6% used augmentation therapy, including 59.3% with an antipsychotic. The non-stringent cohort completed a mean of 3.8 treatment courses; 96.8% used augmentation therapy, including 58.1% with an antipsychotic. CONCLUSION: Regardless of plan stringency, patients initiating esketamine, on average, exceed the US label requirements of 2 prior treatment trials. Patients in non-stringent and stringent plans have similar history of treatment types before the esketamine initiation. PA criteria above label might be excessive in creating unnecessary administrative barriers.