Effects of adjunctive cariprazine formulary restrictions in major depressive disorder.

Objectives: To evaluate the effects of formulary-related rejections of initial adjunctive cariprazine (Vraylar) claims on health care resource utilization (HCRU) among patients with major depressive disorder (MDD).

Study design: Retrospective claims-based analysis.

Methods: Using data from Symphony Health Integrated Dataverse from March 2015 through October 2020, we identified adults with MDD who were being treated with antidepressants and had an initial cariprazine claim that was either rejected for a formulary-related reason (eg, noncoverage, prior authorization requirement, step therapy requirement) or approved; rejected patients were required to receive a subsequent atypical antipsychotic (which helps balance the health status across cohorts but may induce bias and affect generalizability). Rejected and approved cohorts were matched (1:2) using propensity scores. Outcomes included all-cause and mental health (MH)-related HCRU (hospitalizations, emergency department [ED] visits, outpatient visits) and treatment patterns. HCRU was compared between cohorts using rate ratios (RRs), with 95% CIs and P values. Treatment patterns were analyzed using descriptive statistics.

Results: The rejected cohort comprised 566 patients, with 1132 matched patients in the approved cohort. All-cause and MH-related hospitalization rates were 61% and 89% higher, respectively, for the rejected vs approved cohort (all-cause: RR, 1.61; 95% CI, 1.15-2.32; P = .012; MH related: RR, 1.89; 95% CI, 1.18-2.89; P = .016). ED and outpatient visit rates were similar. Patients in the rejected cohort often never received cariprazine (68.4%), and those who did received it after a 6-month delay on average.

Conclusions: Patients with MDD who had an initial adjunctive cariprazine claim rejected for a formulary-related reason and subsequently received an atypical antipsychotic experienced significantly higher hospitalization rates than those with approved initial cariprazine claims, suggesting that formulary restrictions on adjunctive cariprazine may be associated with negative downstream effects.