OBJECTIVES: The aim of this study is to carry out a Budget Impact Analysis (BIA) to estimate the financial impact of the inclusion of brexpiprazole as adjunctive treatment in adults with major depressive disorder (MDD) and inadequate response to antidepressant treatment (ADT) from the perspective of the Mexican National Health System (MNHS).

METHODS: According to the American Psychological Association (APA) and Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for MDD, duloxetine, escitalopram, fluoxetine, sertraline and venlafaxine are ADT monotherapies available for use in the MNHS. A systematic literature review and meta-analysis (MA) were conducted to evaluate the efficacy and safety of adjunctive brexpiprazole vs ADT monotherapies. The MA was completed using Review Manager 5.3 software using the outcome of remission rate, established as >50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The BIA was conducted from the MNHS perspective with a 5-year timeframe through 2021 in Mexican pesos. The initial market penetration rate was 10% with annual increases of 10% until reaching 50% in the fifth year. An equal market share for all the comparators was considered.

RESULTS: Brexpiprazole, when used as adjunctive treatment presented statistically significant differences vs ADT monotherapy in remission rate (RR: 1.28; 95% CI: 1.01 – 1.62; p: 0.04). The BIA showed inclusion of brexpiprazole as adjunctive treatment in adults with MDD from the MNHS perspective has an annual mean budget impact in a 5-year horizon of MXN $21,543,663, representing 0.0124% of their pharmacotherapy budget for all conditions.