OBJECTIVES: There is a need for effective medications to treat patients living with schizophrenia or bipolar I disorder (BD-I). LYBALVI^®, a combination of olanzapine and samidorphan, was recently approved for the treatment of adults with schizophrenia or BD-I. We estimated the budgetary impact of adding LYBALVI to the formulary from Commercial, Medicaid, and Medicare perspectives in the United States (US).

METHODS: A budget impact model (BIM) with a 3-year time horizon was developed for hypothetical Commercial, Medicaid, and Medicare plans, each with 1 million adult covered-lives. The BIM used a prevalence-based approach to estimate the number of patients living with schizophrenia or BD-I treated with atypical antipsychotics. Other model inputs in the BIM included projected market shares for atypical antipsychotics, average number of months on treatment for patients prescribed atypical antipsychotics, and drug-acquisition costs based on published information.

LYBALVI was assumed to displace market share from other branded oral atypical antipsychotics. The projected budgetary impact of LYBALVI was estimated by comparing two scenarios: one without LYBALVI as a treatment option vs. one with LYBALVI as an option on formulary. Results are presented as differences in per-member-per-month (PMPM) costs between these two scenarios.

RESULTS: After applying prevalence-based assumptions, estimated numbers of patients treated with atypical antipsychotics per 1 million covered lives were 4,324, 39,770, and 12,178 patients each year for hypothetical Commercial, Medicaid, and Medicare plans, respectively. After applying market share assumptions, LYBALVI had a net neutral budget impact with no changes in PMPM costs for each payer plan for each of the three years.

CONCLUSIONS: In hypothetical Commercial, Medicaid, and Medicare plans in the US, LYBALVI is estimated to have no additional costs to plans’ budgets. LYBALVI offers a new treatment option for patients living with these chronic and serious mental health conditions, without additional cost.