Cariprazine (Vraylar)

Key Messages

• CADTH recommends that Vraylar should not be reimbursed by public drug plans for use as monotherapy for the acute management of manic or mixed episodes associated with bipolar I disorder (bipolar mania), and acute management of depressive episodes associated with bipolar I disorder (bipolar depression).
• Despite results from 6 clinical trials that showed treatment with Vraylar may improve manic and depressive symptoms associated with bipolar mania and bipolar depression, it is unclear if patients treated with Vraylar in clinical practice would experience the same magnitude of improvement, as patients in the cariprazine studies may not represent the population of patients who will use cariprazine in Canada.
• Although the results for the 1.5 mg dose of Vraylar suggested an improvement in depressive symptoms, the results for the 3 mg dose of Vraylar were inconsistent across studies; therefore, the CADTH Canadian Drug Expert Committee (CDEC) was not confident that Vraylar would fill a treatment gap.
• The potential benefit of Vraylar compared to other treatments for bipolar I disorder are unknown. There were no studies directly comparing Vraylar with any other treatments, and the indirect comparative evidence reviewed had many limitations.