Cariprazine (Vraylar)

Key Messages

• CADTH recommends that Vraylar not be reimbursed by public drug plans for the treatment of schizophrenia in adults. Vraylar was discussed at the March 2022 meeting of the CADTH Canadian Drug Expert Committee (CDEC) and reconsidered at the July 2022 meeting.
• Based on evidence from 5 clinical trials, treatment with Vraylar improved symptoms of schizophrenia or delayed relapse compared with placebo. Vraylar also improved negative symptoms of schizophrenia compared with risperidone. Although these results were statistically significant, it is not clear whether any of these effects result in a clinically meaningful improvement in patient-identified needs.
• It is not clear whether cariprazine offers any clinical benefits over other treatments that are available for schizophrenia because there were no clinical trials in patients with acute schizophrenia that compared Vraylar with any other treatments. The committee did not have confidence in the results of the indirect comparative evidence because it had too many limitations.
• There was not enough robust evidence to show that Vraylar filled a treatment gap.

• This document was initially published on August 26, 2022, and subsequently revised on February 2, 2023, to provide additional details on the expert committee's deliberations and the request for reconsideration filed by the sponsor.