Cariprazine (Vraylar): CADTH Reimbursement Recommendation [Internet]

What Is the CADTH Reimbursement Recommendation for Vraylar?: 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).

Why Did CADTH Make This Recommendation?:

1. 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.

2. 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.

3. 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.

What Is Bipolar I Disorder?: Bipolar I disorder is a condition defined by episodes of mania and depression. During these episodes, patients may experience severe changes in their mood, activity levels, energy, and ability to carry out everyday tasks. It is estimated that 0.87% of those living in Canada are living with bipolar I disorder.

Unmet Needs in Bipolar I Disorder: Patients expressed a need for treatments that control the symptoms of bipolar I disorder, provide an additional therapy for those who do not respond adequately to existing drugs, lower the frequency of administration, and minimize side effects.

How Much Does Vraylar Cost?: Treatment with Vraylar is expected to cost approximately $1,790 per patient annually.