VRAYLAR (cariprazine)

VRAYLAR (cariprazine)

SELF-ADMINISTRATION - ORAL

FDA Approved Indications:

• Treatment of schizophrenia
• Acute treatment of manic or mixed episodes associated with bipolar I disorder
• Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults
• Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults 

Prior authorization criteria:

For diagnosis of schizophrenia or bipolar I disorder:

• Diagnosis of schizophrenia or bipolar I disorder, AND
• 18 years of age or older, AND
• Patient has tried and failed at least 2 preferred atypical antipsychotics (e.g., risperidone, quetiapine, olanzapine, ziprasidone, aripiprazole)

For diagnosis of major depressive disorder (MDD):

• Diagnosis of major depressive disorder (MDD), AND
• 18 years of age or older, AND
• Patient has tried and failed or has contra-indication to generic quetiapine, AND
• Patient has tried and failed a generic anti-depressant (e.g. SSRI or SNRI), AND
• One of the following:
  • Patient will continue to use anti-depressant therapy in combination with Vraylar, OR
  • Antidepressant therapy is contraindicated

Reauthorization Criteria:

For all diagnoses:

• Documentation of a positive clinical response to therapy

Dosing:

• Once-daily (maximum dose is 6 mg/day)
  • Schizophrenia: starting dose 1.5mg/day, Recommended dose is 1.5 mg to 6 mg/day
  • Bipolar mania: starting dose 1.5mg/day, Recommended dose is 3 mg to 6 mg/day
  • Major depressive disorder: starting dose 1.5mg/day, Recommended dose is 3 mg/day
• Reduce Vraylar dosage if used with a strong CYP3A4 inhibitor
• Concomitant use of Vraylar with a CYP3A4 inducer is not recommended

Additional Information:

• BBW - Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions
• BBW - Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors
• The safety and effectiveness of VRAYLAR have not been established in pediatric patients

Approval:

• Initial: 1 year
• Reauthorization: 1 year

Policy Updates:

• 08/15/2023 - Added additional indications and coverage criteria. 

References:

1. Vraylar prescribing information. Allergan, Inc. Madison, NJ. December 2022.