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.

 

Last review date: September 1, 2023

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