Vraylar (cariprazine)

POLICY NUMBER

L.5.01.504

Vraylar (cariprazine)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia in adults, the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, the treatment of depressive episodes associated with bipolar I disorder in adults, and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT_1a receptors and antagonist activity at serotonin 5-HT_2a receptors.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Vraylar (cariprazine) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 18 years of age or older;

2. The individual has a documented diagnosis of ONE of the following:

   1. Schizophrenia;

   2. Mixed or manic episodes associated with bipolar I disorder; OR

   3. Depressive episodes associated with bipolar I disorder;

3. ONE of the following:

   1. The individual has tried and failed treatment (see definition of Failure in Policy Guidelines) with at least two generic second-generation antipsychotic agents (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone); OR

   2. The individual has a documented intolerance or FDA labeled contraindication to ALL medications listed above;

4. The individual is stable on Vraylar (cariprazine) or was started on Vraylar (cariprazine) during a recent hospitalization or behavioral health residential program and is at increased risk of an adverse clinical outcome with the use of an alternative second-generation agent;

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of approval: 6 months

Renewal Criteria:

Vraylar may be considered for renewal when ALL of the following criteria are met:

1. The individual has previously been approved for therapy through BCBSMS PA process;

2. The individual is responding positively to therapy;

3. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medication failure is defined as inadequate response to therapy despite maximally tolerated dose (> 4 weeks use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors.  In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/01/2016: New policy added. Policy number L.5.01.504.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Vraylar. Quantity limits table moved from policy description to policy section. Added statements that prior authorization is required and the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Revised policy statement to state that Vraylar is considered medically necessary for adult members meeting the specified criteria. Sources section updated. Effective 01/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications. Medically necessary statement updated with additional criteria. Added renewal criteria. Policy Exceptions updated to remove FEP and State Health Plan members. Policy Guidelines updated to define medication failure and investigative. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for cariprazine. Moved quantity limit table from the Policy section to the Policy Description section. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial and Renewal criteria revised regarding contraindications and dose requirements. Sources updated.

SOURCE(S)

Vraylar prescribing information. Allergen, Inc. November 2024. Last accessed January 2025.

CODE REFERENCE

None