CurrentmhnPolicy CP.PMN.91

VRAYLAR (PDF)

Defines medical necessity criteria, age limits, step therapy/redirection exceptions, dosing limits, continued therapy and non-covered indications for Vraylar (cariprazine) across Commercial, HIM and Medicaid lines of business, with appendices for therapeutic alternatives and state-specific step therapy limitations.

Policy Summary

Payermhn

PolicyVRAYLAR (PDF)

Policy CodePolicy CP.PMN.91

Change TypeMultiple material and non-material updates (indication addition, pediatric expansions, state step therapy bypasses, dosing/availability updates)

Effective Date11.16.16

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added indication for adjunctive treatment in MDD per prescribing information.

Revised dosing and pediatric age expansions for bipolar disorder (age ≥10) and schizophrenia (age ≥13) and added 0.5 mg and 0.75 mg capsule strengths per PI.

Added dementia-related psychosis to diagnoses/indications for which coverage is not authorized.

Added redirection bypass for members in States with limitations on step therapy in certain mental health settings and included Appendix D listing states (e.g., AR, TX, NV).

Commercial authorization limit revised to 12 months or duration of request, whichever is less.

Added step therapy bypass for IL HIM per IL HB 5395.

Revised continued therapy criteria to allow continuity of care for all indications.

4FDA approved indications listed

12 monthsMedicaid/HIM approval duration

Commercial approval duration

≥4 weeksRequired trial length per prior agent

Coverage Summary

Scope: Defines medical necessity criteria, age limits, step therapy/redirection exceptions, dosing limits, continued therapy, and non-covered indications for cariprazine (Vraylar) across Commercial, HIM, and Medicaid lines of business. Coverage stance: covered_with_criteria for FDA‑approved indications (schizophrenia, bipolar I disorder, bipolar depression, and adjunctive MDD) with medical necessity criteria and step therapy requirements. Status: CURRENT. Typical approval durations: Medicaid/HIM: 12 months; Commercial: 12 months or duration of request, whichever is less. Primary non‑covered indication: dementia‑related psychosis.

Quick facts & thresholds

Trial duration per prior agent≥ 4 weeks at up to maximally indicated doses

Antidepressant failure requirement for MDDFailure of THREE antidepressants from at least TWO different classes

Aripiprazole adjunctive trial for MDD≥ 4-week trial of aripiprazole at up to maximally indicated doses (used with an antidepressant)

Typical approval duration (Commercial)12 months or duration of request, whichever is less

Typical approval duration (Medicaid/HIM)12 months

FDA approved indications listed4

Initial Therapy Criteria — Bipolar Disorder & Schizophrenia

Initial Therapy Criteria — Major Depressive Disorder (MDD)

I. Initial Approval Criteria - Major Depressive Disorder (MDD)

Must meet all

Diagnosis of MDD
Age ≥ 18 years
Prior antidepressant failure or state redirection
- State limitation redirection: Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D)
- Antidepressant failures: Failure of THREE antidepressants from at least TWO different classes (e.g., SSRI, SNRI, TCA, bupropion, mirtazapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless unable due to clinically significant adverse effects, member's age ≥ 65 years, or contraindications

Continuation Therapy Criteria

Documentation Required

Continued therapy requirements

For continuation requests, member must have been receiving Vraylar via the Centene benefit or documentation must support prior use of Vraylar for a covered indication for at least 30 days, and the member must be responding positively to therapy. Submit documentation demonstrating prior Centene benefit use or prior use and clinical response.

Member has received Vraylar via Centene benefit or documentation supports ≥ 30 days of prior use
Documentation that member is responding positively to therapy
If request is for dose increase, new dose must not exceed the per‑indication maximum daily dose and 1 capsule per day limits

Other Indications / Off‑Label Use

If the requested use is not listed in Section I or there has been a recent label change within the last 6 months that is not yet reflected in this policy, follow the line‑of‑business specific policies: For drugs on the formulary use the no coverage criteria policies CP.CPA.190 (Commercial), HIM.PA.33 (HIM marketplace), and CP.PMN.255 (Medicaid). For drugs NOT on the formulary use the non‑formulary policies CP.CPA.190 (Commercial), HIM.PA.103 (HIM marketplace), and CP.PMN.16 (Medicaid). For off‑label requests not covered by Section III, refer to the off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (HIM marketplace), and CP.PMN.53 (Medicaid).

Diagnoses / Indications NOT Authorized

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with failure history or redirection exception

Prior authorization is required unless the member is in a State with redirection/step therapy limitations (see Appendix D) or another bypass applies. Provide documentation of diagnosis, member age, and prior therapy failures per the criteria or documentation that the member is in a State with step therapy/redirection limitations. Illinois HIM requests have a step therapy bypass per IL HB 5395 effective 1/1/2026. See Appendix D for the list of states with limitations.

Documentation of diagnosis (schizophrenia, bipolar disorder, or MDD) and member age
Documentation of prior therapy failures per criteria (e.g., two preferred atypical antipsychotics each used ≥ 4 weeks for bipolar/schizophrenia; three antidepressants from ≥ 2 classes and aripiprazole trial as specified for MDD) or evidence member is in a State with step therapy/redirection limitations (Appendix D)
IL HIM step therapy bypass per IL HB 5395 effective 1/1/2026
Refer to Appendix D for state-specific redirection/step therapy limitation details

Applicable Codes

N/A - No procedure or billing codes specifiedmixed

No codes listed

Clinical Evidence & References

Vraylar (cariprazine) is FDA‑approved for treatment of schizophrenia (adults and pediatric patients ≥ 13 years), acute manic or mixed episodes associated with bipolar I disorder (adults and pediatric patients ≥ 10 years), treatment of depressive episodes associated with bipolar I disorder (adults), and adjunctive therapy to antidepressants for major depressive disorder (adults). Primary source: Vraylar Prescribing Information, Allergan USA, Inc.; December 2025. Recent label updates expanded pediatric age ranges and added additional capsule strengths per the December 2025 prescribing information.

Background

Cariprazine (Vraylar) is an atypical antipsychotic with FDA approvals for schizophrenia, bipolar I disorder (manic/mixed and depressive episodes), and adjunctive treatment for major depressive disorder. This policy outlines medical necessity criteria including age limits (e.g., schizophrenia ≥ 13 years; bipolar disorder ≥ 10 years for manic/mixed episodes; bipolar depression and adjunctive MDD in adults), step therapy and redirection exceptions (state‑specific Appendix D and IL HIM bypass per IL HB 5395), dosing and capsule limits (e.g., schizophrenia adults ≤ 6 mg/day and pediatrics ≤ 4.5 mg/day; bipolar depression and MDD ≤ 3 mg/day; maximum of 1 capsule per day), continuation criteria (member on Vraylar via Centene benefit ≥ 30 days and responding positively to therapy), and diagnoses not authorized (notably dementia‑related psychosis). Product availability includes capsules in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg strengths per the label.

Definitions

MDDMajor depressive disorder

SNRISerotonin/norepinephrine reuptake inhibitor

Revision History

11.16.2016policy_effective

Policy effective date established (Clinical Policy: Cariprazine, CP.PMN.91).

01.09.2023addedLatest

RT4 addition: added indication for adjunctive treatment in MDD per prescribing information and applied template changes to other diagnoses/continued therapy.

01.09.2023addedLatest

Policy Summary

Payermhn

PolicyVRAYLAR (PDF)

Policy CodePolicy CP.PMN.91

Change TypeMultiple material and non-material updates (indication addition, pediatric expansions, state step therapy bypasses, dosing/availability updates)

Effective Date11.16.16

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

On This Page

3 agents from >=2 classes, each >= 4 weeks

Adjunct aripiprazole trial or state redirection

State limitation redirection adj: Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D)
Aripiprazole trial: Failure of a ≥ 4-week trial of aripiprazole at up to maximally indicated doses, used concurrently with an antidepressant, unless contraindicated or clinically significant adverse effects are experienced≥ 4 weeks at up to maximally indicated doses
Must have been used concurrently with an antidepressant

Concurrent antidepressant: Vraylar is prescribed concurrently with an antidepressant

Dose limits

Maximum dose: 3 mg per day3 mg/day
Capsule limit: 1 capsule per day1 capsule/day

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation with the prior authorization to show the member meets approval criteria. Acceptable documentation includes office chart notes, lab results, and other clinical information detailing prior therapy trials and responses.

Office chart notes documenting diagnosis, treatment dates, and clinical response
Laboratory results or other relevant clinical data
Details of prior therapy trials (drug name, dose, duration, reason for discontinuation or inadequate response)

Billing Rule

Dose/capsule limits

Prescribed dose must not exceed the maximum daily dose for the indication and no more than 1 capsule per day.

Schizophrenia or manic/mixed bipolar episodes: Adults — 6 mg/day (maximum); Pediatrics — 4.5 mg/day (maximum); 1 capsule per day
Depressive episodes of bipolar disorder and MDD (adjunctive): 3 mg/day maximum; 1 capsule per day
If request is for dose increase, new dose must adhere to these per‑indication maximums and 1 capsule/day limit

1Q 2023 annual review: dementia-related psychosis added to diagnoses/indications for which coverage is not authorized.

07.05.2023addedLatest

Added redirection bypass for members in States with limitations on step therapy in certain mental health settings and included Appendix D listing states (initially included Arkansas).

07.13.2023updatedLatest

3Q 2023 update: added Texas to Appendix D with requirements for single drug redirection for HIM requests.

08.31.2023updatedLatest

3Q 2023 update: added Nevada to Appendix D with requirements for single drug redirection for Medicaid requests.

05.09.2024annual_review

3Q 2024 annual review: revised continued therapy criteria to allow continuity of care for all indications; references reviewed and updated.

06.27.2025addedLatest

3Q 2025 annual review: added step therapy bypass for Illinois HIM per IL HB 5395.

12.26.2025revisedLatest

RT4 update per December 2025 prescribing information: revised dosing and pediatric age expansions — bipolar disorder age ≥10 and schizophrenia age ≥13 — and added 0.5 mg and 0.75 mg capsule strengths; product availability updated to include 0.5 mg and 0.75 mg strengths.