ModifiedmhnPolicy CP.PMN.91

Cariprazine (Vraylar) coverage

Policy governing medical necessity and prior authorization criteria for Vraylar (cariprazine) for commercial, HIM, and Medicaid lines of business; applies to prescribers requesting coverage for indicated psychiatric diagnoses.

Policy Summary

Payermhn

PolicyCariprazine (Vraylar) coverage

Policy CodePolicy CP.PMN.91

Change TypePediatric extensionstate step therapy bypasses and redirection updates

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, required step therapy failures or applicable state bypass, and dosing within indication-specific limits.

SourceLink

POLICY UPDATE CHANGES

Added pediatric extension to include age 10 years and older for bipolar disorder and age 13 years and older for schizophrenia per prescribing information; added 0.5 mg and 0.75 mg capsule strengths.

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

Added redirection bypass and Appendix D listing states with limitations (Arkansas, Texas, Nevada) and state-specific single-drug redirection rules for certain mental health settings.

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

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

4FDA-approved indications listed

≥13 / ≥10 / ≥18Minimum ages (schiz / bipolar / bipolar depression)

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Coverage Criteria

Initial Therapy: Bipolar Disorder and Schizophrenia

Covered when ALL of the following are met for Bipolar Disorder and Schizophrenia

Bipolar Disorder or Schizophrenia initial approval: 1. Diagnosis of bipolar disorder or schizophrenia; 2. Age is one of the following: (a) schizophrenia: ≥ 13 years; (b) bipolar disorder: ≥ 10 years; (c) depressive episodes of bipolar disorder: ≥ 18 years; 3. Member meets one of the following: (a) request is for treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D) OR (b) failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, olanzapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless clinically significant adverse effects or contraindications; 4. Dose does not exceed one of the following: (a) For schizophrenia or manic/mixed bipolar episodes: (i) Adults: 6 mg/day OR Pediatrics: 4.5 mg/day; and (ii) 1 capsule per day; (b) For depressive episodes of bipolar disorder: (i) 3 mg/day; (ii) 1 capsule per day.

Includes Illinois HIM exception to step therapy as of 1/1/2026 per IL HB 5395

Initial Therapy: Major Depressive Disorder (adjunctive)

Covered when ALL of the following are met for Major Depressive Disorder (adjunctive use)

MDD (adjunctive) initial approval: 1. Diagnosis of major depressive disorder (MDD); 2. Age ≥ 18 years; 3. Member meets one of the following: (a) request is for treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D) OR (b) 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, age ≥ 65, or contraindications; 4. Member meets one of the following: (a) request is for treatment of a member in a State with limitations on step therapy (see Appendix D) OR (b) failure of a ≥ 4-week trial of aripiprazole used concurrently with an antidepressant at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 5. Vraylar (cariprazine) is prescribed concurrently with an antidepressant; 6. Dose does not exceed 3 mg/day and 1 capsule per day.

Includes Illinois HIM exception to step therapy as of 1/1/2026 per IL HB 5395

Continuation Therapy

Continuation therapy (must meet all)

Continuation: 1. Member is currently receiving Vraylar via the Centene benefit, or documentation supports current receipt of Vraylar for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed indication-specific maximums: schizophrenia/manic/mixed adult 6 mg/day (pediatric 4.5 mg/day); bipolar depression or MDD 3 mg/day; and 1 capsule per day.

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Other indications / label changes

Other uses/requests

Other diagnoses/indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., newly approved indication, age expansion, new dosing regimen), refer to the applicable no-coverage or non-formulary policy for the relevant line of business; OR 2. If the requested use (diagnosis, age, dosing) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business.

See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 for specific line-of-business guidance.

Indication-based coverage criteria

Covered when prescribing aligns with FDA‑approved indications and dosing ranges and state‑specific step therapy/redirection rules are met.

Schizophrenia (Adults): Patient is an adult with schizophrenia AND prescriber orders cariprazine within 1.5–6 mg PO once daily (maximum 6 mg/day).dose <=6 mg/day; age adult

Per dosing and administration; pediatric extension included separately.

Schizophrenia (Pediatrics): Patient age 13–17 years with schizophrenia AND prescriber orders cariprazine within 1.5–4.5 mg PO once daily (maximum 4.5 mg/day).age 13–17; dose <=4.5 mg/day

RT4 updated criteria to include pediatric patients age 13+ per PI.

Bipolar I disorder - Manic/Mixed (Adults): Patient is an adult with bipolar I manic or mixed episode AND cariprazine dose 3–6 mg PO once daily (maximum 6 mg/day).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid). The policy's coverage determinations and prior authorization requirements apply to requests for Vraylar (cariprazine) unless an off‑label justification meeting those referenced policies is provided.

Use of Vraylar (cariprazine) for dementia‑related psychosis is explicitly excluded from coverage. The policy lists dementia‑related psychosis among diagnoses/indications for which coverage is not authorized and notes that Vraylar is not approved for treatment of patients with dementia‑related psychosis.

Treatment of dementia‑related psychosis with Vraylar is not authorized. Requests for off‑label use to treat dementia‑related psychosis will be denied because Vraylar is not approved for this indication and antipsychotic treatment in elderly patients with dementia‑related psychosis is associated with an increased risk of death; such requests are not covered under this policy.

Pediatric use of Vraylar outside the specified approved or extended age ranges may be considered not medically necessary unless there is contemporaneous evidence supporting safety and effectiveness. The policy indicates that safety and effectiveness of Vraylar have not been established in pediatric patients, and pediatric requests outside the policy's stated age limits should follow off‑label review processes and the document's pediatric guidance.

Coding and Dosing Summary

No explicit CPT/HCPCS/ICD/NDC codes provided in this document portionmixed

No codes listed

Maximum daily doses by indication — dosing limits and age-specific maxima

Schizophrenia (adults)Maximum 6 mg/day (dosing range 1.5–6 mg PO QD)

Schizophrenia (pediatrics 13–17 yrs)Maximum 4.5 mg/day (dosing range 1.5–4.5 mg PO QD)

Bipolar I — Manic/Mixed (adults)Maximum 6 mg/day (dosing range 3–6 mg PO QD)

Bipolar I — Manic/Mixed (pediatrics ≥10 yrs)Maximum 4.5 mg/day (dosing options 3 mg or 4.5 mg PO QD)

Bipolar I — Depressive episodesMaximum 3 mg/day (dosing options 1.5 mg or 3 mg PO QD)

Major Depressive Disorder — adjunctiveMaximum 3 mg/day (dosing options 1.5 mg or 3 mg PO QD when used with an antidepressant)

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vraylar (cariprazine). Provider must submit clinical documentation (e.g., office chart notes, medication history, lab results) demonstrating the member meets all applicable approval criteria before coverage will be authorized. Approvals are issued for the durations shown in the policy (typically up to 12 months depending on line of business).

Prior authorization required for all indications covered by this policy
Include supporting documentation: office notes, medication trials, duration/tolerability of prior agents, diagnoses, and current dosing

Prior Authorization

State Redirection / Step Therapy Notes

State-specific rules may prohibit or limit step therapy/redirection in certain mental health settings. If the member resides in or the request is for treatment in one of the listed states (see Appendix D), the usual step/failure requirements may be bypassed for the applicable line of business (HIM/Medicaid) — document the member’s state and the basis for the bypass. When redirection is allowed, follow the state-specific single‑drug redirection or reduced-step requirements noted in Appendix D.

Background

Cariprazine (brand name Vraylar) is an atypical antipsychotic indicated for adults for schizophrenia, acute manic or mixed episodes associated with bipolar I disorder, depressive episodes associated with bipolar I disorder, and as adjunctive treatment of major depressive disorder. The product is supplied in multiple capsule strengths (including 0.5, 0.75, 1.5, 3, 4.5, and 6 mg) and the policy aligns coverage with the FDA‑approved indications, dosing ranges, and ages noted in the prescribing information.

Definitions

major depressive disorder — definition/abbrev (MDD)

TermMajor depressive disorder (MDD)

AbbreviationMDD = major depressive disorder

ContextUsed in this policy to identify adults for adjunctive cariprazine therapy (age ≥18 years per criteria).

serotonin/norepinephrine reuptake inhibitor — definition/abbrev (SNRI)

TermSerotonin/norepinephrine reuptake inhibitor (SNRI)

AbbreviationSNRI = serotonin/norepinephrine reuptake inhibitor

Context

Pharmacotherapy

Pharmacotherapy (antipsychotic/adjunctive MDD)

Medication therapy: Cariprazine dosing should follow indication‑specific regimens and be combined with other modalities as clinically appropriate.

Prescribe dosing consistent with dosing ranges and available capsule strengths (0.5, 0.75, 1.5, 3, 4.5, 6 mg).

Policy Summary

Payermhn

PolicyCariprazine (Vraylar) coverage

Policy CodePolicy CP.PMN.91

Change TypePediatric extensionstate step therapy bypasses and redirection updates

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, required step therapy failures or applicable state bypass, and dosing within indication-specific limits.

SourceLink

On This Page

Step Therapy

Step Therapy / Failure Requirements

Approvals are contingent on documented trials of first-line / preferred agents as specified in the criteria. Failure is defined as an adequate trial at up to maximally indicated doses for the durations listed (generally ≥ 4 weeks) unless the agent was discontinued for clinically significant adverse effects or is contraindicated. For MDD adjunctive use, an aripiprazole trial while on an antidepressant is required unless bypass criteria apply.

Bipolar disorder and schizophrenia: failure of two preferred atypical antipsychotics, each trial ≥ 4 weeks at maximally indicated doses unless contraindicated (unless state redirection applies)
MDD: failure of three antidepressants from at least two classes, each ≥ 4 weeks, and failure of a ≥4-week trial of aripiprazole adjunctive therapy (unless contraindicated)
Document duration, dose, and reason for discontinuation for each prior agent to demonstrate treatment failure

Denial Risk

Denial Risk: Insufficient Documentation / Non‑Covered Indications

Insufficient or missing documentation and requests for excluded or non‑covered indications (including dementia‑related psychosis and other non‑FDA uses without appropriate off‑label justification) are at high risk of denial. Provide explicit evidence of prior medication trials, dosing, dates, tolerability issues, and the exact FDA‑approved diagnosis matching the requested indication to reduce denial risk.

Requests for dementia‑related psychosis will be denied — Vraylar is not approved for dementia‑related psychosis
Non‑FDA indications require supporting evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or applicable evidence-of-coverage documents
Common denial reasons: no documentation of prior trials, inadequate trial duration or dose, missing diagnosis, or lack of rationale for bypassing step therapy

MDD adjunctive use — clarify adjunctive meaning and dosing

Meaning of adjunctive useAdjunctive use means cariprazine is prescribed concurrently with an antidepressant for MDD (cariprazine is added to existing antidepressant therapy).

Approved adjunctive dosesCariprazine adjunctive dosing: 1.5 mg or 3 mg PO once daily (maximum 3 mg/day).

Age for adjunctive MDDAdjunctive MDD indication applies to adults (age ≥18 years per initial approval criteria).

Product availability notePrescribe using available capsule strengths consistent with indicated doses (capsules: 0.5, 0.75, 1.5, 3, 4.5, 6 mg).