ModifiedmhnPolicy CP.PMN.145

Vilazodone (Viibryd)

Defines medical necessity and prior authorization criteria for vilazodone (Viibryd) for treatment of major depressive disorder for Centene-affiliated Medicaid lines of business.

Policy Summary

Payermhn

PolicyVilazodone (Viibryd) - coverage criteria for major depressive disorder

Policy CodePolicy CP.PMN.145

Change TypeClarified generic vilazodone applicabilityclarified step-therapy requirement (failure of two antidepressants from ≥2 classes)

Effective Date08.01.12

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, age ≥18, and failure of two antidepressants from at least two different classes.

SourceLink

POLICY UPDATE CHANGES

Clarified policy applies to generic vilazodone and clarified failure of two antidepressants from at least two different drug classes.

Revised continued therapy to allow continuity of care for antidepressants.

Added requirement that if request is for Viibryd, member must use generic vilazodone unless contraindicated or adverse effects occur.

2required failed antidepressant trials from different classes

≥18minimum age for approval (yrs)

40 mg/daymaximum daily dose

12 monthsapproval duration

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Coverage Criteria

inv-01: Initial Therapy — Major Depressive Disorder

Covered when ALL of the following are met:

Initial MDD criteria: 1. Diagnosis of major depressive disorder; 2. Age ≥ 18 years; 3. Failure of TWO antidepressants from at least two different classes, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated (classes: SSRI, SNRI, bupropion, mirtazapine); 4. If request is for Viibryd, member must use generic vilazodone, unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed both of the following: a) 40 mg per day; and b) 1 tablet per day.

Approval duration: 12 months

inv-02: Continued Therapy — Major Depressive Disorder

Covered when ALL of the following are met:

Continued MDD criteria: 1. Currently receiving medication via Centene benefit or documentation supports that member is currently receiving vilazodone for a covered indication and has received the medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for Viibryd, member must use generic vilazodone, unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, new dose does not exceed both of the following: a) 40 mg per day; and b) 1 tablet per day.

Approval duration: 12 months

inv-03: Initial/Step Therapy Criteria

Covered when ALL of the following are met

Antidepressant coverage requirements: Failure of two antidepressants from at least two different drug classes is required2 medications from >=2 classes

clarified in 3Q 2025 annual review

inv-04: Continuation Therapy

Continuation therapy

Continuation of therapy: Revised to allow continuity of care for ongoing antidepressant therapy

revised in 3Q 2024 review

Requests for vilazodone (Viibryd) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient clinical documentation of efficacy and safety in accordance with the payer's Off‑Label Use Policy (CP.PMN.53) or other applicable evidence of coverage documents.

None explicitly listed in this portion of the document.

Use of vilazodone (Viibryd) for indications that are not FDA‑approved and are not addressed in this policy is not authorized unless adequate supporting documentation is provided per the Off‑Label Use Policy (CP.PMN.53).

The provided portion of the document does not list any specific conditions or scenarios designated as not medically necessary beyond the general statement that non‑FDA indications require off‑label justification.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, medication history, or other clinical information) supporting that the member meets all approval criteria, including diagnosis, age, and prior treatment trials.

Required documentation: office notes, labs, medication history/records showing prior antidepressant trials, and other clinical information as applicable.
A request for Viibryd (brand) requires use of generic vilazodone first unless contraindicated or clinically significant adverse effects occur.

Prior Authorization

Prior Authorization and Continuity of Therapy

For members currently receiving vilazodone through the Centene benefit or with documentation showing at least 30 days of current vilazodone therapy, continuity of therapy may be authorized if the member is responding positively to treatment. Continuity applies while supporting documentation is provided.

Continuity duration: approval duration 12 months for continuation requests when criteria met.

Treatment Modalities

inv-21: Medication (Vilazodone/Viibryd)

Vilazodone modality notes: Vilazodone is indicated for major depressive disorder in adults; dosing initiation 10 mg daily for 7 days then 20 mg once daily; maximum dose 40 mg/day; tablet strengths include 10 mg, 20 mg, and 40 mg; contraindicated with monoamine oxidase inhibitors (MAOIs); boxed warning for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients.

inv-22: Pharmacotherapy

Therapeutic alternatives: Appendix B lists therapeutic alternatives including Wellbutrin SR; fluvoxamine used in depression is noted as off-label.

updated per Clinical Pharmacology

Definitions

monoamine oxidase inhibitor (MAOI)

DefinitionMonoamine oxidase inhibitor (MAOI): an agent listed in the policy appendices as 'MAOI' with a contraindication — concomitant use with vilazodone or use within 14 days of stopping an MAOI is contraindicated because of increased risk of serotonin syndrome.

Clinical riskConcomitant use or use within 14 days of stopping an MAOI is contraindicated due to increased risk of serotonin syndrome.

Source noteMAOI is defined in Appendix A as the abbreviation 'MAOI'.

serotonin norepinephrine reuptake inhibitor (SNRI)

DefinitionSerotonin norepinephrine reuptake inhibitor (SNRI): listed in the policy appendices as the abbreviation 'SNRI' and referenced among antidepressant classes used in step-therapy requirements.

Role in criteria

Background

Vilazodone (Viibryd) is an oral antidepressant approved by the FDA for the treatment of major depressive disorder in adults. Dosing guidance in the policy notes initiation and titration to a maintenance dose with a maximum of 40 mg per day and tablet strengths available to support this regimen. The policy also reiterates the standard antidepressant boxed warning regarding an increased risk of suicidal thoughts and behaviors in pediatric and young adult populations and notes contraindication with monoamine oxidase inhibitors (MAOIs) due to risk of serotonin syndrome.

Coding

No billing codes listedmixed

No codes listed

Revision History

2025-08-25Annual review (3Q 2025)Latest

Clarified that the policy applies to generic vilazodone and clarified requirement for failure of two antidepressants from at least two different drug classes; therapeutic alternatives updated per Clinical Pharmacology.

2024-08-24Annual review (3Q 2024)

Revised continued therapy to allow continuity of care for antidepressants; added Wellbutrin SR to therapeutic alternatives and noted fluvoxamine for depression as off-label; references reviewed and updated.

2012-08-01Policy effective