CurrentmhnPolicy CP.PMN.65

Vortioxetine (Trintellix)

Defines medical necessity and prior authorization criteria for vortioxetine (Trintellix) for treatment of major depressive disorder for Centene-affiliated health plans (HIM, Medicaid), including initial and continuation approval criteria, exclusions, dosing limits, therapeutic alternatives, and state-specific step therapy exceptions.

Policy Summary

Payermhn

PolicyVortioxetine (Trintellix)

Policy CodePolicy CP.PMN.65

Change TypeClarified criteria; step therapy bypass added

Effective DateMay 1, 2015

Next Review Date

Key ActionProvider must submit documentation (office notes, labs or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

3Q 2025 annual review clarified failure of two antidepressants from at least two different drug classes and added step therapy bypass for IL HIM per IL HB 5395.

3Q 2024 annual review revised continued therapy to allow continuity of care for antidepressants and updated therapeutic alternatives.

3Q 2021 annual review shortened trial durations of alternative agents from 8 weeks to 4 weeks and added bupropion and mirtazapine as options.

1Covered Indications (FDA-approved)

≥18Minimum Age (years)

20 mg/dayMaximum Daily Dose

4 weeksRequired trial duration

Coverage Summary

Coverage stance: covered_with_criteria for vortioxetine (Trintellix) for the FDA‑approved indication of major depressive disorder. Scope: defines medical necessity and prior authorization criteria for vortioxetine (Trintellix) for treatment of major depressive disorder for Centene‑affiliated health plans, including initial and continuation approval criteria, exclusions, dosing limits, therapeutic alternatives, and state‑specific step therapy exceptions. Key thresholds: Age ≥ 18 years; maximum daily dose ≤ 20 mg/day; tablet limit ≤ 1 tablet/day; required comparator trial durations for redirect/step‑therapy options of ≥ 4 weeks at up to maximally indicated doses. The policy summary: Trintellix is medically necessary when documentation supports the approval criteria (diagnosis of MDD, age threshold, applicable step/redirect or failure of required antidepressant trials, and adherence to dose/tablet limits) and continued therapy requires documentation of current use (≥ 30 days) with positive response and doses that do not exceed policy limits.

Key thresholds

Age≥ 18 years

Dose daily maximum≤ 20 mg/day

Tablet per day limit≤ 1 tablet/day

Comparator trial duration≥ 4 weeks at up to maximally indicated doses

Current therapy duration for continuation≥ 30 days

Initial Approval Criteria — Major Depressive Disorder

Continuation / Renewal Criteria — Major Depressive Disorder

Diagnoses / Indications Not Authorized and Other Uses

Other Diagnoses/Indications / III. Diagnoses/Indications Not Authorized

If requested use is not covered by the policy statements above:

Other Diagnoses/Indications

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow formulary/no-coverage/non-formulary policies referenced: HIM.PA.33 or CP.PMN.255 for formulary/no-coverage and HIM.PA.103 or CP.PMN.16 for non-formularywithin 6 months
If requested use is not specifically listed under section III and the label-change provision does not apply, refer to off-label use policy: HIM.PA.154 for HIM and CP.PMN.53 for Medicaid

Provider Actions & Prior Authorization Requirements

Documentation Required

Documentation submission required

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Include office notes, relevant labs, and any clinical information that documents diagnosis, prior therapies, treatment duration and response to support medical necessity.

Step Therapy

Step therapy / redirect requirements

For initial approval, the member must meet one of these step options: (1) be in a State with limitations on step therapy in certain mental health settings per Appendix D; (2) Fidelis Ambetter (NY Exchange): failure of ONE agent (SSRI, SNRI, bupropion, mirtazapine, or vilazodone) tried ≥ 4 weeks at up to maximally indicated doses unless intolerant or contraindicated; or (3) failure of TWO antidepressants from at least two different classes (SSRI, SNRI, bupropion, mirtazapine, vilazodone), each tried ≥ 4 weeks at up to maximally indicated doses unless intolerant or contraindicated. Note: IL HIM step therapy bypass per IL HB 5395 (effective 1/1/2026) exempts Illinois HIM requests from the step requirements.

Applicable Codes & Product Availability

Product Availability (NDC not specified in policy)mixed

tablet strengths

5 mg, 10 mg, 20 mg tablets

Clinical Evidence and References

References: Trintellix Prescribing Information (Aug 2023); Clinical Pharmacology database; APA Practice Guideline for the Treatment of Patients with Major Depressive Disorder (2010); ACP living clinical guideline (2023).

Background

Background: Vortioxetine (Trintellix) is an antidepressant FDA‑approved for the treatment of major depressive disorder. The policy provides medical necessity criteria, dosage limits, contraindications, boxed warnings, and therapeutic alternatives.

Revision History

3Q 2025 (Date = 05.08.25; P&T Approval Date = 08.25)annual_reviewLatest

Clarified requirement that failure of two antidepressants must be from at least two different drug classes; added step therapy bypass for Illinois HIM per IL HB 5395; updated therapeutic alternatives per Clinical Pharmacology; references reviewed and updated.

3Q 2024 (Date = 05.29.24; P&T Approval Date = 08.24)annual_review

Revised continued therapy to allow continuity of care for antidepressants; added Wellbutrin SR to therapeutic alternatives and clarified that fluvoxamine used in depression is off-label; references reviewed and updated.

3Q 2021 (Date = 05.27.21; P&T Approval Date = 08.21)