CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Trintellix_20250611

Defines Medicaid coverage criteria for Trintellix (vortioxetine) for treatment of major depressive disorder (MDD) in adults, continuation criteria, quantity limits, and that non‑FDA indications are investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Trintellix_20250611

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFor initial 12‑month authorization, document member age ≥18, diagnosis of MDD, and failure or intolerance to at least two formulary antidepressants.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

1Covered Indications (FDA‑approved)

>=2Required prior antidepressant trials

12 moInitial authorization duration

1/dayQuantity limit per day

Coverage Summary & Indications

Defines Medicaid coverage criteria for Trintellix (vortioxetine) for treatment of major depressive disorder (MDD) in adults; covered with criteria. Coverage is limited to the FDA‑approved indication for MDD in adults and requires documentation of failure or intolerance to at least two formulary antidepressants prior to approval. Initial authorization may be granted for 12 months. Quantity limit is 1 tablet per day, and indications other than FDA‑approved MDD are considered experimental/investigational and not medically necessary. Continuation requires evidence of at least one paid claim for a ≥30‑day supply within the last 365 days.

Covered Indications

Covered when ALL of the following are met:

FDA‑approved indication: Trintellix is indicated for the treatment of major depressive disorder (MDD) in adults
No exclusions: All approval criteria (as listed) are met and member has no exclusions to the prescribed therapy

Initial Authorization Criteria (MDD)

Initial Authorization - Major Depressive Disorder (MDD)

Authorization of 12 months may be granted when ALL of the following criteria are met:

Age: Member is 18 years of age or older
Diagnosis: Member has a diagnosis of major depressive disorder (MDD)
Prior therapy: Member has documentation of a failure or intolerance to at least two formulary antidepressants (e.g., citalopram, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine)>=2 failed or intolerant trials

Prior Authorization

Initial authorization requirements

For initial 12-month authorization, document that the member is at least 18 years old, has a diagnosis of major depressive disorder (MDD), and has experienced failure or intolerance to at least two formulary antidepressants.

Member age ≥ 18
Diagnosis: Major Depressive Disorder (MDD)
Failure or intolerance to ≥ 2 formulary antidepressants

Documentation Required

Documentation of prior therapy trials

Document prior therapy trials demonstrating failures or intolerances to at least two formulary antidepressants. Examples of formulary antidepressants include citalopram, duloxetine, escitalopram, fluoxetine, sertraline, and venlafaxine.

Must document failures or intolerances to ≥ 2 formulary antidepressants
Examples: citalopram; duloxetine; escitalopram; fluoxetine; sertraline; venlafaxine

Continuation of Therapy

Trintellix will continue to be covered if the following is met:

Continuation of Therapy: There is at least one paid claim of at least a 30‑day supply within the last 365 days for the respective drug>= 30 days paid claim within last 365 days

Billing Rule

Continuation verification via paid claim

To continue coverage, confirm there is at least one paid claim for the drug of at least a 30-day supply within the last 365 days.

Requirement: ≥ 30-day paid claim within the prior 365 days for continuation

Quantity Limits, Billing & Documentation

Billing Rule

Quantity limit

Dispense and bill no more than one tablet per day for Trintellix 5 mg, 10 mg, and 20 mg formulations.

Quantity limit: 1 tablet per day for Trintellix 5 mg/10 mg/20 mg

Relevant diagnosis codes (documented indication)ICD-10

No codes listed

Formulary antidepressant examples citedmixed

citalopram	Example formulary antidepressant (SSRI)
duloxetine	Example formulary antidepressant (SNRI)
escitalopram	Example formulary antidepressant (SSRI)
fluoxetine	Example formulary antidepressant (SSRI)
sertraline	Example formulary antidepressant (SSRI)
venlafaxine	Example formulary antidepressant (SNRI)

Quantity limit - product dosingNDC|HCPCSCovered

Trintellix 5mg/10mg/20mg

Limit: 1 tablet per day

Providers must document the member is at least 18 years old, has a diagnosis of major depressive disorder (MDD), and has documented failures or intolerances to at least two formulary antidepressants (examples include citalopram, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine). For continuation of therapy, maintain evidence of at least one paid claim for a ≥30‑day supply within the last 365 days.

Evidence & References

Primary reference: Trintellix Prescribing Information, Takeda Pharmaceuticals, March 2025.

Definition: Trintellix — brand name for vortioxetine, an antidepressant indicated for MDD in adults. Note: no additional trial metrics or study outcomes are provided in the brief.

Background

Trintellix (vortioxetine) is FDA‑approved for the treatment of major depressive disorder (MDD) in adults. This policy limits coverage to that FDA‑approved indication, requires documentation of failure or intolerance to at least two formulary antidepressants for initial authorization, and enforces a quantity limit of 1 tablet per day. Continuation of coverage requires at least one paid claim for a 30‑day supply within the last 365 days.