CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trintellix (vortioxetine) — Coverage Criteria for Major Depressive Disorder

Policy governing coverage and authorization criteria for Trintellix (vortioxetine) for treatment of major depressive disorder in adult members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrintellix (vortioxetine) — Coverage Criteria for Major Depressive Disorder

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization showing member is ≥18, diagnosed with MDD, and has failed or been intolerant to at least two formulary antidepressants.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial auth duration

>=2prior failures required

1/dayquantity limit

30 dayscontinuation requirement

Coverage Criteria

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Initial Therapy — Covered when ALL of the following are met for Major Depressive Disorder (MDD).

Covered when ALL of the following are met for Major Depressive Disorder (MDD):

MDD initial approval criteria: Member is 18 years of age or olderage >= 18

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Diagnosis: Member has a diagnosis of major depressive disorder (MDD)diagnosis = MDD

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Prior therapy: Documentation of failure or intolerance to at least two formulary antidepressants (examples: citalopram, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine)>= 2 prior antidepressant failures/intolerances

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Continuation Therapy — Continuation of therapy conditions.

Continuation of therapy:

Continuation requirement: At least one paid claim of at least a 30-day supply within the last 365 days for the respective drug>=1 paid claim of >=30 days within 365 days

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Any use of Trintellix (vortioxetine) for an indication other than the FDA‑approved indication of major depressive disorder (MDD) in adults is considered experimental/investigational and is not medically necessary.

All other indications aside from the FDA‑approved indication of major depressive disorder (MDD) in adults are considered not medically necessary and will not be covered.

Initial Therapy

Initial Therapy — Initial authorization criteria for Trintellix in MDD.

Initial authorization criteria for Trintellix in MDD

Age: Member is 18 years of age or older

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Diagnosis of major depressive disorder (MDD)

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Prior therapy: Documented failure or intolerance to at least two formulary antidepressants (examples listed)

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Continuation Criteria

Continuation — Conditions to approve continued coverage.

Conditions to approve continued coverage

Paid claim requirement: At least one paid claim of at least a 30-day supply within the last 365 days for the respective drug is required to continue coverage

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Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for treatment of major depressive disorder (MDD). Authorization may be granted for up to 12 months when all criteria are met: member is ≥ 18 years of age, has a diagnosis of MDD, and has documentation of failure or intolerance to at least two formulary antidepressants (e.g., citalopram, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine).

Authorization duration: up to 12 months
Failure/intolerance documentation must specify at least two formulary antidepressants

Denial Risk

Non‑FDA Indications Not Covered

Use of the medication for indications other than FDA‑approved MDD (treatment of major depressive disorder in adults) is considered experimental/investigational and not medically necessary. Requests for non‑FDA indications may be denied.

Documentation Required

Required Documentation

Documentation must include: member age (≥18 years), diagnosis of major depressive disorder, and prior treatment history demonstrating failure or intolerance to at least two formulary antidepressants. Include medication names, dates of therapy, and reason for discontinuation (failure or intolerance).

Required: member age and MDD diagnosis
Required: names of ≥2 formulary antidepressants, treatment dates, and reasons for failure/intolerance

Step Therapy

Step Requirement

Step requirement: approval requires documented failure or intolerance to at least two formulary antidepressants prior to approval.

Examples of formulary antidepressants: citalopram, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine

Step Therapy Requirements

Step	Requirement
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Quantity Limits

Quantity limit details

Drugs and strengthsTrintellix 5 mg, 10 mg, 20 mg

Quantity limit1 tablet per day

Limit periodDaily (per day)

FormulationOral tablet

Definitions

FDA‑Approved Indication

IndicationTreatment of major depressive disorder (MDD) in adults.

Covered statusOnly FDA‑approved indication is covered; other uses are experimental/investigational and not medically necessary.

PopulationAdults (age 18 and older)

Background

Trintellix (vortioxetine) is FDA‑approved for the treatment of major depressive disorder (MDD) in adults. Coverage under this policy is limited to this FDA‑approved indication; use for any other condition is considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrintellix (vortioxetine) — Coverage Criteria for Major Depressive Disorder

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization showing member is ≥18, diagnosed with MDD, and has failed or been intolerant to at least two formulary antidepressants.

SourceLink

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