Trintellix - NC Standard

Restricted Product(s):

• Trintellix (vortioxetine)

FDA Approved Use: 

• Treatment of major depressive disorder (MDD).

Criteria for Approval of Restricted Product(s):

1. The patient is currently stable on Trintellix, and cannot be safely transitioned to an unrestricted alternative; OR
2. The patient has experienced a therapeutic failure or inadequate response to ONE generic antidepressant; OR
3. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to ALL generic antidepressants.

Duration of Approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:  365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

April 2025: Criteria change: Combined all formularies to an NC Standard policy. Updated trial and failure language to allow ONE generic antidepressant, or contraindication to all.

May 2023: Criteria change: Changed step requirement to one step for Essential Formulary. Combined Essential and Net Results formularies into one policy.

July 2022: Criteria update: Quantity limits added to Trintellix.

May 2022: Criteria update: Duration of therapy changed to 365 days.

June 2021: Criteria update: Annual criteria review.

Sep 2019: Criteria Change: Removed diagnosis requirement and change from a double to single prerequisite for Net Results formulary.

Jan 2019: Original utilization management criteria issued.