Trintellix - Essential & Net Results

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 stable on Trintellix, with at least a 4 week trial, OR
2. The patient has tried and failed ONE other antidepressant within the selective serotonin reuptake inhibitor (SSRI) or selective serotonin/norepinephrine reuptake inhibitor (SNRI) class (4 week trial required).
   
   Duration of Approval: 365 days (1 year)

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.

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.