Pharmacy Policy Bulletin

Viibryd and Trintellix (vilazodone and vortioxetine) – Commercial
Number: J-0750	Category: Managed Rx Coverage
Line(s) of Business: Commercial Healthcare Reform Medicare	Benefit(s): Commercial (1. and 2.): Psychotherapeutic Drugs = Yes a. or b. Rx Mgmt Step Therapy = Preferred Rx Mgmt Performance = MRXC = Yes
Region(s): All Delaware New York Pennsylvania West Virginia	Additional Restriction(s): Not applicable

Viibryd and Trintellix (vilazodone and vortioxetine) – Commercial

Number: J-0750

Category: Managed Rx Coverage

Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1. and 2.):

Psychotherapeutic Drugs = Yes
a. or b.

Rx Mgmt Step Therapy = Preferred
Rx Mgmt Performance = MRXC = Yes

Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

Not applicable

Approval Criteria
I. When a benefit, coverage of Viibryd or Trintellix may be approved when all of the following criteria are met (A. and B.): A. The member has a diagnosis of major depressive disorder (MDD). B. The member and has tried and failed at least 1 prior antidepressant (e.g., SSRI, TCA, MAOI). II. For Commercial members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

Approval Criteria

I. When a benefit, coverage of Viibryd or Trintellix may be approved when all of the following criteria are met (A. and B.):

A. The member has a diagnosis of major depressive disorder (MDD).

B. The member and has tried and failed at least 1 prior antidepressant (e.g., SSRI, TCA, MAOI).

II. For Commercial members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

Limitations of Coverage
I. For Commercial members, coverage of Viibryd (vilazodone) or Trintellix (vortioxetine) in disease states outside of its FDA-approved indication should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. II. For Commercial members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined in this policy.

Limitations of Coverage

I. For Commercial members, coverage of Viibryd (vilazodone) or Trintellix (vortioxetine) in disease states outside of its FDA-approved indication should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

II. For Commercial members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined in this policy.

Authorization Duration
Commercial: If approved, up to a 2 year authorization may be granted.

Authorization Duration

Commercial: If approved, up to a 2 year authorization may be granted.

Automatic Approval Criteria
Members who meet one of the criteria (A. or B.) as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required. A. The member has at least one claim for 1 prior antidepressant agent (e.g., SNRI, SSRI, TCA, MAOI) in their prescription drug claims history within the past 24 months B. The member has a previous paid claim for Viibryd (vilazodone) or Trintellix (vortioxetine) within the previous 120 days. Members who do not meet any of the above criteria will require prior authorization.

Automatic Approval Criteria

Members who meet one of the criteria (A. or B.) as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

A. The member has at least one claim for 1 prior antidepressant agent (e.g., SNRI, SSRI, TCA, MAOI) in their prescription drug claims history within the past 24 months

B. The member has a previous paid claim for Viibryd (vilazodone) or Trintellix (vortioxetine) within the previous 120 days.

Members who do not meet any of the above criteria will require prior authorization.

References:

Viibryd [package insert]. Irvine, CA: Allergan USA, Inc.; January 2017
Trintellix [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; October 2018..
Vilazodone. Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2016. Updated March 10, 2017..
Vortioxetine. Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2015. Updated April 6, 2017..
Rickels K , Athanasiou M , Robinson DS , et al. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: A randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2009;70(3):326-333.
Vilazodone. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2016.UpdatedJune 22, 2017.
Vortioxetine. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2016.UpdatedJune 22, 2017.
McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health System Pharmacists:2013;2410-2413.

Drugs Products	Viibryd (vilazodone) Trintellix (vortioxetine)
FDA-Approved Indications:	Treatment of major depressive disorder (MDD)