Pharmacy Policy Bulletin
Viibryd and Brintellix/Trintellix (vilazodone and vortioxetine) – Commercial NSF
Number: J-0750 Category: Managed Rx Coverage
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1. and 2.):

1. Psychotherapeutic Drugs = Yes
2. a. or b.
         a. Rx Mgmt Step Therapy = Preferred
         b. Rx Mgmt Performance = MRXC = Yes
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

Applies to Commercial National Select formulary only


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


Background:
  • Viibryd (vilazodone) acts as a selective serotonin reuptake inhibitor and a partial agonist at the serotonergic 5-HT1A receptor. The combined action is thought to be responsible for its antidepressant effects, but the exact mechanism is not fully understood.
  • Brintellix/Trintellix (vortioxetine) is a serotonergic drug with a mechanism of action that is not fully understood but is likely related to its enhancement of serotonergic activity in the brain by blocking serotonin reuptake. It also acts as a 5-HT3 receptor antagonist and 5-HT1A receptor agonist. The contribution of these activities to the antidepressant effect of Brintellix/Trintellix (vortioxetine) has not been established.
  • Multiple safe and effective but lower cost agents are available in the US market place for the treatment of MDD.


Approval Criteria

When a benefit, coverage of Viibryd or Brintellix/Trintellix may be approved when all of the following criteria are met:

A. The member has a diagnosis of major depressive disorder (MDD) (ICD-9 296.2X, 296.3X) (ICD-10 F32.X, F33.X).

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

II. For Commercial and Healthcare Reform 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 or HCR members, coverage of Viibryd (vilazodone) or Brintellix/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 or HCR 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 lifetime authorization may be granted.


Automatic Approval Criteria

Members who meet one of the criteria 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 Brintellix/Trintellix (vortioxetine) within the previous 120 days.

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


Version: J-0750-001
Effective Date Begin: 07/01/2018
Effective End Begin: 08/31/2018
Original Date: 07/01/2018
Review Date: 06/20/2018


References:

  1. Viibryd [package insert]. Forest Pharmaceuticals, Inc.: St. Louis, MO; March 2015.
  2. Brintellix [package insert]. Takeda Pharmaceuticals America, Inc.: Deerfield, IL; July 2014.
  3. Trintellix [package insert]. Takeda Pharmaceuticals America, Inc.: Deerfield, IL; April 2017.
  4. Vilazodone. Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2016. Updated March 10, 2017..
  5. Vortioxetine. Clinical Pharmacology. Tampa, FL: Gold Standard Multimedia; 2015. Updated April 6, 2017..
  6. 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.
  7. Vilazodone. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2016.UpdatedJune 22, 2017.
  8. Vortioxetine. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2016.UpdatedJune 22, 2017.
  9. McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health System Pharmacists:2013;2410-2413.




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.