Clinical Policy: Vilazodone (Viibryd) Reference Number: ERX.ST.12 Effective Date: 06.01.15 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description ® Vilazodone (Viibryd ) is a selective serotonin reuptake inhibitor (SSRI) and a 5HT1A receptor partial agonist.

FDA approved indication Viibryd is indicated for the treatment of major depressive disorder.

Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Viibryd is medically necessary when the following criteria are met:

I. Initial Approval Criteria A. Step Therapy for Viibryd (must meet all): 1. Age ≥ 18 years; 2. Previous use of ≥ 30 days of one SSRI unless contraindicated or clinically significant adverse effects are experienced; 3. Previous use of ≥ 30 days of one serotonin/norepinephrine reuptake inhibitor (SNRI) unless contraindicated or clinically significant adverse effects are experienced; 4. One of the aforementioned trials occurred within the past 6 months, unless all are contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 40 mg/day (1 tablet/day). Approval duration: 12 months

II. Continued Therapy A. Step Therapy for Viibryd (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met all initial approval criteria; 2. If request is for a dose increase, new dose does not exceed 40 mg/day (1 tablet/day). Approval duration: 12 months

III. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration SNRI: serotonin and norepinephrine reuptake inhibitor SSRI: selective serotonin reuptake inhibitor

Appendix B: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose SSRIs Citalopram (Celexa) Depression 40 mg/day (≤ 60 years)

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Drug Dosing Regimen Dose Limit/ Maximum Dose 20 mg PO QD; may increase to 40 mg 20 mg/day (> 60 years) PO QD after one week Escitalopram (Lexapro) Depression 20 mg/day 10 mg PO QD; may increase to 20 mg PO QD after 1 week Fluoxetine (Prozac, Depression Prozac: 80 mg/day Prozac Weekly) Prozac: 20 mg PO QD; may increase by 10-20 mg after several weeks Prozac Weekly: 90 mg/week Prozac Weekly: 90 mg PO q week beginning 7 days after the last daily dose Paroxetine (Paxil, Paxil Depression Paxil, Pexeva: 50 mg/day CR, Pexeva) Paxil, Pexeva: 20 mg PO QD; may increase by 10 mg every week as Paxil CR: 62.5 mg/day needed

Paxil CR: 25 mg PO QD; may increase by 12.5 mg every week as needed Sertraline (Zoloft) Depression 200 mg/day 50 mg PO QD; may increase every week as needed SNRIs Duloxetine (Cymbalta) Depression 120 mg/day 20 mg PO BID or 30 mg PO BID or 60 mg PO QD Venlafaxine (Effexor, Depression Effexor: 225 mg/day Effexor XR) Effexor: 75 mg/day PO in 2-3 divided (outpatient) or 375 mg/day doses; may increase by 75 mg every 4 (inpatient) days as needed Effexor XR: 225 mg/day Effexor XR: 75 mg PO QD; may increase by 75 mg every 4 days as needed Desvenlafaxine (Pristiq, Depression 400 mg/day Khedezla) 50 mg PO QD Fetzima® Depression 120 mg/day (levomilnacipran) 20 mg PO QD for 2 days, then 40 mg PO QD; may increase by 40 mg every 2 days

IV. Dosage and Administration Indication Dosing Regimen Maximum Dose Major depressive disorder 10 mg PO QD for 7 days, followed by 40 mg/day 20 mg PO QD; may increase to 40 mg PO QD after 7 days

V. Product Availability Tablets: 10 mg, 20 mg, and 40 mg

VI. References 1. Viibryd Prescribing Information. Cincinnati, OH: Forest Pharmaceuticals, Inc.; January 2017. Available at: www.viibryd.com. Accessed June 22, 2017. 2. Gelenberg AJ et al. Practice guideline for the treatment of patients with major depressive disorder, third edition. Arlington, VA: American Psychiatric Association; May 2010. Available

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online at https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines. July 6, 2017.

Reviews, Revisions, and Approvals Date P&T Approval Date Policy created 06/15 06/15 Updated to new template (converted algorithm to bulleted 07/16 09/16 criteria, added background and references). Converted to new template. Clarified trial/failure requirement to 06/17 08/17 indicate that 1 SSRI and 1 SNRI should have been trialed. Specified that at least one of the trials should have occurred in the last 6 months. Replaced general max dosing with specific max dosing.

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information.

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members.

This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions.

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