Non-Preferred SNRI Policy Number: C4719-A

Prior Authorization Criteria

Non-preferred SNRI Policy Number: C4719-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 04/2012 12/2018 12/2019 J CODE TYPE OF CRITERIA LAST P&T APPROVAL NA RxPA Q3

PRODUCTS AFFECTED: FETZIMA (levomilnacipran), KHEDEZLA (desvenlafaxine), PRISTIQ (desvenlafaxine)

DRUG CLASS: Serotonin - Norepinephrine reuptake inhibitors (SNRI)

ROUTE OF ADMINISTRATION: Oral

PLACE OF SERVICE: Retail Pharmacy

AVAILABLE DOSAGE FORMS: Fetzima Extended-Release capsule: 20mg, 40mg, 80mg, 120mg, 20-40mg titration pak Khedezla Extended-Release tablet: 100mg, 50mg; Desvenlafaxine Extended-Release tablet: 100mg, 50mg Pristiq extended release tablet : 25mg, 50mg, 100mg; Desvenlafaxine succin

FDA-APPROVED USES: Major Depressive Disorder in Adults

COMPENDIAL APPROVED OFF-LABELED USES: None

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS: Treatment of Major Depressive Disorder in Adults, Treatment of Hot Flashes associated with Menopause – off label (Pristiq and Khedezla)

REQUIRED MEDICAL INFORMATION: A. FOR ALL INDICATIONS: 1. Documentation of an adequate trial (3 months) and therapeutic failure of at least 3 formulary antidepressants including Effexor XR (venlafaxine) AND 2. Documentation of and adequate trial (3 months) and therapeutic failure to formulary preferred SNRI products.

DURATION OF APPROVAL: Initial authorization: 12 months Continuation of Therapy: for up to 12 months

Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 2 Prior Authorization Criteria

QUANTITY: Maximum 1 tablet daily

PRESCRIBER REQUIREMENTS: None

AGE RESTRICTIONS: Treatment: Adults 18 years and older

GENDER: Male and female

CONTINUATION OF THERAPY: Patient is compliant with medication (as evidenced by claims history, if available)

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: Pristiq/Khedzela: Desvenlafaxine should not be given to any patient with a known desvenlafaxine hypersensitivity or venlafaxine hypersensitivity, or a reaction to any other ingredient in the formulation. Desvenlafaxine is not FDA approved for the treatment of major depressive disorder (MDD) in children or adolescents. Desvenlafaxine is contraindicated for concomitant use in patients receiving monoamine oxidase inhibitor therapy (MAOI therapy), due to the risk for serotonin syndrome. Caution is advised when prescribing desvenlafaxine in patients with hepatic disease or in patients with renal impairment, due to increased drug exposure. Patients receiving desvenlafaxine should have regular monitoring of blood pressure since increases in blood pressure were observed in clinical studies. Caution is recommended when prescribing desvenlafaxine to patients with closed- angle glaucoma Fetzima:Levomilnacipran is contraindicated in patients with a hypersensitivity to levomilnacipran or any ingredient in the formulation, and also in patients with a milnacipran hypersensitivity. Levomilnacipran is not approved for use in neonates, infants or children under 18 years of age. Due to the effects of levomilnacipran on serotonin and norepinephrine, the drug is contraindicated during MAOI therapy or within 14 days of taking an MAOI. Levomilnacipran is contraindicated in patients with uncontrolled closed-angle glaucoma. Caution is advisable when administering levomilnacipran to patients with pre-existing urinary retention, urinary hesitancy, urinary tract obstruction, or those prone to obstructive urinary disorders. Levomilnacipran should be used cautiously in patients with cardiac disease, including those with a recent history of myocardial infarction, unstable coronary artery disease, hypertension, or cerebrovascular disease since levomilnacipran has been associated with elevations in heart rate and blood pressure

OTHER SPECIAL CONSIDERATIONS: None

BACKGROUND: None

APPENDIX: None

REFRENCES: Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2018: http://www.clinicalpharmacology.com. Updated February, 2018.