Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) C4719-A

Prior Authorization Criteria

Serotonin - Norepinephrine Reuptake Inhibitors (SNRI) Policy Number: C4719-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 04/2012 12/16/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION NA RxPA Q1 2021 20210127C4719-A

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 succinate extended release tablet: 25mg, 50mg, 100mg

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 patient’s diagnosis requiring treatment with product requested AND 2. Product being requested has an FDA labeled indication or compendia supported use for diagnosis, age, and dose AND

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Prior Authorization Criteria

3. Documentation of an adequate trial (3 months) and therapeutic failure to at least 3 formulary preferred SNRI products.

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

QUANTITY: Maximum 1 tablet daily

PRESCRIBER REQUIREMENTS: None

AGE RESTRICTIONS: Treatment: Adults 18 years and older

CONTINUATION OF THERAPY: FOR ALL INDICATIONS 1. Adherence to therapy at least 85% of the time as verified by the prescriber or member medication fill history AND 2. Documentation of no intolerable adverse effects or drug toxicity AND 3. Documentation of positive clinical response as demonstrated by low disease activity and/or improvements in the condition’s signs and symptoms.

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

Prior Authorization Criteria

BACKGROUND: None

APPENDIX: None

Documentation Requirements: Molina Healthcare reserves the right to require that additional documentation be made available as part of its coverage determination; quality improvement; and fraud; waste and abuse prevention processes. Documentation required may include, but is not limited to, patient records, test results and credentials of the provider ordering or performing a drug or service. Molina Healthcare may deny reimbursement or take additional appropriate action if the documentation provided does not support the initial determination that the drugs or services were medically necessary, not investigational or experimental, and otherwise within the scope of benefits afforded to the member, and/or the documentation demonstrates a pattern of billing or other practice that is inappropriate or excessive.

REFERENCES: 1. Fetzima (levomilnacipran) [product monograph]. Markham, Ontario, Canada: Allergan Inc; November 2019 2. Khedezla (desvenlafaxine) [prescribing information]. Morristown, NJ: Pernix Therapeutics LLC; January 2019. 3. Pristiq (desvenlafaxine) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals LLC; November 2018. 4. 10.Bauer M, Pfennig A, Severus E, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of unipolar depressive disorders, part 1: update 2013 on the acute and continuation treatment of unipolar depressive disorders. World J Biol Psychiatry 2013; 14:334. 5. 14.Kupfer DJ, Frank E, Phillips ML. Major depressive disorder: new clinical, neurobiological, and treatment perspectives. Lancet 2012; 379:1045. 6. 16.Marcus SC, Olfson M. National trends in the treatment for depression from 1998 to 2007. Arch Gen Psychiatry 2010; 67:1265.