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Prior Authorization Criteria

Cymbalta, Irenka (duloxetine) Policy Number: C4211-C

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE

3/1/2012 LAST REVIEWED DATE

8/1/2018 NEXT REVIEW DATE

8/1/2019 J CODE NA

TYPE OF CRITERIA RxPA

LAST P&T APPROVAL Q3

PRODUCTS AFFECTED: Cymbalta, Irenka (duloxetine)

DRUG CLASS: Serotonin - Norepinephrine reuptake inhibitors (SNRI)

ROUTE OF ADMINISTRATION: Oral

PLACE OF SERVICE: Retail Pharmacy

AVAILABLE DOSAGE FORMS: Cymbalta Cap 20MG, Duloxetine Cap 20MG DR, Cymbalta CAP 30MG, Duloxetine CAP 30MG DR, Cymbalta CAP 60MG, Duloxetine Cap 60MG DR

FDA-APPROVED USES: For the treatment of major depression, treatment of pain associated with diabetic neuropathy, treatment of pain associated fibromyalgia, treatment of generalized anxiety disorder (GAD), treatment of chronic musculoskeletal pain and Osteoarthritis

COMPENDIAL APPROVED OFF-LABELED USES: None

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS: For the treatment of major depression, treatment of pain associated with diabetic neuropathy, treatment of pain associated fibromyalgia, treatment of generalized anxiety disorder (GAD), treatment of chronic musculoskeletal pain and Osteoarthritis

REQUIRED MEDICAL INFORMATION: A. DEPRESSION: 1. Trial of TWO formulary antidepressants and Venlafaxine. B. DIABETIC NEUROPATHY: 1. Trial of a therapeutic dose of 1200 to 2400mg per day of gabapentin

C. FIBROMYALGIA: 1. Trial of a therapeutic dose of 1200 to 2400mg per day of gabapentin. D. GENERALIZED ANXIETY DISORDER (GAD): 1. Trial of TWO formulary antidepressants E. MUSCULOSKELETAL PAIN:

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

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Prior Authorization Criteria

1. Trial of ONE formulary muscle relaxant AND ONE formulary NSAID medication F. OSTEOARTHRITIS: 1. Trial of TWO formulary NSAID medications

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

QUANTITY: One capsule daily for diabetic neuropathy, fibromyalgia, musculoskeletal pain, osteoarthritis, and generalized anxiety disorder. Up to two capsules daily for major depression.

PRESCRIBER REQUIREMENTS: No restriction

AGE RESTRICTIONS: 7 years of age and older for generalized anxiety disorder, 18 years of age and older for all other indications

GENDER: Male and female

CONTINUATION OF THERAPY: A. FOR ALL INDICATIONS: 1. The prescribed medication is effective and tolerated without adverse effects.

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: Uncontrolled narrow-angle glaucoma due to increased risk of mydriasis. Known hypersensitivity to duloxetine. Duloxetine has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. BLACK BOX WARNING: Children younger than 7 years of age. October 2004, the FDA directed manufacturers of all antidepressants to add a boxed warning to their product labels detailing the risk of suicide in pediatric patients.

OTHER SPECIAL CONSIDERATIONS: Avoid use in patients with any chronic hepatic disease or cirrhosis, due to an increased risk for hepatotoxicity

BACKGROUND: None

APPENDIX: None

REFERENCES: 1. Cymbalta [package insert]. Indianapolis, IN: Eli Lilly and Company; June 2015. 2. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed September 2015. 3. Micromedex Solutions [database online]. Greenwood Village, CO: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 2015. 4. Timming R, Hooten WM, et al. Institute for Clinical Systems Improvement. Assessment and Management of Chronic

Prior Authorization Criteria

Pain. Sixth Edition. Updated November 2013. www.icsi.org. Accessed September 2015. 5. Dworkin RH, O’Connor AB, Backonja M, et al. Pharmacologic Management of Neuropathic Pain: Evidence-based Recommendations. Pain 2007;132(3):237-251.

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 p ermission 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 3 of 3