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Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: ERX.SPMN.98 Effective Date: 07/16 Revision Log Last Review Date: 06/16

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Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: ERX.SPMN.98 Effective Date: 07/16 Revision Log Last Review Date: 06/16 Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: ERX.SPMN.98 Effective Date: 07/16 Revision Log Last Review Date: 06/16 See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions® that nafarelin acetate (Synarel®) is medically necessary for members meeting the following criteria: I. Initial Approval Criteria A. Central Precocious Puberty (CPP) (must meet all): 1. Females age ≥ 2 and ≤ 11 years or males age ≥ 2 and ≤ 12 years; 2. Diagnosis of CPP confirmed by a through c: a. Elevated basal LH level and/or elevated leuprolide stimulated LH level > 5 IU/I; b. Assessment shows significantly advanced bone age versus chronological age; c. Age at onset of secondary sex characteristics is < 8 years, if female, or < 9 years, if male; 3. The following conditions have been ruled out: a. Intracranial tumor with diagnostic brain imaging; b. Steroid secreting tumors with pelvic/testicular/adrenal ultrasound; c. Chorionic gonadotropin secreting tumor via measurement of human chorionic gonadotropin levels; d. Congenital adrenal hyperplasia via measurement of adrenal steroids; 4. Prescribed dose does not exceed 1800 micrograms/day administered as 600 micrograms three times a day. Approval duration: 12 months B. Endometriosis or Chronic Refractory Pelvic Pain (must meet all): 1. Age ≥ 18 years; 2. Diagnosis of one of the following: a. Endometriosis and one of the following: i. Diagnosis surgically confirmed; or ii. Clinically diagnosed and failed a three-month trial of analgesics and/or combined oral estrogen-progesterone contraceptives within the last year; b. Chronic refractory pelvic pain and all of the following: i. Pain for at least six months; ii. The pain is severe enough to cause functional disability or require treatment; iii. Diagnostic laparoscopy, if done, was normal; iv. Other causes of pelvic pain have been ruled out; Page 1 of 4 CLINICAL POLICY Nafarelin Acetate v. Failed a three-month trial of analgesics and/or combined oral estrogen- progesterone contraceptives within the last year; 3. Prescribed total daily dose does not exceed 800 micrograms. Approval Duration: 6 months (two 6-month courses total) C. Other diagnoses/indications: Refer to ERX.SPMN.16 - Global Biopharm Policy II. Continued Approval (must meet all as applicable) A. Central Precocious Puberty (CPP): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria; 2. Females age ≥ 2 and ≤ 11 years, or males age ≥ 2 and ≤ 12 years; 3. Therapeutic effect is evidenced by decreased growth velocity, cessation of menses, if female, and arrested pubertal progression. Approval Duration: 12 months B. Endometriosis or Chronic Refractory Pelvic Pain (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria. Approval Duration: 6 months (two 6-month courses total) C. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy; or 2. Refer to ERX.SPMN.16 - Global Biopharm Policy. Background Description/Mechanism of Action: Nafarelin acetate is a potent agonistic analog of gonadotropin-releasing hormone (GnRH). At the onset of administration, nafarelin stimulates the release of the pituitary gonadotropins, LH and FSH, resulting in a temporary increase of gonadal steroidogenesis. Repeated dosing abolishes the stimulatory effect on the pituitary gland. Twice-daily administration leads to decreased secretion of gonadal steroids by about 4 weeks; consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. FDA-Approved Indication: Synarel is a GnRH agonist/nasal solution indicated for: Treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes; Management of endometriosis, including pain relief and reduction of endometriotic lesions. Page 2 of 4 CLINICAL POLICY Nafarelin Acetate Appendices Appendix A: Abbreviation Key CPP: central precocious puberty GnRH: gonadotropin-releasing hormone LH: luteinizing hormone Reviews, Revisions, and Approvals Date Approval Date Policy created. 05/16 06/16 References 1. Synarel Prescribing Information. New York, NY: G.D. Searle; August 2015. http://labeling.pfizer.com/ShowLabeling.aspx?id=515. Accessed January 21, 2016. 2. Harrington J and Pamert MR. Definition, etiology, and evaluation of precocious puberty. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 3. Harrington J and Pamert MR. Treatment of precocious puberty. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 4. Schenken RS. Endometriosis: pathogenesis, clinical features, and diagnosis. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 5. Schenken RS. Endometriosis: overview of the treatment of endometriosis. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 6. Hornstein MD and Gibbons WE. Gonadotropin releasing hormone agonists for long- term treatment of endometriosis. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 7. Howard F. Evaluation of chronic pelvic pain in women. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. 8. Howard F. Treatment of chronic pelvic pain in women. In: UpToDate, Waltham, MA: Walters Kluwer Health; 2016. Available at UpToDate.com. Accessed February 2, 2016. Page 3 of 4 CLINICAL POLICY Nafarelin Acetate 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. ©2016 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 4 of 4 .
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