Clinical Policy: naloxegol (Movantik) Reference Number: ERX.NSMN.02 Effective Date: 07/16 Last Review Date: 03/16 Clinical policies are intended to be reflective of current scientific research and clinical thinking. This policy is current at the time of approval, may be updated and therefore is subject to change. 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. Description The intent of the criteria is to ensure that patients follow selection elements established by Envolve Pharmacy Solutions for the use of naloxegol (MovantikTM). Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions that naloxegol (Movantik) is medically necessary for members meeting the following criteria: Initial Approval Criteria: I. Opioid-Induced Constipation (OIC) (must meet all) A. Age is ≥ 18 years old; B. Diagnosis of opioid-induced constipation; C. Member has used an opioid analgesic ≥ 4 weeks; D. Member is not being treated for cancer pain; E. Member has failed ≥ 2 non-bulk forming laxatives (see Table A) from different classes while on opioid therapy, unless contraindicated; F. Member has used at least one laxative in past 30 days, unless contraindicated; G. Requested dose does not exceed 1 tablet per day. Approval duration: 3 months Continued Approval (must meet all as applicable): A. Existing member and currently receiving the requested medication per pharmacy record or office notes showing adherence to therapy; B. Member has received an opioid analgesic within the last 30 days; C. If request is for dose increase, does not exceed 1 tablet per day. Approval duration: 12 months Page 1 of 3 CLINICAL POLICY Movantik (naloxegol) Workflow Document Algorithm Movantik.docx Background Description/Mechanism of Action Naloxegol is an antagonist of opioid binding at the mu-opioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naloxegol is a PEGylated derivative of naloxone, and is a substrate for the P-glycoprotein transporter (P-gp). Also, the presence of the PEG moiety in naloxegol reduces its passive permeability as compared with naloxone. Due to the reduced permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is expected to be negligible at the recommended dose levels limiting the potential for interference with centrally mediated opioid analgesia. FDA Approved Indication Movantik is FDA approved for the treatment of opiate agonist-induced constipation in adult patients with chronic non-cancer pain. Table A: Different Classes of Laxatives Osmotic Bulk -forming Surfactant Stimulants lactulose methylcellulose docusate bisacodyl polyethylene glycol psyllium senna sorbitol malt soup extract cascara magnesium calcium hydroxide polycarbophil magnesium sulfate sodium phosphate References 1. Movantik [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP.; January, 2016. 2. Movantik Drug Monograph. Clinical Pharmacology. http://www.clinicalpharmacology- ip.com. Accessed January 2016. Page 2 of 3 CLINICAL POLICY Movantik (naloxegol) Reviews, Revisions, and Approvals Date Approval Date Policy created 06/1 06/15 Converted policy to new format in written form; 03/16 06/16 Added background to include description, mechanism of action, and FDA approved indication; Added table to show different laxative types; Updated references to show most recent literature search; Page 3 of 3 .