Medical Policy An independent licensee of the Blue Cross Blue Shield Association

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1 Opioid Antidote Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Opioid Antidote Prime Therapeutics will review Prior Authorization request Prior Authorization Form: Link to Drug List (Formulary): Professional Institutional Original Effective Date: December 1, 2016 Original Effective Date: December 1, 2016 Revision Date(s): December 1, 2016; February 1, 2017 Revision Date(s): December 1, 2016; February 1, 2017 Current Effective Date: February 1, 2017 Current Effective Date: February 1, 2017 State and Federal mandates and health plan member contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. To verify a member's benefits, contact Blue Cross and Blue Shield of Kansas Customer Service. The BCBSKS Medical Policies contained herein are for informational purposes and apply only to members who have health insurance through BCBSKS or who are covered by a self-insured group plan administered by BCBSKS. Medical Policy for FEP members is subject to FEP medical policy which may differ from BCBSKS Medical Policy. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents of Blue Cross and Blue Shield of Kansas and are solely responsible for diagnosis, treatment and medical advice. If your patient is covered under a different Blue Cross and Blue Shield plan, please refer to the Medical Policies of that plan.

2 Opioid Antidote Page 2 of 5 DESCRIPTION The intent of the Opioid Antidote Prior Authorization program is to promote the use of more cost effective naloxone products. The program will accommodate for patients who are unable to use more cost effective naloxone agents due to an FDA labeled contraindication, intolerance, or hypersensitivity; and for patients who have a documented inability to use more cost effective naloxone agents. The program will not approve for patients with contraindications to the requested agent. Target Drugs Evzio (naloxone auto-injector) FDA Approved Indications and Dosing 1-3 Agent Indications Dose and Interval Evzio (naloxone) injection solution Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Evzio is intended for immediate administration as emergency therapy in settings where opioids may be present. Evzio is not a substitute for emergency medical care. Administer the initial dose of Evzio to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer Evzio as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. The requirement for repeat doses of Evzio depends upon the amount, type, and route of administration of the opioid being antagonized. If the desired response is not obtained after 2 or 3 minutes, another Evzio dose may be administered. If there is still no response and additional doses are available, additional Evzio doses may be administered every 2 to 3 minutes until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. naloxone injection solution a Complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Diagnosis of suspected or known acute opioid over dosage Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. Adults: mg initially. Repeat dose every 2-3 minutes as needed. Doses should be titrated to response. Pediatrics: mg/kg initially. Repeat dose every 2-3 minutes as needed. Doses should be titrated to response. Neonates: 0.01 mg/kg initially

3 Opioid Antidote Page 3 of 5 Agent Indications Dose and Interval Narcan (naloxone) nasal spray Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Initial dosing: The recommended initial dose of NARCAN Nasal Spray in adults and pediatric patients is one spray delivered by intranasal administration, which delivers 4 mg of naloxone hydrochloride. Narcan Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Narcan Nasal Spray is not a substitute for emergency medical care. Repeat Dosing: Seek emergency medical assistance as soon as possible after administering the first dose of NARCAN Nasal Spray. The requirement for repeat doses of NARCAN Nasal Spray depends upon the amount, type, and route of administration of the opioid being antagonized. Administer NARCAN Nasal Spray in alternate nostrils with each dose. If the patient responds to NARCAN Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of NARCAN Nasal Spray using a new NARCAN Nasal Spray and continue surveillance of the patient. If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of NARCAN Nasal Spray using a new NARCAN Nasal Spray. If there is still no response and additional doses are available, administer additional doses of NARCAN Nasal Spray every 2 to 3 minutes using a new NARCAN Nasal Spray with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. Dosing Modifications due to Partial Agonists or Mixed Agonist/Antagonists: Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require higher doses of naloxone hydrochloride or repeated administration of NARCAN Nasal Spray using a new nasal spray

4 Opioid Antidote Page 4 of 5 POLICY Prior Authorization Criteria for Approval Requests for the targeted agent(s) will be approved when ALL of the following are met: 1. Patient has ONE of the following risk factors for opioid overdose: a. History of opioid overdose b. History of substance use disorder c. The patient is receiving 50 morphine milligram equivalents (MME) d. The patient is concomitantly using opioids with another Central Nervous System (CNS) depressant (e.g. benzodiazepines, alcohol, or muscle relaxants) AND 2. ONE of the following: a. The patient has a documented inability to use generic naloxone injection AND Narcan Nasal Spray b. The patient has an FDA labeled contraindication, intolerance, or hypersensitivity to generic naloxone injection AND Narcan Nasal Spray that is not expected to occur with the requested agent AND 3. The patient does not have any FDA labeled contraindications to the requested agent Length of approval: 12 months Agent Evzio (naloxone auto-injector) Contraindication Patients known to be hypersensitive to naloxone hydrochloride RATIONALE The Center for Disease Control and Prevention (CDC) recommends that the prescription of naloxone along with opioids be considered in patients who are at risk of developing overdose. These risks include a history of opioid overdose, a history of substance use disorder, opioid therapy at 50 morphine milligram equivalents (MME), and concomitant use of another Central Nervous System (CNS) depressant.

5 Opioid Antidote Page 5 of 5 REVISIONS Policy added to the bcbsks.com web site on Policy effective Policy published Policy retro-effective to A new strength of Evzio is now available. References updated REFERENCES 1. Evzio prescribing information. Kaleo, Inc. October Narcan prescribing information. Adapt Pharma, Inc. December naloxone prescribing information. West-Ward Pharmaceuticals Corp. April CDC Guideline for Prescribing Opioids for Chronic Pain United States, Center for Disease Control and Prevention. Accessed on 5/13/