Naloxone (Evzio) Form

Naloxone (Evzio®) is an opioid antagonist. FDA Approved Indication(s) Evzio is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric patients. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Evzio is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Opioid Overdose (must meet all):

1. Member may have access to opioids;
   2. Member must use generic naloxone nasal spray and naloxone solution for injection, unless contraindicated or clinically significant adverse effects are experienced;
   3. Requested quantity does not exceed two boxes (4 autoinjectors) per prescription. Approval duration:
      Medicaid – 6 months Commercial – 6 months or to member's renewal period, whichever is longer
      B. Other diagnoses/indications (must meet 1 or 2):
2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 1 of 6

   CLINICAL POLICY
   Naloxone Autoinjector criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Opioid Overdose (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
5. If request is for a dose increase, the requested quantity does not exceed two boxes (4 autoinjectors) per prescription. Approval duration:
   Medicaid – 12 months
   Commercial – 6 months or to member's renewal period, whichever is longer
   B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviations/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
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   CLINICAL POLICY
   Naloxone Autoinjector Drug Name Dosing Regimen naloxone nasal spray (Narcan®) naloxone 0.4 mg/mL solution 4 mg intranasally as a single spray in one nostril. Repeat as needed every 2 to 3 minutes with a new nasal spray in alternate nostrils. Additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives Adults: 0.4 to 2 mg IV, repeat every 2 to 3 minutes as needed; if no response after 10 mg, reconsider diagnosis of opioid toxicity; may administer IM or SC if IV route is unavailable Pediatrics: 0.01 mg/kg IV followed by 0.1 mg/kg IV if desired clinical response has not been achieved; divided doses may be given via IM or SC route if IV route is not available Dose Limit/ Maximum Dose Not applicable Not applicable Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to naloxone hydrochloride • Boxed warning(s): none reported Appendix D: General Information • 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. 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. If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of narcotic-induced or partial narcotic induced toxicity should be questioned. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. • As of November 2020, Kaléo, the makers of Evzio, have recently discontinued the production of the Evzio naloxone auto-injector and its generic equivalent. The reason for discontinuation of the auto-injectors are unknown; however, the existing product will remain in pharmacies and Kaleo did not express concerns regarding continued use of the product through the expiration date.
   _ Subject: production discontinued for Evzio naloxone auto-injector and its generic equivalent. Clinical Bulletin. November 18, 2020. Available at https://www.coventrywcs.com/sites/default/files/pdf/CLINICAL_BULLETIN-Production- discontinued-for-Evzio-naloxone-auto-injector-and-its-generic-equivalent-20201118.pdf. Accessed April 13, 2022.
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   CLINICAL POLICY
   Naloxone Autoinjector V. Dosage and Administration 0.4 mg or 2 mg IM or SC. Indication Dosing Regimen Known or suspected opioid overdose Repeat doses of Evzio may be required depending upon the amount, type, and route of administration of the opioid being antagonized. 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. Maximum Dose Not applicable VI. Product Availability Pre-filled autoinjector: 0.4 mg/0.4 mL or 2 mg/0.4 mL; each carton contains two auto- injectors VII.