Naltrexone (Vivitrol) Form

Naltrexone (Vivitrol®) is an opioid antagonist.
FDA Approved Indication(s) Vivitrol is indicated: • For the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol. Patients should not be actively drinking at the time of initial Vivitrol administration • For the prevention of relapse to opioid dependence, following opioid detoxification ____ *Vivitrol should be part of a comprehensive management program that includes psychosocial support. 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 Vivitrol is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Alcohol and Opioid Dependence (must meet all):

1. Diagnosis of one of the following (a or b): a. Alcohol dependence; b. Opioid dependence;

   2. Member meets one of the following (a or b): a. Member is currently hospitalized or is being treated in a residential addiction treatment facility, and request is for Vivitrol treatment post-hospital or facility discharge; b. Member meets both of the following (i and ii): i. If diagnosis is alcohol dependence, recent alcohol screening test (within past 7 days) confirms that member has been alcohol-free;
      ii. Member meets one of the following (1 or 2): 1) Recent naloxone challenge test or urine drug screen (within past 7 days) confirms that member is opioid-free; 2) Member is currently being treated at an addiction treatment center, and chart note documentation is submitted demonstrating daily treatment with oral naltrexone; Page 1 of 7

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   3. Dose does not exceed 380 mg every 4 weeks or once a month. Approval duration: Medicaid/Commercial – 6 months (12 months for New Hampshire) HIM – 12 months
      B. Other diagnoses/indications (must meet 1 or 2):
   4. 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, HIM.PA.33 for health insurance marketplace, 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, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   5. 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, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Alcohol and Opioid Dependence (must meet all):
2. 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);
3. Member is responding positively to therapy;
4. Member does not have concurrent opioid claims per pharmacy record;

5. Evidence of adherence to Vivitrol per pharmacy claims record or provider’s notes; *If not adherent to treatment, member must meet initial approval criteria

   5. If request is for a dose increase, new dose does not exceed 380 mg every 4 weeks or once a month. Approval duration: 12 months 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: Page 2 of 7

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   CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, 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, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. 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, HIM.PA.154 for health insurance marketplace, 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 policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
      o Patients receiving opioid analgesics;
      o Patients with current physiologic opioid dependence;
      o Patients in acute opioid withdrawal; o Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids; o Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co- glycolide (PLG), carboxymethylcellulose, or any other components of the diluent. • Boxed warning(s): none reported Appendix D: General Information • Opioid-dependent and opioid-using patients, including those being treated for alcohol dependence, should be opioid-free before starting Vivitrol treatment, and should notify healthcare providers of any recent opioid use. An opioid-free duration of a minimum of 7-10 days is recommended for patients to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization. • Although the safety and efficacy of Vivitrol have not been established in the pediatric population, the consensus opinion of the American Society of Addiction Medication (ASAM) national practice guideline committee is that opioid agonists (methadone and buprenorphine) and antagonists (naltrexone) may be considered for treatment of opioid Page 3 of 7

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   use disorder in adolescents. The American Academy of Pediatrics recommends that pediatricians consider offering medication-assisted treatment to their adolescent and young adult patients with severe opioid use disorders or discuss referrals to other providers for this service. V. Dosage and Administration
   Indication Alcohol and opioid dependence 380 mg IM every 4 weeks or once a Dosing Regimen Maximum Dose 380 mg/dose
   month VI. Product Availability
   Injectable suspension (vial): 380 mg naltrexone microspheres and 4 mL diluent VII.