Last Review Date: 09/05/2023

Date of Origin: 01/01/2012

Dates Reviewed: 12/2011, 02/2013, 02/2014, 12/2014, 10/2015, 10/2016, 10/2017, 08/2018, 08/2019, 08/2020, 08/2021, 08/2022, 08/2023, 09/2023

1. Length of Authorization

Coverage will be provided for 12 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Vivitrol 380 mg single-dose vial: 1 vial per 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 380 billable units (380 mg) every 28 days

3. Initial Approval Criteria* ¹

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient does not have acute hepatitis or severe hepatic impairment (Child-Pugh C); AND
• Patient is not receiving concurrent treatment with opioid analgesics; AND
• Patient does not have current physiologic opioid dependence; AND
• Patient is not experiencing acute opioid withdrawal; AND
• Patient has not failed the naloxone challenge test or does not have positive urine screen for opioids; AND
• Documented participation in and adherence to a comprehensive management program including psychosocial support; AND

Alcohol Dependence † ^1,3

• Patient has failed to adhere to oral naltrexone, disulfiram, or acamprosate therapy; AND
• Patient has not had an alcoholic drink for 7 days prior to initiation of therapy

Opioid Dependence † ^1,8

• Patient has undergone opioid detoxification for at least 7 days; AND
• Patient has, or is anticipated to have, difficulty adhering to daily oral naltrexone

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria* ^1,3,8

Coverage may be renewed based on the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements, (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Documented continued clinical benefit to the patient as defined by complete abstinence from alcohol/opioids confirmed on urine drug screen; AND
• Continued administration is necessary to prevent relapse; AND
• Absence of unacceptable toxicity from the drug.  Examples of unacceptable toxicity include: hepatotoxicity (e.g., acute hepatitis, clinically significant liver dysfunction, etc.), severe injection site reactions (e.g., induration, cellulitis, hematoma, abscess, sterile abscess, necrosis, etc.), eosinophilic (allergic) pneumonia, hypersensitivity reactions including anaphylaxis, development of depression or suicidal thinking, etc.

5. Dosage/Administration ^1,8

6. Billing Code/Availability Information

HCPCS Code:

• J2315 – Injection, naltrexone, depot form, 1 mg; 1 billable unit = 1 mg

NDC:

• Vivitrol 380 mg/5 mL single-dose vial: 65757-0300-xx

7. References

1. Vivitrol [package insert]. Waltham, MA; Alkermes, Inc; September 2022. Accessed July 20232.
2. The American Society of Addiction Medicine (ASM). National Practice Guideline for the Use of Medications in Treatment of Addiction Involving Opioid Use. December 2019. Available at: https://www.asam.org/docs/default-source/quality-science/npg-jam-supplement.pdf?sfvrsn=a00a52c2_2.
3. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. Am J Psychiatry. 2018 Jan 1;175(1):86-90.
4. Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011;377(9776):1506-1513.
5. Lee JD, Nunes EV Jr, Novo P, et al. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018;391(10119):309-318.
6. Tanum L, Solli KK, Latif ZE, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: a randomized clinical noninferiority trial. JAMA Psychiatry. 2017;74(12):1197-1205.
7. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625.
8. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update. J Addict Med. 2020 Mar/Apr;14(2S Suppl 1):1-91. doi: 10.1097/ADM.0000000000000633.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):  N/A