ph-0139
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Vivitrol (naltrexone)

Policy Number: PH-0139

 

(Intramuscular)

Last Review Date: 08/05/2019

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

  1. Length of Authorization

Coverage will be for six months and may be renewed.

  1. Dosing Limits

A. Quantity Limit (max daily dose) [Pharmacy Benefit]:

  • Vivitrol 380 mg vial: 1 vial every 28 days

B. Max Units (per dose and over time) [Medical Benefit]:

  • 380 billable units every 28 days
  1. Initial Approval Criteria*

Coverage is excluded for compounded naltrexone pellets.

  • Patient must be 18 years old or over; AND
  • Patient does not have acute hepatitis or severe hepatic impairment (Child-Pugh C); AND

      Alcohol dependence †

  • Documented participation in a comprehensive management program including psychosocial support; AND
  • 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; AND
  • Patient is not taking any opioid medications as evidenced by a urine screen

      Opioid dependence †

  • Patient is in a comprehensive rehabilitation program; AND
  • Patient has undergone opioid detoxification for at least 7 days; AND
  • Patient has tested negative for opioids as evidenced by a urine screen or naloxone challenge test; AND
  • Patient has, or is anticipated to have, difficulty adhering to daily oral naltrexone

FDA Approved Indication(s)

    IV. Renewal Criteria*

  • Patient continues to meet the criteria identified in section III; AND
  • Documented continued clinical benefit to the patient as defined by complete abstinence from the use of alcohol/opioids confirmed on urine drug screen; AND
  • Documented participation in and adherence to a comprehensive management program including psychosocial support; AND
  • Continued administration is necessary to prevent relapse; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: symptoms or signs of acute hepatitis, severe injection site reactions, eosinophilic (allergic) pneumonia, hypersensitivity reactions including anaphylaxis, development of depression or suicidal thinking, etc. ; AND
  • If the diagnosis is alcohol dependence, the patient has been alcohol free for at least 7 days
  • If the diagnosis is opioid dependence, the patient meets ALL of the following:
    • The patient has been through opioid detoxification; AND
    • The patient is opioid free for at least the last 7 days as determined by ONE of the following:
    • The patient has passed a naloxone challenge test; OR
    • The patient has a negative opioid urine screen

*Note: compounded naltrexone products are not covered by this policy

  1. Dosage/Administration

Indication

Dose

All indications

380 mg administered intramuscularly every 4 weeks

  • VI. Billing Code/Availability Information

Jcode:

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

NDC:

Vivitrol 380 mg vial: 65757-0300-xx

  1. References

1. Vivitrol [package insert]. Waltham, MA; Alkermes, Inc; December 2018. Accessed June 2019.

2. American Society of Addiction Medicine. National Practice Guideline for the Use of Medications in Treatment of Addiction Involving Opioid Use. June 2015. Available at: https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf

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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

F10.20

Alcohol dependence, uncomplicated

F10.21

Alcohol dependence, in remission

F10.220

Alcohol dependence with intoxication, uncomplicated

F10.221

Alcohol dependence with intoxication, delirium

F10.229

Alcohol dependence with intoxication, unspecified

F10.230

Alcohol dependence with withdrawal, uncomplicated

F10.231

Alcohol dependence with withdrawal, delirium

F10.232

Alcohol dependence with withdrawal, with perceptual disturbance

F10.239

Alcohol dependence with withdrawal, unspecified

F10.24

Alcohol dependence with alcohol-induced mood disorder

F10.250

Alcohol dependence with alcohol-induced psychotic disorder, with delusions

F10.251

Alcohol dependence with alcohol-induced psychotic disorder, with hallucinations

F10.259

Alcohol dependence with alcohol-induced psychotic disorder, unspecified

F10.26

Alcohol dependence with alcohol-induced persisting amnestic disorder

F10.27

Alcohol dependence with alcohol-induced persisting dementia

F10.280

Alcohol dependence with alcohol-induced anxiety disorder

F10.281

Alcohol dependence with alcohol-induced sexual dysfunction

F10.282

Alcohol dependence with alcohol-induced sleep disorder

F10.288

Alcohol dependence with other alcohol-induced disorder

F10.29

Alcohol dependence with unspecified alcohol-induced disorder

F11.20

Opioid dependence, uncomplicated

F11.21

Opioid dependence, in remission

F11.220

Opioid dependence with intoxication, uncomplicated

F11.221

Opioid dependence with intoxication delirium

F11.222

Opioid dependence with intoxication with perceptual disturbance

F11.229

Opioid dependence with intoxication, unspecified

F11.23

Opioid dependence with withdrawal

F11.24

Opioid dependence with opioid-induced mood disorder

F11.250

Opioid dependence with opioid-induced psychotic disorder with delusions

F11.251

Opioid dependence with opioid-induced psychotic disorder with hallucinations

F11.259

Opioid dependence with opioid-induced psychotic disorder, unspecified

F11.281

Opioid dependence with opioid-induced sexual dysfunction

F11.282

Opioid dependence with opioid-induced sleep disorder

F11.288

Opioid dependence with other opioid-induced disorder

F11.29

Opioid dependence with unspecified opioid-induced disorder

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) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-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): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

VIVITROL® (naltrexone) Prior Auth Criteria
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