Medical Policy: 05.01.13 

Original Effective Date: September 2006 

Reviewed: June 2018 

Revised: June 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

The intent of the Vivitrol (naltrexone for extended-release injectable suspension) drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies.

 

Vivitrol (naltrexone for extended-release injectable suspension) is a long acting opioid antagonist given once monthly by intramuscular injection. It is approved by the Food and Drug Administration (FDA) for the following indications:

  • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to receiving treatment
  • Prevention of relapse to opioid dependence following opioid detoxification

 

Prior Approval:

Not applicable

 

Policy:

Injectable extended-release naltrexone (Vivitrol™) is considered not medically necessary for all applications because there is a similar and less expensive form of the drug available for oral administration.

 

Clinical Rationale

Naltrexone is an opioid antagonist reported to reduce the cravings for opioids and alcohol in dependent patients; it does not diminish or prevent withdrawal symptoms. It also does not ensure abstinence from alcohol and opioids; it may, however, decrease patients' motivation to continue utilizing these substances by blocking some of their reinforcing effects.

 

The Guidelines for Psychosocially Assisted Pharmacological Treatment of Opioid Dependence recommend naltrexone in the prevention of relapse following detoxification. Consensus guidelines from the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Health indicate treatment with naltrexone decreases relapses to heavy drinking by curbing alcohol consumption.

 

Vivitrol, an extended-release injectable formulation of naltrexone, was developed in an effort to address the non-adherence that occasionally occurs with daily oral pharmacotherapy. However, there is no evidence demonstrating significant improvements in remission rates for both opioid and alcohol dependence in patients receiving the injectable formulation in comparison to those receiving the oral formulations.

 

One of the largest and longest US studies comparing extended-release naltrexone (XR-NTX) to buprenorphine-naloxone (BUP-NX) included 570 participants with a follow-up period of 36 weeks post-treatment completion. Participants were randomized to receive XR-NTX every 28 days or BUP-NX sublingual film daily for a duration of 24 weeks. Detoxification protocols varied by site and were included in the analysis. The primary outcome was time to a relapse event, with both intention-to-treat and per-protocol analyses performed. Secondary outcomes included successful induction, adverse events including overdose, opioid use, and opioid craving.

 

For the intention-to-treat population, BUP-NX was favored over XR-NTX in regards to relapse-free survival, successful induction, and proportion of opioid-relapse events. 18 overdoses occurred in the group of participants assigned to receive XR-NTX, compared to 10 for BUP-NX. 8 of the XR-NTX overdoses occurred in individuals that failed induction, compared to 1 of the BUP-NX overdoses. The per-protocol analysis found no statistical difference between the two treatment groups for any of the outcomes, other than adverse events, in which participants receiving XR-NTX experienced injection site reactions.

 

Successful induction onto XR-NTX treatment occurred more frequently for participants that completed detoxification at an extended-stay, opioid-free program. Of those participants initiated onto treatment, no difference in death or overdose events was observed between the two treatments.

 

Another randomized trial comparing XR-NTX and BUP-NX took place in Norway and included 159 patients discharged from detoxification units, inpatient treatment, or prison. The primary outcomes included retention in the study, urine drug tests without illicit opioids, and number of days of use of illicit opioids and heroin. Retention rates were similar between treatment groups, and no significant difference was found between treatment groups for proportion of opioid-negative urine drug tests or illicit opioid and heroin use.

 

Overall, current evidence has not demonstrated superiority of Vivitrol over alternative treatments for opioid use disorder. For study participants successfully completing detoxification, outcomes between treatments are comparable. In addition, extended-release naltrexone requires an individual to be opioid-free for 7-10 days before starting treatment. These detoxification requirements have resulted in poor treatment induction rates, and a subsequent increase in overdoses for study participants assigned to receive XR-NTX.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • J2315 Injection, naltrexone, depot form, 1 mg

 

Selected References:

  • Garbutt JC, Kranzler HR, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1617-25.
  • Krupitsky E, Zvartau E, et al. Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence. Arch Gen Psychiatry. 2012;69(9):973-81.
  • Garbutt JC. New therapeutic options for alcohol dependence: long-acting intramuscular formulations of naltrexone. J Clin Psychiatry. 2006;67 [suppl 14]:30-4.
  • World Health Organization (2009). Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence.
  • US Department of Health and Human Services (2005). Helping patients who drink too much: a clinician's guide.
  • Naltrexone. Drug Facts and Comparisons. Facts and Comparisons [database online]. St. Louis, MO: Wolters Kluwers Health, Inc; December 2012. Accessed July 2013.
  • Vivitrol [package insert]. Waltham, MA: Alkermes;2010.
  • Lee JD, Nunes Jr EV, Novo P, et al. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicenter, open-label, randomized controlled trial. Lancet. 2018;391(10118):309-318.
  • Tanum L, Klemmetsby Solli K, Latif Z, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence. JAMA Psychiatry. 2017;74(12):1197-1205.

 

Policy History:

  • June 2018 - Annual Review, Policy Revised
  • June 2017 - Annual Review, Policy Revised
  • July 2016 - Annual Review, Policy Renewed
  • July 2015 - Annual Review, Policy Renewed
  • April 2015 - Policy Revised
  • July 2014 - Annual Review, Policy Renewed
  • July 2013 -  - Annual Review, Policy Renewed
  • August 2012 - Annual Review, Policy Renewed
  • September 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.