Medical Policy: 05.01.13 
Original Effective Date: September 2006 
Reviewed: July 2016 
Revised: April 2015 


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 naltrexone drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. 

 

Naltrexone 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 naltrexone (Vivitrol™) is considered not medically necessary for all applications because there is an equivalent and less expensive form of the drug available for oral administration.

 

CLINICAL RATIONALE
Naltrexone hydrochloride is an opioid antagonist reported to reduce the cravings for opioids and alcohol in dependant 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.

 

Sustained-release injectable naltrexone was developed in an effort to address the non-adherence that occasionally occurs with daily oral pharmacotherapy. However, clinical trials have failed to demonstrate significant improvements in remission rates for both opioid and alcohol dependence in patients receiving the injectable formulation versus those receiving the oral formulations.



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.

Policy History:

  • 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.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.