Subject: Alcohol Dependence Products

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	acampro cal
P	disulfiram
P	naltrexone
NP	Revia®  (naltrexone)
NP	Antabuse®  (disulfiram)
FE	Campral®  (acamprosate)					X

Policy:

 

1. Medical Exception Criteria

Campral is currently listed on the Aetna Formulary Exclusions List.* Therefore, Campral is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Campral to be medically necessary for those members who meet the following criteria:

A. A documented

• Contraindication to one preferred alternative indicated for the member's condition OR
• Intolerance to one preferred alternative indicated for the member's condition OR
• Allergy to one preferred alternative indicated for the member's condition OR
• Failure of an adequate trial of one month of one preferred alternative indicated for the member's condition.
  

Special Notes:

Acamprosate (Campral) is an agent designed to aid in the treatment of alcohol dependence. It is structurally related to gamma aminobutyric acid (GABA). The exact mechanism of acamprosate is not fully understood, but it is thought to involve the restoration of balance between the glutamate (neuronal excitation) and GABA (neuronal inhibition) neurotransmitter systems. Acamprosate is indicated for the maintenance of abstinence from alcohol in patients who have stopped drinking prior to initiation of the drug. The efficacy of acamprosate in patients who have not undergone alcohol detoxification has not been proven. Acamprosate has not been adequately assessed in polysubstance abusers.

According to the manufacturer:
It is recommended that treatment with acamprosate be in conjunction with psychosocial support.
The usual dose of acamprosate is two 333 mg tablets (666 mg) three times daily. Some patients may respond to a lower dose. Treatment should be started as soon as possible after alcohol withdrawal and once abstinence is achieved. Treatment should continue if the patient relapses.
The most common adverse effects reported include headache, diarrhea, flatulence, and nausea.

Disulfiram works by inhibiting aldehyde dehydrogenase, the enzyme responsible for metabolizing acetaldehyde (a toxic metabolite of alcohol). The resulting accumulation of acetaldehyde causes hypotension, flushing, nausea, and vomiting in the person consuming alcohol. There is not much evidence that disulfiram enhances abstinence, but there is some evidence that it reduces drinking days.

Naltrexone is an opioid antagonist used to reduce the pleasurable effects of alcohol. Consumption of alcohol stimulates the release of beta-endorphins which initiates a cascade of events thought to contribute to the positive reinforcing effects of alcohol.3 Use of naltrexone blocks the opioid receptors and some of the rewarding effects of alcohol.

Acamprosate works by a different mechanism than naltrexone or disulfiram to treat alcohol dependence. It's believed to reduce the negative reinforcing effects of alcohol (e.g., tension, anxiety, and dysphoria associated with the absence of alcohol).

Place of Service:

Outpatient

The above policy is based on the following references:

1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
6. Pettinati HM, Rabinowitz AR. Choosing the right medication for the treatment of alcoholism. Curr Psychiatry Rep. 2006;8(5):383-8.
7. Morley KC, Teesson M, Reid SC, et al. Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial. Addiction. 2006 Oct;101(10):1451-62.
8. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006;295(17):2003-17.
9. Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatr Res. 2006;40(5):383-93.
10. Anton RF. Naltrexone for the management of alcohol dependence. NEJM 2008;359:715-21.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2013