Prior Authorization Guideline

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1 Prior Authorization Guideline Guideline: PDP IBT Inj - Vivitrol Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Opiate Antagonist Client: 2007 PDP IBT Inj Approval Date: 2/20/2007 Revision Date: I. BENEFIT COVERAGE Table 1. Formulary Status Non-Formulary Product Formulary Products Vivitrol (naltrexone injection) Tier 1: Revia (naltrexone) Tier 2: Antabuse (disulfiram) Tier 3: Campral (acamprosate) II. INDICATION A. FDA Approved Indication 1 Vivitrol is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol. Patients should not be actively drinking at the time of initial Vivitrol administration. Treatment with Vivitrol should be part of a comprehensive management program that includes psychosocial support. III. GUIDELINES A. Initial Therapy 1. Vivitrol will be approved based on all of the following criteria: a. History of alcohol dependence with confirmed abstinence at treatment initiation -AND- b. Concurrently receiving appropriate counseling or actively participating in a recognized support group (e.g. Alcoholics Anonymous)

2 -AND- c. Contraindication, failure, or intolerance to any one of the following formulary medications: Campral (acamprosate), Antabuse (disulfiram), or oral naltrexone Initial authorization of therapy will be restricted to a maximum of 24 weeks. B. Reauthorization 1. Vivitrol will be approved for continuation of therapy based on all of the following: a. Confirmation of clinical benefit to the patient -AND- b. Confirmation that the patient is concurrently receiving appropriate counseling or actively participating in a recognized support group (e.g. Alcoholics Anonymous) Reauthorization will be issued for 24 weeks IV. CONTRAINDICATIONS AND WARNINGS A. Contraindications 1 Naltrexone is contraindicated in: 1. Patients receiving opioid analgesics 2. Patients with current physiologic opioid dependence 3. Patients in acute opiate withdrawal 4. Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids 5. Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent B. Warnings 1 1. Hepatotoxicity Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in patients with acute hepatitis or liver failure, and its use in patients with acute liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only 5-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses. Patients should be warned of the risk of hepatic injury and advise them to seek medical attention if they experience symptoms of acute hepatitis. Use of naltrexone should be discontinued in the event of symptoms and/or signs of acute hepatitis.

3 2. Eosinophilic pneumonia In clinical trials with naltrexone, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Both cases required hospitalization and resolved after treatment with antibiotics and corticosteroids. Should a person receiving naltrexone develops progressive dyspnea and hypoxemia, consider the diagnosis of eosinophilic pneumonia. Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia. Clinicians should consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics. 3. Unintended Precipitation of Opioid Withdrawal To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids or exacerbation of a preexisting subclinical abstinence syndrome, patients must be opioid free for a minimum of 7 to 10 days before starting naltrexone treatment. Since the absence of an opioid drug in the urine is often not sufficient proof that a patient is opioid free, a naloxone challenge test should be employed if the prescribing physician feels there is a risk of precipitating a withdrawal reaction following administration of naltrexone. 4. Opioid Overdose Following an Attempt to Overcome Opiate Blockade: Naltrexone is not indicated for the purpose of opioid blockade or the treatment of opiate dependence. Although naltrexone is a potent antagonist with a prolonged pharmacological effect, the blockade produced by naltrexone is surmountable. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Indeed, any attempt by a patient to overcome the antagonism by taking opioids is very dangerous and may lead to fatal overdose. Injury may arise because the plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. As a consequence, the patient may be in immediate danger of suffering life-endangering opioid intoxication (e.g., circulatory collapse, respiratory arrest). Patients should be told of the serious consequences of trying to overcome the opioid blockade. There is also the possibility that patients who had been treated with naltrexone will respond to lower doses of opioids than previously used. This could result in potentially life-threatening opioid intoxication (eg, circulatory collapse, respiratory compromise or arrest). Patients should be aware that they may be more sensitive to lower doses of opioids after naltrexone treatment is discontinued. 5. Patients under 18 years of age Vivitrol has not been studied in children under the age of V. DOSING 1 A. Dosing Information Naltrexone must be administered by a health care provider.

4 1. Dosage The recommended dose of naltrexone is 380 mg delivered intramuscularly (IM) every 4 weeks or once a month. The injection should be administered by a health care provider as an IM gluteal injection, alternating buttocks, using the carton components provided. Naltrexone must not be administered intravenously (IV). If patients miss doses, they should be instructed to receive the next dose as soon as possible. Pretreatment with oral naltrexone is not required before using naltrexone injection. 2. Reinitiation of treatment in patients previously discontinued There are no data to specifically address reinitiation of treatment. 3. Switching from oral naltrexone for alcohol dependence There are no systematically collected data that specifically address the switch from oral naltrexone to naltrexone injection. VI. AVAILABILITY 1 Vivitrol 380mg per vial suspension (extended release) for injection. Supplied with diluent, prepackaged syringe (5 ml), and appropriate needles VII. BACKGROUND A. Description Naltrexone is an opiate antagonist. Its primary site of action is believed to be the mu opioid receptor. It does not appear to have significant intrinsic effects, other than its action on opioid receptors. Naltrexone is not associated with tolerance or dependence; however, it can precipitate withdrawal symptoms in those who are physically opioid dependent. Moreover, due to its antagonistic effects on mu receptors, in can interfere with the effects of endogenous opioid peptides. The precise mechanism by which naltrexone acts to reduce alcohol consumption, in dependent individuals, is not well characterized. But currently, it is believed that its action on opioid receptors plays an important role in this effect. B. Clinical Trials 1. In a double-blind, randomized controlled trial, 624 patients participated in treatment with long-acting, intramuscular naltrexone or a placebo. The sample population included participants from twenty-four U.S. hospitals, including Veterans Administration clinics and tertiary medical centers. Naltrexone 380 mg was administered to 205 individuals. Naltrexone 190 mg was administered to 210 individuals, with the remaining participants receiving placebo. The entire trial spanned six months. The primary outcome measure was the percentage of heavy drinking days. Compared against placebo, there was a 25% reduction in the event rate of heavy drinking days with naltrexone 380 mg and 17% decrease with naltrexone 190 mg. However, only the 380 mg dose represented a statistically

5 significant outcome. In addition, 14 patients receiving naltrexone 380 mg, 13 patients receiving the 190 mg dose, and 11 placebo patients maintained total abstinence. The authors concluded that naltrexone was well tolerated and may be of benefit in the treatment of alcohol dependence. 3 VIII. NATIONAL GUIDELINES A. National Institutes on Alcohol Abuse and Alcoholism (NIAAA) 4 1. Candidates for Pharmacotherapy NIAAA advises adding medications when: a. An individual is actively alcohol dependent b. An individual is experiencing alcohol cravings c. An individual has failed psychosocial treatment options 2. Abstinence and Pharmacotherapy With the exception of disulfiram, NIAAA does not consider abstinence to be a requirement for initiating pharmacotherapy. NIAAA recognizes the benefit of oral and injectable naltrexone in reducing the risk of heavy drinking, even if the individual fails to abstain. However, because of injectable naltrexone s current indications mandating abstinence prior to therapy, its use in non-abstainers is not openly advocated. This also applies to acamprosate, indicated in patients who are abstinent at the initiation of treatment. 3. Medication Management a. Medication Choice NIAAA recognizes four medications for treating alcohol dependence. These include: naltrexone (oral), naltrexone (long-acting injectable), acamprosate, and disulfiram. No formal advice or recommendation is provided by NIAAA. Specific medication choice will depend on the health care provider s clinical judgment and the patient s preference. b. Length of Therapy A minimum trial of 3 months (12 weeks) is advocated by the NIAAA. After this time, consideration may be given to an alternative medication. A sequential approach to therapy is the common practice; however, there is no evidence demonstrating the effectiveness of a particular ordering of medications. c. In Conjunction with Counseling No single approach to therapy has been found to be universally successful. Moreover, nearly all medication trials have included some form of counseling. For this reason, NIAAA advocates some form of brief medical counseling in conjunction with medication therapy. Support groups should also be encouraged (e.g. Alcoholics Anonymous). IX. DEFINITIONS

6 Addiction Addiction is characterized by aberrant behavior, including one or more of the following: inability to control drug use, compulsive use of the drug, continued use despite harm, and craving. Addiction is a primary, chronic, and neurobiologic disease. There are also genetic, psychosocial, and environmental factors that may influence its development and manifestation. Physical Dependence Physical dependence refers to the physiologic adaptation to a drug or a drug class, increasing the likelihood of a withdrawal syndrome upon abrupt cessation of the drug, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Tolerance Tolerance is a state of physiologic adaptation. Exposure to the drug induces changes that result in a decrease of one or more of the drug s effects over time. X. REFERENCES 1. Vivitrol Prescribing Information. Alkermes, Inc Vivitrol Patient Prescribing Information. Alkermes, Inc 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): National Institute on Alcohol Abuse and Alcoholism. Helping patients who drink too much. January Available at: tm. Accessed January 3, This Prior Authorization Guideline represents the recommendation of Prescription Solutions Pharmacy and Therapeutics (P&T) Committee. It is based upon the P&T Committee s review of the available evidence as of the date of drafting or revision of this Prior Authorization Guideline. It is subject to updating from time to time, based upon changes in scientific knowledge and information. This Prior Authorization Guideline is intended as a resource for making coverage decisions for Health Plan members, but it does not replace an individualized case-by-case review and medical necessity determination for each Health Plan member. Copyright 2006 by Prescription Solutions. All rights reserved. This Prior Authorization Guideline is intended for use by Prescription Solutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in this Prior Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferred in whole or in part without Prescription Solutions prior written consent.

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