Prior Authorization Guideline

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1 Prior Authorization Guideline Guideline: CSD - Suboxone Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Analgesics and Antipyretics (Opiate Partial Agonists) Client: County of San Diego Approval Date: 5/22/2007 Revision Date: I. BENEFIT COVERAGE Table 1. Formulary status Non-Formulary Products Suboxone (buprenorphine/naloxone) Subutex (buprenorphine) Formulary Products II. INDICATIONS A. FDA Approved Indications 1. Opioid dependence Suboxone and Subutex are indicated for the treatment of opioid dependence. 1 III. GUIDELINE A. Suboxone or Subutex will be approved based on all of the following criteria: 1. For treatment of opioid dependence. 1 -AND- 2. Prescribed by physician with a DATA 2000 prescribing identification number. 1 IV. CONTRAINDICATIONS AND WARNINGS A. Contraindications 1 1. Hypersensitivity Suboxone is contraindicated in individuals with a known hypersensitivity to buprenorphine or naloxone or any of its components or ingredients.

2 B. Warnings 1 1. Respiratory Depression Buprenorphine, especially when given intravenously, has been associated with severe respiratory depression. Deaths have been reported in addicts that misused buprenorphine with benzodiazepines and in concomitant use with other depressants such as alcohol or other opioids. Caution is advised when using Suboxone in patients with compromised respiratory function (i.e. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnea, or pre-existing respiratory depression). In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required; naloxone may not be effective in reversing any respiratory depression produced by buprenorphine. 2. CNS Depression Increased CNS depression may be seen in patients taking buprenorphine with other narcotic analgesics, general anesthetics, benzodiazepines phenothiazines, other tranquilizers, sedative/hypnotics, or other CNS depressants such as alcohol. 3. Dependence Due to buprenorphine s partial agonist abilities at the mu-opioid receptor, an opioid type of dependence may develop. Abrupt discontinuation or rapid tapering may produce a milder or delayed withdrawal syndrome as seen with full agonists. 4. Hepatitis, hepatic events In the addict population, cases of cytolytic hepatitis and hepatitis with jaundice have been observed while receiving buprenorphine. The severity of hepatic events range from mild transient asymptomatic elevations in hepatic transaminase levels to more severe hepatic failure, hepatic necrosis, hepatorenal syndrome and hepatic encephalopathy. Measurement of liver function tests are recommended at baseline and during therapy. If a hepatic event requires the need to discontinue therapy, careful tapering to avoid withdrawal symptoms, return to illicit drugs use and strict monitoring of the patient should be initiated. 5. Allergic Reactions Acute and chronic allergic reactions to buprenorphine have been reported. Signs and symptoms such as rash, hives, pruitis, bronchospasm, sngioneurotic edema and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine or naloxone is a contraindication to Suboxone. 6. Use in Ambulatory Patients Suboxone may impair the mental and physical abilities of the patient to perform potentially dangerous tasks such as driving or operating machinery, especially during initiation and dose adjustment. Patients should not engage in such activities until they are reasonably certain that Suboxone does not affect their performance in these activities. Suboxone may produce orthostatic hypotension in the ambulatory patient population.

3 7. Head Injury and Increased Intracranial Pressure Suboxone may increase intracranial pressure and should be used in caution inpatients with head injury, intracranial lesions and other circumstances where intracranial pressure may be increased. Suboxone may cause miosis and changes in the level of consciousness that may interfere with patient evaluation. 8. Opioid withdrawal effects Suboxone may produce withdrawal symptoms if administered before the opioid agonist effects have subsided. When misused by intravenously by individuals dependant on heroin, morphine, or methadone, intense withdrawal effects is very likely. V. DOSING Subutex or Suboxone sublingual tablets 1 Administer sublingually as a single daily dose in the range of 12 to 16 mg/day. When taken sublingually, Suboxone and Subutex have similar clinical effects and are interchangeable. There are no adequate and well-controlled studies using Suboxone as initial therapy. Subutex contains no naloxone and is preferred for use during induction. Following induction, Suboxone, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of Subutex for unsupervised administration should be limited to those patients who cannot tolerate Suboxone, for example those patients who have been shown to be hypersensitive to naloxone. VI. AVAILABILITY Suboxone: hexagonal orange sublingual tablets containing 2 mg buprenorphine with 0.5 mg naloxone or 8 mg buprenorphine with 2 mg naloxone. 1 Subutex: white sublingual tablets containing 2 mg or 8 mg buprenorphine VII. BACKGROUND A. Description 1,2 Suboxone is a combination product comprising of a partial opioid agonist called buprenorphine and an opioid antagonist called naloxone. It is used for treatment of opioid dependence in an office-based setting under the Drug Addiction Treatment Act of (2000). The partial opioid agonist provides limited opioid effects to help suppress the symptoms of opioid withdrawal. The opioid antagonist is included to prevent its use intravenously where it induces withdrawal symptoms and block the effects of other opioids.

4 B. Clinical Studies 1. Opioid Dependence 3 During a 4-week, randomized, double-blind, placebo-controlled trail of 326 opioiddependent patients, Suboxone was evaluated for treatment of opioid dependence. Patients received 16 mg of buprenorphine plus 4 mg of naloxone, 16 mg of buprenorphine alone or placebo. Patients were evaluated on weekdays and received up to one hour of individual counseling each week. The primary endpoint to assess effectiveness was the percentage of urine samples negative for non-study opioids. Suboxone (17.8%) showed a significantly higher rate of success than placebo (5.8%) (P<0.001). A similar trial evaluated the efficacy of four different doses of buprenorphine. Significantly more patients taking 16 mg (26.8%) were negative for non-study opioids than patients that received 1 mg (8.6%) (P<0.001). C. National Guidelines 4 1. Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA) (2004) Treatment should be initiated with buprenorphine/naloxone 4/1-8/2 mg per day on the first day of treatment. On day 2, up to 16/4 mg per day of buprenorphine/naloxone may be used to relieve withdrawal symptoms. From then on, increments of 2/0.5 4/1 mg per day may be adjusted up to a maximum of 32/8 mg per day of burenorphine/naloxone to manage withdrawal symptoms. Target dose is usually between 12/3 16/4 mg per day to relieve symptoms of withdrawal. Patients who are dependant on long-acting opioids should be initiated on methadone or levo-alpha acetyl methadol (LAAM) on day 1, prior to use of buprenorphine/naloxone. VIII. DEFINITIONS DATA The Drug Addiction Treatment Act of 2000 (DATA 2000) permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with Schedule III, IV, and V opioid medications or combinations of such medications that have been specifically approved by the Food and Drug Administration (FDA) for that indication. Such medications may be prescribed and dispensed. IX. REFERENCES 1. Suboxone, Subutex Prescribing Information. Reckitt Benckiser Healthcare (UK) Ltd, June DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed November 20, Fudala Pj, Beidge TP, Herbert S, et al. Office-Based Treatemtn of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone. N Eng J Med 2003; 349:

5 4. U.S. Department of Health and Human Services. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: Available at Accessed December 6, U.S. Department of Health and Human Services. Drug Addiction Treatment Act of 2000 (DATA 2000). Available at Accessed December 10, 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 2007 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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