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Federal Employee Program® 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.20 Section: Effective Date: April 1, 2016 Subsection: Analgesics and Anesthetics Original Policy Date: December 29, 2011 Subject: Page: 1 of 4 Prescription Drugs Butorphanol Last Review Date: March 18, 2016 Butorphanol Description Butorphanol (Stadol) Background Butorphanol is a mixed agonist-antagonist with low intrinsic activity at receptors of the µ-opioid type (morphine-like). It is also an agonist at к-opioid receptors. Its interactions with these receptors in the central nervous system apparently mediate most of its pharmacologic effects, including analgesia. In addition to analgesia, CNS effects include depression of spontaneous respiratory activity and cough, stimulation of the emetic center, miosis, and sedation (1-2). Regulatory Status FDA-approved indications: Butorphanol tartrate injection is indicated for the management of pain when the use of an opioid analgesic is appropriate. Butorphanol tartrate injection is also indicated as a preoperative or preanesthetic medication, as a supplement to balanced anesthesia, and for the relief of pain during labor (1). Butorphanol tartrate nasal spray is indicated for the management of pain when the use of an opioid analgesic is appropriate (2). Butorphanol is not recommended for use in patients dependent on narcotics. Such patients should have an adequate period of withdrawal from opioid drugs prior to beginning butorphanol therapy. Butorphanol tartrate, by all routes of administration has been associated with episodes of abuse. Prolonged, continuous use of butorphanol tartrate may result in physical dependence 5.70.20 Section: Effective Date: April 1, 2016 Subsection: Analgesics and Anesthetics Original Policy Date: December 29, 2011 Subject: Page: 2 of 4 Prescription Drugs Butorphanol or tolerance. Special care should be exercised in administering butorphanol to patients with a history of drug abuse or to patients receiving the drug on a continuous basis for an extended period (1). Butorphanol is not recommended for use in patients below 18 years of age because safety and efficacy have not been established in this population (1,2). Related policies Fentanyl, Ketalar, Ketamine Powder Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Butorphanol may be considered medically necessary for the treatment of pain in patients 18 years of age or older with physician providing length of treatment, directions of use and quantity required for 180 days. Butorphanol may be considered investigational for patients below 18 years of age at dosages exceeding those specified below. Prior-Approval Requirements Age 18 years of age or older Diagnosis Patient must have the following: Pain AND ALL of the following must be provided: 1. Length of treatment 2. Directions for use 3. Quantity required per 180 days Prior – Approval Renewal Requirements Same as above 5.70.20 Section: Effective Date: April 1, 2016 Subsection: Analgesics and Anesthetics Original Policy Date: December 29, 2011 Subject: Page: 3 of 4 Prescription Drugs Butorphanol Policy Guidelines Pre - PA Allowance Age 18 years of age or greater Quantity Butorphanol 10 mg/ml nasal spray 24 canisters per 180 days Butorphanol 1 mg/ml or 2 mg/ml injection 180 ml per 180 days Duration 12 months Prior - Approval Limits Quantity Butorphanol 10 mg/ml nasal spray 48 canisters per 180 days Butorphanol 1 mg/ml or 2 mg/ml injection 360 ml per 180 days Duration 6 months Prior – Approval Renewal Limits Same as above Rationale Summary Butorphanol is a mixed agonist-antagonist with low intrinsic activity at receptors of the µ-opioid type (morphine-like). Butorphanol tartrate injection is indicated for the management of pain when the use of an opioid analgesic is appropriate. Butorphanol tartrate injection is also indicated as a preoperative or preanesthetic medication, as a supplement to balanced anesthesia, and for the relief of pain during labor. Butorphanol tartrate nasal spray is indicated for the management of pain when the use of an opioid analgesic is appropriate. Proper patient selection, dose and prescribing limitations, appropriate directions for use, and frequent monitoring are important to minimize the risk of abuse and physical dependence. The safety and effectiveness have not been established in the pediatric population (1-2). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Butorphanol while maintaining optimal therapeutic outcomes. References 1. Butorphanol Injection [package insert]. Toronto, Ontario. Apotex, Inc. August 2005. 5.70.20 Section: Effective Date: April 1, 2016 Subsection: Analgesics and Anesthetics Original Policy Date: December 29, 2011 Subject: Page: 4 of 4 Prescription Drugs Butorphanol 2. Butorphanol Nasal Spray [package insert]. Columbus, OH. Roxane Laboratories, Inc. August 2015. Policy History Date Action December 2011 Lowered dosages limits to more accurately reflect dosages used in clinical practice. Annual editorial review and reference update Annual editorial review and reference update Annual editorial review and reference update Annual editorial review and reference update Annual editorial review Policy number changed from 5.02.20 to 5.70.20 December 2012 December 2013 June 2014 June 2015 March 2016 Keywords This policy was approved by the FEP® Pharmacy Medical Policy Committee on March 18, 2016 and is effective April 1, 2016. Deborah M. Smith, MD, MPH