Download Butorphanol - FEP Blue Cross Blue Shield Federal Employees

Federal Employee Program®
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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