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DESCRIPTIONIn patients who have moderate to severe cancer pain, two components are usually present: persistent cancer pain (lasting 12 or more hours/day) and breakthrough cancer pain (BTCP), a transitory flare of pain of moderate to severe intensity occurring on a background of otherwise controlled cancer pain.
Spontaneous and incident breakthrough cancer pain episodes need to be differentiated from the type of pain resulting from end-of-dose failure—that is, pain appearing with greater frequency at the end of the dosing interval of the around-the-clock opioid medication. This type of pain is marked by a more gradual onset and prolonged duration than other breakthrough pain episodes, and can be linked to the dissipating analgesic effect of the around-the-clock medication used for persistent cancer pain. Pain resulting from end-of-dose failure is often best managed by adjusting the dose of the around-the-clock medication.
Fentanyl, a pure opioid antagonist, acts primarily through interaction with opioid mu-receptors located in the brain, spinal cord, and smooth muscle. The primary site of therapeutic action is the central nervous system. The most clinically useful pharmacologic effects of fentanyl with mu-receptors are analgesia and sedation.
Actiq® (oral transmucosal fentanyl citrate) is useful in the management of breakthrough cancer pain by providing opioid tolerant patients with personal pain control in 15 minutes.
FDA APPROVED INDICATIONS
Actiq® (oral transmucosal fentanyl citrate) is a Schedule II controlled substance that is indicated only for the management of breakthrough cancer pain (BTCP) in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The initial dose of Actiq® (oral transmucosal fentanyl citrate) to treat episodes of breakthrough cancer pain should be 200mcg. Patients should be prescribed an initial titration supply of six 200mcg Actiq® (oral transmucosal fentanyl citrate) units. Each additional titration supply should consist of six units of Actiq® (oral transmucosal fentanyl citrate) and patients should be advised to use no more than two units per episode of breakthrough cancer pain during the titration phase. All units should be used before increasing to a higher dose.
Patients should be followed closely and the dosage level changed until the patient reaches a dose that produces adequate analgesia using a single Actiq® (oral transmucosal fentanyl citrate) dosing unit. Once a successful dose has been found, the patient should limit consumption to four or fewer units per day.
Generic Name: Oral Transmucosal Fentanyl Citrate
POLICYPrior authorization is required for Actiq® (oral transmucosal fentanyl citrate) prescriptions written by physicians other than an oncologist.
Actiq® (oral transmucosal fentanyl citrate) is considered medically necessary for the management of breakthrough cancer pain (BTCP) in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
In accordance with FDA dosing recommendations described in the product’s labeling, prescriptions may be written for a maximum of 4 units per day.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY9/30/2004: Code Reference section completed
11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee
1/10/2007: Policy reviewed, no changes
05/06/2013: Policy reviewed; no changes.
SOURCE(S)Actiq website. Available at: http://www.actiq.com/physicians/aboutbtcp/whatisbtcp.asp. Accessed on July 15, 2004.
Actiq package insert. Available at: http://www.actiq.com/pdf/Package Insert.pdf. Accessed on July 15, 2004.
Drug Facts & Comparisons website. Available at: http://www.efactsonline.com/Fac/servlet/MonoViewer?set=o915h&sys=1&id=983&sec=7. Accessed on July 15, 2004.
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.