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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.

Boxed warnings:

• Actiq® (oral transmucosal fentanyl citrate) is contraindicated in the management of acute or post-operative pain due to the fact that life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates.
• This product must not be used in opioid nontolerant patients.
• Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.
• Actiq® (oral transmucosal fentanyl citrate) is intended for use only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
• Actiq® (oral transmucosal fentanyl citrate) may be habit forming.

IDENTIFICATION

Generic Name: Oral Transmucosal Fentanyl Citrate
Brand Name: Actiq®

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.

11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee

1/10/2007: Policy reviewed, no changes

05/06/2013: Policy reviewed; no changes.

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.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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