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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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/14/2015: Medical policy revised to add ICD-10 codes. Extended ICD-9 diagnosis code 208.9 to the fifth digit (208.92).
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.
05/26/2016: Policy number added.
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.