following oral transmucosal fentanyl products require prior authorization:
Actiq, Onsolis, Lazanda, and Subsys are not covered.
patient is diagnosed with a terminal illness, the prior authorization request
will be approved pursuant to Act 992 of 2015 of the Arkansas Legislature.
Terminal Illness is defined as an illness, a progressive disease, or an advanced
disease state from which: (A) there is no expectation of recovery; and (B) death
as a result of the illness or disease is reasonably expected within six (6)
oral transmucosal fentanyl products are considered medically necessary for
members who meet all of the following criteria:
18 years of age or older (16 years of age or older for Actiq) AND
requires transmucosal fentanyl for the treatment of cancer-related breakthrough
opioid tolerant prior to initiating therapy. Must include list of opioids
member is currently taking, including dose and frequency. Previous opioid
dosing should be equivalent to at least 60mg/day oral morphine, 30mg/day oral
oxycodone, 8mg/day oral hydromorphone, or 25mcg transdermal fentanyl per hour.
short-acting strong narcotic analgesic alternative (other than fentanyl) have
been ineffective, not tolerated, or contraindicated (i.e. concentrated morphine
oral solution, oxycodone, or hydromorphone) AND
requests, a generic transmucosal fentanyl citrate has been ineffective or not
prescriber and patient are registered in the Transmucosal Immediate Release
Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) AND
none of the following contraindications: use is for the management of acute or
postoperative pain, including headache/migraine, dental pain, or use in the
emergency room; opioid non-tolerant patient.
BLACK BOX WARNINGS
Fentanyl is an opioid
agonist and a Schedule II controlled substance with an abuse liability similar
to other opioid analgesics. Fentanyl can be abused in a manner similar to other
opioid agonists, legal or illicit. This should be considered when prescribing or
dispensing fentanyl in situations in which the health care provider or
pharmacist is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid
substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and
methadone, have the highest potential for abuse and risk of fatal overdose due
to respiratory depression.
The fentanyl lozenge and
buccal tablet are indicated only for the management of breakthrough cancer pain
in patients with cancer already receiving and tolerant to opioid therapy for
their underlying persistent cancer pain. Patients considered opioid-tolerant are
those who are taking oral morphine 60 mg/day or more, transdermal fentanyl 25
mcg/h, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an equianalgesic
dose of another opioid for a week or longer.
respiratory depression could occur at any dose in patients not taking chronic
opiates, it is contraindicated in the management of acute or postoperative pain.
This product is not indicated for use in opioid nontolerant patients.