Coverage Policies

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Effective Date: 08/03/2011 Title: Oral Transmucosal Fentanyl Products
Revision Date: 11/01/2016 Document: BI304:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Oral transmucosal fentanyl products require prior authorization.

2)    Oral transmucosal fentanyl products are used to treat cancer related pain.

3)    Oral transmucosal fentanyl products are subject to quantity limits per prescription.

4)    Oral transmucosal fentanyl products are covered under the pharmacy benefit.

Medical Statement

1)     The following oral transmucosal fentanyl products require prior authorization:

a.     Fentora

b.     Fentanyl citrate lozenges

2)    Abstral, Actiq, Onsolis, Lazanda, and Subsys are not covered.

3)    If the 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) months.

4)     Covered oral transmucosal fentanyl products are considered medically necessary for members who meet all of the following criteria:

a.     Patient is 18 years of age or older (16 years of age or older for Actiq) AND

b.     Member requires transmucosal fentanyl for the treatment of cancer-related breakthrough pain

c.     Member is 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.

d.     Other 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

e.     For brand requests, a generic transmucosal fentanyl citrate has been ineffective or not tolerated AND

f.      The prescriber and patient are registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) AND

g.     Patient has 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.




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.


Because life-threatening 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.


Oral transmucosal fentanyl products are limited to 4 units per day under the pharmacy benefit.



  1. Actiq Product Information.  Cephalon.  2009
  2. Abstral Product Information.  Orexo.  January 2011
  3. Fentora Product Information.  Cephalon.  January 2011


Effective 11/01/2016: Added statement that PA would be approved if patient has terminal illness and added definition of terminal illness pursuant to Act 992. Added Abstral and Actiq to non-covered products listed.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.