WHA

Oral Fentanyl Products

Indications for Prior Authorization

Fentanyl citrate oral transmucosal lozenge
  • For diagnosis of Breakthrough pain
    Indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking Oral Transmucosal Fentanyl Citrate (OTFC). This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of opioid-tolerant 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. Limitations of Use: As a part of the TIRF REMS Access program, OTFC may be dispensed only to outpatients enrolled in the program. For inpatient administration of OTFC (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain.

Fentora (fentanyl buccal tablet)
  • For diagnosis of Breakthrough pain
    Indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg/hr of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking Fentora. This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, Fentora is contraindicated in the management of acute or postoperative pain. Fentora is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain. Limitations of Use: As a part of the TIRF REMS Access program, Fentora may be dispensed only to outpatients enrolled in the program. For inpatient administration of Fentora (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required. Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain.

Criteria

Fentora*, Generic fentanyl citrate*

*Product may be excluded depending on the plan

Prior Authorization

Length of Approval: 12 Month(s)

  • For the management of breakthrough cancer pain [A]
    • AND
  • Patient must have at least a one week history of one of the following medications to demonstrate tolerance to opioids: [3, B]
    • Morphine sulfate at doses of greater than or equal to 60 mg/day
    • Fentanyl transdermal patch at doses greater than or equal to 25 µg/hr
    • Oxycodone at a dose of greater than or equal to 30 mg/day
    • Oral hydromorphone at a dose of greater than or equal to 8 mg/day
    • Oral oxymorphone at a dose of greater than or equal to 25 mg/day
    • Oral hydrocodone at a dose of greater than or equal to 60mg/day
    • An alternative opioid at an equianalgesic dose (e.g., oral methadone greater than or equal to 20 mg/day)
    AND
  • Trial and failure or intolerance to generic fentanyl lozenge
    • AND
  • The patient is currently taking a long-acting opioid around the clock for cancer pain
    • AND
  • Prescribed by or in consultation with one of the following:
    • Pain specialist
    • Oncologist
    • Hematologist
    • Hospice care specialist
    • Palliative care specialist
Generic fentanyl lozenge

Prior Authorization

Length of Approval: 12 Month(s)

  • For the management of breakthrough cancer pain [A]
    • AND
  • Patient must have at least a one week history of one of the following medications to demonstrate tolerance to opioids: [3, B]
    • Morphine sulfate at doses of greater than or equal to 60 mg/day
    • Fentanyl transdermal patch at doses greater than or equal to 25 µg/hr
    • Oxycodone at a dose of greater than or equal to 30 mg/day
    • Oral hydromorphone at a dose of greater than or equal to 8 mg/day
    • Oral oxymorphone at a dose of greater than or equal to 25 mg/day
    • Oral hydrocodone at a dose of greater than or equal to 60mg/day
    • An alternative opioid at an equianalgesic dose (e.g., oral methadone greater than or equal to 20 mg/day)
    AND
  • The patient is currently taking a long-acting opioid around the clock for cancer pain
    • AND
  • Prescribed by or in consultation with one of the following:
    • Pain specialist
    • Oncologist
    • Hematologist
    • Hospice care specialist
    • Palliative care specialist
Fentora*, Generic fentanyl citrate*, Generic fentanyl lozenge

*Product may be excluded depending on the plan.

Quantity Limit

Length of Approval: 12 Month(s)

  • For the management of breakthrough cancer pain
    • AND
  • Prescribed by or in consultation with one of the following:
    • Pain specialist
    • Oncologist
    • Hematologist
    • Hospice care specialist
    • Palliative care specialist
    AND
  • The prescriber maintains and provides chart documentation of the patient’s evaluation, including all of the following: [3]
    • An appropriate patient medical history and physical examination
    • A description of the nature and intensity of the pain
    • Documentation of appropriate dose escalation
    • Documentation of ongoing, periodic review of the course of opioid therapy
    • An updated, comprehensive treatment plan (the treatment plan should state objectives that will be used to determine treatment success, such as pain relief or improved physical and/or psychosocial function)
    • Verification that the risks and benefits of the use of the controlled substance have been discussed with the patient, significant other(s), and/or guardian

  • Guideline ID
    GL-403214

  • Formulary
    EHB

  • Effective date
    Dec 1, 2025

  • P&T approval date
    Nov 16, 2001

P & T Revisions

2025-10-01, 2024-09-20, 2023-08-11, 2022-08-19, 2021-09-14, 2021-05-25, 2020-08-19, 2019-07-30

  1. Fentanyl Citrate Prescribing Information. Teva Pharmaceuticals USA, Inc. Parsippany, NJ. January 2024.
  2. Fentora Prescribing Information. Cephalon. North Wales, PA. December 2023.
  3. American Academy of Pain Medicine. The use of opioids for the treatment of chronic pain (2013). Available at: http://www.painmed.org/files/use-of-opioids-for-the-treatment-of-chronic-pain.pdf. Accessed August 12, 2020.
  1. Oral Transmucosal Fentanyl Citrate (OTFC) and Fentora are intended to be used 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 [1, 2, 4, 5]
  2. Oral Transmucosal Fentanyl Citrate (OTFC) and Fentora are only intended for patients who are opioid tolerant. Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily, at least 60 mg of oral hydrocodone daily, or an equianalgesic dose of another opioid for a week or longer. [1, 2, 4, 5]
  • 2025-10-01: 2025 Annual Review: Updated background and references. Removed obsolete products.
  • 2024-09-20: 2024 Annual Review. Added oral hydrocodone as example of opioid tolerant dose. Removed obsolete products. Background and reference updates.
  • 2023-08-11: Annual review
  • 2022-08-19: Annual review - updated references.
  • 2021-09-14: Annual review
  • 2021-05-25: Addition of EHB formulary. No changes to criteria
  • 2020-08-19: Annual Review
  • 2019-07-30: New authorized brand alternative for Fentora. Mirror brand Fentora criteria (pending IR confirmation for embedded step)