Fentanyl transmucosal products

Coverage decision

L&I does not cover oral fentanyl transmucosal products (see the list below) for the management of breakthrough non-cancer pain.

The Food and Drug Administration (FDA) has approved fentanyl transmucosal products for the management of breakthrough cancer pain in patients who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.  Patients considered opioid tolerant are those who are taking, for a week or longer, at least:

• Morphine 60 mg/day or more,
• Fentanyl Transdermal 25 mcg/hour,
• Oxycodone 30mg/day,
• Hydromorphone oral 8mg/day, or
• An equianalgesic dose of another opioid.

FDA approved fentanyl transmucosal products:

• Abstral® (fentanyl sublingual tablet)
• Actiq® (fentanyl citrate transmucosal lozenge)
• Fentoral (Fentora) ® (fentanyl buccal tablet)
• Lazanda® (fentanyl nasal spray)
• Onsolis® (fentanyl buccal soluble film)
• Subsys® (fentanyl sublingual spray)