Coverage Decisions for Drugs

Fentanyl transdermal products

Coverage decision

L&I will cover on an exception basis fentanyl transdermal system when the patient requires continuous opioid analgesia for pain that cannot be managed by lesser means AND, either

  • Other long-acting opioids cannot be tolerated or,
  • Medical contraindications preclude the use of oral opioids (e.g., the patient can't swallow pills, the patient has dementia and might not take the right amount of pills at the right time).

We have reviewed the literature and safety profile of this product. While the drug is absorbed relatively slowly, it reaches peak levels equivalent to intravenous use. Therefore, because the pharmacokinetics of transdermal fentanyl demonstrates systemic availability that is equivalent to injectable routes, this product will not be routinely covered (See WAC 296-20-03014 (2)).
The Food and Drug Administration has approved fentanyl transdermal system for the management of persistent, moderate to severe chronic pain that:

  • Requires continuous, around-the-clock opioid administration for an extended period of time, and
  • Cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

Fentanyl transdermal system should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal 25 mcg/hr. Patients considered opioid tolerant are those who are taking, for a week or longer, at least:

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

 


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