compounded fentanyl — United Healthcare

Initial criteria

• Submission of medical records demonstrating all of the following:
• Use is for the management of breakthrough pain associated with a cancer diagnosis (cancer diagnosis must be documented in medical record)
• AND Patient must have at least a one week history of one of the following medications to demonstrate tolerance to opioids:
• - Oral morphine sulfate ≥ 60 mg/day
• - Fentanyl transdermal patch ≥ 25 mcg/hr
• - Oral oxycodone ≥ 30 mg/day
• - Oral hydromorphone ≥ 8 mg/day
• - Oral oxymorphone ≥ 25 mg/day
• - Oral hydrocodone ≥ 60 mg/day
• - An alternative opioid at an equianalgesic dose (e.g., oral methadone ≥ 20 mg/day)
• AND The patient is currently taking a long-acting opioid around the clock for cancer pain
• AND A unique dosage form is required for a product that is not commercially available due to patient’s age or weight
• AND One of the following:
• - The patient is not concurrently receiving an alternative transmucosal fentanyl product
• - OR The patient is currently receiving an alternative transmucosal fentanyl product AND the prescriber is requesting termination of all current authorizations for alternative transmucosal fentanyl products in order to begin treatment with the requested medication (only one transmucosal fentanyl product will be approved at a time; if previous authorizations cannot be terminated, the request will be denied)
• OR The patient is currently taking a compounded fentanyl citrate product and does not meet the notification criteria requirements based on the FDA-approved indication for breakthrough cancer pain (a one-time fill may be approved for transition to an alternative treatment)

Approval duration

12 months