Immediate Release Opioid Prior Authorization – NC Standard

FDA Approved Use:

• Apadaz
  • For the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 
• Levorphanol tartrate 
  • For the management of moderate to severe pain or as a preoperative medication where an opioid analgesic is appropriate.
• Oxaydo 
  • For the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 
• Prolate
  • For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults
• Qdolo
  • For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
• RoxyBond
  • For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
• Limitations of Use:
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve these products for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):  
    • have not been tolerated, or are not expected to be tolerated, 
    • have not provided adequate analgesia or are not expected to provide adequate analgesia.

Criteria for Approval of Restricted Product(s):

1. The request is for Apadaz; AND
   1. The patient has a contraindication or intolerance to hydrocodone and codeine (medical record documentation required); AND
   2. If the patient is opioid naïve (no opioid in the past 180 days), the prescription is for no more than a 7 day supply; AND
   3. For patients who are NOT opioid naïve, the prescription is for no more than a 14 day supply; OR
2. The request is for Levorphanol Tartrate; AND
   1. The patient has tried and failed TWO of the following; methadone, morphine, and tapentadol (Nucynta) (medical record documentation required); OR
   2. The patient has a FDA labeled contraindication to ALL of the alternatives that have not been tried (medical record documentation required); OR
3. The request is for Oxaydo, RoxyBond, or oxycodone HCl abuse-deterrent (authorized generic RoxyBond); AND
   1. The patient has a history of substance abuse; AND
   2. The provider attests that it is clinically appropriate for the patient to receive an opiate; OR
4. The request is for Prolate 10-300 mg/5 mL solution; AND
   1. The patient is 18 years of age and older; AND
   2. The patient has tried and failed TWO of the following: generic oxycodone/acetaminophen tablets, Percocet tablets, and Endocet tablets (medical record documentation required); OR
      1. The patient has a FDA labeled contraindication to ALL of the alternatives that have not been tried (medical record documentation required); AND
   3. The provider attests that the patient is unable to take solid dosage forms; AND 
   4. The patient is not taking any other medication in a solid dosage form; AND 
   5. If a patient is using an enteral feeding tube, the tablet/capsule formulation cannot be crushed for administration; OR
5. The request is for Prolate tablets or oxycodone/acetaminophen tablets (authorized generic Prolate); AND
   1. The patient is 18 years of age and older; AND
   2. The patient has tried and failed TWO of the following: generic oxycodone/acetaminophen tablets, Percocet tablets, and Endocet tablets (medical record documentation required); OR
      1. The patient has a FDA labeled contraindication to ALL of the alternatives that have not been tried (medical record documentation required); OR
6. The request is for Qdolo solution or tramadol solution (authorized generic Qdolo); AND
   1. The patient is 12 years of age and older; AND
   2. The patient has tried and failed tramadol tablets/capsules (medical record documentation required); OR
      1. The patient has a contraindication or intolerance to tramadol tablets/capsules (medical record documentation required); AND
   3. The provider attests that the patient is unable to take solid dosage forms; AND
   4. The patient is not taking any other medication in a solid dosage form; AND
   5. If a patient is using an enteral feeding tube, the tablet/capsule formulation cannot be crushed for administration; AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  365 days (1 year)