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Prior Authorization Protocol
XARTEMIS XR TM (oxycodone hydrochloride and acetaminophen)



NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For use in the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.
  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to TWO formulary short acting narcotic analgesics: hydrocodone/acetaminophen, immediate-release oxycodone/acetaminophen, oxycodone/aspirin, immediate-release oxycodone, immediate-release hydromorphone.
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This section intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    Hydrocodone/acetaminophen (NorcoR)

    2.5 - 10 mg PO Q4 - 6H

    The total daily dose of acetaminophen should be limited to ≤4 g/day

    Immediate-release oxycodone / acetaminophen (PercocetR, RoxicetTM)

    2.5 - 10 mg PO Q4 - 6H

    The total daily dose of acetaminophen should be limited to ≤4 g/day

    Oxycodone / aspirin (PercodanR)

    4.8355 - 325 mg PO Q6H

    The total daily dose of aspirin should be limited to ≤4 g/day

    Immediate-release oxycodone (RoxicodoneR)

    5 - 20 mg PO Q4-6H

    Reserve use of single doses greater than 40 mg or
    total daily doses greater than 80 mg for opioid-tolerant patients only

    Immediate-release hydromorphone (DilaudidR)
    Opioid-naive:
    2 - 4 mg PO Q4-6H

    Severe pain:
    4 - 8 mg PO Q4-6H

    Doses should be titrated to provide adequate pain relief

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Xartemis XR

    Two tablets PO Q12

    Length of Benefit

  7. Product Availability:
    Tablet: 7.5 mg/325 mg (oxycodone hydrochloride/acetaminophen)
  8. References:
    1. Xartemis XR [Prescribing Information]. Hazelwood, MO: Mallinckrodt Pharmaceuticals; March 2014.
    2. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc.; Accessed June 5, 2015.
    3. DRUGDEX System Micromedex 2.0. Greenwood Village, CO: Thompson Reuters (Healthcare) Inc.; Accessed June 5, 2015.
    4. Singla N, Barrett T, Sisk L, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain. Curr Med Res Opin. 2014 Mar;30(3):349-59.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.