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Prior Authorization Protocol
OXTELLAR XRR (oxcarbazepine)

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:
    • Adults: Adjunctive therapy in the treatment of partial seizures
    • Children: Adjunctive therapy in the treatment of partial seizures in children 6 to 17 years
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of partial seizures
    AND
    • Failure or clinically significant adverse effects to TrileptalR
  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

    oxcarbazepine (Trileptal)

    Children (4 to 16 years old):
    Initial dose 8-10 mg/kg PO BID not to exceed 600 mg/day.
    Target maintenance dose should be achieved over two weeks,
    and is dependent upon patient weight:
    20-29 kg:
    900 mg/day,
    29.1-39 kg:
    1200 mg/day,
    greater than 39 kg:
    1800 mg/day.

    Adults:
     300 mg PO BID,
    may increase dose by 600 mg/day at
    weekly intervals to 1200 mg/day
    Children
    1,800 mg/day
    Adults
    1,200 mg/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Oxtellar XR (oxcarbazepine)
    Adults:
    Initiate with a dose of 600 mg PO QD.
    Dose increases can be made at weekly intervals of 600 mg PO/day
    increments to achieve 1200 mg to 2400 mg/day.

    Children (6 to 17 years old):
     Target maintenance dose should be achieved over two to three weeks,
    and is dependent upon patients weight.
    Initiate with 8 - 10 mg/kg PO QD.
    Increase in weekly increments of 8 - 10 mg/kg once daily,
    not to exceed 600 mg.
    To achieve daily target dose:
    20 - 29 kg:
    900 mg per day,
    29.1-39 kg:
    1200 mg per day,
    greater than 39 kg:
    1800 mg per day.

    Length of Benefit

  7. Product Availability:
    Extended-release tablets: 150 mg, 300 mg and 600 mg
  8. References:
    1. Oxtellar XR. Prescribing information. Patheon Inc., October 2012.
    2. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 22, 2015.
    3. Trileptal. Prescribing information. Novartis Corporation., June 2014
    4. Clinical Pharmacology Web site. Available at: http://cpip.qsm.com/. Accessed June 22, 2015.
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.
Draft Prepared: 02-MAY-13 RG
Approved By Health Net National P&T: 19-NOV-14, 18-NOV-15
Revised: 23-JUN-14 HT, 19-JUN-15 TY