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Prior Authorization Protocol
LAMICTAL ODTR (lamotrigine) Orally Disintegrating Tablets

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:
    • Adjunctive therapy in patients 2 years of age for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome.
    • Monotherapy in patients ≥16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single antiepileptic drug.
    • Bipolar Disorder: maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.
  2. Health Net Approved Indications and Usage Guidelines:
    • Member has a documented swallowing disorder or an inability to swallow tablets or capsules
  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 field intentionally left blank
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    lamotrigine immediate release (LamictalR)

    25 to 500 mg PO QD, divided doses

    400 to 500 mg PO QD, in divided doses

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Lamictal ODT (lamotrigine orally disintegrating tablets)

    25 to 500 mg PO QD, in divided doses

    Length of Benefit

  7. Product Availability:
    Orally Disintegrating Tablets: 25 mg, 50 mg, 100 mg, and 200 mg.
    Titration Blue Kit for Patients Taking Valproate: 25 mg (21) & 50 mg (7)
    Titration Green Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate: 50 mg (42) & 100 mg (14)
    Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate: 25 mg (14) & 50 mg (14) & 100 mg (7)
  8. References:
    1. Lamictal ODT [Prescribing Information] GlaxoSmithKline, Research Triangle Park, NC. May, 2015
    2. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June, 08, 2015 .
    3. Lamictal. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June, 08, 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.