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Prior Authorization Protocol
LAMICTAL XRR (lamotrigine) Extended-Release Tablets, LAMICTAL ODT R (lamotrigine) Orally Disintegrating Tablets



HNMC
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:
    Lamictal XR
    • Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients ≥ 13 years of age
    • Conversion to monotherapy in patients ≥13 years of age with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED)

    Lamictal ODT

    • Adjuctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients ≥ 2 years of age
    • Conversion to monotherapy in patients ≥ 16 years of age with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
    • Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to immediate-release lamotrigine
  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:
    • For patients being converted from immediate-release lamotrigine to Lamictal XR, the initial dose of Lamictal XR should match the total daily dose of the immediate-release lamotrigine.
    • Micromedex classifies the use of lamotrigine for the Non-FDA Labeled indication of intractable convulsions in newborns as a Class IIa strength of recommendation
    • Lamictal ODT: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of Lamictal in the acute treatment of mood episodes has not been established.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    lamotrigine, (LamictalR) immediate-release

    25 QOD to 500 mg PO QD, divided

    400 to 500 mg PO QD, in divided doses

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

    lamotrigine extended release (Lamictal XR)

    25 mg QOD to 600 mg PO QD

    Length of Benefit

    lamotrigine orally disintegrating tablet (Lamictal ODT)

    Epilepsy:
    25 mg QOD to 500 mg QD, in divided doses

    Bipolar:
    25 mg QOD to 400 mg QD, in divided doses

    Length of Benefit

  7. Product Availability:
    • Lamictal XR Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg
    • Lamictal XR Titration Kit for Patients Taking Valproate: 25 mg (21) & 50 mg (7)
    • Lamictal XR Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate: 50 mg (14) & 100 mg (14) & 200 mg (7)
    • Lamictal XR Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate:25 mg (14) & 50 mg (14) & 100 mg (7)
    • Lamictal ODT Tablets: 25 mg, 50 mg, 100 mg, and 200 mg
    • Lamictal ODT Titration Kit for Patients Taking Valproate: 25 mg (21) & 50 mg (7)
    • Lamictal ODT Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate: 50 mg (42) & 100 mg (14)
    • Lamictal ODT 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 XR. [Prescribing Information] Research Triangle Park, NC: GlaxoSmithKline; March 2015.
    2. Lamictal tablets, Lamictal chewable dispersible tablets, Lamictal ODT [Prescribing Information] Research Triangle Park, NC: GlaxoSmithKline; May 2015.
    3. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed July 7, 2015.
    4. Lamictal. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 7, 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.