Prior Auth Protocol

FDA Approved Indications:

Adjunctive therapy for primary generalized tonic-clonic (PGTC) 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 seizures who are receiving treatment with a single antiepileptic drug (AED)

Health Net Approved Indications and Usage Guidelines:

Failure or clinically significant adverse effects to immediate-release lamotrigine

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

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.
Serious, life-threatening rashes requiring hospitalization and discontinuation of treatment have been caused by lamotrigine in adults and children. The risk of rash may also be increased by co-administration of lamotrigine with valproate, exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Benign rashes also occur; however, it is not possible to predict which rashes prove to be serious or life-threatening. Lamotrigine should usually be discontinued at the first sign or rash, unless the rash is clearly not drug related.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
lamotrigine, (Lamictal^R) immediate-release	25 to 500 mg PO QD in divided doses	400 to 500 mg PO QD in divided doses

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
lamotrigine extended release (Lamictal XR)	25 to 600 mg PO QD	Length of Benefit

Product Availability:

Extended-Release Tablet: 25, 50, 100, 200, 250, and 300 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 (14) & 100 mg (14) & 200 mg (7)
Titration Orange Kit for patients not taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate: 25 mg (14) & 50 mg (14) & 100 mg (7)

References:

Lamictal XR. [Prescribing Information] GlaxoSmithKline, Research Triangle Park, NC. March 2015.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 23, 2015.
Lamictal. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 23, 2015.