Prior Auth Protocol

FDA Approved Indications:

Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older
Adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older

Health Net Approved Indications and Usage Guidelines:

OR

AND

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:

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Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Gabitril^R (tiagabine)	32 - 56 mg PO QD in 2 - 4 divided doses in patients on enzyme-inducing AEDs Patients not on enzyme-inducing AEDs require lower doses	56 mg daily
levetiracetam (Keppra^R)	1000 - 3000 mg PO QD in two divided doses	3000 mg daily
lamotrigine (Lamictal^R)	100 - 500 mg PO QD in 2 divided doses depending on utilization of other AEDs that may induce enzymes or glucuronidation	500 mg daily
Lyrica^R (pregabalin)*	150 - 600 mg PO QD in 2 - 3 divided doses	600 mg daily
gabapentin (Neurontin^R)	900 - 1800 mg PO QD in 3 divided doses	1800 mg daily (PI notes that up to 2400 mg QD tolerated in long-term studies, and up to 3600 mg QD tolerated in short-term studies.)
Sabril^R (vigabatrin)	1 - 3 gm PO QD in 2 divided doses	3 gm daily
topiramate (Topamax^R)	200 - 400 mg PO QD in 2 divided doses	400 mg daily
oxcarbazepine (Trileptal^R)	600 - 1200 mg PO QD in 2 divided doses	1200 mg daily (2400 mg daily slightly more effective than 1200 mg, but not well tolerated in clinical trials.)
Potiga^TM (ezogabine)	Initial dose - 100 mg TID; increase by no more than 50 mg TID at weekly intervals.	400 mg TID
carbamazepine (Tegretol^R, Tegretol^RXR)	800-1200 mg PO QD in 2 divided doses	1600 mg daily
phenytoin (Dilantin^R)	100-600 mg PO QD in 2 or 3 divided doses	600 mg daily
valproic acid (Depakene^R) divalproex (Depakote^R)	10-60 mg/kg/day PO	60 mg/kg daily

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Fycompa	Partial-Onset Seizures Starting dose is 2 mg PO QHS in patients not on enzyme-inducing AEDs and 4 mg in patients on enzyme-inducing AEDs. May increase based on clinical response and tolerability by a maximum of 2 mg PO QHS in weekly increments to a dose of 4 mg to 12 mg PO QHS. Dose increases should occur no more frequently than at weekly intervals Maximum recommended daily dose is 12 mg PO QHS Primary Generalized Tonic-Clonic Seizures Starting dose is 2 mg PO QHS in patients not on enzyme-inducing AEDs and 4 mg in patients on enzyme-inducing AEDs. May increase based on clinical response and tolerability by a maximum of 2 mg PO QHS in weekly increments to a dose of 4 mg to 12 mg PO QHS. Dose increases should occur no more frequently than at weekly intervals. Maximum recommended daily dose is 12 mg PO QHS.	Length of Benefit

Product Availability:

Fycompa tablets: 2, 4, 6, 8, 10, and 12 mg

References:

1. Fycompa [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc.; June 2015.

2. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 25, 2015.