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Transcript
Prior Authorization Protocol
FYCOMPA (perampanel)
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.
I.
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

II.
Health Net Approved Indications and Usage Guidelines:

Diagnosis of partial-onset seizures
OR

Diagnosis of primary generalized tonic-clonic seizures
AND

III.
Coverage is Not Authorized For:

IV.
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:

V.
Patient is receiving treatment with at least one other antiepileptic drug (AED)
This section intentionally left blank
Therapeutic Alternatives:
Drug
Gabitril®
(tiagabine)
levetiracetam
(Keppra®)
lamotrigine
(Lamictal®)
Lyrica®
(pregabalin)*
gabapentin
(Neurontin®)
Dosing Regimen
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
1000 – 3000 mg PO QD in two divided
doses
100 - 500 mg PO QD in 2 divided doses
depending on utilization of other AEDs
that may induce enzymes or
glucuronidation
150 – 600 mg PO QD in 2 – 3 divided
doses
900 – 1800 mg PO QD in 3 divided
doses
Dose/Limit/Maximum Dose
56 mg daily
3000 mg daily
500 mg daily
600 mg daily
1800 mg daily
(PI notes that up to 2400 mg QD
Confidential and Proprietary
Draft Prepared: 11.15.12 S Redline
Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15
Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian
Page
-1
Prior Authorization Protocol
FYCOMPA (perampanel)
NATL
Drug
Sabril®
(vigabatrin)
topiramate
(Topamax®)
oxcarbazepine
(Trileptal®)
Potiga™
(ezogabine)
Dosing Regimen
1 – 3 gm PO QD in 2 divided doses
Dose/Limit/Maximum Dose
tolerated in long-term studies, and
up to 3600 mg QD tolerated in shortterm studies.)
3 gm daily
200 – 400 mg PO QD in 2 divided doses
400 mg daily
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.)
400 mg TID
Initial dose - 100 mg TID; increase by
no more than 50 mg TID at weekly
intervals.
800-1200 mg PO QD in 2 divided doses
carbamazepine
(Tegretol®,
Tegretol® XR)
phenytoin
100-600 mg PO QD in 2 or 3 divided
(Dilantin®)
doses
valproic acid
10-60 mg/kg/day PO
(Depakene®)
divalproex
(Depakote®)
*Requires Prior Authorization
VI.
1600 mg daily
600 mg daily
60 mg/kg daily
Recommended Dosing Regimen and Authorization Limit:
Drug
Dosing Regimen
Confidential and Proprietary
Draft Prepared: 11.15.12 S Redline
Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15
Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian
Authorization Limit
Page
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Prior Authorization Protocol
FYCOMPA (perampanel)
NATL
Drug
Fycompa
Dosing Regimen
Partial-Onset Seizures
Starting dose is 2 mg PO QHS in patients not on enzymeinducing AEDs and 4 mg in patients on enzyme-inducing
AEDs.
Authorization Limit
Length of Benefit
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 enzymeinducing 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.
VII.
Product Availability:
Fycompa tablets: 2, 4, 6, 8, 10, and 12 mg
Fycompa Oral Suspension: 0.5 mg/ml
VIII.
References:
1. Fycompa [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc.; April 2016.
2. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson
Healthcare. Updated periodically. Accessed May 20, 2016.
The materials provided to you are guidelines used by this health plan to authorize, modify, or determine
coverage for persons with similar illnesses or conditions. Specific care and treatment may vary
depending on individual needs and the benefits covered under your contract.
Confidential and Proprietary
Draft Prepared: 11.15.12 S Redline
Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15
Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian
Page
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