FYCOMPA, Perampanel Form

Perampanel (Fycompa®) is a non-competitive α-amino-3-hydroxy-5-methyl-4- isoxazolepropionic acid (AMPA) glutamate receptor antagonist.
FDA Approved Indication(s) Fycompa is indicated:
• For the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. • For adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Fycompa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Partial-Onset Seizures (must meet all):

1. Diagnosis of partial-onset seizures;
2. Age ≥ 4 years;
3. Member meets one of the following (a or b): a. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D); b. Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated;
   
   4. Dose does not exceed any of the following (a and b): a. 12 mg per day; b. 1 tablet per day.
      Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Primary Generalized Tonic-Clonic Seizures (must meet all):
4. Diagnosis of primary generalized tonic-clonic seizures;

5. Age ≥ 12 years; Page 1 of 7

   CLINICAL POLICY Perampanel

   3. Member meets one of the following (a or b): a. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D); b. Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated;
   4. Fycompa will be used as adjunctive therapy;
6. Dose does not exceed any of the following (a and b): a. 12 mg per day; b. 1 tablet per day. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. All Indications in Section I (must meet all):
   3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Fycompa for seizures and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;

7. If request is for a dose increase, new dose does not exceed any of the following (a and b): a. 12 mg per day; b. 1 tablet per day.
   Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less Page 2 of 7

   CLINICAL POLICY Perampanel B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AMPA: α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Drug Class Examples Dose Limit/ Maximum Dose Varies according to the agent used Varies according to the agent used Anticonvulsants for partial seizures Anticonvulsants for tonic-clonic seizures carbamazepine (Tegretol®), felbamate (Felbatol®), gabapentin (Neurontin®), lamotrigine (Lamictal®), levetiracetam (Keppra®), oxcarbazepine (Trileptal®), phenytoin (Dilantin®), tiagabine (Gabitril®), topiramate (Topamax®), valproic acid (Depakene®), divalproex sodium (Depakote®), zonisamide (Zonegran®) carbamazepine (Tegretol®), lamotrigine (Lamictal®), levetiracetam (Keppra®), phenytoin (Dilantin®), primidone (Mysoline®), topiramate Page 3 of 7

   CLINICAL POLICY Perampanel Drug Class Examples Dose Limit/ Maximum Dose (Topamax®), valproic acid (Depakene®), divalproex sodium (Depakote®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings
   • Contraindication(s): none reported • Boxed warning(s): serious or life-threatening psychiatric and behavioral adverse reactions Appendix D: States with Limitations against Redirections in Certain Settings State Step Therapy Notes Prohibited? No NV Applies to Medicaid requests only Failure of ONE preferred alternative (see Appendix B for examples), unless all are contraindicated or clinically significant adverse effects are experienced. V. Dosage and Administration
   Indication Partial-onset seizures
   Dosing Regimen 2 mg PO QHS (4 mg if on CYP3A4 enzyme- inducers). May increase based on clinical response and tolerability by increments of 2 mg QD, no more frequently than at weekly intervals.
   Maximum Dose 12 mg/day
   The recommended maintenance dose range is 8 mg to 12 mg QD, although some patients may respond to a dose of 4 mg QD. 2 mg PO QHS (4 mg if on CYP3A4 enzyme- inducers). May increase based on clinical response and tolerability by increments of 2 mg QD, no more frequently than at weekly intervals.
   Primary generalized tonic-clonic seizures
   12 mg/day The recommended maintenance dose is 8 mg QHS. Patients who are tolerating Fycompa at 8 mg QD and require further reduction of seizures may benefit from a dose increase up to 12 mg QD if tolerated.
   VI. Product Availability
   • Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg
   • Oral suspension: 0.5 mg/mL (340 mL) Page 4 of 7

   CLINICAL POLICY Perampanel VII.