Partial-onset seizures, also known as focal seizures

begin in a specific part of the brain. These seizures can be categorized into two types: simple and complex. Simple partial seizures typically do not cause loss of consciousness, while complex partial seizures may impair consciousness. Symptoms can vary widely depending on the area of the brain where the seizure originates.

• 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.

Primary Generalized Tonic-Clonic Seizures (PGTCS), previously known as grand mal seizures

involve the entire brain from the onset of the seizure. These seizures typically have two phases. The tonic phase involves a sudden loss of consciousness and muscle stiffening, while the subsequent clonic phase involves rapid muscle contractions or convulsions.

• FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

Lennox-Gastaut Syndrome (LGS)

is a severe form of epilepsy that typically begins in early childhood. It is characterized by multiple types of seizures, including atonic (drop attacks), tonic, atypical absence, and myoclonic seizures. Cognitive development is also often affected.

• The FDA has recognized perampanel as an orphan drug for managing seizures linked to Lennox-Gastaut syndrome, but it hasn't been officially approved by the FDA for this specific use.

Definitions

• Antiepileptic Drugs Medications used to prevent or reduce the severity and frequency of seizures in various types of epilepsy.
• Partial seizures are an older term that has been used to describe seizures that start in a specific part of the brain. The term "partial" reflects the fact that these seizures are localized to a specific area at the onset.
• Focal seizures is a term that has been more recently adopted by the International League Against Epilepsy, replacing "partial seizures." This term is more descriptive of the fact that the seizure originates from a specific 'focus' in the brain.
• Lennox-Gastaut Syndrome (LGS) is a rare and severe form of childhood-onset epilepsy characterized by multiple types of seizures and cognitive dysfunction. It typically begins between the ages of 2 and 6 and can be caused by various brain abnormalities or injuries, though in many cases its cause remains unknown.
• Orphan Drug refers to a medicinal product designed for the prevention, diagnosis, or treatment of rare diseases or disorders. These are conditions that affect a small percentage of the population. In the United States, the Food and Drug Administration (FDA) defines an orphan drug as one "intended for the treatment, prevention, or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US" or meets cost recovery provisions of the act.
• Partial-onset Seizures (Focal Seizures) are seizures that begin in a specific region or 'focus' of thebrain. They can be further categorized into:
  1. Focal Onset Aware Seizures: Seizures where the individual remains conscious and aware throughout the event.
  2. Focal Onset Impaired Awareness Seizures: Seizures that impact an individual's consciousness or awareness during the event.

Medical Necessity Criteria for Initial Authorization

The Plan considers Fycompa (perampanel) medically necessary when ALL of the following criteria are met:

1. The medication is prescribed by or in consultation with a neurologist or epilepsy specialist; AND
2. IF the request is for Fycompa 0.5mg/mL Suspension, documentation indicating the member's inability or unwillingness to take the tablet form; AND
3. Fycompa (perampanel) is being prescribed at a dose and frequency that is within FDA approved labeling OR is supported by compendia or evidence-based published dosing guidelines; AND

The member has a diagnosis of epilepsy and meets the medical necessity criteria for the applicable indication listed below:

Partial-onset Seizures (Focal Seizures)

1. The member is 4 years of age or older; AND
2. The member has a diagnosis of focal seizures (i.e., partial-onset seizures, partial seizures); AND
3. The member has documented evidence of inadequate seizure control with at least two alternate antiepileptic drugs at maximally tolerated doses. These may include, but are not limited to, the following:
   • Carbamazepine; and/or
   • Divalproex; and/or
   • Fosphenytoin; and/or
   • Lamotrigine; and/or
   • Levetiracetam; and/or
   • Oxcarbazepine; and/or
   • Phenobarbital; and/or
   • Phenytoin; and/or
   • Pregabalin; and/or
   • Topiramate; and/or
   • Valproic acid; and/or
   • Zonisamide.

Primary Generalized Tonic-Clonic Seizures

4. The member is 12 years of age or older; AND
5. The member has a diagnosis of primary generalized tonic-clonic seizures; AND
6. The member has documented evidence of inadequate seizure control with at least two alternate antiepileptic drugs at maximally tolerated doses. These may include, but are not limited to, the following:
   • Carbamazepine; and/or
   • Divalproex; and/or
   • Fosphenytoin; and/or
   • Lamotrigine; and/or
   • Levetiracetam; and/or
   • Phenobarbital; and/or
   • Phenytoin; and/or
   • Topiramate; and/or
   • Valproic acid.

Seizures Associated with Lennox-Gastaut Syndrome

4. The member has a diagnosis of Lennox-Gastaut Syndrome; AND
5. The member has documented evidence of inadequate seizure control with at least two alternate antiepileptic drugs at maximally tolerated doses. These may include, but are not limited to, the following:
   • Cannabidiol; and/or
   • Clobazam; and/or
   • Clonazepam; and/or
   • Felbamate; and/or
   • Fenfluramine; and/or
   • Lamotrigine; and/or
   • Rufinamide; and/or
   • Topiramate.

If the above prior authorization criteria are met, the requested product will be authorized for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12-months will be granted if the member has recent (within the last 3 months) clinical chart documentation demonstrating ALL of the following criteria:

1. The requested medication is prescribed by or in consultation with a neurologist or epilepsy specialist; AND
2. The member has experienced a documented improvement in seizure control validated by clinical documentation showing:
   • Decreased seizure frequency from baseline; or
   • Decreased seizure severity from baseline; or
   • Decreased seizure duration from baseline.

Experimental or Investigational / Not Medically Necessary

FYCOMPA (perampanel) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Alcohol Disorders
• Amyotrophic Lateral Sclerosis (ALS)
• Bipolar Disorder (BD)
• Diabetic Neuropathies
• Electroencephalography
• Essential Tremor
• Major Depressive Disorder (MDD)
• Neuropathic Pain
• Other forms of Epilepsies
• Parkinson's Disease (PD)
• Post Traumatic Stress Disorder (PTSD)
• Prophylaxis of migraine headaches

References

1. Eisai Inc. FYCOMPA® (perampanel) tablets and oral suspension prescribing information. Woodcliff Lake, NJ; 2017 Jul.
2. Fisher R.S., et al.: Operational classification of seizure types by the International League Against Epilepsy: position paper of the ILAE commission for classification and terminology. Epilepsia 2017; 58 (4): pp. 522-530.
3. Food and Drug Administration. FDA Application: Search Orphan Drug Designations and Approvals. Rockville, MD. From FDA website. Accessed September 2023..
4. Kanner AM, Ashman E, Gloss D, Harden C, Bourgeois B, Bautista JF, Abou-Khalil B, Burakgazi-Dalkilic E, Park EL, Stern J, Hirtz D, Nespeca M, Gidal B, Faught E, French J.

References

4. Krumhold A., et al.: Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the American Epilepsy Society and the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Epilepsy Curr. 2018 Jul-Aug; 18(4):269-278. PMID: 30254528; PMCID: PMC6145395.
5. Pack A.M., et al.: Evidence-based guideline: management of an unprovoked first seizure in adults. Report of the Guideline Development Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2015; 84 (16): pp. 1705-1713.
6. Pack A.M., et al.: Epilepsy overview and revised classification of seizures and epilepsies. Continuum (Minneap Minn) 2019; 25 (2): pp. 306-321.

Clinical Guideline Revision / History Information

Original Date: 9/21/2023

Reviewed/Revised: