Partial-onset Seizures

Partial-onset seizures, also known as focal seizures, start in a specific area or 'focus' in the brain. These seizures can further be categorized into two types: focal onset aware seizures, where the individual remains conscious and aware throughout the seizure, and focal onset impaired awareness seizures, where the individual's awareness is impacted during the seizure. The specific symptoms of a partial- onset seizure can vary widely depending on the area of the brain where the seizure originates.

Briviact (brivaracetam)

Briviact (brivaracetam) is a prescription medication that is used to treat partial-onset seizures. It is indicated for use in patients who are 1 month of age and older. Brivaracetam operates by binding to synaptic vesicle protein 2A (SV2A) in the brain, which is thought to play a role in the release of neurotransmitters. By doing so, it helps to reduce the excessive electrical signals in the brain that can lead to seizures.¹

Briviact (brivaracetam) can be used alone or in conjunction with other anti-seizure medications. The exact dosage and administration of brivaracetam will depend on the specific needs of the patient, including their age, weight, and overall health status.

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.
• Partial-onset Seizures (Focal Seizures): are seizures that begin in a specific region or 'focus' of the brain. They can be further categorized into:
  • Focal Onset Aware Seizures: Seizures where the individual remains conscious and aware throughout the event.
  • 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 Briviact (brivaracetam) 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. 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:
   • a. Carbamazepine; and/or
   • b. Divalproex; and/or
   • c. Fosphenytoin; and/or²
   • d. Lamotrigine; and/or
   • e. Levetiracetam; and/or
   • f. Oxcarbazepine; and/or
   • g. Phenobarbital; and/or
   • h. Phenytoin; and/or
   • i. Pregabalin; and/or
   • j. Topiramate; and/or
   • k. Valproic acid; and/or
   • l. Zonisamide; AND
4. IF the request is for Briviact (brivaracetam) 10mg/mL Solution, documentation indicating the member's inability or unwillingness to take the tablet form; AND
5. Briviact (brivaracetam) 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.

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:
   • a. Decreased seizure frequency from baseline; OR
   • b. Decreased seizure severity from baseline; OR
   • c. Decreased seizure duration from baseline.

Experimental or Investigational / Not Medically Necessary

Briviact (brivaracetam) 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:

• Neuropathic Pain
• Other forms of Epilepsies³
• Postherpetic Neuralgia
• Spinal Cord Injuries

References

1. 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.
2. 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. 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.
3. Krumhold A., 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.
4. Pack A.M., et al.: Epilepsy overview and revised classification of seizures and epilepsies.Continuum (Minneap Minn) 2019; 25 (2): pp. 306-321.
5. UCB, Inc. Briviact® (brivaracetam) tablets, oral solution, and injection prescribing information. Smyrna, GA; 2016 Jun.

Clinical Guideline Revision / History Information

Original Date: 9/21/2023

Reviewed/Revised: