BRIVIACT, Brivaracetam Form

Brivaracetam (Briviact®) is an anticonvulsant. FDA Approved Indication(s) Briviact is indicated for the treatment of partial-onset seizures in patients 1 month 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 Briviact is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Partial-Onset Seizure (must meet all):

1. Diagnosis of partial-onset seizure;
2. Age ≥ 1 month;
3. Failure of two preferred agents for partial-onset seizures (see Appendix B) unless all are contraindicated or clinically significant adverse effects are experienced; May require prior authorization.
   4. If request is for intravenous (IV) Briviact, oral Briviact administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
   5. Documentation of member’s current weight, for dose calculation purposes;

4. Dose does not exceed any of the following (a-d): a. For adults and pediatric patients weighing ≥ 50 kg: 200 mg per day; b. For pediatric patients weighing 20 kg to < 50 kg: 4 mg/kg/day; c. For pediatric patients weighing 11 kg to < 20 kg: 5 mg/kg/day; d. For pediatric patients weighing < 11 kg: 6 mg/kg/day. Approval duration: 12 months (oral formulation); 1 month (IV formulation) 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): Page 1 of 7

   CLINICAL POLICY Brivaracetam 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 and HIM.PA.33 for health insurance marketplace; 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 and HIM.PA.103 for health insurance marketplace; 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 and HIM.PA.154 for health insurance marketplace.
      II. Continued Therapy A. Partial-Onset Seizure (must meet all):
   3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Briviact for a covered indication and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;
5. Documentation of member’s current weight, for dose calculation purposes;

6. Dose does not exceed any of the following (a-d): a. For adults and pediatric patients weighing ≥ 50 kg: 200 mg per day; b. For pediatric patients weighing 20 kg to < 50 kg: 4 mg/kg/day; c. For pediatric patients weighing 11 kg to < 20 kg: 5 mg/kg/day; d. For pediatric patients weighing < 11 kg: 6 mg/kg/day. Approval duration: 12 months (oral formulation); 1 month (IV formulation) 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 and HIM.PA.33 for health insurance marketplace; 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 and HIM.PA.103 for health insurance marketplace; 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 and HIM.PA.154 for health insurance marketplace.
      Page 2 of 7

   CLINICAL POLICY Brivaracetam 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 or HIM.PA.154 for health insurance marketplace, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key 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 Name Dosing Regimen Dose Limit/ Maximum Dose Varies See full prescribing information Preferred drugs for partial-onset seizures: carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol XR®)
   clonazepam (Klonopin®)
   ethosuximide (Zarontin®) gabapentin (Neurontin®) lamotrigine (Lamictal®, Lamictal® ODT)
   levetiracetam (Keppra®, Keppra XR®) oxcarbazepine (Trileptal®) phenobarbital
   phenytoin (Dilantin®, Dilantin Infatabs®, Phenytek®) pregabalin (Lyrica®) primidone (Mysoline®)
   tiagabine (Gabitril®) topiramate (Topamax®, Topamax® Sprinkle) valproate (Depakene®, Depacon, Depakote®, Depakote® ER) Vimpat® (lacosamide) zonisamide (Zonegran®) 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): hypersensitivity to brivaracetam or any of the inactive ingredients in Briviact. • Boxed warning(s): none reported. Page 3 of 7

   Maximum Dose 200 mg/day CLINICAL POLICY Brivaracetam V. Dosage and Administration
   Indication Dosing Regimen Monotherapy or adjunctive therapy Adults (age ≥ 16 years):
   • Initial dosage: 50 mg PO or IV BID (100 mg/day) • Maintenance dosage: 25 mg to 100 mg PO or IV BID (50 to 200 mg/day; based on individual tolerability, therapeutic response) Pediatrics (age ≥ 1 month):
   • Weight ≥ 50 kg o Initial dosage: 25 mg to 50 mg PO or IV BID (50 mg to 100 mg/day) o Maintenance dosage: 25 mg to 100 mg PO or IV BID (50 to 200 mg/day; based on individual tolerability, therapeutic response) • Weight 20 kg to < 50 kg o Initial dosage: 0.5 mg/kg to 1 mg/kg PO or IV BID (1 mg/kg to 2 mg/kg per day) o Maintenance dosage: 0.5 mg/kg to 2 mg/kg PO or IV BID (1 mg/kg to 4 mg/kg per day; based on individual tolerability, therapeutic response) • Weight 11 kg to < 20 kg o Initial dosage: 0.5 mg/kg to 1.25 mg/kg PO or IV BID (1 mg/kg to 2.5 mg/kg per day) o Maintenance dosage: 0.5 mg/kg to 2.5 mg/kg PO or IV BID (1 mg/kg to 5 mg/kg per day; based on individual tolerability, therapeutic response)
   • Weight < 11 kg
   o Initial dosage: 0.75 mg/kg to 1.5 mg/kg PO or IV BID (1.5 mg/kg to 3 mg/kg per day) o Maintenance dosage: 0.75 mg/kg to 3 mg/kg PO or IV BID (1.5 mg/kg to 6 mg/kg per day; based on individual tolerability, therapeutic response) VI. Product Availability
   Tablets: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg Oral solution: 10 mg/mL (300 mL) Injection: 50 mg/5mL (5 mL) VII.