BANZEL, Rufinamide Form

Rufinamide (Banzel®) is a triazole derivative. FDA Approved Indication(s) Banzel is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older and in adults. 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 Banzel is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Lennox-Gastaut Syndrome (must meet all):

1. Diagnosis of LGS;
   
   2. Prescribed by or in consultation with a neurologist;
   3. Age ≥ 1 year;
   4. 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. Both of the following (i and ii): i. Failure of two preferred alternatives for LGS (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated;
      ii. For brand name Banzel requests, member must use generic rufinamide, if available, unless contraindicated or clinically significant adverse effects are experienced;

2. Dose does not exceed any of the following (a and b): a. 3,200 mg per day; b. Any of the following (i or ii): i. 8 tablets per day; ii. 80 mL per day.
   Approval duration: 12 months
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   CLINICAL POLICY Rufinamide B. Other diagnoses/indications (must meet 1 or 2):

3. 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: 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: 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Lennox-Gastaut Syndrome (must meet all):
4. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Banzel for LGS and has received this medication for at least 30 days;
5. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed any of the following (a and b): a. 3,200 mg per day; b. Any of the following (i or ii): i. 8 tablets per day; ii. 80 mL per day.
      Approval duration: 12 months
      B. Other diagnoses/indications (must meet 1 or 2):

6. 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: 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: 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
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   CLINICAL POLICY Rufinamide 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 – 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 FDA: Food and Drug Administration LGS: Lennox-Gastaut syndrome 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 Age ≥ 17: 400 mg/day
   Age 2 – 16: 25 mg/day With valproate: 100 mg/day
   With enzyme- inducing drugs: 400 mg/day
   topiramate (Topamax®, Qudexy® XR) lamotrigine (Lamictal® CD, ODT, XR) • Adults and Adolescents 17 years and older: Initial dose is 25 to 50 mg/day orally. Maintenance dose is 200 to 400 mg/day orally (divided and given twice daily). • Children and Adolescents 2 to 16 years: Initial dose is 1 to 3 mg/kg/day (max: 25 mg/day) orally once daily in the evening. Maintenance dose is 5 to 9 mg/kg/day orally. • Patients receiving enzyme-inducing AEDs (e.g., carbamazepine, phenobarbital, phenytoin, primidone) NOT to include valproate: o Adults and Adolescents: Initial dose is 50 mg orally daily. Maintenance dose is 300 to 500 mg/day orally given in 2 divided doses.
   o Children 2 to 12 years: Initial dose is 0.6 mg/kg/day orally in 2 divided doses. Maintenance dose is 5 to 15 mg/kg/day (max 400 mg/day) orally given in 2 divided doses. • Patients receiving valproate:
   o Adults and Adolescents: Initial dose is 25 mg orally every other day is given for 2 weeks. Maintenance dose is 100 to 400 mg/day orally, given in 1 to 2 divided doses.
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   CLINICAL POLICY Rufinamide Drug Class Examples felbamate (Felbatol®) clobazam (Sympazan®, Onfi®) o Children 2 to 12 years: Dosage depends on weight.
   Adolescents and Children 2 - 14 years: Add felbamate at 15 mg/kg/day orally in 3-4 divided doses while reducing doses of other AEDs by 20-30%. Increase felbamate dose by 15 mg/kg/day increments at weekly intervals to 45 mg/kg/day orally. Max dose is 3,600 mg/day orally. For Adults, Adolescents, & Children older than 2 years: • Patients weighing > 30 kg: Initial dose is 5 mg orally twice daily. Max dose is 20 mg orally twice daily. Dosing should be individualized based upon efficacy and tolerability. • Patients weighing ≤ 30 kg: Initial dose is 5 mg orally once daily. Max dose is 10 mg orally twice daily. Dosing should be individualized based upon efficacy and tolerability.
   clonazepam (Klonopin®) For Adults, Adolescents, & Children: • Patients weighing > 30 kg: Initial dose is 1.5 mg/day orally, given in three equally divided doses. Max dose is 20 mg/day orally, given in three equally divided doses. • Patients weighing ≤ 30 kg: Initial dose is 0.01 to 0.03 mg/kg/day orally, given in three equally divided doses. Max dose is 0.1 to 0.2 mg/kg/day orally, given in three equally divided doses. Initial dose is 7 to 10 mg/kg/day PO, given three to four times daily for nonenteric-coated capsules or syrup, BID for delayed-release tablets, and QD for the extended-release preparation. A typical adult starting dose is 500 mg QD. The max dose is 60 mg/kg/day or 3,000 mg/day.
   Initial dose is 5 mg/kg/day PO, given in two or three equal doses per day. Max dose is 20 to 80 mg/kg/day PO, according to effectiveness and tolerability. valproic acid (Depakene®), divalproex sodium (Depakote®)ǂ levetiracetam (Spritam®, Keppra®)ǂ Dose Limit/ Maximum Dose 3,600 mg/day LGS: ≤ 30 kg: 0.2 mg/kg/day

   30 kg: 20 mg/day
   ≤ 30 kg: 0.2 mg/kg/day 30 kg: 20 mg/day
   60 mg/kg/day or 3,000 mg/day 80 mg/kg/day 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. Page 4 of 8

   CLINICAL POLICY Rufinamide ǂ Off-label Appendix C: Contraindications / Boxed Warnings • Contraindication(s): familial short QT syndrome • Boxed warning(s): none reported 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 of the following, unless all are contraindicated or clinically significant adverse effects are experienced: generic rufinamide or preferred alternative for LGS (see Appendix B for examples). V. Dosage and Administration
   Indication Dosing Regimen LGS Pediatric patients 1 year to less than 17 years:
   Starting daily dose: 10 mg/kg/day PO in two equally divided doses; increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg/day, not to exceed 3,200 mg/day, in two divided doses
   Maximum Dose 3,200 mg/day Adults (17 years and older): Starting daily dose: 400-800 mg/day PO in two equally divided doses; increase by 400- 800 mg every other day until a maximum dose of 3,200 mg per day, in two divided doses, is reached
   VI. Product Availability
   • Film-coated tablets: 200 mg, 400 mg
   • Oral suspension: 40 mg/mL
   VII.