SABRIL, Vigabatrin Form

Vigabatrin (Sabril®) is an anticonvulsant. FDA Approved Indication(s) Sabril is indicated: • For the treatment of refractory complex partial seizures as adjunctive therapy in patients ≥ 2 years of age who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; Sabril is not indicated as a first line agent for complex partial seizures. • For the treatment of infantile spasms as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. 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 Sabril is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Infantile Spasms (must meet all):

1. Diagnosis of infantile spasms;
2. Prescribed by or in consultation with a neurologist;
3. Age between 1 month to 2 years;
4. Dose does not exceed 150 mg/kg per day. Approval duration: 3 months B. Refractory Complex Partial Seizures (must meet all):
5. Diagnosis of refractory complex partial seizures;
6. Prescribed by or in consultation with a neurologist;
7. Age ≥ 2 years;
8. Sabril will be used as adjunctive therapy;

9. 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 three preferred alternative anticonvulsant drugs (see Appendix B for examples); Page 1 of 7

   CLINICAL POLICY Vigabatrin

   6. Dose does not exceed any of the following (a or b): a. Pediatric members aged 2 to 16 years (members > 60 kg should be dosed as adults) (i and ii):
      i. 2,000 mg per day; ii. 4 tablets or packets per day; b. Adults aged ≥ 17 years (i and ii):
      i. 3,000 mg per day; ii. 6 tablets or packets per day. Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):
   7. 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
10. 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. Infantile Spasms (must meet all):
    
    1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Sabril for infantile spasms and has received this medication for at least 30 days;
11. Age between 1 month to 2 years;
12. Member is responding positively to therapy;
13. If request is for a dose increase, new dose does not exceed 150 mg/kg per day. Approval duration: 12 months or up to 2 years of age, whichever is less B. Refractory Complex Partial Seizures (must meet all):
    
    1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Sabril for refractory complex partial seizures and has received this medication for at least 30 days;
14. Member is responding positively to therapy;

15. If request is for a dose increase, new dose does not exceed any of the following (a or b): a. Pediatric members aged 2 to 16 years (members > 60 kg should be dosed as adults) (i and ii):
    i. 2,000 mg per day; Page 2 of 7

    CLINICAL POLICY Vigabatrin ii. 4 tablets or packets per day; b. Adults aged ≥ 17 years (i and ii):
    i. 3,000 mg per day; ii. 6 tablets or packets per day. Approval duration: 12 months
    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: 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

16. 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.
    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 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 Anticonvulsants for partial 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®) Page 3 of 7

    CLINICAL POLICY Vigabatrin 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 warnings: permanent vision loss 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 alternative anticonvulsant drug (see Appendix B for examples), unless all are contraindicated or clinically significant adverse effects are experienced. V. Dosage and Administration
    Indication Infantile spasms Complex partial seizures Dosing Regimen 50 mg/kg/day (25 mg/kg PO BID); increase total daily dose in increments of 25 mg/kg/day PO every 3 days to 50 mg/kg/day Adults (≥ 17 years): 1,000 mg/day (500 mg PO BID); increase total daily dose weekly in 500 mg/day increments to 3,000 mg/day Pediatrics (2-16 years):
    • Weight 10-15 kg: 175 mg PO BID to 525 mg PO BID • Weight > 15 kg to 20 kg: 225 mg PO BID to 650 mg PO BID • Weight > 20 kg to 25 kg: 250 mg PO BID to 750 mg PO BID • Weight > 25 kg to 60 kg: 250 mg PO BID to 1,000 mg PO BID • Patients weighing > 60 kg should be dosed according to adult recommendations. Maximum Dose 150 mg/kg/day (75 mg/kg twice daily) Adults: 3,000 mg/day (1,500 mg twice daily) Pediatrics: 2,000 mg/day (1,000 mg twice daily) VI. Product Availability
    • Tablet: 500 mg
    • Powder for oral solution: 500 mg
    VII.