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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPeach State Health Plan vigabatrin Coverage Update…
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    ModifiedPeach State Health PlanPolicy CP.PHAR.169

    Vigabatrin (Sabril, Vigafyde) coverage

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    Defines medical necessity criteria, prior authorization, and coverage conditions for vigabatrin products (Sabril, Vigafyde) across Peach State Health Plan lines of business including Commercial, ICHRA, and Medicaid.

    Policy Summary
    PayerPeach State Health Plan
    PolicyVigabatrin (Sabril, Vigafyde) coverage
    Policy CodePolicy CP.PHAR.169
    Change TypeCoverage updatebrand redirectionstep therapy redirection added
    Effective DateFeb 1, 2016
    Next Review DateN/A
    Key ActionPrior authorization is required for vigabatrin products; submit documentation showing member meets criteria (diagnosis, prescriber specialty, age, prior therapy failures where required).
    SourceLink
    POLICY UPDATE CHANGES

    Updated Initial Approval duration for infantile spasms and refractory complex partial seizures to 12 months (placing an upper age limit of 2 years for infantile spasms).

    Added generic redirection requirement for brand Sabril (must use generic vigabatrin unless contraindicated or adverse effects).

    Added redirection bypass for members in states with limitations on step therapy (Appendix D), with Nevada noted for Medicaid-specific rules.

    Updated Initial Approval duration for infantile spasms and refractory complex partial seizures from 3 months or 6 months, respectively, to 12 months and placed an upper age limit of 2 years for infantile spasms.

    Added Commercial line of business and ICHRA line of business since PA is required on Tier 3 and Tier 4 Commercial formularies.

    Added newly FDA-approved Vigafyde oral solution and later added a generic redirection for brand Sabril.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 moInitial approval duration
    1mo–2yrInfantile spasms age range
    ≥2yrRefractory seizures min age
    150 mg/kg/dayMax dose (infantile)
    Vision lossBoxed warning
    VigafydeNew product

    Coverage Criteria

    inv-01: Initial Therapy — Infantile Spasms

    Covered when ALL of the following are met

    Infantile Spasms Initial: 1. Diagnosis of infantile spasms; 2. Prescribed by or in consultation with a neurologist; 3. Age between 1 month to 2 years; 4. For brand Sabril requests, member must use generic vigabatrin, unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 150 mg/kg per day.

    Approval duration: 12 months or up to 2 years of age, whichever is less

    inv-02: Initial Therapy — Refractory Complex Partial Seizures

    Covered when ALL of the following are met

    Refractory Complex Partial Seizures Initial: 1. Diagnosis of refractory complex partial seizures; 2. Request is for Sabril; 3. Prescribed by or in consultation with a neurologist; 4. Age ≥ 2 years; 5. Sabril will be used as adjunctive therapy; 6. 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); 7. For brand Sabril requests, member must use generic vigabatrin, unless contraindicated or clinically significant adverse effects are experienced; 8. 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. 2,000 mg per day; ii. 4 tablets or packets per day; b. Adults aged ≥ 17 years: i. 3,000 mg per day; ii. 6 tablets or packets per day.

    Approval duration: 12 months

    inv-03: Continued Therapy — Infantile Spasms

    Covered when ALL of the following are met

    Infantile Spasms Continued: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Sabril or Vigafyde for infantile spasms and has received this medication for at least 30 days; 2. Age between 1 month to 2 years; 3. Member is responding positively to therapy; 4. For brand Sabril requests, member must use generic vigabatrin, unless contraindicated or clinically significant adverse effects are experienced; 5. 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

    inv-04: Continued Therapy — Refractory Complex Partial Seizures

    Covered when ALL of the following are met

    Refractory Complex Partial Seizures Continued: 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; 2. Member is responding positively to therapy; 3. For brand Sabril requests, member must use generic vigabatrin, unless contraindicated or clinically significant adverse effects are experienced; 4. 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. 2,000 mg per day; ii. 4 tablets or packets per day; b. Adults aged ≥ 17 years: i. 3,000 mg per day; ii. 6 tablets or packets per day.

    Approval duration: 12 months

    Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety. Such documentation must meet the applicable off‑label use policies for the member's line of business: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid, or otherwise be supported by the member's evidence of coverage.

    This policy references Appendix C for all contraindications and boxed warnings associated with vigabatrin products. Providers should review Appendix C for the full list of contraindications and the boxed warning for permanent vision loss before initiating or continuing therapy.

    Initial Therapy Criteria

    inv-22: Initial therapy nodes — criteria differ by indication (infantile spasms vs refractory complex partial seizures)

    Initial therapy criteria differ by indication (infantile spasms vs refractory complex partial seizures).

    ONE of the following initial therapy pathways

    • Infantile Spasms pathway: See Initial Therapy — Infantile Spasms criteria
    • Refractory Complex Partial Seizures pathway: See Initial Therapy — Refractory Complex Partial Seizures criteria

    inv-23: Initial Therapy — Initial approval criteria and durations for labeled indications

    Initial approval criteria and durations for labeled indications.

    Initial approval durations:

    Continued Therapy / Continuation Criteria

    inv-24: Continued therapy nodes — Continued therapy requires documentation of current use and positive response

    Continued therapy requires documentation of current use and positive response

    Continued therapy nodes: See coverage continued therapy criteria: current use ≥30 days for ongoing therapy, age and indication-specific requirements, positive response to therapy, generic preference for brand Sabril, and dose limits on any requested increase.

    inv-25: Continued Therapy — Continued therapy approval durations aligned with initial approvals and labeling

    Continued therapy approval durations aligned with initial approvals and labeling.

    Continued therapy alignment: Continued therapy approval duration aligns with initial approval of 12 months for infantile spasms and refractory complex partial seizures

    Step Therapy Requirements

    RequirementDetails
    Step therapy requirement
    Required unless member is in a state with step therapy redirection limitations (see Appendix D) or all preferred alternatives are contraindicated or cause clinically significant adverse effects. For refractory complex partial seizures, failure of three preferred alternative anticonvulsant drugs is required (see Appendix B for examples).
    Redirection bypassAppendix D / State rules
    Allowed for members in states with limitations on step therapy
    Appendix D lists states with limitations; Nevada is included (applies to Medicaid requests and allows single‑drug redirection — failure of one alternative unless contraindicated or adverse effects).

    Dosing and Coding Limits

    inv-07: Infantile spasms maximum dose — 150 mg/kg/day
    Maximum dose150 mg/kg per day (infantile spasms)
    Dosing regimen referenceStart 25 mg/kg PO twice daily (50 mg/kg/day), increase every 3 days in 25 mg/kg/day increments to 50 mg/kg/day; max 150 mg/kg/day (75 mg/kg twice daily)
    Approval criteria noteDose must not exceed 150 mg/kg/day for initial or continued therapy per policy criteria
    inv-08: Adult maximum dose for complex partial seizures — 3,000 mg/day
    Maximum adult dose3,000 mg per day (adults ≥17 years)
    Dosing regimen referenceInitiate 1,000 mg/day (500 mg PO BID), increase weekly in 500 mg/day increments to 3,000 mg/day

    Provider Actions and Documentation

    Prior Authorization

    Prior authorization required for vigabatrin

    Prior authorization is required for vigabatrin products. This policy applies to Commercial, ICHRA, and Medicaid lines of business.

    Prior Authorization

    PA applies to Commercial and ICHRA; 12-month approval durations

    Prior authorization is required for vigabatrin; Commercial and ICHRA lines of business were added because PA is required on Tier 3 and Tier 4 Commercial formularies. Initial approval durations for the covered indications are set to 12 months.

    Step Therapy

    Step therapy: failure of three preferred alternatives required

    For refractory complex partial seizures, the member must have failed three preferred alternative anticonvulsant drugs unless the request qualifies for a state-specific redirection bypass or alternatives are contraindicated or cause clinically significant adverse effects.

    Background

    Vigabatrin is an anticonvulsant indicated as monotherapy for infantile spasms in pediatric patients and as adjunctive therapy for refractory complex partial seizures in patients who have not responded adequately to other anticonvulsant treatments. Use of vigabatrin carries a boxed warning for permanent vision loss, so prescribers must ensure the potential benefit outweighs the risk. Per the labeled indication and policy updates, coverage for infantile spasms is limited to patients aged 1 month to 2 years, and initial and continued approvals align to an approval duration of 12 months (or up to 2 years of age, whichever is less).

    Definitions

    inv-19: Infantile spasms — definition and labeled age (1 month to 2 years)
    DefinitionAn epilepsy syndrome in infants characterized by infantile spasms; vigabatrin is indicated as monotherapy for infantile spasms when benefits outweigh vision loss risk.
    Labeled age rangeCoverage limited to patients aged 1 month to 2 years for infantile spasms per labeled indication
    Prescriber requirementMust be prescribed by or in consultation with a neurologist per initial therapy criteria
    inv-20: Refractory complex partial seizures — definition and adjunctive use
    DefinitionComplex partial seizures not controlled by several alternative anticonvulsant therapies; considered refractory when inadequate response to other treatments.
    Use of vigabatrinSabril is indicated as adjunctive therapy for refractory complex partial seizures in patients ≥ 2 years of age who have responded inadequately to several alternative treatments

    Quantity Limits

    inv-28: Sabril / vigabatrin — 4 tablets/packets per day (pediatric 2-16) or 6 per day (adults ≥17) depending on dosing
    Quantity limits (pediatric 2–16 years)Up to 4 tablets or packets per day for pediatric patients aged 2–16 years (per dosing and tablet/packet limits)
    Quantity limits (adults ≥17 years)Up to 6 tablets or packets per day for adults aged ≥17 years (per dosing and tablet/packet limits)
    Policy linkageTablet/packet per-day limits correspond with maximum daily mg dosing (pediatrics 2,000 mg/day; adults 3,000 mg/day)

    Site of Care Considerations

    Note

    State- and setting-specific redirection/step therapy rules

    Redirection bypass and limits on step therapy may vary by state and setting; refer to Appendix D for state-specific redirection rules (for example, Nevada has Medicaid-specific single‑drug redirection requirements).

    • Appendix D lists states with limitations against redirections in certain settings; NV notes apply to Medicaid requests.
    Policy Summary
    PayerPeach State Health Plan
    PolicyVigabatrin (Sabril, Vigafyde) coverage
    Policy CodePolicy CP.PHAR.169
    Change TypeCoverage updatebrand redirectionstep therapy redirection added
    Effective DateFeb 1, 2016
    Next Review DateN/A
    Key ActionPrior authorization is required for vigabatrin products; submit documentation showing member meets criteria (diagnosis, prescriber specialty, age, prior therapy failures where required).
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaContinued Therapy / Continuation CriteriaStep Therapy RequirementsDosing and Coding LimitsProvider Actions and DocumentationBackgroundDefinitionsQuantity LimitsSite of Care Considerations
    Initial approval duration set to 12 months for infantile spasms (with upper age limit 2 years) and for refractory complex partial seizures
    Tablet/packet limitAdults: up to 6 tablets or packets per day per dosing limits in policy
    inv-09: Pediatric maximum dose for complex partial seizures (2-16 years) — 2,000 mg/day
    Maximum pediatric dose (2–16 years)2,000 mg per day
    Weight-based dosing examplesPediatrics: dosing varies by weight (e.g., >25–60 kg: 250 mg PO BID to 1,000 mg PO BID); patients >60 kg dosed as adults
    Tablet/packet limitPediatrics 2–16 years: up to 4 tablets or packets per day per policy limits
    Step Therapy

    Redirection bypass for states with step therapy limitations

    A redirection bypass is allowed for members in States with limitations on step therapy in certain settings (see Appendix D); Nevada is specifically included with Medicaid‑specific redirection rules.

    • See Appendix D for state-specific redirection rules (example: Nevada).
    Documentation Required

    Submit supporting clinical documentation

    Providers must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

    • Include evidence of diagnosis, prescriber specialty, age, prior therapy trials, and response as applicable.
    Documentation Required

    Follow Health Plan administrative policies and benefit terms

    Providers must follow Health Plan-level administrative policies and submit coverage requests consistent with benefit terms and applicable legal and regulatory requirements; this policy guides medical necessity determinations.

    Denial Risk

    Denial risk for insufficient documentation or non‑covered indications

    Requests that lack documentation showing the member meets approval criteria (e.g., diagnosis, prescriber specialty, age, required prior therapy failures) or that request non‑FDA indications without off‑label policy support may be denied.

    Denial Risk

    State Medicaid coverage provisions take precedence

    For Medicaid members, state Medicaid coverage provisions take precedence; if state rules conflict with this clinical policy, the request may be denied in accordance with the state Medicaid manual.

    Step therapy requirementPolicy requires failure of three preferred alternative anticonvulsant drugs unless state-specific redirection bypass applies
    inv-21: Health Plan — definition of Health Plan adopting policy
    Health Plan definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates.
    Policy roleThis clinical policy provides guidance for medical necessity determinations and does not constitute a contract or guarantee of payment
    ApplicabilityCoverage decisions remain subject to terms of coverage documents and applicable state and federal requirements