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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCareSource Georgia Diacomit Prior Auth | OpenPayer
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    CurrentCareSource GeorgiaPolicy GA-MED-P-366579

    Diacomit (stiripentol) Coverage for Dravet Syndrome

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    This policy governs pharmacy prior authorization for Diacomit (stiripentol) used to treat seizures associated with documented Dravet syndrome in Georgia Medicaid members. It establishes initial authorization, reauthorization, dosing, quantity-limit, and medical-necessity requirements.

    Policy Summary
    PayerCareSource Georgia
    PolicyDiacomit (stiripentol) Coverage for Dravet Syndrome
    Policy CodePolicy GA-MED-P-366579
    Change TypeMaterial revision
    Effective DateFebruary 1, 2026
    Next Review DateN/A
    Key ActionBefore initial authorization, document that the member has tried and failed valproic acid or has a contraindication to it.
    SourceLink
    POLICY UPDATE CHANGES

    The February 2025 revision changed the required prior antiseizure medication trial from valproic acid and clobazam to valproic acid alone.

    The February 2025 revision removed redundant documentation of member weight from the policy requirements.

    The February 2025 revision updated the policy references.

    6 months; 7 kgMinimum age and weight
    50 mg/kg/dayAllowed daily dosage
    3,000 mg/dayMaximum daily dose

    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.

    180/30 daysQuantity limit
    3 monthsInitial approval
    12 monthsReauthorization

    Coverage Criteria

    Initial therapy

    Covered for initial authorization when ALL of the following are met:

    Initial authorization

    • Eligibility and clinical requirements

      • Age and weight: Member is at least 6 months of age and weighs 7 kg or more.age >= 6 months; weight >= 7 kg
      • Specialist involvement: Medication is prescribed by or in consultation with a neurologist.
      • Covered diagnosis: Medication is used for the treatment of seizures associated with a documented diagnosis of Dravet syndrome.
      • Current seizure documentation: Chart notes document the member's seizure frequency on current treatment.
      • Prior valproic acid therapy: Member has tried and failed valproic acid or has a contraindication to valproic acid.
      • Concomitant clobazam: Diacomit will be taken in combination with clobazam.

    Continuation therapy

    Covered for reauthorization when ALL of the following are met:

    Reauthorization

    • Adjunctive clobazam use: Diacomit is being used as an adjunct to clobazam.
    • Clinical response: Chart notes have been provided showing that the member has a decrease in frequency of seizures.

    Treatment of conditions or indications not listed in this policy is excluded from medical necessity under this policy. Other indications should be referred for evaluation under the Off-Label policy.

    CareSource considers Diacomit (stiripentol) not medically necessary when it is used to treat conditions that are not listed in this document.

    Dosage and Quantity Parameters

    Minimum age
    Minimum ageAt least 6 months of age
    Covered treatmentSeizures associated with a documented diagnosis of Dravet syndrome
    Authorization phaseInitial authorization
    Minimum weight
    Minimum weight7 kg or more
    Covered treatmentSeizures associated with a documented diagnosis of Dravet syndrome
    Authorization phaseInitial authorization

    Authorization and Documentation Actions

    Prior Authorization

    Initial Prior Authorization Required

    Prior authorization is required for Diacomit (stiripentol). When all initial criteria are met, approval is granted for 3 months.

    • Use for seizures associated with documented Dravet syndrome in members at least 6 months of age and weighing at least 7 kg.
    • Prescription must be by or in consultation with a neurologist.
    • Diacomit must be used in combination with clobazam; monotherapy is not supported.
    • Dose limit: 50 mg/kg/day in 2 or 3 divided doses, with a maximum of 3,000 mg/day. Quantity limit: 180 capsules or packets per 30 days.
    Prior Authorization

    Reauthorization Requirements

    For reauthorization, document that Diacomit continues to be used as adjunctive therapy with clobazam and that the member has experienced decreased seizure frequency. Meeting both requirements supports an additional 12-month approval.

    • Provide chart notes showing decreased seizure frequency.

    Clinical Background

    Diacomit (stiripentol) is FDA-approved for seizures associated with Dravet syndrome in patients who are at least 6 months old, weigh at least 7 kg, and are taking clobazam.

    Key Definition

    Dravet syndrome
    ConditionDevelopmental and epileptic encephalopathy (DEE)
    Typical onsetUsually presents in the first year of life
    Characteristic seizuresRecurrent seizures that are often prolonged and triggered by fever
    ProgressionAdditional seizure types, intellectual disability, neurological abnormalities, behavioral issues, and other comorbidities may develop
    Seizure controlComplete seizure control is rarely achievable

    Initial Authorization Requirements

    Initial authorization

    For initial authorization, ALL of the following are required:

    • Eligibility: Member is at least 6 months of age and weighs 7 kg or more.age >= 6 months; weight >= 7 kg
    • Prescriber specialty: Medication must be prescribed by or in consultation with a neurologist.
    • Diagnosis and seizure indication: Medication must be used for the treatment of seizures associated with a documented diagnosis of Dravet syndrome.
    • Documentation:

    Reauthorization Requirements

    Reauthorization

    For reauthorization, ALL of the following are required:

    • Adjunctive clobazam use: Diacomit is being used as an adjunct to clobazam.
    • Seizure reduction: Chart notes have been provided that show the member has a decrease in frequency of seizures.

    Required Prior Therapy

    StepRequirementFailure or exception
    1Try valproic acid before DiacomitMember must have tried and failed valproic acid or have a contraindication to valproic acid.

    Quantity Limit

    Diacomit quantity limit
    MedicationDiacomit (stiripentol)
    Quantity limit180
    Limit period and unitCapsules or packets per 30 days
    Policy Summary
    PayerCareSource Georgia
    PolicyDiacomit (stiripentol) Coverage for Dravet Syndrome
    Policy CodePolicy GA-MED-P-366579
    Change TypeMaterial revision
    Effective DateFebruary 1, 2026
    Next Review DateN/A
    Key ActionBefore initial authorization, document that the member has tried and failed valproic acid or has a contraindication to it.
    SourceLink
    On This Page
    Coverage CriteriaDosage and Quantity ParametersAuthorization and Documentation ActionsClinical BackgroundKey DefinitionInitial Authorization RequirementsReauthorization RequirementsRequired Prior TherapyQuantity Limit
    Maximum dosage
    Daily dosage50 mg/kg/day
    AdministrationIn 2 or 3 divided doses
    Maximum daily dose3,000 mg/day
    Quantity limit
    Quantity limit180 capsules or packets per 30 days
    Dosage formsCapsules or powder for oral suspension
    MedicationDiacomit (stiripentol)
  1. Document continued combination use with clobazam.

    2. Unsupported block type: step_therapy

    Documentation Required

    Clinical Documentation Required

    Initial clinical documentation must support the covered indication and establish the member's baseline seizure activity.

    • Chart notes must document current seizure frequency.
    • Document a diagnosis of Dravet syndrome.
    • Include the member's age and weight and the prescribing neurologist's involvement when submitting the request.
    Documentation Required

    Response Documentation

    Reauthorization submissions must include chart notes demonstrating a clinical response to therapy.

    • Document decreased seizure frequency compared with the member's prior or baseline status.

    Unsupported block type: denial_risk

    Denial Risk

    Failure to Meet Initial Criteria

    Initial authorization is at risk of denial when required eligibility, specialist, diagnosis, documentation, prerequisite-treatment, or combination-therapy criteria are not met.

    • Member is younger than 6 months or weighs less than 7 kg.
    • Prescription is not by or in consultation with a neurologist.
    • Dravet syndrome or current seizure frequency is not documented.
    • Valproic acid trial-and-failure or contraindication is not documented.
    • Diacomit is not prescribed in combination with clobazam.
    Denial Risk

    Failure to Meet Reauthorization Criteria

    Reauthorization is at risk of denial when continued adjunctive use with clobazam or a documented decrease in seizure frequency is absent.

    • Chart notes do not show decreased seizure frequency.
    • Diacomit is not being used as adjunctive therapy with clobazam.
    Chart notes must document the member's seizure frequency on current treatment.
  2. Prior therapy: Member has tried and failed valproic acid or has a contraindication to valproic acid.
  3. Combination therapy: Diacomit will be taken in combination with clobazam.