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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAgency AHCA Diacomit Prior Auth Policy | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Diacomit (stiripentol) Coverage Criteria

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    Prior authorization coverage for Diacomit (stiripentol) in patients with Dravet syndrome, including clinical criteria, specialist involvement, adjunctive clobazam therapy, and hematologic monitoring.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyDiacomit (stiripentol) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and document that all initial or continuation review criteria are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥ 6 monthsMinimum patient age
    1 yearMaximum authorization length
    Every 6 monthsHematologic testing
    Dravet syndromeCovered diagnosis

    Coverage Criteria

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    Initial Therapy Criteria

    Covered when ALL of the following initial review criteria are met:

    Initial therapy

    • Patient and diagnosis

      • Patient must be at least 6 months of age.Age ≥ 6 months
      • Patient must have a diagnosis of Dravet syndrome (DS).

    • Prescriber and concomitant therapy

      • Diacomit (stiripentol) must be prescribed by or in consultation with a neurologist or epileptologist.
      • Diacomit must be used as adjunctive therapy to clobazam.

    • Baseline monitoring

      • Baseline serum hematologic testing must have been completed before therapy.Completed before therapy

    Continuation Therapy Criteria

    Continuation therapy is covered when ALL of the following criteria are met:

    Continuation therapy

    • Initial criteria

      • Patient met the initial review criteria.

    • Clinical response and tolerability

      • Documentation shows an improved clinical response.Improved clinical response
      • Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects

    • Dosing

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Prior Authorization Required

    Prior authorization is required for initial Diacomit (stiripentol) therapy. When the initial review criteria are met, approval may be granted for up to one year.

    • Initial approval is subject to the review criteria and required documentation below.
    Prior Authorization

    Continuation Prior Authorization

    Continuation prior authorization requires documentation that the patient remains eligible for therapy and is receiving clinically appropriate and tolerated treatment.

    • Patient met the initial review criteria.
    • Improved clinical response is documented.
    • No treatment-restricting adverse effects have occurred.
    • Dosing is appropriate according to labeling or supported by compendia.
    • Hematologic testing has been completed every 6 months.
    Documentation Required

    Initial Clinical Documentation

    For initial review, submit documentation confirming that the patient meets all clinical criteria for Diacomit therapy.

    • Patient is 6 months of age or older.
    • Patient has a diagnosis of Dravet syndrome (DS).
    • Diacomit is prescribed by or in consultation with a neurologist or epileptologist.
    • Diacomit will be used as an adjunct to clobazam.
    • Baseline serum hematologic testing has been completed.
    Documentation Required

    Continuation Documentation

    Continuation requests must document the patient's prior eligibility, clinical benefit, treatment tolerability, appropriate dosing, and required laboratory monitoring.

    • Document that the patient met the initial review criteria.
    • Provide documentation of improved clinical response.
    • Document that the patient has not experienced treatment-restricting adverse effects.
    • Confirm dosing is consistent with labeling or supported by compendia.
    • Provide evidence that hematologic testing has been completed every 6 months.
    Denial Risk

    Initial Authorization Requirements

    Initial authorization may be denied when any required eligibility or documentation criterion is not met.

    • Patient is younger than 6 months of age.
    • Diagnosis of Dravet syndrome (DS) is not documented.
    • Prescriber is not a neurologist or epileptologist and consultation with one is not documented.
    • Diacomit is not being used as an adjunct to clobazam.
    • Baseline serum hematologic testing has not been completed.
    Denial Risk

    Continuation Requirements

    Continuation authorization may be denied when the patient does not remain eligible for therapy, treatment is not effective or tolerated, dosing is unsupported, or required monitoring is incomplete.

    • Initial review criteria were not met.
    • Improved clinical response is not documented.
    • The patient has experienced treatment-restricting adverse effects.
    • Dosing is not appropriate according to labeling and is not supported by compendia.
    • Hematologic testing has not been completed every 6 months.

    Initial Therapy

    Initial Therapy Criteria

    Initial therapy is covered when ALL of the following criteria are met:

    Initial therapy

    • Patient and diagnosis

      • Patient must be at least 6 months of age.Age ≥ 6 months
      • Patient must have a diagnosis of Dravet syndrome (DS).

    • Prescriber and concomitant therapy

      • Diacomit (stiripentol) must be prescribed by or in consultation with a neurologist or epileptologist.
      • Diacomit must be used as adjunctive therapy to clobazam.

    • Baseline monitoring

      • Baseline serum hematologic testing has been completed.Completed before therapy

    Continuation Therapy

    Continuation Therapy Criteria

    Continuation therapy is covered when ALL of the following criteria are met:

    Continuation therapy

    • Patient met the initial review criteria.
    • Documentation shows an improved clinical response.Improved clinical response
    • Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects
    • Dosing is appropriate according to labeling or is supported by compendia.Per labeling or compendia-supported
    • Hematologic testing has been completed every 6 months.Every 6 months

    Authorization Duration

    Quantity limits
    MedicationDiacomit (stiripentol)
    Authorization lengthUp to one year
    Applies toAuthorization period
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyDiacomit (stiripentol) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and document that all initial or continuation review criteria are met.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation RequirementsInitial TherapyContinuation TherapyAuthorization Duration
    • Dosing is appropriate according to labeling or is supported by compendia.Per labeling or compendia-supported

  1. Hematologic monitoring

    • Hematologic testing has been completed every 6 months.Every 6 months