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    Diacomit

    Drug - Diacomit® (stiripentol) [Biocodex Inc.]

    September 2019

    Therapeutic area - Anticonvulsants

    Approval criteria

    • Patient must be ≥ 2 years of age AND
    • Patient has a diagnosis of Dravet syndrome (DS) AND
    • Prescriber is a neurologist AND
    • Baseline serum hematologic test results must be provided at time of request AND
    • Stiripentol will be used in adjunct to ≥ 1 antiepileptic drug AND
    • Stiripentol will be used in conjunction with clobazam AND
    • If the oral powder for suspension is prescribed, the patient does not have phenylketonuria (PKU) AND
    • Patient is not taking imported stiripentol

    Renewal criteria

    • Patient continues to meet above criteria AND
    • Results of hematologic test (performed every 6 months) must be provided at time of request AND
    • Patient has no treatment-limiting adverse effects (e.g., thrombocytopenia, neutropenia, new onset or worsened depression; suicidal thoughts, worsened seizure control) AND
    • Prescriber to provide attestation of stiripentol effectiveness (e.g., reduced seizure frequency) AND
    • If the patient was prescribed two Diacomit strengths during the initial approval period, prescriber must provide attestation that when patient becomes stabilized on one Diacomit strength, reasonable efforts will be or has been taken to ensure that the other Diacomit strength will be or has been used up to minimize waste

    Quantity limits

    • 50 mg/kg/day; not to exceed 3,000 mg/day. If the exact dosage is not achievable given the available strengths, round to the nearest possible dosage, which is usually within 50 mg to 150 mg of the recommended 50 mg/kg/day
    • Patient’s weight (in kg) must be submitted at time of request
    • When a combination of the two Diacomit strengths must be prescribed, the prescriber must provide:
      • Attestation that two separate prescriptions for two Diacomit strengths will be issued AND
      • The requested quantity, number of refill(s), and directions for use for each Diacomit strength on the prior authorization request form AND
      • Attestation that when patient becomes stabilized on one Diacomit strength, reasonable efforts will be taken to ensure that the other Diacomit strength will be used up to minimize waste

    Background Information

    Beginning June 1, 2019, Minnesota Fee-for-Service Medical Assistance (FFS MA) will cover only the FDA-approved Diacomit. On or after June 1, 2019, FFS MA will no longer cover imported-Diacomit previously dispensed by Caligor Rx Inc. Prior authorization requests for refill Diacomit prescriptions will be granted for all patients with active FFS MA coverage. Prior authorization request for new Diacomit prescriptions will be granted if patients have active FFS MA coverage AND meet prior authorization criteria above.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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