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    Stiripentol

    Drug - stiripentol (Diacomit) [Biocodex]

    May 2019

    Therapeutic Area - Antiepileptic

    Approval criteria

    Stiripentol may be covered by Minnesota Health Care Programs (MHCP) if ALL of the following conditions are met:

    • At the time of request, patient is 20 years of age or younger AND
    • At the time of request, patient must be eligible for Fee-for-Service Medical Assistance AND
    • At time of request, the prescriber must submit a letter of medical necessity along with the prior authorization request AND
    • Patient must have a documented diagnosis of Dravet syndrome OR
    • Patient must have documented diagnosis of malignant migrating partial epilepsy in infancy (MMPSI) due to an SCN2A genetic mutation AND
    • Prescriber must provide a list of medications that have been tried without successful outcomes AND
    • Prescriber must provide documentation that the United States Food and Drug Administration (US FDA) has approved the patient investigational new drug (IND) application for the use of stiripentol

    Renewal criteria

    • Prior authorization must be requested annually AND
    • Patient must meet ALL approval criteria 

    Background

    The prior authorization criteria above for imported Diacomit will be discontinued as of May 31, 2019. Please see below for new coverage policy for FDA-approved Diacomit effective June 1, 2019

    Questions?

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

    New Diacomit (stiripentol) coverage policy for Minnesota Fee-for-Service Medical Assistance

    In light of Biocodex’s recent launch of FDA-approved Diacomit (stiripentol) in the US, Minnesota Fee-for-Service Medical Assistance will implement new Diacomit coverage policy beginning June 1, 2019.

    What is changing?
    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.

    What do prescribers need to do?
    In order to obtain coverage for new or refill Diacomit prescription dispensed on or after June 1, 2019, a prior authorization must be obtained by faxing the MHCP Prescription Drug PA Review Agent:

    MHCP Prescription Drug PA Review Agent
    Hours: Monday–Friday, 8:00 a.m. to 5:30 p.m. Central Time
    Fax: 866-648 4574
    Phone: 866-205 2818

    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 for new drugs.

    In order to arrange for FDA-approved Diacomit to be dispensed and shipped to patients, prescribers will need to contact:

    Diacomit Support Services (US Bioservices)
    Phone: 833-248-0467 (Monday-Friday, 7 AM to 7 PM CST)

    FFS MA members with Other Insurance Coverage/Third Party Liability (TPL)
    FFS MA members with Other Insurance Coverage/Third Party Liability (TPL) must obtain coverage of FDA-approved Diacomit through primary insurance first.

    If providers have any questions regarding this change in coverage policy, please contact:

    MHCP Provider Call Center
    Hours: Monday–Friday, 8:00 a.m. to 4:30 p.m. Central Time
    Phone: 651-431-2700 or 800-366-5411

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