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    Elevidys

    Drug - Elevidys (delandistrogene moxeparvovec-rokl) [Sarepta Therapeutics Inc.]

    October 2024

    Therapeutic Area - Duchene muscular dystrophy (DMD)

    Approval criteria

    • Age 4 through 5 years*; AND
    • Diagnosis of Duchenne muscular dystrophy (DMD); AND
    • Patient has a confirmed mutation of the DMD gene between exons 18 to 58; AND
    • Patient does not have any deletion in exon 8 and/or exon 9 in the DMD gene; AND
    • Patient must have a baseline anti-AAVrh74 total binding antibody titer of < 1:400 as measured by ELISA; AND
    • Patient is ambulatory as confirmed by the North Star Ambulatory Assessment (NSAA) scale (score of ≥ 1); AND
    • Patient is not on concomitant therapy with DMD-directed antisense oligonucleotides (e.g., golodirsen, casimersen, viltolarsen, eteplirsen); 
      • Current authorization for any DMD-directed antisense oligonucleotides will be discontinued upon Elevidys approval
    • Patient has not received a DMD-directed antisense oligonucleotide within the past 7 days; AND
    • Patient does not have an active infection, including clinically important localized infections; AND
    • Patient has been on a stable dose of a corticosteroid, unless contraindicated or intolerance, prior to start of therapy and will be used concomitantly with a corticosteroid regimen pre- and postinfusion (refer to the package insert for recommended corticosteroid dosing during therapy); AND
    • Patient’s troponin-I levels will be monitored at baseline and subsequently as clinically indicated; AND
    • Patient will have liver function assessed prior to and following therapy for at least 3 months and as indicated; AND
    • Prescriber attests that multidisciplinary rehabilitation assessments are conducted every 6-12 months AND
    • Approval is for one time administration and may not be renewed
      • Authorization will be for up to 60 days from approval or until the day before the patient’s 6th birthday, whichever comes first

    Quantity limits

    • 1 kit based on patient weight 
    • Patient’s most current weight (in kg) must be submitted at time of request

    Billing for Elevidys

    Elevidys must be billed as a medical claim

    *For FDA-approved extended indication, see prior authorization criteria sheet, Drugs with new or expanded indication

    Questions?

    MHCP Provider Resource Center: 651- 431-2700 or 1-800-366-5411

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