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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCDPHP DMD Drug Coverage Prior Auth | OpenPayer
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    CurrentCapital District Physicians' Health Plan (CDPHP)Policy N/A

    Medicaid Coverage Policies for Drugs Used to Treat Duchenne Muscular Dystrophy (DMD)

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    This policy governs Medicaid coverage and prior authorization requirements for injectable drugs used to treat Duchenne muscular dystrophy (DMD), including eteplirsen, viltolarsen, golodirsen, and casimersen.

    Policy Summary
    PayerCapital District Physicians' Health Plan (CDPHP)
    PolicyMedicaid Coverage Policies for Drugs Used to Treat Duchenne Muscular Dystrophy (DMD)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming DMD, an eligible exon 45, 51, or 53 mutation, corticosteroid status, and kidney function testing when applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    4DMD drugs listed
    4HCPCS codes listed
    3Exon-skipping targets
    RequiredPrior authorization

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    DMD
    Covered indication

    Coverage Criteria

    Initial therapy prior authorization criteria

    Covered when all applicable prior authorization criteria are met.

    All applicable criteria

    • DMD diagnosis and mutation eligibility: Member has a diagnosis of Duchenne muscular dystrophy (DMD), and genetic testing confirms that the DMD gene mutation is amenable to exon 45, 51, or 53 skipping.
    • Corticosteroid status: Documentation confirms a stable dose of corticosteroids before starting therapy, or provides a documented reason not to use corticosteroids.Stable dose before therapy
    • Kidney function testing: Documentation indicates kidney function testing before starting therapy when applicable.Before therapy
    • Concurrent exon-skipping therapy: Member is not currently being treated with another exon-skipping therapy.

    Concurrent treatment with another exon-skipping therapy is excluded from approval.

    Covered Coding

    Covered HCPCS CodesHCPCSCovered
    J1428Exondys 51 (eteplirsen)
    J1429Viltepso (viltolarsen)
    J1427Vyondys 53 (golodirsen)
    J1426Amondys 45 (casimersen)
    Covered NDC CodesNDCCovered
    60923-0363-02Exondys 51 (eteplirsen)
    60923-0284-10Exondys 51 (eteplirsen)
    73292-0011-01Viltepso (viltolarsen)
    60923-0465-02Vyondys 53 (golodirsen)
    60923-0227-02Amondys 45 (casimersen)
    Covered ICD-10 DiagnosisICD-10Covered
    G70.Duchenne muscular dystrophy (DMD)

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    The solution for injection 50 mg/mL requires prior authorization before therapy is started. Approval requires documentation that the member meets the applicable Duchenne muscular dystrophy (DMD) clinical criteria.

    Documentation Required

    Required Clinical Documentation

    Submit clinical documentation confirming the diagnosis, genetic eligibility, corticosteroid status, kidney function evaluation, and absence of concurrent exon-skipping therapy.

    • DMD diagnosis: Confirm the member has Duchenne muscular dystrophy.
    • Genetic eligibility: Genetic testing must confirm a DMD gene mutation amenable to exon 45, 51, or 53 skipping.
    • Corticosteroid use: Confirm a stable corticosteroid dose before starting therapy, or document the reason the member cannot take corticosteroids.
    • Kidney function: Document kidney function testing before therapy is started.

    Policy Background

    This policy addresses injectable exon-skipping therapies for Duchenne muscular dystrophy (DMD), including therapies for DMD gene mutations amenable to skipping of exons 45, 51, or 53.

    Initial Therapy

    Initial therapy

    Initial treatment requires prior authorization and documentation of all applicable criteria.

    All applicable criteria

    • Diagnosis: Member has a diagnosis of Duchenne muscular dystrophy (DMD).
    • Genetic testing confirms that the DMD gene mutation is amenable to exon 45, 51, or 53 skipping.Exon 45, 51, or 53
    • Corticosteroids: Member has a stable corticosteroid dose before starting therapy, or there is a documented reason not to use corticosteroids.Stable dose before therapy
    Policy Summary
    PayerCapital District Physicians' Health Plan (CDPHP)
    PolicyMedicaid Coverage Policies for Drugs Used to Treat Duchenne Muscular Dystrophy (DMD)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming DMD, an eligible exon 45, 51, or 53 mutation, corticosteroid status, and kidney function testing when applicable.
    SourceLink
    On This Page
    Coverage CriteriaCovered CodingAuthorization and Documentation RequirementsPolicy BackgroundInitial Therapy
  1. Concurrent therapy: Confirm the member is not currently receiving another exon-skipping therapy.
    2. Denial Risk

    Clinical Criteria Not Met

    Authorization may be denied when required clinical criteria are not met or cannot be verified in the submitted documentation.

    • DMD diagnosis is absent or not confirmed.
    • Genetic testing is absent or does not confirm a mutation amenable to exon 45, 51, or 53 skipping.
    • A stable corticosteroid dose is not documented and no reason for not using corticosteroids is provided.
    • Required kidney function testing is not documented.
    • The member is currently receiving another exon-skipping therapy.
    • Required clinical documentation is incomplete or does not support the requested therapy.
    Kidney function testing is documented before starting therapy when applicable.Before therapy
  2. No concurrent exon-skipping therapy: Member is not currently being treated with another exon-skipping therapy.