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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Amondys 45 Coverage | OpenPayer
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    CurrentClover HealthPolicy 4564-A

    Amondys 45 (casimersen) Coverage Criteria

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    This policy governs Medicare Part B coverage and prior authorization for Amondys 45, including initial and continuation treatment of Duchenne muscular dystrophy. Coverage applies when the member meets the genetic, functional, age, dosing, and response criteria described in the policy.

    Policy Summary
    PayerClover Health
    PolicyAmondys 45 (casimersen) Coverage Criteria
    Policy CodePolicy 4564-A
    Change TypeNo material change
    Effective DateNot specified
    Next Review DateNot specified
    Key ActionSubmit prior authorization with genetic confirmation, exon 45-skipping eligibility, initiation before age 14, an average independent six-minute walk distance of at least 300 meters, and a dose no greater than 30 mg/kg once weekly.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsInitial authorization period
    12 monthsContinuation authorization period
    30 mg/kg weeklyMaximum dose
    ≥300 mMinimum six-minute walk distance
    <14 years
    Policy Summary
    PayerClover Health
    PolicyAmondys 45 (casimersen) Coverage Criteria
    Policy CodePolicy 4564-A
    Change TypeNo material change
    Effective DateNot specified
    Next Review DateNot specified
    Key ActionSubmit prior authorization with genetic confirmation, exon 45-skipping eligibility, initiation before age 14, an average independent six-minute walk distance of at least 300 meters, and a dose no greater than 30 mg/kg once weekly.
    SourceLink
    On This Page
    Coverage CriteriaClinical and Dosing ParametersAuthorization and DocumentationClinical BackgroundKey DefinitionsAmondys 45 Initial TherapyAmondys 45 Continuation TherapyDose and Quantity Limits

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    Treatment initiation age

    Coverage Criteria

    Initial Therapy

    Covered for Duchenne muscular dystrophy when all of the following criteria are met.

    Initial therapy

    • Genetic confirmation: Genetic testing was conducted to confirm the diagnosis of Duchenne muscular dystrophy and to identify the specific type of DMD gene mutation.
    • Exon 45 skipping eligibility: The DMD gene mutation is amenable to exon 45 skipping.

      Refer to the examples in the Appendix; the list is not all-inclusive.

    • Age at initiation: Treatment with Amondys 45 is initiated before the age of 14.Before age 14
    • Ambulation: The member is able to achieve an average distance of at least 300 meters while walking independently over 6 minutes.At least 300 meters over 6 minutes
    • Dose: The dose will not exceed 30 mg/kg once weekly.30 mg/kg once weekly maximum

    Continuation Therapy

    Covered for continuation of therapy when all of the following criteria are met.

    Continuation therapy

    • Current treatment: The member is currently receiving therapy with Amondys 45.
    • Covered indication: Amondys 45 is being used to treat an indication in the coverage criteria section.
    • Response to therapy: The member has demonstrated a response to therapy as evidenced by remaining ambulatory, such as being able to walk with or without assistance and not being wheelchair dependent.Remaining ambulatory
    • Dose: The member will not exceed a dose of 30 mg/kg once weekly.

    Clinical and Dosing Parameters

    Six-minute walk test
    Required distanceAt least 300 meters
    Assessment periodOver 6 minutes
    Walking statusThe member must achieve the distance while walking independently
    Amondys 45 dose
    Maximum dose30 mg/kg
    FrequencyOnce weekly
    ApplicabilityApplies to both initial and continuation therapy

    Authorization and Documentation

    Prior Authorization

    Initial Authorization Required

    Prior authorization is required for Amondys 45 treatment of Duchenne muscular dystrophy (DMD). Authorization may be granted for an initial period of six months when all applicable coverage criteria are met.

    • Genetic testing confirms DMD and identifies a DMD gene mutation amenable to exon 45 skipping.
    • Treatment is initiated before the member turns 14.
    • The member can walk independently for an average of at least 300 meters over six minutes.
    • The dose does not exceed 30 mg/kg once weekly.
    Prior Authorization

    Continuation Authorization Required

    Continuation authorization is required for all members, including new members, requesting ongoing treatment. Authorization may be granted for 12 months when all continuation criteria are met and the member is currently receiving Amondys 45.

    • Amondys 45 is being used for an indication addressed in the coverage criteria.

    Clinical Background

    Amondys 45 (casimersen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed DMD gene mutation amenable to exon 45 skipping. The indication received accelerated approval based on increased dystrophin production in skeletal muscle; continued approval may depend on verification of clinical benefit in confirmatory trials.

    Key Definitions

    Mutation amenable to exon 45 skipping
    Genetic alterationA mutation in the DMD gene
    Treatment eligibilityThe mutation must be amenable to exon 45 skipping
    Processing mechanismThe alteration can be treated by skipping exon 45 during pre-mRNA processing
    Duchenne muscular dystrophy (DMD)
    ConditionDuchenne muscular dystrophy (DMD)
    Diagnostic requirementDiagnosis must be confirmed through identification of a DMD gene mutation
    Covered treatment context

    Amondys 45 Initial Therapy

    Amondys 45 Initial Therapy

    Initial authorization may be granted for 6 months when all coverage criteria are met.

    Initial therapy

    • Genetic confirmation: Genetic testing was conducted to confirm the diagnosis of Duchenne muscular dystrophy and to identify the specific type of DMD gene mutation.
    • Exon 45 skipping eligibility: The DMD gene mutation is amenable to exon 45 skipping.

      Refer to the examples in the Appendix; the list is not all-inclusive.

    • Age at initiation: Treatment with Amondys 45 is initiated before the age of 14.Before age 14

    Amondys 45 Continuation Therapy

    Amondys 45 Continuation Therapy

    Continuation authorization may be granted for 12 months when all criteria are met.

    Continuation therapy

    • Current treatment: The member is currently receiving therapy with Amondys 45.
    • Covered indication: Amondys 45 is being used to treat an indication in the coverage criteria section.
    • Response to therapy: The member has demonstrated a response to therapy as evidenced by remaining ambulatory, such as being able to walk with or without assistance and not being wheelchair dependent.Remaining ambulatory

    Dose and Quantity Limits

    Quantity limit
    DrugAmondys 45 (casimersen)
    Maximum quantity30 mg/kg
    Quantity intervalOnce weekly maximum
    30 mg/kg once weekly maximum
    Treatment initiation age
    Age requirementTreatment must be initiated before age 14
    MedicationAmondys 45
    Therapy phaseInitial treatment
  1. The member has demonstrated response to therapy by remaining ambulatory, with or without assistance, and is not wheelchair dependent.
  2. The dose does not exceed 30 mg/kg once weekly.
    3. Documentation Required

    Required Clinical Documentation

    The following documentation must be available upon request for all submissions. Initial requests require laboratory confirmation of DMD and a qualifying mutation; continuation requests require documentation of response to therapy.

    • Initial requests: Laboratory confirmation of DMD diagnosis with a DMD gene mutation amenable to exon 45 skipping; refer to the examples in the Appendix.
    • Continuation requests: Documentation such as chart notes demonstrating response to therapy.
    Denial Risk

    Initial Therapy Criteria Not Met

    Initial authorization may be denied when any required coverage criterion is not met.

    • Genetic testing has not confirmed DMD and identified the specific type of DMD gene mutation.
    • The mutation is not amenable to exon 45 skipping.
    • Treatment with Amondys 45 is initiated at or after age 14.
    • The member cannot achieve an average distance of at least 300 meters while walking independently over six minutes.
    • The requested dose exceeds 30 mg/kg once weekly.
    Denial Risk

    Continuation Criteria Not Met

    Continuation authorization may be denied when the member is not currently receiving Amondys 45 or when any required continuation criterion is not met.

    • The member is not currently receiving therapy with Amondys 45.
    • Amondys 45 is not being used to treat an indication addressed in the coverage criteria.
    • The member has not demonstrated response to therapy by remaining ambulatory, with or without assistance, and not being wheelchair dependent.
    • The requested dose exceeds 30 mg/kg once weekly.
    Amondys 45 is indicated for patients with confirmed DMD and a mutation amenable to exon 45 skipping
  3. Ambulation: The member is able to achieve an average distance of at least 300 meters while walking independently over 6 minutes.At least 300 meters over 6 minutes
  4. Dose: The dose will not exceed 30 mg/kg once weekly.30 mg/kg once weekly maximum
    5. Dose: The member will not exceed a dose of 30 mg/kg once weekly.30 mg/kg once weekly maximum