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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/NeurosurgerySierra Health and Life Amondys 45 Coverage Update …
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    Currentsierra health and lifePolicy 2026D0105I

    Amondys 45 (casimersen) — coverage criteria for Duchenne muscular dystrophy

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    Defines coverage criteria and requirements for Amondys 45 (casimersen) for treatment of Duchenne muscular dystrophy in members covered under UnitedHealthcare Commercial and Individual Exchange benefit plans.

    Policy Summary
    Payersierra health and life
    PolicyAmondys 45 (casimersen) — coverage criteria for Duchenne muscular dystrophy
    Policy CodePolicy 2026D0105I
    Change TypeRevised coverage criteriaadded concomitant-use exclusion
    Effective DateMay 1, 2026
    Next Review Date
    Key ActionSubmit prior authorization with medical records verifying DMD amenable to exon 45 skipping, ambulatory status, prescriber specialty, dosing per label, and absence of excluded concomitant therapies.
    SourceLink
    POLICY UPDATE CHANGES

    Revised coverage criteria; added criterion requiring Amondys 45 will not be used concomitantly with Duvyzat (givinostat).

    Added Application section to indicate this policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

    12

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    initial authorization maximum duration
    12reauthorization maximum duration
    J1426HCPCS code for casimersen
    G71.01Diagnosis code referenced
    ≥300m6MWT threshold

    Coverage Criteria for Amondys 45 (casimersen)

    Initial Therapy

    Covered when ALL of the following are met

    Initial Therapy criteria: Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD; submission of medical records confirming the DMD gene mutation is amenable to exon 45 skipping; and one of the following: (a) submission of medical records confirming a 6-Minute Walk Test (6MWT) ≥ 300 meters while walking independently prior to beginning Amondys 45; OR (b) submission of medical records confirming the patient is ambulatory without needing an assistive device AND one of: NSAA score > 17 OR time to rise (TTR) < 7 seconds. Additionally, the patient must either not have previously received gene therapy for DMD or, if previously treated with gene replacement therapy, have submitted medical records documenting a clinically meaningful functional decline since gene therapy. Amondys 45 must not be used concomitantly with Duvyzat (givinostat) or other exon skipping therapies (e.g., eteplirsen, viltolarsen, golodirsen); therapy must be prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; dosing must follow the FDA-approved labeling; initial authorization up to 12 months.

    Structured as combined AND/OR conditions per policy

    Continuation Therapy

    Covered for continuation when ALL of the following are met

    Continuation Therapy criteria: Submission of medical records confirming the patient remains ambulatory without needing an assistive device; Amondys 45 is not used concomitantly with Duvyzat (givinostat) or other exon skipping therapies (e.g., eteplirsen, viltolarsen, golodirsen); prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; dosing is in accordance with the United States FDA-approved labeling; reauthorization will be for no more than 12 months.

    Continuation requires ongoing ambulatory status and absence of excluded concomitant therapies.

    Unproven / Not Medically Necessary

    Unproven / Not medically necessary: Use of Amondys 45 for the treatment of other forms of muscular dystrophy (e.g., Becker muscular dystrophy) is considered unproven and not medically necessary.

    Amondys 45 (casimersen) must not be administered at the same time as Duvyzat (givinostat) or any other exon skipping therapies for Duchenne muscular dystrophy (for example, Exondys 51/eteplirsen, Viltepso/viltolarsen, Vyondys 53/golodirsen). This concomitant-use restriction applies to both initial and continuation therapy and is a requirement for authorization.

    Use of Amondys 45 for muscular dystrophy forms other than Duchenne muscular dystrophy—such as Becker muscular dystrophy—is considered unproven and not medically necessary and is therefore not covered.

    Coding and Test Thresholds

    Applicable HCPCS CodesHCPCS
    J1426Injection, casimersen, 10 mg
    Diagnosis CodesICD-10
    G71.01Duchenne or Becker muscular dystrophy
    6-Minute Walk Test
    6-Minute Walk Test threshold>= 300 meters (walking independently prior to starting Amondys 45)
    Alternate ambulatory criteriaAmbulatory without assistive device plus NSAA > 17 or time to rise (TTR) < 7 seconds
    Trial population mentionESSENCE trial entry criterion included mean 6MWT >= 300 m and <= 450 m

    Provider Requirements, Authorization & Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization required. Submit medical records (e.g., chart notes, laboratory values) verifying diagnosis of Duchenne muscular dystrophy and that the DMD mutation is amenable to exon 45 skipping. Include documentation of baseline ambulatory status per criteria (e.g., 6-Minute Walk Test ≥ 300 meters while walking independently, or NSAA > 17 or time to rise < 7 seconds) as applicable. Initial authorizations are for up to 12 months.

    • Submit completed prior authorization request form
    • Attach chart notes, laboratory values, genetic testing confirming exon 45 amenability
    • Include baseline functional measures (6MWT, NSAA, TTR)
    Step Therapy

    Concomitant Therapy Restriction

    Do not submit Amondys 45 for concurrent use with Duvyzat (givinostat) or with other exon skipping therapies for DMD (for example, Exondys 51, Viltepso, Vyondys 53). Concomitant use is not allowed and will result in denial of the request.

    Background

    Duchenne muscular dystrophy (DMD) is an X-linked degenerative neuromuscular disorder that leads to progressive skeletal and cardiac muscle weakness, declining pulmonary function, and early disability. Casimersen (Amondys 45) is an antisense oligonucleotide indicated for patients with DMD who have a confirmed mutation amenable to exon 45 skipping. Treatment with Amondys 45 is subject to specific coverage criteria including documentation of the qualifying genetic mutation and ambulatory function, adherence to FDA dosing, prescriber specialty requirements, and the exclusion of concomitant exon skipping agents such as Duvyzat and other listed therapies.

    Key Definitions

    Amenable to exon 45 skipping
    DefinitionPresence of a confirmed DMD gene mutation that can be targeted so exon 45 is skipped during pre-mRNA splicing to produce functional dystrophin
    Documentation requiredSubmission of medical records confirming the DMD mutation is amenable to exon 45 skipping
    Regulatory indicationAmondys 45 (casimersen) is indicated for DMD patients with a confirmed mutation amenable to exon 45 skipping (FDA accelerated approval)
    Clinical trial contextESSENCE trial enrolled ambulatory patients with out-of-frame deletion mutations amenable to exon 45 skipping
    Policy Summary
    Payersierra health and life
    PolicyAmondys 45 (casimersen) — coverage criteria for Duchenne muscular dystrophy
    Policy CodePolicy 2026D0105I
    Change TypeRevised coverage criteriaadded concomitant-use exclusion
    Effective DateMay 1, 2026
    Next Review Date
    Key ActionSubmit prior authorization with medical records verifying DMD amenable to exon 45 skipping, ambulatory status, prescriber specialty, dosing per label, and absence of excluded concomitant therapies.
    SourceLink
    On This Page
    Coverage Criteria for Amondys 45 (casimersen)Coding and Test ThresholdsProvider Requirements, Authorization & DocumentationBackgroundKey Definitions
  1. Prohibited concurrent therapies: Duvyzat (givinostat); other exon skipping therapies (eteplirsen, viltolarsen, golodirsen)
    2. Documentation Required

    Post-Gene Therapy Documentation

    If the patient previously received gene replacement therapy for DMD (e.g., Elevidys), submit documentation demonstrating a clinically meaningful functional decline since gene therapy (for example, loss of a motor milestone or decline in strength/motor ability). Without documentation of decline after prior gene therapy, coverage may be denied.

    • If prior gene therapy received, attach records documenting functional decline since gene replacement therapy (chart notes, functional testing results)
    Denial Risk

    Documentation and Clinical Criteria Missing — Denial Risk

    Denial risk if required documentation is missing or does not confirm all applicable criteria. Specifically, authorization may be denied if records do not confirm: DMD mutation amenable to exon 45 skipping; baseline ambulatory status per the policy criteria (e.g., 6MWT ≥ 300 m or NSAA/TTR thresholds); prescribing or consult by a neurologist with DMD expertise; or, when applicable, documentation of functional decline after prior gene therapy.

    • Missing genetic test or documentation of exon 45 amenability
    • Absent or inadequate baseline ambulatory measures or functional assessments
    • No documentation of neurologist involvement or consultation
    • No evidence of decline after prior gene therapy when applicable