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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/NeurosurgerySierra Health and Life Viltepso Coverage Update | …
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    Modifiedsierra health and lifePolicy 2026D0095J

    Viltolarsen (Viltepso) for Duchenne muscular dystrophy

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    Policy governing medical benefit coverage criteria for viltolarsen (Viltepso) to treat Duchenne muscular dystrophy (DMD) in patients with DMD gene mutations amenable to exon 53 skipping; applies to the payer's commercial and individual exchange plans.

    Policy Summary
    Payersierra health and life
    PolicyViltolarsen (Viltepso) for Duchenne muscular dystrophy
    Policy CodePolicy 2026D0095J
    Change TypeRevised coverage criteria — prohibited concurrent use with givinostat
    Effective DateMay 1, 2026
    Next Review Date
    Key ActionObtain prior authorization with medical records confirming a DMD mutation amenable to exon 53 skipping and required baseline functional assessments.
    SourceLink
    POLICY UPDATE CHANGES

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

    Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans.

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

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    8-10%Proportion amenable to exon 53
    ≤12 moInitial auth duration
    ≤12 moReauth duration
    J1427HCPCS code
    G71.01Diagnosis code
    no SAEsSafety signal

    Coverage Criteria for Viltolarsen (Viltepso)

    Initial Therapy Criteria

    Covered when ALL of the following are met (Initial therapy):

    Initial Therapy Core Requirements

    • Baseline ambulatory function (one of): Either 6-Minute Walk Test (6MWT) ≥ 300 meters while walking independently prior to beginning therapy; OR patient is ambulatory without an assistive device AND one of: NSAA > 17 OR time to rise (TTR) < 7 seconds.6MWT >= 300 m OR NSAA > 17 OR TTR < 7 s

      6MWT must be performed without side-by-side assist or assistive devices.

    • Gene therapy history: Either patient has not previously received gene therapy for DMD (e.g., Elevidys) OR patient has previously received gene therapy AND there is submission of medical records documenting a clinically meaningful functional decline (e.g., loss of a motor milestone) since gene replacement therapy.

      If prior gene therapy, objective documentation of decline is required.

    Continuation Therapy Criteria

    Covered when ALL of the following are met (Continuation therapy):

    Continuation Therapy Core Requirements: Submission of medical records confirming the patient remains ambulatory without needing an assistive device; Viltepso will not be used concomitantly with Duvyzat (givinostat) or other exon skipping therapies; prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; dosing in accordance with the U.S. FDA–approved labeling; reauthorization for no more than 12 months.

    Continuation requires ongoing ambulatory status without assistive devices.

    Initial Coverage Criteria

    Covered when ALL of the following are met (informed by clinical evidence and FDA indication):

    FDA indication: Patient has genetically confirmed DMD with a mutation amenable to exon 53 skipping (Viltepso FDA indication; accelerated approval based on increased dystrophin).

    See FDA accelerated approval information and indication.

    Clinical evidence of potential benefit: Clinical trials demonstrated increased dystrophin and functional improvements versus historical comparator for timed tests (TTSTAND, TTRW) with significant differences beginning as early as week 37 and persisting through week 205; RACER53 is an ongoing randomized phase 3 trial in ambulatory boys age 4–8 years.

    Efficacy and trial design details described in clinical evidence.

    No concomitant givinostat: Viltepso will not be used concomitantly with Duvyzat (givinostat).

    Operational revision added prohibition of concurrent use with givinostat.

    Unproven Indications

    Unproven/Not Medically Necessary: Use of viltolarsen (Viltepso) for forms of muscular dystrophy other than DMD amenable to exon 53 skipping (e.g., Becker muscular dystrophy) is considered unproven and not medically necessary.

    Viltepso is indicated only for DMD patients with mutations amenable to exon 53 skipping.

    Concomitant use is prohibited: Viltepso will not be used concomitantly with Duvyzat (givinostat) or other exon skipping therapies for DMD (for example, Amondys/casimersen, Exondys 51/eteplirsen, Vyondys 53/golodirsen). This prohibition is an explicit coverage requirement and may result in denial of coverage if documentation shows concurrent use.

    Viltolarsen has not been studied in DMD that is not amenable to exon 53 skipping and has not been studied in other forms of muscular dystrophy (e.g., Becker muscular dystrophy). The FDA indication for Viltepso is limited to patients with a confirmed DMD gene mutation amenable to exon 53 skipping, and clinical trial enrollment and ongoing studies focus specifically on this population.

    Use of viltolarsen for muscular dystrophies that are not amenable to exon 53 skipping (for example, Becker muscular dystrophy) is considered unproven and not medically necessary and therefore is excluded from coverage.

    Requests for Viltepso in patients without documentation of a confirmed exon 53–amenable DMD mutation lack supporting clinical evidence and fall outside the FDA indication; such use is not supported by the available studies and may be denied.

    Applicable Billing and Diagnosis Codes

    Applicable HCPCS CodesHCPCS
    J1427Injection, viltolarsen, 10 mg.
    Applicable Diagnosis CodesICD-10
    G71.01Duchenne or Becker muscular dystrophy

    Provider Requirements, Prior Authorization, and Denial Conditions

    Prior Authorization

    Prior Authorization Required

    Prior authorization required — submission of medical records confirming diagnosis, mutation amenable to exon 53 skipping, baseline assessments.

    • Required documentation: chart notes, laboratory values, genetic test results confirming DMD mutation amenable to exon 53 skipping
    • Baseline functional assessments: 6-Minute Walk Test (6MWT), North Star Ambulatory Assessment (NSAA), time to rise (TTR) as applicable
    • Authorization duration: initial authorization up to 12 months
    Note

    Policy Application

    Prior authorization expected consistent with UnitedHealthcare Medical Benefit Drug Policy application to Commercial and Individual Exchange benefit plans.

    • Application: UnitedHealthcare Commercial and Individual Exchange benefit plans

    Background on Duchenne Muscular Dystrophy and Exon Skipping

    Duchenne muscular dystrophy (DMD) is an X-linked progressive muscle-wasting disorder caused by loss-of-function variants in the DMD gene that result in markedly reduced dystrophin levels. DMD leads to early progressive weakness with respiratory and cardiac complications; viltolarsen is an antisense oligonucleotide designed to skip exon 53 of dystrophin pre-mRNA to produce an internally truncated but functional dystrophin protein and is indicated for patients with mutations amenable to exon 53 skipping.

    Key Definitions

    inv-21: Exon 53 skipping — definition of the molecular approach using antisense oligonucleotides
    DefinitionA molecular approach using antisense oligonucleotides to bind to exon 53 of dystrophin pre-mRNA, causing exclusion of exon 53 during mRNA processing to allow production of an internally truncated but functional dystrophin protein.
    Therapeutic modalityAntisense oligonucleotide (Viltepso/viltolarsen) designed to target exon 53 of dystrophin pre-mRNA.
    Intended effectRestore reading frame in selected DMD mutations to increase dystrophin expression in skeletal muscle.
    Population proportionApproximately 8%–10% of DMD patients have out-of-frame deletion mutations amenable to exon 53 skipping.
    inv-22: Amenable to exon 53 skipping — definition regarding confirmed DMD gene mutation targetable by exon 53 skipping
    Definition
    Policy Summary
    Payersierra health and life
    PolicyViltolarsen (Viltepso) for Duchenne muscular dystrophy
    Policy CodePolicy 2026D0095J
    Change TypeRevised coverage criteria — prohibited concurrent use with givinostat
    Effective DateMay 1, 2026
    Next Review Date
    Key ActionObtain prior authorization with medical records confirming a DMD mutation amenable to exon 53 skipping and required baseline functional assessments.
    SourceLink
    On This Page
    Coverage Criteria for Viltolarsen (Viltepso)Applicable Billing and Diagnosis CodesProvider Requirements, Prior Authorization, and Denial ConditionsBackground on Duchenne Muscular Dystrophy and Exon SkippingKey Definitions
    Step Therapy

    Step Therapy

    Operational note — therapy is not specified as step therapy; no step edits are provided in this excerpt.

    • Therapy is not designated as step therapy in this policy excerpt
    • No step therapy specifics or step edits provided
    Documentation Required

    Documentation and Denial Risk

    Documentation required and denial risks — lack of documentation confirming the DMD diagnosis or the DMD gene mutation amenable to exon 53 skipping, or missing baseline functional assessments, may lead to denial of coverage.

    • Denial risk if genetic confirmation of an exon 53–amenable DMD mutation is not provided
    • Denial risk if baseline functional assessments (e.g., 6MWT, NSAA, TTR) are missing
    Denial Risk

    Concomitant Use Prohibited

    Concomitant therapy prohibition — Viltepso will not be used concomitantly with specified excluded therapies; coverage may be denied if requested with prohibited agents.

    • Excluded concomitant therapies: Duvyzat (givinostat)
    • Excluded concomitant therapies: Other exon skipping therapies (casimersen, eteplirsen, golodirsen)
    • Coverage may be denied if Viltepso is requested to be used concomitantly with Duvyzat (givinostat) or other listed exon skipping therapies
    A confirmed mutation of the DMD gene that can be targeted by exon 53 skipping therapy (i.e., an out-of-frame deletion or other variant for which exclusion of exon 53 restores the dystrophin reading frame).
    Regulatory contextViltepso is indicated for DMD patients with a confirmed DMD gene mutation amenable to exon 53 skipping (FDA accelerated approval).
    Trial inclusionRACER53 enrolls ambulatory boys 4–8 years with genotypically confirmed DMD and out-of-frame deletion mutations amenable to exon 53 skipping.
    Not applicable toViltolarsen has not been studied and is not supported for DMD that is not amenable to exon 53 skipping or for other muscular dystrophies (e.g., Becker).