ModifiedUnitedHealthcarePolicy 2026D0126G

Elevidys (delandistrogene moxeparvovec-rokl) gene therapy for Duchenne muscular dystrophy

Defines UnitedHealthcare medical benefit coverage criteria and limitations for Elevidys (delandistrogene moxeparvovec-rokl) in the treatment of Duchenne muscular dystrophy, specifying patient selection, monitoring, and administrative limits for commercial and community plan members.

Policy Summary

PayerUnitedHealthcare

PolicyElevidys (delandistrogene moxeparvovec-rokl)

Policy CodePolicy 2026D0126G

Change TypeMaterial revisions to hepatic impairment definition and monitoring language

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of hepatic status (GGT, total bilirubin), infection/vaccination history, and prescriber attestation to monitor troponin-I and liver function per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Replaced broad hepatic impairment criterion with a more specific definition: preexisting hepatic impairment defined as GGT > 2x ULN or total bilirubin > ULN not due to Gilbert's syndrome, or acute hepatic viral infection.

Replaced prescriber attestation language about troponin-I monitoring to require monitoring 'in accordance with the FDA approved labeling' rather than the prior more prescriptive schedule.

Updated FDA section to reflect the most current information.

one lifetimemaximum authorized treatments per member

4-5 yrscovered age group

ambulatory only

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ambulation requirement

G71.01diagnosis code

Coverage Criteria for Elevidys

Initial Coverage Criteria

Covered when ALL of the following are met:

Elevidys coverage criteria: Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a pediatric neuromuscular specialist with expertise in the diagnosis of DMD; Submission of medical records confirming a mutation in the DMD gene that is not a deletion in exon 8 or exon 9; Patient is aged 4 or 5 years at time of treatment; Medical records confirming the patient is ambulatory without needing an assistive device; No preexisting hepatic impairment (defined as GGT > 2 x upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert's syndrome) or acute liver disease (e.g., acute hepatic viral infection); Prescriber attests that liver function (clinical exam, GGT, and total bilirubin) will be monitored weekly for the first 3 months following Elevidys administration and thereafter in accordance with FDA-approved labeling; Left ventricular ejection fraction (LVEF) is not < 40%; Prescriber attests that troponin-I will be monitored weekly for the first month following Elevidys administration and thereafter in accordance with FDA-approved labeling; Anti-AAVrh74 total binding antibody titer is < 1:400 (i.e., not ≥ 1:400); Patient will receive a corticosteroid regimen prior to and following Elevidys per FDA-approved labeling; Elevidys is prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD; Patient will not receive exon-skipping therapies for DMD concomitantly or following Elevidys treatment; Patient has not previously received gene therapy for DMD; Provider does not request a planned inpatient admission for the sole purpose of administering Elevidys; Elevidys dosing is in accordance with FDA-approved labeling; Authorization is limited to no more than one treatment per lifetime and for no longer than 45 days from approval or until 6 years of age, whichever is first.

Structured AND logic; all conditions required

Not Medically Necessary / Unproven

Not covered / considered unproven when ANY of the following apply:

Unproven or not medically necessary uses: Use of Elevidys for Becker muscular dystrophy; Duchenne muscular dystrophy in ambulatory patients younger than 4 years of age or patients 6 years of age and older; Duchenne muscular dystrophy in patients of any age who are non-ambulatory; use outside the 4–5 year subgroup with demonstrated benefit (insufficient evidence of improved outcomes).

Any one of these applies makes use unproven / not medically necessary

Elevidys is not recommended for patients with certain hepatic conditions, active hepatic viral infection, recent vaccination, or active/recent infections. Specifically, treatment is contraindicated for members with preexisting liver impairment or active hepatic viral infection because of the high risk of acute serious liver injury and acute liver failure. Providers should also defer treatment when the patient has received a vaccination within the prior 4 weeks or has an active or recent infection within 4 weeks due to immunogenicity and safety concerns. Additionally, Elevidys is considered unproven and not medically necessary for Becker muscular dystrophy and for ambulatory DMD patients younger than 4 years or ≥ 6 years, and for DMD patients who are non-ambulatory at any age.

Per the prescribing information and this policy, preexisting liver impairment is defined using laboratory thresholds: gamma‑glutamyl transferase (GGT) greater than 2 × the upper limit of normal, or total bilirubin greater than the upper limit of normal when the elevation is not attributable to Gilbert's syndrome. Members meeting either of these lab criteria are not recommended for Elevidys because of the increased risk of severe liver injury.

Elevidys is considered unproven or not medically necessary for several uses outside the demonstrated benefit population. This includes treatment of Becker muscular dystrophy, ambulatory DMD patients younger than 4 years or ≥ 6 years, and non-ambulatory patients at any age. The evidence base (including EMBARK and Study 102) supports clinical benefit primarily in the 4 through 5 year old ambulatory subgroup; outside that subgroup, trials did not show consistent improvement in NSAA scores.

Requests to treat patients who meet the policy’s limitations of use should be denied or considered not medically necessary. These limitations include preexisting hepatic impairment as defined by the GGT and total bilirubin thresholds, active hepatic viral infection, and recent vaccination or active/recent infection within 4 weeks. Providers must document absence of these conditions when seeking prior authorization.

Coding and Diagnostic Codes

Applicable HCPCS CodesHCPCS

J1413

Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Referenced Diagnosis CodesICD-10

G71.01

Duchenne or Becker muscular dystrophy

anti-AAVrh74 total binding antibody titer — threshold

anti-AAVrh74 total binding antibody titerMust be < 1:400 (requests with titer ≥ 1:400 are not eligible)

Test requirement timingMeasured prior to Elevidys administration as part of prior authorization documentation

Action on positive resultTiter ≥ 1:400 is a contraindication and may lead to denial of therapy

GGT threshold for hepatic impairment

GGT threshold for preexisting hepatic impairment> 2 x upper limit of normal

ImplicationGGT > 2 x ULN defines preexisting liver impairment and is a contraindication to Elevidys

Provider Actions, Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization is limited to a single lifetime treatment and will be issued for no more than 45 days from approval or until the member reaches 6 years of age, whichever occurs first. Providers must submit required documentation to support medical necessity and eligibility prior to treatment.

Authorization limit: one treatment per lifetime
Authorization duration: up to 45 days from approval or until member is 6 years old, whichever is first
Dosing must follow FDA-approved labeling

Documentation Required

Required Documentation

Providers must supply documentation demonstrating the member meets all coverage criteria. Required records include diagnostic confirmation of Duchenne muscular dystrophy, documentation of the DMD gene mutation (and confirmation the mutation is not a deletion in exon 8 or exon 9), evidence of ambulatory status, baseline and serial hepatic and cardiac testing plans, antibody titer results, and a corticosteroid treatment plan in accordance with FDA labeling. Prescriber attestations described below must be included.

Definitions and Limitations of Use

Elevidys — drug and indication

Brand nameElevidys

Generic namedelandistrogene moxeparvovec-rokl

Indication summaryAAV-vector gene therapy indicated for ambulatory patients 4 years of age and older with Duchenne muscular dystrophy and a confirmed DMD gene mutation

Limitations of Use — liver and infection

Preexisting liver impairmentDefined as GGT > 2 x ULN or total bilirubin > ULN (not due to Gilbert's syndrome); presence is not recommended for treatment

Recent vaccinationRecent vaccination within 4 weeks of planned treatment is a contraindication/limitation

Background

Duchenne muscular dystrophy (DMD) is a progressive X‑linked neuromuscular disorder caused by mutations in the dystrophin gene, typically presenting in early childhood with progressive muscle weakness that leads to loss of ambulation and life‑threatening cardiopulmonary complications. Elevidys (delandistrogene moxeparvovec‑rokl) is an adeno‑associated virus vector gene therapy that delivers a micro‑dystrophin transgene and is indicated for ambulatory patients 4 years and older with a confirmed DMD mutation; clinical benefit has been demonstrated primarily in the 4–5 year age subgroup.

Policy Revision History

2026-03-01material_revisionLatest

Revised coverage criteria to specify preexisting hepatic impairment as GGT > 2x ULN or total bilirubin > ULN not due to Gilbert's syndrome and aligned troponin-I monitoring language to 'in accordance with the FDA approved labeling'; archived prior policy version 2026D0126F.

2026-03-01clarification

Updated supporting information to align FDA section with the most current prescribing information.

Policy Summary

PayerUnitedHealthcare

PolicyElevidys (delandistrogene moxeparvovec-rokl)

Policy CodePolicy 2026D0126G

Change TypeMaterial revisions to hepatic impairment definition and monitoring language

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

DocumentationProviders must document GGT result as part of prior authorization

Total bilirubin threshold for hepatic impairment

Total bilirubin threshold for preexisting hepatic impairment> upper limit of normal (not due to Gilbert's syndrome)

ClarificationElevated total bilirubin due to Gilbert's syndrome is excluded from this criterion

DocumentationProviders must document total bilirubin result as part of prior authorization

Medical records confirming DMD diagnosis and specialist consultation (pediatric neuromuscular specialist)
Genetic testing report confirming DMD gene mutation and that mutation is not a deletion in exon 8 or exon 9
Documentation confirming patient age is 4 or 5 years at time of treatment
Documentation that patient is ambulatory without assistive device
Baseline anti-AAVrh74 total binding antibody titer showing < 1:400
Plan for corticosteroid regimen per FDA labeling

Documentation Required

Required Prescriber Attestations and Infection/Vaccination History

Providers must document absence of defined hepatic impairment or active hepatic viral infection and attest to specified monitoring. Prescribers must attest to monitoring plans for liver function and troponin-I as outlined in the policy and per FDA labeling. Vaccination and infection history must be documented and recent vaccinations or active/recent infections may preclude treatment.

Attestation that patient does not have preexisting hepatic impairment defined as GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome
Attestation that liver function (clinical exam, GGT, total bilirubin) will be monitored weekly for the first 3 months after administration and thereafter per FDA labeling
Attestation that troponin-I will be monitored weekly for the first month after administration and thereafter in accordance with FDA labeling
Documentation of vaccination history (no recent vaccinations within 4 weeks prior to treatment)
Documentation that the patient has no active or recent (within 4 weeks) infections

Denial Risk

Triggers for Denial

Treatment will be denied when the member does not meet coverage criteria or has contraindications outlined below.

Member is non-ambulatory
Member is younger than 4 years or 6 years of age or older
Member has preexisting liver impairment as defined (GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) or active hepatic viral infection
Member has elevated anti-AAVrh74 total binding antibody titer ≥ 1:400
Member has left ventricle ejection fraction (LVEF) < 40%
Recent vaccination within 4 weeks or active/recent infection within 4 weeks
Member previously received gene therapy for DMD
Request for planned inpatient admission solely for administration of Elevidys
Request to receive exon-skipping therapies concomitantly or following Elevidys

Denial Risk

Contraindications / Denial Triggers

Contraindications that should result in denial include the presence of defined hepatic impairment or active hepatic viral infection due to high risk of serious liver injury and acute liver failure. Recent vaccination or active/recent infection is also a contraindication. Non-ambulatory status and age outside the covered range are additional contraindications.

Preexisting hepatic impairment (GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) or active hepatic viral infection — explicit contraindication
Recent vaccination within 4 weeks of proposed treatment — contraindication
Active or recent (within 4 weeks) infections — contraindication
Non-ambulatory patients at any age — not covered
Patients < 4 years or ≥ 6 years of age — not covered

Active or recent infectionActive or recent (within 4 weeks) infections are a contraindication/limitation

Preexisting liver impairment — formal definition

Definition of preexisting liver impairmentGGT > 2 x upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert's syndrome

Clinical consequencePreexisting liver impairment as defined increases risk of acute serious liver injury and acute liver failure and is not recommended for Elevidys

Documentation requirementProviders must document GGT and total bilirubin results to demonstrate absence of preexisting hepatic impairment for prior authorization