ModifiedUnitedHealthcarePolicy IEXD00126.07

Elevidys (Delandistrogene Moxeparvovec-Rokl) — Medical Benefit Drug Policy

This policy governs medical benefit drug coverage for Elevidys for Individual Exchange plans (excludes MA, NV, NY) and specifies clinical eligibility, monitoring, and utilization limits for pediatric patients with Duchenne muscular dystrophy.

Policy Summary

PayerUnitedHealthcare

PolicyElevidys (Delandistrogene Moxeparvovec-Rokl) — Medical Benefit Drug Policy

Policy CodePolicy IEXD00126.07

Change TypeRevised coverage criteria and clarified monitoring language

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit medical records confirming DMD diagnosis, confirmed DMD gene mutation, ambulatory status, and prescriber attestation to required monitoring per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

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

Replaced a prescriber attestation about troponin-I monitoring 'per prescribing information' with attestation 'in accordance with the FDA approved labeling.'

Updated FDA section to reflect the most current information in the policy.

1treatment per lifetime authorized

ages 4-5age group with proven benefit

≥1:400antibody titer exclusion

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GGT > 2 x ULNhepatic impairment threshold

IEXD00126.06previous version

Coverage Criteria for Elevidys

Initial Coverage Criteria

Covered when ALL of the following are met

Elevidys initial coverage criteria: 1) Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a pediatric neuromuscular specialist with expertise in DMD; 2) Submission of medical records confirming a DMD gene mutation and that the mutation is not a deletion in exon 8 or exon 9; 3) Patient is age 4 or 5 years at time of treatment; 4) Patient is ambulatory without needing an assistive device; 5) No preexisting hepatic impairment (defined as GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) and no acute hepatic viral infection, and prescriber attests that liver function (clinical exam, GGT, and total bilirubin) will be monitored weekly for the first 3 months following administration and thereafter in accordance with the FDA approved labeling; 6) Left ventricular ejection fraction (LVEF) is ≥ 40% and prescriber attests that troponin-I will be monitored weekly for the first month following administration and thereafter in accordance with the FDA approved labeling; 7) Anti-AAVrh74 total binding antibody titer is < 1:400; 8) Patient will receive a corticosteroid regimen prior to and following Elevidys per FDA approved labeling; 9) Elevidys is prescribed by, or in consultation with, a pediatric neuromuscular specialist experienced in the treatment of DMD; 10) No concomitant or subsequent exon-skipping therapies for DMD; 11) Patient has not previously received gene therapy for DMD; 12) No planned inpatient admission solely for Elevidys administration; 13) Dosing conforms to FDA approved labeling; 14) Authorization limited to one treatment per lifetime and for no longer than 45 days from approval or until 6 years of age, whichever is first.

All listed conditions must be satisfied for coverage.

Initial coverage criteria

Covered when ALL of the following are met

Elevidys coverage criteria: Patient is ambulatory AND age ≥ 4 years AND has a confirmed DMD gene mutation AND does not have preexisting hepatic impairment (defined as GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) AND does not have active or recent (within 4 weeks) hepatic viral infection AND has not received recent vaccination within 4 weeks AND does not have active or recent infections within 4 weeks

Prescriber attests that troponin-I will be monitored weekly for the first month following administration and thereafter in accordance with the FDA approved labeling.

Elevidys is not recommended for patients who meet the exclusions listed below. Specifically, treatment may be denied for patients with preexisting hepatic impairment or an active hepatic viral infection because of a heightened risk of serious liver injury or acute liver failure. Requests will also be subject to review and may be denied when there is a recent vaccination within 4 weeks or an active or recent infection within 4 weeks of the proposed treatment date.

For purposes of this policy, preexisting hepatic impairment is defined numerically as a gamma-glutamyl transferase (GGT) greater than 2 times the upper limit of normal (GGT > 2 x ULN), or a total bilirubin greater than the upper limit of normal when the elevation is not attributable to Gilbert’s syndrome. Members meeting these laboratory thresholds will be excluded from Elevidys treatment.

Elevidys is considered not medically necessary for the following uses: treatment of Becker muscular dystrophy (BMD), treatment of ambulatory DMD patients who are younger than 4 years of age or who are 6 years or older, and treatment of DMD patients of any age who are non-ambulatory.

In summary, Elevidys is not medically necessary when used for indications outside the policy’s defined population (e.g., Becker MD, ambulatory DMD patients < 4 years or ≥ 6 years, or non-ambulatory patients). It is also excluded for patients with preexisting hepatic impairment by the numeric thresholds above, and for patients with recent vaccination or active/recent infections within 4 weeks because of safety concerns.

Billing and Coding

HCPCS Covered CodeHCPCSCovered

J1413

Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Diagnosis CodesICD-10

G71.01

Duchenne or Becker muscular dystrophy

No explicit CPT/HCPCS/ICD-10 codes in this part of documentmixed

No codes listed

inv-10: Anti-AAVrh74 total binding antibody titer — eligibility threshold

Eligibility thresholdAnti-AAVrh74 total binding antibody titer must be less than 1:400 for eligibility (requests with titer ≥1:400 are excluded)

Test typeTotal binding antibody titer to AAVrh74 (anti-AAVrh74)

TimingMeasured prior to Elevidys administration as part of pre-treatment screening

inv-11: Preexisting hepatic impairment threshold — GGT and bilirubin criteria

GGT criterionGamma‑glutamyl transferase (GGT) > 2 × upper limit of normal defines preexisting hepatic impairment

Total bilirubin criterion

Provider Actions, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization and Utilization Limits

Prior authorization is required. Elevidys is limited to one therapeutic dose per lifetime. Authorization will be issued for no more than one treatment and for no longer than 45 days from approval or until the member reaches 6 years of age, whichever is first.

Prior authorization required
One therapeutic dose per lifetime
Authorization valid ≤ 45 days from approval or until age 6, whichever is first

Documentation Required

Required Documentation

Submit medical records confirming diagnosis and eligibility prior to authorization. Documentation should include genetic testing demonstrating a DMD gene mutation (not a deletion in exon 8 or 9), clinical notes confirming ambulatory status without assistive device, age documentation showing the patient is 4 or 5 years old, and records showing planned corticosteroid regimen.

Background

Duchenne muscular dystrophy (DMD) is an X-linked progressive neuromuscular disorder caused by mutations in the dystrophin gene. It typically presents in early childhood with progressive muscle weakness leading to loss of ambulation and eventual cardiopulmonary complications. Elevidys is an adeno-associated viral (AAV) gene therapy that delivers a micro-dystrophin transgene intended to produce a shortened functional dystrophin protein and address the underlying genetic defect in eligible pediatric patients.

Definitions

inv-21: Preexisting hepatic impairment — defined as GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome

DefinitionPreexisting hepatic impairment is defined as GGT > 2 × upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert's syndrome

Clinical implicationPatients meeting this definition are not recommended for Elevidys because of high risk of acute serious liver injury and acute liver failure

Related exclusionAlso excludes patients with active hepatic viral infection

inv-22: Ambulatory — definition of ambulatory used in policy

DefinitionAmbulatory: patient is ambulatory without needing an assistive device (e.g., without side‑by‑side assist, cane, walker, wheelchair, etc.)

Age relevance

Revision History

2026-03-01revised_coverage_criteriaLatest

Revised coverage criteria to define preexisting hepatic impairment numerically (GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) and to clarify troponin-I monitoring attestation to be in accordance with the FDA-approved labeling; updated supporting FDA information; archived previous policy version IEXD00126.06.

Policy Summary

PayerUnitedHealthcare

PolicyElevidys (Delandistrogene Moxeparvovec-Rokl) — Medical Benefit Drug Policy

Policy CodePolicy IEXD00126.07

Change TypeRevised coverage criteria and clarified monitoring language

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

Total bilirubin > upper limit of normal (unless elevation is due to Gilbert's syndrome) defines preexisting hepatic impairment

Associated exclusionsPatients meeting these hepatic thresholds or with active hepatic viral infection are not recommended for Elevidys due to risk of serious liver injury

Medical records confirming DMD diagnosis and genetic mutation (mutation not deletion in exon 8 or 9)
Documentation of ambulatory status without assistive device
Proof of patient age (4 or 5 years)
Evidence of planned corticosteroid regimen per FDA labeling

Documentation Required

Required Monitoring Attestation

Prescriber must attest to monitoring per FDA labeling: • Liver function (clinical exam, GGT, total bilirubin) weekly for the first 3 months following administration and thereafter per FDA labeling; • Troponin‑I weekly for the first month following administration and thereafter per FDA labeling.

Attestation that liver function (clinical exam, GGT, total bilirubin) will be monitored weekly × first 3 months and thereafter per FDA labeling
Attestation that troponin‑I will be monitored weekly × first month and thereafter per FDA labeling

Prior Authorization

Prior Authorization Requirements (summary)

Confirm all of the following before approving Elevidys: patient is ambulatory, aged 4–5 years, has confirmed DMD mutation, prescribed by or in consultation with a pediatric neuromuscular specialist, will not receive exon‑skipping therapies concomitantly or following Elevidys, and has not previously received gene therapy for DMD.

Patient ambulatory without assistive device
Age 4 or 5 years
Confirmed DMD gene mutation
Prescribed by/with pediatric neuromuscular specialist
No concomitant or subsequent exon‑skipping therapy
No prior gene therapy for DMD

Denial Risk

Contraindications / Exclusions that May Trigger Denial

Do not authorize when contraindications or exclusions are present. These include preexisting hepatic impairment (GGT > 2× upper limit of normal or total bilirubin > ULN not due to Gilbert's syndrome), active hepatic viral infection or acute liver disease, LVEF < 40%, elevated anti‑AAVrh74 total binding antibody titer ≥ 1:400, recent vaccination within 4 weeks, active or recent (within 4 weeks) infection, planned inpatient admission solely for administration, or when diagnosis is Becker muscular dystrophy or non‑ambulatory DMD or age outside 4–5 years.

Preexisting hepatic impairment: GGT > 2× ULN or total bilirubin > ULN (not due to Gilbert's)
Active hepatic viral infection or acute liver disease
Left ventricular ejection fraction (LVEF) < 40%
Anti‑AAVrh74 total binding antibody titer ≥ 1:400
Recent vaccination within 4 weeks of planned treatment
Active or recent (within 4 weeks) infection
Planned inpatient admission solely for Elevidys administration
Becker muscular dystrophy (BMD)
DMD patients who are non‑ambulatory or age <4 years or ≥6 years

Note

Provider Actions (summary)

Provider action: confirm ambulatory status and age, submit the required documentation and attestations, and ensure no excluded conditions are present. Use consultation with a pediatric neuromuscular specialist as required.

Confirm ambulatory status and age 4–5 years
Ensure required documentation and monitoring attestations are submitted
Verify absence of contraindications/exclusions before request

Policy requires ambulatory status for patients aged ≥4 years to be eligible for Elevidys

DocumentationSubmission of medical records (e.g., chart notes) confirming ambulatory status is required

inv-23: Preexisting hepatic impairment (alternate index entry) — GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome

Definition (alternate entry)Preexisting hepatic impairment: GGT > 2 × upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert's syndrome

Exclusion consequencePatients meeting this threshold are not recommended for Elevidys due to high hepatic risk

Excludes acute hepatic viral infectionPolicy separately excludes active hepatic viral infection in addition to the numeric hepatic thresholds