CurrentUnitedHealthcarePolicy CS2025D00126J

Elevidys (delandistrogene moxeparvovec-rokl) medical benefit drug policy

Defines UnitedHealthcare medical benefit coverage criteria, required documentation, and limitations for Elevidys gene therapy for Duchenne muscular dystrophy (DMD); applies to commercial plans except where state-specific guidance overrides.

Policy Summary

PayerUnitedHealthcare

PolicyElevidys (delandistrogene moxeparvovec-rokl) medical benefit drug policy

Policy CodePolicy CS2025D00126J

Change TypeRevised (application language) and archived prior version

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records confirming DMD gene mutation (excluding deletions in exon 8 or 9) and documentation that the patient is ambulatory without an assistive device.

SourceLink

POLICY UPDATE CHANGES

Application section updated to refer to state-specific Medicaid clinical policy for North Carolina and other listed states.

Previous policy version CS2025D00126I archived.

1lifetime treatments authorized per patient

4-5approved patient age (ambulatory)

J1413HCPCS code

G71.01ICD-10 code

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.

Coverage Criteria

Initial therapy (medical necessity)

Covered when ALL of the following are met

Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a pediatric neuromuscular specialist with expertise in the diagnosis of DMD

Genetic confirmation: Submission of medical records confirming a mutation in the DMD gene AND the mutation is not a deletion in exon 8 or exon 9

Examples: chart notes, laboratory values

Age: Patient is aged 4 or 5 years

Coverage limited to these ages

Ambulatory status: Submission of medical records confirming patient is ambulatory without needing an assistive device

Examples: documentation that patient does not require side-by-side assist, cane, walker, wheelchair

Hepatic and monitoring: No preexisting hepatic impairment, acute liver disease, chronic hepatic condition, or elevated GGT AND prescriber attests to weekly liver function monitoring (clinical exam, GGT, total bilirubin) for the first 3 months and thereafter per FDA labeling

Prescriber attestation required

Cardiac and monitoring: Left ventricle ejection fraction (LVEF) is not < 40% AND prescriber attests to weekly troponin-I monitoring for the first month and thereafter per prescribing information>= 40% LVEF

Prescriber attestation required

Antibody titer: Anti-AAVrh74 total binding antibody titer is < 1:400< 1:400

Elevated titer (>= 1:400) is a trigger for denial

Corticosteroid regimen: Patient will receive a corticosteroid regimen prior to and following Elevidys in accordance with FDA approved labeling

Specialist prescriber: Prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD

No concomitant exon-skipping: Patient will not receive exon-skipping therapies for DMD concomitantly or following Elevidys treatment

Examples listed in policy: Amondys, Exondys 51, Viltepso, Vyondys 53

No prior gene therapy: Patient has not previously received gene therapy for the treatment of DMD

Dose and authorization limits: Elevidys dosing per FDA approved labeling; authorization issued for no more than one treatment per lifetime and for no longer than 45 days from approval or until the patient reaches 6 years of age, whichever is first

Elevidys is considered unproven and not medically necessary for certain patient populations. Specifically, coverage does not apply to treatment of Becker muscular dystrophy (BMD), to ambulatory patients with Duchenne muscular dystrophy (DMD) who are younger than 4 years or who are 6 years or older, or to any patient with DMD who is non-ambulatory at any age.

Requests for Elevidys for the indications listed above should be denied as not medically necessary. These exclusions reflect populations for whom the therapy is considered unproven in the available evidence and therefore are not eligible for coverage under this policy.

Coding

Covered HCPCS CodesHCPCSCovered

J1413

Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Relevant Diagnosis CodesICD-10

G71.01

Duchenne or Becker muscular dystrophy

anti-AAVrh74 total binding antibody titer (threshold exclusion)

Exclusion thresholdAnti-AAVrh74 total binding antibody titer >= 1:400 (patients with titer at or above this value are excluded)

Threshold formatReported as total binding antibody titer with cutoff at 1:400

Policy actionRequests will be denied for patients with anti-AAVrh74 total binding antibody titer >= 1:400

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required before Elevidys (delandistrogene moxparvovec-rokl) is furnished. Authorization is limited to a single lifetime treatment. When approved, authorization duration will be issued for no more than 45 days from approval or until the patient reaches 6 years of age, whichever occurs first.

Prior authorization required
Authorization limited to 1 treatment per lifetime
Authorization duration: ≤ 45 days from approval or until age 6, whichever is first

Note

Concomitant Therapy Restriction

Do not administer exon-skipping therapies concomitantly with or after Elevidys. Examples of exon-skipping products include Amondys (casimersen), Exondys 51 (eteplirsen), Viltepso (viltolarsen), and Vyondys 53 (golodirsen).

Prohibition on concomitant or subsequent exon-skipping therapies: Amondys, Exondys 51, Viltepso, Vyondys 53

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 cardiopulmonary complications. Elevidys is an AAV‑based gene therapy that delivers a micro‑dystrophin transgene intended to produce a shortened, functional dystrophin protein to address the underlying genetic defect.

Definitions

Shortened dystrophin protein (~138 kDa) produced from the Elevidys transgene

Definition (micro-dystrophin)Shortened dystrophin protein produced from the Elevidys transgene (~138 kDa)

Comparison to native dystrophinMicro-dystrophin (~138 kDa) vs normal dystrophin (~427 kDa)

Functional noteContains selected domains of the dystrophin protein present in normal muscle cells to improve muscle function

Initial Therapy Requirements

Initial therapy requirements

Initial coverage when criteria are met

See coverage criteria: Refer to the coverage criteria set for eligibility (diagnosis, genetic mutation exclusions, age, ambulatory status, hepatic and cardiac status and monitoring, anti-AAVrh74 antibody titer, corticosteroid regimen, specialist involvement, no prior gene therapy, dosing and authorization limits)

Step Therapy / Therapy Sequence

Step	Requirement	Coverage
1	Patient must not receive exon-skipping therapies for DMD (examples: Amondys [casimersen], Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen]) concomitantly or following Elevidys treatment.

Quantity Limits

Elevidys quantity limit

Quantity limit1 treatment per lifetime

Authorization durationAuthorization issued for no longer than 45 days from approval or until patient reaches 6 years of age, whichever is first

Dose adherenceElevidys dosing must be in accordance with FDA approved labeling

Site of Care and Monitoring

Note

Infusion administration and mandatory post‑infusion monitoring attestation

Elevidys must be administered and monitored per the FDA‑approved labeling in an appropriate infusion setting; the prescriber must attest to required post‑infusion monitoring including weekly liver function tests (clinical exam, GGT, total bilirubin) for the first 3 months and weekly troponin‑I monitoring for the first month.

Prescriber attestation of weekly liver monitoring for first 3 months and thereafter per labeling
Prescriber attestation of weekly troponin‑I monitoring for first month and thereafter per labeling