ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0126G

Elevidys (delandistrogene moxeparvovec-rokl) — coverage criteria for Duchenne muscular dystrophy

This policy governs coverage and medical necessity criteria for Elevidys, an FDA‑approved gene therapy for ambulatory patients with Duchenne muscular dystrophy, and applies to UnitedHealthcare commercial/Colorado Rocky Mountain Health Plans members as specified in the policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyElevidys (delandistrogene moxeparvovec-rokl) — coverage criteria for Duchenne muscular dystrophy

Policy CodePolicy 2026D0126G

Change TypeRevised coverage criteriaclarified limitations of use

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including DMD gene mutation, ambulatory status, anti‑AAVrh74 titer, liver labs, and prescriber attestation to troponin‑I monitoring per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria to redefine preexisting hepatic impairment using specific laboratory thresholds (GGT > 2x ULN or total bilirubin > ULN not due to Gilbert's) and to reference FDA-approved labeling for troponin-I monitoring.

Clarified limitations of use listing preexisting liver impairment (with lab definitions), recent vaccination within 4 weeks, and active/recent infections as not recommended.

age 4-5age group with demonstrated benefit in trials

ambulatoryrequired ambulatory status for coverage

1/lifetimeauthorization limit

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J1413billing code for product

<1:400required antibody status

Coverage and Medical Necessity Criteria

Initial Therapy Criteria

Covered when ALL of the following are met:

Initial coverage criteria: Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a pediatric neuromuscular specialist with expertise in the diagnosis of DMD; and submission of medical records confirming a DMD gene mutation that is not a deletion in exon 8 or exon 9; and patient is aged 4 or 5 years; and records confirm the patient is ambulatory without needing an assistive device; and patient does not have preexisting hepatic impairment or acute liver disease (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); and 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 per FDA labeling; and patient does not have left ventricular ejection fraction (LVEF) < 40%; and prescriber attests that troponin-I will be monitored weekly for the first month following Elevidys administration and thereafter per FDA labeling; and patient does not have anti-AAVrh74 total binding antibody titer ≥ 1:400; and patient will receive a corticosteroid regimen prior to and following receipt of Elevidys in accordance with FDA labeling; and Elevidys is prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD; and patient will not receive exon-skipping therapies for DMD concomitantly or following Elevidys; and patient has not previously received gene therapy for the treatment of DMD; and provider does not request a planned inpatient admission for the sole purpose of administering Elevidys; and dosing is in accordance with FDA approved labeling; and authorization will be issued for 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.

All conditions must be met for coverage

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

Elevidys is not recommended for patients with preexisting liver impairment as defined by laboratory thresholds: gamma‑glutamyl transferase (GGT) > 2 × upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert’s syndrome. Requests may be denied for patients with active hepatic viral infection. Additionally, treatment is not recommended for patients who received a recent vaccination within 4 weeks or who have an active or recent (within 4 weeks) infection because of immunogenicity and safety concerns.

Use of Elevidys for any indication listed under the policy’s Unproven category is considered not medically necessary. This includes treatment for Becker muscular dystrophy, ambulatory DMD patients outside the demonstrated 4–5 year age window (i.e., < 4 years or ≥ 6 years), and any non‑ambulatory DMD patients at any age.

Billing and Coding

Applicable HCPCS CodeHCPCSCovered

J1413

Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Diagnosis Codes (reference)ICD-10

G71.01

Duchenne or Becker muscular dystrophy

Anti-AAVrh74 total binding antibody titer

Eligibility thresholdAnti-AAVrh74 total binding antibody titer < 1:400

Test requirementDocumented total binding antibody titer to AAVrh74 must be provided prior to Elevidys administration

Exclusion if elevatedRequests will not meet criteria if titer is ≥ 1:400

GGT threshold for hepatic impairment

GGT threshold> 2 x upper limit of normal (GGT)

Role in exclusionGGT > 2 x ULN defines preexisting hepatic/liver impairment for Elevidys consideration

Provider Requirements, Prior Authorization, and Restrictions

Prior Authorization

Prior Authorization and Limits

Prior authorization is required. Authorization will be 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 comes first.

Prior authorization required
Maximum one lifetime treatment
Authorization duration: up to 45 days from approval or until 6 years of age, whichever is first

Documentation Required

Prescriber Attestations and Laboratory Monitoring

Prescriber must attest that the patient does not have preexisting hepatic impairment and will follow required monitoring. Preexisting hepatic impairment is defined as GGT > 2 x upper limit of normal or total bilirubin > upper limit of normal not due to Gilbert's syndrome. Prescriber must also attest that troponin‑I will be monitored weekly for the first month after administration and thereafter in accordance with FDA labeling.

Clinical Background

Duchenne muscular dystrophy (DMD) is an X‑linked, progressive neuromuscular disorder caused by mutations in the dystrophin gene. Onset is typically in early childhood (commonly between ages 3 and 5) and the disease course involves progressive skeletal muscle weakness leading to loss of ambulation, as well as progressive cardiomyopathy and respiratory failure. Elevidys is an adeno‑associated virus vector gene therapy designed to deliver a micro‑dystrophin transgene to muscle cells with the intent of producing a truncated dystrophin‑like protein.

Definitions and Key Terms

Elevidys (delandistrogene moxeparvovec-rokl)

ProductElevidys (delandistrogene moxeparvovec-rokl)

Therapy typeA recombinant adeno-associated virus (AAV) vector-based gene therapy delivering a micro-dystrophin transgene to produce micro-dystrophin protein in muscle cells

HCPCSBilling code: J1413 — Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Preexisting hepatic impairment

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

ImplicationPatients meeting these lab criteria are not recommended for Elevidys due to increased risk of acute serious liver injury or acute liver failure

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyElevidys (delandistrogene moxeparvovec-rokl) — coverage criteria for Duchenne muscular dystrophy

Policy CodePolicy 2026D0126G

Change TypeRevised coverage criteriaclarified limitations of use

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

Assessment timingGGT should be measured and documented prior to authorization

Total bilirubin threshold for hepatic impairment

Total bilirubin threshold> upper limit of normal (total bilirubin) not due to Gilbert's syndrome

Exclusion conditionTotal bilirubin > ULN (when not explained by Gilbert's syndrome) meets definition of preexisting hepatic/liver impairment

Documentation noteLaboratory total bilirubin should be reported and interpreted with consideration of Gilbert's syndrome before denial

Attestation: No preexisting hepatic impairment (GGT >2x ULN or total bilirubin > ULN not due to Gilbert's)
Attestation: Troponin‑I monitored weekly for first month and then per FDA labeling
Attestation: Liver function (clinical exam, GGT, total bilirubin) monitored weekly for first 3 months and thereafter per FDA labeling

Denial Risk

Safety-based Exclusions

Elevidys must not be prescribed for patients with the following safety-based exclusions due to increased risk of serious hepatic injury or other safety concerns.

Preexisting hepatic impairment (GGT > 2 x ULN or total bilirubin > ULN not due to Gilbert's syndrome) or active hepatic viral infection
Recent vaccination within 4 weeks of planned treatment
Active or recent infection within 4 weeks of planned treatment
Left ventricular ejection fraction (LVEF) < 40%

Documentation Required

Required Documentation for Authorization

Submit clinical documentation including: consultation notes from a pediatric neuromuscular specialist, documentation confirming diagnosis and genetic testing demonstrating a DMD mutation that is not a deletion in exon 8 or exon 9, documentation confirming patient age (4 or 5 years) and ambulatory status without assistive device, baseline and serial laboratory values (GGT, total bilirubin, troponin‑I), anti‑AAVrh74 total binding antibody titer, and the planned corticosteroid regimen. Also document that the patient has not previously received gene therapy for DMD and that no inpatient admission is planned solely for administration.

Pediatric neuromuscular specialist consultation or documented consultation
Genetic test confirming DMD mutation (not deletion of exon 8 or 9)
Documentation of age (4 or 5 years) and ambulatory status without assistive device
Baseline and follow-up labs: GGT, total bilirubin, troponin‑I
Anti‑AAVrh74 total binding antibody titer (must be < 1:400)
Planned corticosteroid regimen per FDA labeling
Documentation patient has not received prior gene therapy for DMD
No planned inpatient admission solely for administration

Denial Risk

Concurrent Therapy Restrictions

Concurrent or subsequent use of exon‑skipping therapies for DMD is prohibited.

No concomitant or subsequent exon‑skipping therapies (examples: Amondys/casimersen, Exondys 51/eteplirsen, Viltepso/viltolarsen, Vyondys 53/golodirsen)
Patient must not have previously received gene therapy for DMD

Authorization requirementPrior authorization requires attestation that patient does not have preexisting hepatic impairment per this definition

Preexisting liver impairment

Alternate phrasingPreexisting liver impairment: GGT > 2 times the upper limit of normal or total bilirubin > the upper limit of normal not due to Gilbert's syndrome

ContextListed under Limitations of Use; recent vaccination or active/recent infection are additional safety considerations

Policy historyDefinition updated in 03/01/2026 policy revision to replace broader hepatic language with these specific laboratory thresholds