Elevidys (delandistrogene moxeparvovec-rokl) — Medical Benefit Drug Policy (coverage criteria)
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Defines medical benefit coverage criteria and limits for Elevidys gene therapy for treatment of Duchenne muscular dystrophy (DMD) under UnitedHealthcare Commercial/Community Plan benefits; affects prescribers, infusion providers, and prior authorization reviewers.
Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Elevidys.
Archived previous policy version 2025D0126E.
Coverage Criteria for Elevidys
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
All conditions must be satisfied for approval
Revised coverage criterion (admission restriction) — added requirement about inpatient admissions
Policy history notes a revision to coverage criteria including an added requirement about inpatient admissions.
Added in 01/01/2026 revision; archived previous policy version 2025D0126E.
Elevidys (delandistrogene moxeparvovec-rokl) is not considered medically necessary for certain indications where evidence is insufficient. Specifically, Elevidys is unproven and not medically necessary for: Becker muscular dystrophy (BMD); for Duchenne muscular dystrophy (DMD) in ambulatory patients who are younger than 4 years or 6 years or older; and for DMD patients of any age who are non-ambulatory.
The policy rationale notes limited trial evidence outside the narrow ambulatory 4–5 year population: neither the EMBARK Phase III trial nor Study 102 (Phase II) demonstrated consistent, statistically significant functional benefit across broader age groups, and only the 4–5 year subgroup showed improvement in NSAA total score at Week 48 in Study 102. Use outside the defined covered population is therefore considered unproven/not medically necessary.
The policy history was updated effective 01/01/2026 to revise the coverage criteria. The revision adds a requirement that the provider must not request a planned inpatient admission solely for the purpose of administering Elevidys. This admission restriction is now an explicit element of the coverage rationale and may affect approval decisions.
Coverage is limited to the ambulatory pediatric population in whom benefit has been demonstrated. Use of Elevidys in populations outside the covered ambulatory 4–5 year age group is considered unproven. Likewise, administration to any non-ambulatory patients or to patients with Becker muscular dystrophy (BMD) is regarded as unproven and not medically necessary due to insufficient evidence of improved clinical outcomes.
Operationally, the revised admission-for-administration condition means that requests which include a planned inpatient admission solely for the purpose of giving Elevidys may be denied under the updated criteria. The 01/01/2026 revision explicitly states the provider must not request such an admission when seeking coverage.
Initial Therapy Coverage Requirements
Initial therapy coverage — Initial coverage requires meeting all of the following clinical and administrative requirements
Initial coverage requires meeting all of the following clinical and administrative requirements.
All listed clinical and administrative requirements must be met for initial coverage approval; associated HCPCS code J1413 links authorization to the treatment.
Provider Actions, Documentation & Denial Risks
Prior Authorization Required
Prior authorization is required. Authorization will be issued for no more than one Elevidys treatment per lifetime and for no longer than 45 days from approval or until the member reaches 6 years of age, whichever occurs first. Providers must follow UnitedHealthcare Medical Benefit Drug Policy procedures and obtain prior approval before administration.
- Limit: one treatment per lifetime
- Authorization duration: <=45 days from approval or until age 6, whichever first
Member-specific benefit & mandate check
Before submitting a request, check the member-specific benefit plan document and any applicable federal or state mandates; the member-specific benefit plan governs in the event of a conflict. This policy is intended to assist interpretation of UnitedHealthcare standard benefit plans but does not replace the member-specific plan or mandates.
- Verify member-specific benefits and applicable mandates
- In case of conflict, the member-specific benefit plan governs
Required Clinical Documentation
Submit complete medical records to support the request. Required documentation includes confirmation of Duchenne muscular dystrophy diagnosis and genetic testing details, ambulatory status, specialist consultation, baseline laboratory and cardiac assessments, and treatment history.
- Clinical documentation confirming DMD diagnosis by or in consultation with a pediatric neuromuscular specialist
- Medical records confirming a DMD gene mutation and that the mutation is not a deletion in exon 8 or exon 9
- Documentation confirming patient age is 4 or 5 years
- Records confirming the patient is ambulatory without an assistive device
- Baseline and planned monitoring documentation: hepatic function (GGT and total bilirubin) and troponin-I monitoring plans as attested by prescriber
- Documentation that anti-AAVrh74 total binding antibody titer is < 1:400
- Attestation that a corticosteroid regimen will be given per FDA labeling
- Documentation that the patient has not previously received gene therapy for DMD
Planned inpatient admission — provider action
Do not request a planned inpatient admission solely for the purpose of administering Elevidys. Requests for planned inpatient admission for the sole purpose of Elevidys administration may trigger denial.
- Planned inpatient admission solely for Elevidys administration may be denied
Concomitant therapy restriction
Patient must not receive exon-skipping therapies for DMD (for example: Amondys, Exondys 51, Viltepso, Vyondys 53) concomitantly with or following Elevidys treatment.
- Concomitant or subsequent exon-skipping therapies for DMD are prohibited
Step therapy
No step therapy requirements are specified in this policy.
Applicable Codes
| J1413 | Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose. |
| G71.01 | Duchenne or Becker muscular dystrophy |
Site of Care Restrictions
Avoid planned inpatient admission for infusion‑center administration
Planned inpatient admission for the sole purpose of Elevidys administration should not be requested for infusion‑center care; this is an administrative exclusion in the coverage criteria.
- Do not request planned inpatient admission solely to administer Elevidys
Planned inpatient admission solely for administration is not allowed
Requests that include planned inpatient admission solely to administer Elevidys are not allowed under the revised coverage criteria for hospital outpatient administration; do not submit inpatient admission requests for this sole purpose.
- Revised coverage criteria disallow planned inpatient admission solely for administration
Step Therapy / Concomitant Therapy
| Step | Requirement / Restriction |
|---|---|
| 1 | Patient must not receive exon‑skipping therapies for DMD (e.g., Amondys (casimersen), Exondys 51 (eteplirsen), Viltepso (viltolarsen), Vyondys 53 (golodirsen)) concomitantly or following Elevidys treatment. |
Quantity Limits
Definitions
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 is a recombinant AAV‑based gene therapy that delivers a micro‑dystrophin transgene systemically to skeletal muscle with the goal of producing a shortened functional dystrophin‑like protein.
Clinical trial evidence has focused on ambulatory pediatric populations; the most robust signal of functional benefit to date has been observed in younger ambulatory children (notably ages 4–5 in Study 102), while data in older or non‑ambulatory patients and in Becker muscular dystrophy are limited or absent. Providers should consider the natural history of DMD and the trial population when evaluating candidates for Elevidys.
Revision History
Revised coverage criteria to add a requirement that the provider must not request a planned inpatient admission solely for the purpose of administering Elevidys.
Archived previous policy version 2025D0126E.
Previous policy versions are retained in the policy history for reference. The 01/01/2026 entry documents the revision that added the inpatient admission restriction and notes that the prior version (2025D0126E) was archived; this is a non‑material archival reference for record keeping.
Recent clinical literature and trial reports cited in this policy include publications from 2020 through 2023 describing systemic delivery of micro‑dystrophin gene therapies and follow‑up results. Examples include the 2020 JAMA Neurology report of systemic rAAVrh74.MHCK7.micro‑dystrophin delivery and 2023 publications reporting expression and motor function outcomes up to 1–2 years post‑treatment. These references informed the assessment of benefit and the limits of evidence for specific age and functional subgroups.
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