Delandistrogene moxeparvovec (Elevidys) — Coverage Criteria for Duchenne muscular dystrophy
Customize your policy alerts
Sign up for all Community-Care policy alerts
Know when Community-Care releases new policies or updates existing guidance.
Monitor payer policy activity
This medical benefit medication utilization policy defines coverage criteria, quantity limits, and authorization period for delandistrogene moxeparvovec (Elevidys) for members with Duchenne muscular dystrophy (DMD). It applies to providers seeking prior authorization for this therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria for delandistrogene moxeparvovec (Elevidys)
Initial Therapy
Covered when ALL of the following are met for initial approval:
Coverage is not allowed for patients whose DMD gene mutation is a deletion involving exon 8 and/or exon 9. Genetic testing documentation must confirm the specific DMD mutation and demonstrate that the mutation is not a deletion in exon 8 and/or exon 9 to meet eligibility for delandistrogene moxeparvovec (Elevidys).
Treatment with delandistrogene moxeparvovec (Elevidys) is not indicated when the coverage criteria are not met. Common reasons for denial include: anti-AAVrh74 total binding antibody titers ≥ 1:400, patient age < 4 years, documented non-ambulatory status or requirement for an assistive device, prior treatment with delandistrogene moxeparvovec, or failure to discontinue or plan to continue exon-skipping therapies prior to gene therapy.
Coding and Laboratory Thresholds
| J1413 | Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose |
Provider Actions, Documentation, and Authorization
Prior Authorization Required
Prior authorization is required before Elevidys (delandistrogene moxeparvovec) will be covered. Submit clinical documentation demonstrating the member meets all coverage criteria (diagnosis, genetic testing, antibody titers, age, ambulatory status, prior treatment history, and specialist involvement) as part of the authorization request.
- Submit genetic testing confirming a DMD gene mutation and that the mutation is not a deletion in exon 8 and/or exon 9.
- Provide anti-AAVrh74 total binding antibody titer results showing <1:400.
- Document patient age (must be ≥ 4 years) and that treatment is prescribed by, or in consultation with, a neurologist.
- Include confirmation (medical records or chart notes) that the member is ambulatory without an assistive device.
- Document that the member has not previously received delandistrogene moxeparvovec.
- List any current exon-skipping therapies and confirm planned discontinuation prior to Elevidys administration.
Triggers for Denial
Requests will be denied when required coverage criteria or documentation are missing, or when specific exclusion conditions apply.
- Missing or incomplete prior authorization request or lacking required documentation (genetic testing, antibody titer, neurologist involvement, ambulatory confirmation, prior treatment history).
- Anti-AAVrh74 total binding antibody titer ≥ 1:400.
- Patient younger than 4 years of age at time of request.
- Genetic testing shows a deletion in exon 8 and/or exon 9 of the DMD gene.
- Member has previously been treated with delandistrogene moxeparvovec.
- Exon-skipping therapies are not discontinued prior to planned Elevidys treatment or are planned to be re-initiated after Elevidys.
Definitions and Key Clinical Terms
Background
Duchenne muscular dystrophy (DMD) is a genetic neuromuscular disorder caused by mutations in the DMD gene. Delandistrogene moxeparvovec (Elevidys) is a single-dose gene therapy intended for eligible ambulatory patients with DMD who meet specific genetic and immunologic criteria, including a DMD mutation that is not a deletion in exon 8 and/or exon 9 and an anti-AAVrh74 total binding antibody titer < 1:400. Additional requirements for treatment include age ≥ 4 years, prescription by or consultation with a neurologist, no prior exposure to delandistrogene moxeparvovec, and discontinuation of exon-skipping therapies before treatment.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.