Elevidys (delandistrogene moxeparvovec-rokl) coverage and authorization
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Clinical coverage and utilization management rules for Elevidys gene therapy for Duchenne muscular dystrophy across multiple lines of business for Univera Healthcare; affects prescribers, infusion providers, and prior authorization reviewers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Commercial/Essential/Child Health Plus Coverage Stance
Commercial/Essential/Child Health Plus:
Refer to Corporate Medical Policy #11.01.03 Experimental or Investigational Services
MMC/HARP Initial Therapy
MMC/HARP Coverage Criteria — covered when ALL of the following are met:
Medicare Advantage Coverage
Medicare Advantage:
Prior Gene/Cell Therapy Exposure Exclusion
Not eligible when ANY of the following prior exposures are present
Retreatment or repeat administration with Elevidys or any other gene or cellular therapy is not authorized under this policy. The policy states that most gene and cellular therapies are designed and studied as one-time treatments and that repeat dosing, reinfusion, or sequential therapy has not been established as safe, effective, or clinically appropriate. Retreatment with the same product is considered experimental and investigational because clinical trials evaluated single administrations only and the safety, efficacy, and durability of a second administration have not been established. The policy also highlights increased risks such as immune activation, insertional mutagenesis, or vector immunity with repeat dosing.
Individuals with prior exposure to gene or cellular therapies are generally not eligible for additional gene or cellular therapy under this policy. The policy lists prior exposures that trigger ineligibility, including receipt of any autologous cellular therapy (e.g., CAR-T, TCR-T, TIL), any allogeneic genetically modified cellular therapy, any in vivo gene therapy (for example AAV or lentiviral vector), or any ex vivo gene‑modified cell product. The guidance further states that treatment with an additional or different gene/cellular therapy after prior exposure is considered experimental and investigational because anticipated clinical benefit, sequential safety, and justification for a second intervention have not been demonstrated.
For Commercial, Essential, and Child Health Plus lines of business, Elevidys (delandistrogene moxeparvovec-rokl) is considered not medically necessary. The policy rationale cites an assessment of peer-reviewed medical literature concluding that evidence is inconclusive regarding a definite positive effect on health outcomes, long-term improvement in outcomes, and effectiveness in standard clinical practice. Reviewers should refer to Corporate Medical Policy #11.01.03 (Experimental or Investigational Services) for related guidance.
Initial Therapy Criteria
MMC/HARP Initial Therapy
MMC/HARP Coverage Criteria — covered when ALL of the following are met:
Provider Actions and Requirements
MMC/HARP prior authorization requirements
Submit prior authorization for MMC/HARP members with documentation that the prescribing clinician is a DMD specialist or that the request is in consultation with a DMD specialist; confirm patient age (≥4 years at time of treatment); provide genetic testing confirming a DMD mutation between exons 18–58 (document absence of a deletion in exon 8 and/or 9 and that the mutation is not fully contained within exon 45); document ambulatory status with NSAA (score ≥1); provide baseline anti‑AAVrh74 total binding antibody result showing <1:400 by ELISA; document absence of clinical signs or symptoms of infection at administration; document stable corticosteroid use for ≥3 months prior or a documented reason not to be on corticosteroids; attest that Elevidys will not be given with exon‑skipping therapies; and confirm one‑time single‑dose IV administration (approval is provided for 3 months to allow administration).
- Prescriber: specialist in DMD or consultation with DMD specialist (chunk 9).
- Age: ≥4 years at treatment (chunk 9).
- Genetics: confirmed DMD mutation between exons 18–58; must NOT have deletion in exon 8 and/or 9; must NOT have mutation fully within exon 45 (chunk 9).
- Ambulatory: NSAA score ≥1 (chunk 9).
- Antibody titer: anti‑AAVrh74 total binding antibodies <1:400 by ELISA (chunk 9).
- Infection: no clinical signs/symptoms at time of administration (chunk 9).
- Corticosteroids: stable dose ≥3 months prior or documented reason not to be on steroids (chunk 9).
- Concomitant therapy: not authorized with exon‑skipping therapies (chunk 9).
- Dosing: one‑time single‑dose IV only; approval provided for 3 months to allow administration (chunks 10, 9).
Prior authorization and billing (HCPCS J1413)
Obtain prior authorization per this policy and bill Elevidys using HCPCS code J1413 (effective 1/1/2024); confirm coverage is subject to member contract and the policy's coverage criteria.
- Submit authorization request consistent with policy guidelines and contract-dependent coverage (chunk 12, 19).
- Use HCPCS J1413 for Elevidys (effective 1/1/2024) when billing (chunk 20).
Medicare Advantage coverage and potential step therapy
For Medicare Advantage members, follow applicable NCDs/LCDs (for example, LCD L33394) and any plan‑imposed step therapy in addition to LCD/NCD requirements; confirm the MAO's coverage determination when no NCD/LCD applies.
- Check LCD L33394 and other applicable Medicare coverage guidance on the CMS website (chunk 11).
- Be aware that MA plans may impose step therapy in addition to LCD/NCD criteria; follow plan/contract rules (chunk 12).
Sequencing and prior therapy considerations
Document prior therapy history and sequencing to identify exclusions — switching between autologous and allogeneic cellular therapies, sequential use of CAR‑T/TCR‑T/NK‑cell or other genetically engineered cell therapies, receiving a gene therapy after prior gene/cellular therapy exposure, or receiving an in vivo gene therapy after prior vector‑based therapy may affect eligibility.
- Provide complete history of any prior autologous or allogeneic genetically modified cellular therapies, CAR‑T/TCR‑T/TIL, NK‑cell therapies, or other gene/cellular therapies (chunk 18).
- Note that prior vector‑based or gene therapy exposures are relevant to coverage determinations and may preclude authorization (chunk 18).
Required supporting documentation
Include complete clinical documentation with each authorization request and any recertification: progress notes, prior treatment history, diagnostic and laboratory test results (including genetic testing and anti‑AAVrh74 ELISA), imaging, and objective/subjective measures of clinical benefit.
- Progress notes documenting prior treatments and treatment history (chunk 12).
- Diagnostic testing, laboratory results, genetic testing/biomarker results, and imaging (chunk 12).
- Objective or subjective measures of clinical benefit and any provider attestation required (chunk 12).
Reimbursement eligibility and documentation
Verify reimbursement eligibility against the member's subscriber contract and submit documentation per the contract and policy guidelines because codes and coverage may be contract‑dependent and not covered in all circumstances.
- Eligibility for reimbursement depends on benefits in the member's subscriber contract; codes may not be covered under all circumstances (chunk 19).
- Refer to policy guidelines and contract language for exclusions and coverage limitations (chunk 12).
Not medically necessary determination for Commercial/Essential/Child Health Plus
Recognize that for Commercial, Essential, and Child Health Plus lines of business Elevidys is considered not medically necessary based on inconclusive evidence; requests may be denied under these lines of business.
- Elevidys is labeled not medically necessary for Commercial/Essential/Child Health Plus because peer‑reviewed evidence is inconclusive regarding definitive health benefit (chunk 8).
- Refer to Corporate Medical Policy #11.01.03 for investigational/experimental determinations as applicable (chunk 8).
Prior gene/cell therapy exposure may trigger denial
Patients with prior exposure to autologous cellular therapy, allogeneic genetically modified cellular therapy, any in vivo gene therapy (e.g., AAV, lentiviral vector), or any ex vivo gene‑modified cell product are generally not eligible and authorization may be denied.
- Prior autologous cellular therapies (e.g., CAR‑T, TCR‑T, TIL) and prior allogeneic genetically modified cellular therapies are exclusionary (chunk 18).
- Any prior in vivo gene therapy (AAV, lentiviral) or ex vivo gene‑modified cell product may preclude eligibility (chunk 18).
Coding
| No codes listed |
| J1413 | Elevidys (Effective 1/1/2024) |
Step Therapy / Sequencing
| Medicare Advantage guidance | Details |
|---|---|
| Follow applicable NCD/LCD (e.g., LCD L33394) | Medicare reviews are to follow the Local Coverage Determination (LCD) for Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (L33394). |
| MAO may establish coverage when no NCD/LCD exists | In the absence of a Medicare NCD or LCD, a Medicare Advantage Organization (MAO) may establish its own coverage determinations per 42 CFR § 422.101(b)(6). |
| Plan-imposed step therapy may apply | Step therapy requirements may be imposed by the plan in addition to LCD/NCD requirements; utilization management is contract dependent and providers should refer to specific contract/benefit language. |
| Sequencing concern | Policy statement / impact on eligibility |
|---|---|
| Switching between autologous and allogeneic cellular therapies | Policy identifies switching between autologous and allogeneic cellular therapies as a sequencing concern relevant to eligibility determinations for additional gene/cellular therapies. |
| Sequential use of CAR-T, TCR-T, NK-cell or other genetically engineered cell therapies | Sequential administration of CAR-T, TCR-T, NK-cell therapies or other genetically engineered cell therapies is called out as a consideration when evaluating eligibility for subsequent gene/cellular therapies. |
| Receiving a gene therapy after prior gene or cellular therapy exposure | Receiving any gene therapy after previous gene or cellular therapy exposure is a listed sequencing concern and may render an individual generally not eligible for additional gene/cellular therapy. |
| Receiving an in vivo gene therapy following prior vector-based therapy | Administration of an in vivo gene therapy following any prior vector-based therapy is noted as a sequencing concern impacting eligibility and coverage decisions. |
| Prior gene/cell therapy exposure — general exclusion | An individual is generally not eligible for additional gene or cellular therapy if they have previously received any autologous cellular therapy, any allogeneic genetically modified cellular therapy, any in vivo gene therapy (e.g., AAV, lentiviral vector), or any ex vivo gene-modified cell product. |
Site of Care
Specify administration site: infusion center, hospital outpatient, office, or home (review required)
Document the requested site of care on the authorization; Elevidys is administered intravenously and may be covered under the medical benefit when given in an infusion center, hospital outpatient department, office, or home (home administration is subject to review).
- Specify site of infusion: infusion center, hospital outpatient, office, or home (subject to review)
- Note that site of care may affect approval timeframe and medical benefit coverage
Quantity Limits
Definitions
Background
Elevidys is an AAV vector–based in vivo gene therapy that delivers a micro-dystrophin transgene intended to treat Duchenne muscular dystrophy. The product was initially granted accelerated approval based on surrogate increases in micro-dystrophin expression, and regulatory action converted approval for ambulatory patients aged 4 years and older. Clinical trials demonstrated increased micro-dystrophin expression as a surrogate biomarker, but effects on primary functional endpoints were inconsistent or not statistically significant; safety concerns observed include liver injury and immune‑mediated myositis.
Revision History
Policy revised (document last review dated 2026-06-12).
Policy revised.
Policy revised.
Policy reviewed and approved by the P&T Committee.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
Policy created and implemented.
Policy reviewed and approved by the P&T Committee.
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