CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Delandistrogene moxeparvovec-rokl (Elevidys) — Coverage Criteria

This policy states the coverage stance for the gene therapy delandistrogene moxeparvovec-rokl (Elevidys) for treatment of Duchenne muscular dystrophy (DMD) for BCBSRI members across Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDelandistrogene moxeparvovec-rokl (Elevidys) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not expect coverage: therapy is considered not covered for Medicare Advantage and not medically necessary for Commercial products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance for Elevidys

FDA approved Jun 2024Regulatory status

J1413Not covered code

2 RCTs + 1 cohortClinical evidence

Coverage Determination and Criteria

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Overall coverage determination

Covered when ALL of the following are met:

Policy stance: Delandistrogene moxeparvovec-rokl is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for all indications including treatment of Duchenne muscular dystrophy.

Policy cites insufficient evidence of improvement in net health outcome.

All uses of delandistrogene moxeparvovec-rokl (Elevidys) are excluded (not covered) for Medicare Advantage Plans. The policy designates HCPCS code J1413 (Elevidys; per therapeutic dose) as not covered for Medicare Advantage members. Prior to 1/1/2024, unlisted codes C9399 or J3590 were used for billing, but the service remains not covered under Medicare Advantage.

For Commercial products, delandistrogene moxeparvovec-rokl (Elevidys) is considered not medically necessary. The policy states the evidence is insufficient to demonstrate an improvement in net health outcome; the randomized controlled trials failed to show statistically significant benefit on the primary efficacy endpoint (NSAA total score) and supportive post-hoc or secondary analyses are inconclusive and of uncertain clinical significance.

Provider Billing and Authorization Actions

Prior Authorization

Prior authorization not applicable — therapy not covered/not medically necessary

Prior authorization is not applicable for delandistrogene moxeparvovec-rokl (Elevidys); however, the policy states the therapy is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for all indications.

Step Therapy

No step therapy specified; therapy not covered/not medically necessary

No step therapy requirements are specified in this policy; the therapy is designated not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Billing Rule

Billing code and documentation when submitting a claim

If billed, use HCPCS code J1413 — Elevidys; Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose (new code effective 1/1/2024). For dates of service prior to 1/1/2024, unlisted HCPCS codes C9399 or J3590 were used.

Report J1413 for Elevidys per therapeutic dose (effective 1/1/2024).
For services before 1/1/2024, report C9399 or J3590 as applicable.

Denial Risk

Denial risk for claims billed with J1413

Claims for delandistrogene moxeparvovec-rokl (HCPCS J1413) are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products and are therefore subject to denial.

J1413 is listed as not covered/not medically necessary in the policy coding section.

Clinical Background

Duchenne muscular dystrophy (DMD) is an X-linked inherited disorder caused by variants in the DMD gene that lead to absent or nonfunctional dystrophin, resulting in progressive muscle degeneration, loss of independent ambulation in childhood, and cardiopulmonary complications. Delandistrogene moxeparvovec-rokl is an adeno-associated virus vector–based gene therapy that encodes an engineered micro-dystrophin protein intended to slow or stabilize disease progression, but current trial data have not demonstrated clear clinical benefit on key functional endpoints.

Definitions

delandistrogene moxeparvovec-rokl (Elevidys) — description and regulatory note

MechanismAdeno-associated virus (AAV) vector–based gene therapy encoding an engineered micro‑dystrophin protein (138 kDa) intended to replace/express a shortened functional dystrophin in muscle tissue.

Manufacturer / Brand nameElevidys (delandistrogene moxeparvovec-rokl).

Regulatory status (key note)FDA approved June 2023 for ambulatory pediatric patients aged 4–5 years with DMD (accelerated approval); FDA expanded approval June 2024 for ambulatory and non‑ambulatory individuals ≥4 years — traditional approval for ambulatory ≥4 years and accelerated approval for non‑ambulatory ≥4 years.

Intended clinical effectIntended to slow or stabilize progression of Duchenne muscular dystrophy and alter disease trajectory toward a milder, Becker‑like phenotype.

Basis for initial approvalAccelerated approval was based on expression of micro‑dystrophin in skeletal muscle observed in treated patients; continued approval may be contingent on confirmatory trials.

Duchenne muscular dystrophy (DMD) — definition and clinical course

DefinitionDuchenne muscular dystrophy (DMD) is an X‑linked inherited disorder caused by nonsense or frameshifting variants in the DMD gene leading to absent or nonfunctional dystrophin and progressive muscle weakness and loss of muscle mass, primarily affecting males.

Clinical courseProgressive muscle degeneration with loss of independent ambulation (typically in childhood) and development of respiratory and cardiac complications.

Genetic diagnosisDefinitive diagnosis requires genetic testing to identify DMD gene variant(s); absence of dystrophin protein by muscle biopsy does not replace genetic confirmation.

Epidemiology / variantsThere are over 4,700 reported DMD gene variants (Leiden database), with most common variants concentrated between exons 45 and 53.