CurrentEmblemHealthPolicy MG.MM.PH.393

Elevidys (delandistrogene moxeparvovec-rokl) Intravenous

This policy governs coverage for Elevidys gene therapy for pediatric patients with Duchenne muscular dystrophy and outlines EmblemHealth's medical necessity and coding positions for payers and providers.

Policy Summary

PayerEmblemHealth

PolicyElevidys (delandistrogene moxeparvovec-rokl) Intravenous

Policy CodePolicy MG.MM.PH.393

Change TypeAnnual review — no criteria changes

Effective Date

Next Review DateMar 27, 2025

Key ActionSubmit clinical evidence with the prior authorization request so EmblemHealth can properly review coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

Ages 4-5Label age

NumerousNDCs listed

Duchenne/BeckerDiagnosis

3/27/2025Last revision

Coverage Determination

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Not covered

Coverage determination

Primary coverage stance: EmblemHealth will not cover Elevidys due to lack of conclusive evidence confirming clinical efficacy.

Policy statement from EmblemHealth.

EmblemHealth will not cover Elevidys. The policy exclusion is based on the payer’s determination that the available evidence is insufficient to confirm clinical efficacy for Elevidys; therefore the product is excluded from coverage under this policy.

Elevidys is not covered by EmblemHealth because there is a lack of conclusive evidence confirming clinical efficacy; coverage is denied despite the manufacturer indication.

Billing and Coding

Applicable Procedure Codesmixed

No codes listed

Applicable NDCsNDC

60923-0501-10	ELEVIDYS 10-10.4 KG (10ML X10)
60923-0502-11	ELEVIDYS 10.5-11.4 KG (10ML X11)
60923-0503-12	ELEVIDYS 11.5-12.4 KG (10ML X12)
60923-0504-13	ELEVIDYS 12.5-13.4 KG (10ML X13)
60923-0505-14	ELEVIDYS 13.5-14.4 KG (10ML X14)
60923-0506-15	ELEVIDYS 14.5-15.4 KG (10ML X15)
60923-0507-16	ELEVIDYS 15.5-16.4 KG (10ML X16)
60923-0508-17	ELEVIDYS 16.5-17.4 KG (10ML X17)
60923-0509-18	ELEVIDYS 17.5-18.4 KG (10ML X18)
60923-0510-19	ELEVIDYS 18.5-19.4 KG (10ML X19)

1–10 of 59

1/6

ICD-10 DiagnosesICD-10

671.01

Duchenne or Becker muscular dystrophy

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must submit a request for prior authorization and include the necessary clinical documentation to support that the member meets the policy criteria. EmblemHealth will review submitted clinical evidence to determine medical necessity prior to coverage.

Affected services: Elevidys — no coverage due to lack of conclusive efficacy evidence
Include all relevant clinical records, test results, prior treatments, and treating physician/PCP rationale

Step Therapy

No step therapy changes were made in the most recent annual review. There are no step-therapy overrides or alternative step requirements documented in the current policy revision.

Documentation Required

Required Clinical Documentation

The treating physician or primary care provider must submit clinical evidence to support that the member meets the criteria for the requested treatment or procedure. This documentation should be submitted with the authorization request and include pertinent clinical notes, diagnostic testing, prior therapies and response to treatment.

Denial Risk

Documentation Requirement and Denial Risk

Failure to submit the required clinical evidence may prevent EmblemHealth from properly reviewing the request and can lead to denial of the authorization or post-payment denial upon review. Providers should ensure timely and complete submission of all requested records to avoid claim delay or denial.

Incomplete or missing documentation may result in denial
Providers may be asked to provide additional information during review

Product Definition

Elevidys — components and mechanism

VectorAAVrh74 adeno-associated virus vector that delivers the micro-dystrophin transgene to muscle cells

PromoterMHCKZ promoter that drives selective gene expression in muscle cells

TransgeneMicro-dystrophin–encoding gene that produces a shortened dystrophin protein expressed in muscle cells

Indicated population (manufacturer labeling)Ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy and a confirmed DMD mutation

Protein localizationMicro-dystrophin has been demonstrated to localize to the sarcolemma

Initial Therapy

Initial therapy — manufacturer indication vs payer coverage

Manufacturer indication vs payer coverage

Manufacturer indication: Indicated for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed DMD mutation.

From manufacturer labeling: Elevidys is comprised of an AAVrh74 vector, the MHCKZ promoter, and a micro-dystrophin transgene; micro-dystrophin localizes to the sarcolemma.

Payer coverage position: EmblemHealth will not cover Elevidys due to lack of conclusive evidence confirming clinical efficacy.

Coverage position overrides manufacturer indication for this payer.

Step	Step therapy requirement	Change during most recent annual review
1
No step therapy criteria documented.
No step therapy criteria changes documented in the most recent annual review (Annual Review: no criteria changes).