CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Elevidys (delandistrogene moxeparvovec-rokl) — Clinical Documentation and Prior Authorization

Requirements for clinical documentation and prior authorization for Elevidys gene therapy for Duchenne muscular dystrophy (DMD) for Blue Cross Blue Shield of Massachusetts members and their providers.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyElevidys (delandistrogene moxeparvovec-rokl) — Clinical Documentation and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests for Elevidys using Authorization Manager (or fax for out-of-network) with appropriate servicing provider and facility NPIs and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1required specialist consultation

4-5 yrspatient age specified

≤1:400anti-AAVrh74 titer

≥12 wkscorticosteroid stability

J3590/J3490/C9399

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Coverage Criteria

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

DMD diagnosis and genetic criteria: Diagnosis of Duchenne muscular dystrophy (DMD) confirmed by or in consultation with a pediatric neuromuscular specialist, with a confirmed DMD gene mutation that is not a deletion in exon 8 and/or 9.

Prescriber and specialist: Elevidys is prescribed by or in consultation with a pediatric neuromuscular specialist in DMD.

Age: Patient is 4-5 years old.

Ambulatory status: Patient is ambulatory without need of assistive devices (for example: cane, walker, wheelchair, side-by-side assistance) as determined by medical records or physician attestation.

Anti-AAVrh74 antibody titer: Patient does not have an anti-AAVrh74 total binding antibody titer > 1:400 (i.e., titer ≤ 1:400 required).

Corticosteroid therapy: Patient is on a stable corticosteroid regimen defined as ≥ 12 weeks prior to screening and following infusion, OR corticosteroid therapy is not medically/clinically appropriate per managing provider.

Prior gene therapy: Patient has not previously received gene therapy with Elevidys in their lifetime.

Exon skipping therapies: Prescriber attests patient will not receive exon skipping therapies for DMD (for example: Amondys [casimersen], Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen]) concomitantly or following treatment with Elevidys.

Pre-infusion assessments: Prescriber will assess liver function, platelets, and troponin-I levels prior to Elevidys infusion.

Patients with a confirmed DMD gene mutation are eligible only when the mutation does NOT include a deletion in exon 8 and/or exon 9. The policy explicitly excludes patients with deletions in exon 8 and/or 9 from meeting the mutation criterion for Elevidys coverage. Additionally, the prescriber must attest that the patient will not receive exon skipping therapies (for example: Amondys, Exondys 51, Viltepso, Vyondys 53) concomitantly or following Elevidys, which further restricts concurrent or subsequent mutation-targeted exon-skipping treatment approaches.

If submitted documentation does not demonstrate that the patient meets all required criteria (including specialist confirmation of DMD and mutation details, ambulatory status, antibody titer, corticosteroid stability, and pre-infusion assessments), the request may be considered not medically necessary. In such cases, submit a letter of medical necessity with a request for a Clinical Exception (Individual Consideration) explaining why an exception is justified and providing supporting clinical evidence.

Providers must include clinical documentation that supports each medical necessity element for Elevidys: diagnosis by or in consultation with a pediatric neuromuscular specialist, confirmed DMD mutation (documenting absence of exon 8/9 deletions when applicable), antibody titer results, corticosteroid regimen details, ambulatory status, and pre-infusion laboratory assessments. Lack of required documentation can lead to denial; a detailed letter of medical necessity and request for exception is the pathway to request coverage when criteria are not met in the record.

Initial Therapy — Detailed Criteria

Initial therapy — Initial coverage requires meeting all criteria below

Initial coverage requires meeting all criteria below.

Specialist diagnosis: Diagnosis of DMD by or in consultation with a pediatric neuromuscular specialist with a confirmed DMD mutation not involving deletion of exon 8 or 9.

Age and ambulatory status: Patient age 4-5 years and ambulatory without assistive devices.

Antibody titer: Anti-AAVrh74 total binding antibody titer ≤ 1:400.

Corticosteroid requirement: Stable corticosteroid regimen ≥ 12 weeks prior to screening OR corticosteroids not clinically appropriate per managing provider.

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit initial authorization requests using Authorization Manager (available 24/7) to request authorizations, submit required clinical documentation, check case status, and view/print decision letters. For out-of-network providers, submit requests and required attachments by fax to 888-973-0726. When submitting via Authorization Manager, enter the servicing surgeon's NPI or provider ID (not the billing group) and the facility's NPI or provider ID for the service location.

Authorization Manager is the preferred submission method for initial requests and clinical documentation
Out-of-network provider requests and attachments: Fax to 888-973-0726
Ensure correct servicing provider NPI and facility NPI are entered in the request

Documentation Required

Required Clinical Documentation

Clinical documentation supporting each medical necessity criterion must be submitted with the prior authorization request. This includes demographics, diagnosis, relevant testing (e.g., DMD genetic testing, anti-AAVrh74 antibody titers, liver function, platelets, troponin-I), and specialist notes (pediatric neuromuscular specialist). Use the Complete Prior Authorization Request Form for Elevidys when available in Authorization Manager.

Billing and Coding

HCPCSHCPCS

J3590	Unclassified biologics
J3490	Unclassified drugs or biologicals
C9399	Unclassified drugs

HCPCS (listed)HCPCS

J3590	Unclassified biologics
J3490	Unclassified drugs or biologicals
C9399	Unclassified drugs

Anti-AAVrh74 antibody titer

ThresholdAnti-AAVrh74 total binding antibody titer ≤ 1:400

Measurement typeTotal binding antibody titer to AAVrh74

Eligibility impactTiter above 1:400 disqualifies patient from Elevidys per policy criteria

Corticosteroid stability

RequirementStable corticosteroid regimen ≥ 12 weeks prior to screening for Elevidys infusion (and continued following infusion)

Alternate allowanceIf corticosteroids are not medically/clinically appropriate, managing provider may document that in lieu of stability requirement

Definitions

Ambulatory (definition)

DefinitionAmbulatory = patient is ambulatory without need of assistive devices (for example: cane, walker, wheelchair, side-by-side assistance) as determined by medical records or physician attestation

AssessmentAmbulatory status must be documented in medical records or via physician attestation

Eligibility roleAmbulatory without assistive devices is required for Elevidys initial therapy coverage

Step Therapy / Attestations

Step	Requirement
1	Prescriber attests patient will not receive any exon skipping therapies for DMD (for example: Amondys [casimersen], Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen]) concomitantly or following treatment with Elevidys.

Place of Service Requirements

Billing Rule

Report place of service and include facility information on prior authorization

Report place of service (Outpatient or Inpatient) and include facility information and facility NPI on the prior authorization request.

Indicate Place of Service: Outpatient or Inpatient on the request form.
Provide facility name, address, phone/fax, and facility NPI.

Background

Elevidys (delandistrogene moxeparvovec-rokl) is a gene therapy indicated for Duchenne muscular dystrophy. Use for eligible patients must be coordinated with a pediatric neuromuscular specialist; the policy requires the diagnosis and treatment decision be made by or in consultation with a pediatric neuromuscular specialist in DMD. Before infusion, the prescriber is responsible for required pre-treatment assessments including anti-AAVrh74 antibody testing, liver function, platelet count, and troponin‑I, and for documenting corticosteroid management and ambulatory status as part of specialist-led care.