CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Delandistrogene moxeparvovec-rokl (Elevidys) — Coverage Criteria

This policy governs prior authorization, medical necessity criteria, and coverage limits for Elevidys gene therapy to treat Duchenne muscular dystrophy (DMD) for Blue Cross Blue Shield of Massachusetts members across commercial and Medicare product lines.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyDelandistrogene moxeparvovec-rokl (Elevidys) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNew policyadministrative clarification

Effective DateAug 9, 2023

Next Review DateN/A

Key ActionSubmit prior authorization requests through Authorization Manager using the Elevidys Prior Authorization Request Form (025).

SourceLink

POLICY UPDATE CHANGES

New medical policy describing medically necessary and investigational indications: Effective 8/9/2023.

Policy clarified to include prior authorization requests using Authorization Manager.

<1:400Eligibility antibody titer

one lifetimeTreatment limit

180 daysAuthorization length

1.33e14 vg/kgStudy dose (ddPCR)

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Coverage and Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Elevidys medical necessity criteria: 1) Diagnosis of Duchenne muscular dystrophy (DMD) confirmed by or in consultation with a pediatric neuromuscular specialist; 2) Confirmed pathogenic mutation in the DMD gene; 3) Mutation is not a deletion of exon 8 or exon 9; 4) Patient age 4 to 5 years old; 5) Patient is ambulatory without need for assistive devices (e.g., cane, walker, wheelchair) as documented in medical records or by physician attestation; 6) Anti-AAVrh74 total binding antibody titer < 1:400; 7) Patient is on a stable corticosteroid regimen for >= 12 weeks prior to screening (or corticosteroid therapy is not medically appropriate per the managing provider); 8) Prescriber attestation that the patient will not receive exon‑skipping therapies concomitantly or following Elevidys (examples: Amondys 45/casimersen, Exondys 51/eteplirsen, Viltepso/viltolarsen, Vyondys 53/golodirsen); 9) No prior receipt of Elevidys gene therapy (one lifetime treatment only); 10) Prescriber will assess liver function tests, platelets, and troponin‑I levels prior to infusion.

These items reflect the policy's enumerated conditions for initial coverage.

Use of delandistrogene moxeparvovec-rokl (Elevidys) that does not meet the medical necessity criteria in this policy is considered experimental/investigational and non-covered. Authorization is limited to one lifetime treatment, and the length of authorization is up to 180 days from date of approval or until the member reaches 6 years of age, whichever comes first. The safety and effectiveness of repeat administration have not been evaluated; therefore repeat treatment is not covered.

Prior authorization for Elevidys must be submitted using Authorization Manager as described in the policy history clarifications; failure to follow the prior authorization submission process may result in administrative denial. Additionally, if clinical or administrative requirements in this policy are not met (including antibody titer, age/ambulatory status, or prescriber attestation requirements), the use of Elevidys is considered investigational and non-covered.

Repeat administration of delandistrogene moxeparvovec-rokl is considered investigational and not medically necessary because safety and effectiveness of repeat dosing have not been established in the published literature; coverage is therefore limited to a single lifetime therapeutic dose.

No additional coverage criteria or exclusions are specified beyond those detailed in this policy and its history. Any administrative updates to submission processes (for example, use of Authorization Manager) are documented in the policy history and should be followed by providers.

Coding and Diagnostic Requirements

HCPCS CodesHCPCS

J1413	Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose (Elevidys)
J3590	Unclassified biologics
J3490	Unclassified drugs
C9399	Unclassified drugs or biologicals

ICD-10 Diagnosis CodeICD-10

G71.01

Duchenne or Becker muscular dystrophy

inv-08: Anti-AAVrh74 total binding antibody titer — eligibility threshold

Eligibility thresholdAnti-AAVrh74 total binding antibody titer < 1:400

Measurement method referencedInvestigational total binding antibody ELISA used in studies

Clinical contextBaseline anti-AAVrh74 antibody titers <1:400 required in pivotal studies

inv-09: ddPCR dose — specified dose value

Specified dose (ddPCR)1.33 x 10^14 vg/kg

Dose contextMinimum recommended dose and dose administered to all patients in reported studies

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Elevidys (delandistrogene moxeparvovec-rokl) for applicable Commercial and Medicare products. Authorization is required prior to the procedure for outpatient services described in this policy and when the procedure is performed inpatient. For commercial members, requests must meet medical policy guidelines.

Commercial Managed Care (HMO and POS): Prior authorization is required
Commercial PPO and Indemnity: Prior authorization is required
Medicare HMO Blue: Prior authorization required where noted
Medicare PPO Blue: Prior authorization is required

Prior Authorization

How to Request Prior Authorization

Submit initial authorization requests and any supporting clinical documentation via Authorization Manager (available 24/7). Authorization Manager is the preferred and quickest method to: review authorization requirements, request authorizations, submit clinical documentation, check case status, and view/print the decision letter. Out-of-network providers should fax requests to 888-973-0726 if needed.

Clinical Background

Duchenne muscular dystrophy (DMD) is an X-linked, progressive neuromuscular disorder caused by mutations in the DMD gene that result in near absence of dystrophin and progressive muscle weakness, typically presenting in early childhood. Elevidys is an AAV-based gene therapy that delivers a truncated micro-dystrophin transgene designed to increase dystrophin expression; because of AAV payload constraints the transgene encodes a shortened but functional form of dystrophin (micro-dystrophin) and is administered at a high vector dose measured in vector genomes per kilogram.

Key Definitions and Terms

inv-19: Definition — micro-dystrophin (shortened dystrophin protein)

DefinitionMicro-dystrophin is a shortened dystrophin protein produced from a truncated transgene used in gene therapy (approximately 138 kDa) that contains selected domains of normal dystrophin.

Reason for useUsed because the full dystrophin gene is too large to package into AAV vectors; micro-dystrophin is sized (~3.5-4 kb) for AAV delivery.

Functional noteDesigned to function like normal dystrophin but requires high dose delivery due to smaller size.

inv-20: Definition — micro-dystrophin expression

DefinitionMicro-dystrophin expression = measurable increase in micro-dystrophin protein in skeletal muscle after Elevidys administration, assessed in studies (e.g., Week 12 changes reported).

Measurement site

Initial Coverage Requirements

Initial therapy — initial coverage requirements for Elevidys

Initial coverage requirements for Elevidys

Initial Elevidys requirements: Prescribed by or in consultation with a pediatric neuromuscular DMD specialist; confirmed DMD gene mutation (not deletion of exon 8 or 9); patient aged 4 to 5 years and ambulatory without assistive devices; anti‑AAVrh74 total binding antibody titer <1:400; stable corticosteroid regimen for >=12 weeks prior to screening (or corticosteroid not medically appropriate); prescriber will assess liver function, platelets, and troponin‑I prior to infusion; prescriber attestation to avoid exon‑skipping therapies concomitantly or after Elevidys; no prior Elevidys therapy; authorization limited to one lifetime treatment; minimum recommended dose 1.33 x 10^14 vg/kg per policy guidelines.Dose: minimum 1.33 x 10^14 vg/kg per lifetime

Length of authorization: 180 days from approval or up to age 6, whichever comes first.

Study dosing and biomarker response — study dose and Week 12 biomarker response criteria

Study dosing and early biomarker response (Week 12)

Step Therapy / Treatment Sequencing

Step	Requirement	Provider attestation / action
1
Prescriber must attest the patient will not receive exon-skipping therapies concomitantly or following Elevidys (examples: Amondys 45, Exondys 51, Viltepso, Vyondys 53).
Attest in the medical record and on the authorization request that exon‑skipping therapies will not be administered concurrently with or after Elevidys; documentation must be available to support the attestation.

Step	Requirement	Provider attestation / action
1
No step therapy requirements specified in these sections.
If applicable, follow any updated prior authorization procedures (see policy history and Authorization Manager guidance).

Quantity Limits and Dosing

inv-26: delandistrogene moxeparvovec-rokl (Elevidys) — one therapeutic dose (quantity limit)

Quantity limitOne therapeutic dose per lifetime (injection)

Authorization lengthAuthorization limited to 180 days from approval or up to 6 years of age, whichever comes first.

RationaleSafety and effectiveness of repeat administration have not been evaluated; repeat treatment considered investigational and non-covered.

Site of Care and Monitoring Requirements

Billing Rule

Infusion center: preauthorization and laboratory monitoring schedule

Preauthorization is required for infusion‑center administration; monitor liver function before infusion and weekly for the first 3 months post‑infusion, and monitor troponin‑I before infusion and weekly for the first month.

Weekly liver function tests for first 3 months post infusion (continue until unremarkable).
Weekly troponin‑I monitoring for the first month post infusion; consult specialist if acute liver injury suspected.

Note

Hospital outpatient: biopsy site and systemic administration details

Muscle biopsy specimens for micro‑dystrophin expression were obtained from the gastrocnemius in studies; Elevidys is administered systemically at the reported ddPCR dose used in trials.