CurrentMississippi Division of MedicaidPolicy N/A

ELEVIDYS (delandistrogene moxeparvovec-rokl) prior authorization

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Prior authorization criteria for coverage of ELEVIDYS for treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) aged 4 years and older; applies to Mississippi Division of Medicaid members seeking coverage for ELEVIDYS.

Policy Summary

PayerMississippi Division of Medicaid

PolicyELEVIDYS (delandistrogene moxeparvovec-rokl) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit the Universal PA Form with supporting clinical documentation and meet all listed clinical and monitoring criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1dose per lifetime allowed

>=4minimum patient age

exons 18-58required mutation location

<1:400antibody titer requirement

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CurrentMississippi Division of MedicaidPolicy N/A

ELEVIDYS (delandistrogene moxeparvovec-rokl) prior authorization

Customize your policy alerts

Sign up for all Mississippi Division of Medicaid policy alerts

Know when Mississippi Division of Medicaid releases new policies or updates existing guidance.

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Policy Summary

PayerMississippi Division of Medicaid

PolicyELEVIDYS (delandistrogene moxeparvovec-rokl) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit the Universal PA Form with supporting clinical documentation and meet all listed clinical and monitoring criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1dose per lifetime allowed

>=4minimum patient age

exons 18-58required mutation location

<1:400antibody titer requirement

Coverage Criteria

Refer to the product package insert for the complete list of contraindications, warnings, and precautions. Patients who have any contraindication listed in the package insert are not eligible for ELEVIDYS under this policy.

Patients with preexisting liver impairment or an active hepatic viral infection are excluded from coverage. Preexisting liver impairment is defined as gamma‑glutamyl transferase (GGT) more than 2× the upper limit of normal or total bilirubin greater than the upper limit of normal not due to Gilbert's syndrome.

Initial Therapy

Initial therapy

Covered when ALL of the following are met

Core eligibility

Age: Patient is 4 years of age or older.
Diagnosis: Patient has been diagnosed with Duchenne muscular dystrophy (DMD).
Ambulatory status: Patient is ambulatory (able to walk without assistive devices and not wheelchair dependent).
Genetic mutation: Patient has a confirmed mutation of the DMD gene between exon 18 and exon 58, and the mutation is not a deletion in exon 8 and/or exon 9.
Antibody titer: Baseline anti-AAVrh74 total binding antibody titer measured by ELISA is less than 1:400.< 1:400
Therapy participation: Patient is receiving physical and/or occupational therapy.
Concomitant medications: Patient is not on concomitant DMD-directed antisense oligonucleotides (e.g., golodirsen, casimersen, viltolarsen, eteplirsen) and has not received one within the past 30 days.
Hepatic status: Patient does not have preexisting liver impairment (GGT > 2x ULN or total bilirubin > ULN not due to Gilbert's syndrome) or active hepatic viral infection.
Infection and vaccination: Patient has not had a recent vaccination within 4 weeks and does not have an active or recent (within 4 weeks) infection, including clinically important localized infections.
Corticosteroid use: Patient has been on a stable dose of a corticosteroid prior to start of therapy (unless contraindicated or intolerant) and will use a corticosteroid regimen pre- and post-infusion per the package insert.
Refer to package insert for dosing recommendations.
Monitoring & follow-up: Prescriber attests to monitoring troponin-I, platelet counts, and liver labs at specified frequencies (troponin-I: baseline, weekly for 1 month, then as clinically indicated; platelets: baseline, weekly for first 2 weeks, then as clinically indicated; liver labs: baseline, weekly for first 3 months, then as indicated) and to maintaining proximity to an appropriate healthcare facility for at least 2 months post-infusion.
Troponin-I: baseline, weekly for 1 month, then as needed; Platelets: baseline, weekly for first 2 weeks, then as needed; Liver labs: baseline, weekly for first 3 months, then as indicated.
Dose limitation: One single dose per lifetime; one kit based on patient weight.

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title': 'Initial therapy

ref': 'b0_0

Coding and Key Parameters

inv-04: Anti-AAVrh74 total binding antibody titer (ELISA) requirement

Required baseline titerAnti-AAVrh74 total binding antibody titer (ELISA) must be less than 1:400.

Assay methodMeasured by enzyme-linked immunosorbent assay (ELISA).

TimingMust be documented at baseline prior to infusion.

inv-05: Minimum age for coverage

Minimum agePatient must be 4 years of age or older.

Age verificationAge must be documented in the medical record and prior authorization submission.

Applies to

Provider Actions and Requirements

Prior Authorization

Prior authorization required — approval contingent on meeting all criteria

Prior authorization is required for ELEVIDYS. Approval will be considered only when all specified clinical criteria, monitoring, and administrative requirements in the policy are met.

Submit Universal PA Form with the request
Ensure all eligibility criteria (age, diagnosis, ambulatory status, eligible DMD mutation, antibody titer <1:400, absence of disqualifying hepatic disease or recent infection/vaccination, corticosteroid regimen, monitoring plan, and one lifetime dose limit) are documented

Step Therapy

Concomitant therapy restriction — no concurrent or recent antisense oligonucleotide therapy

Do not initiate ELEVIDYS if the patient is currently receiving DMD-directed antisense oligonucleotide therapy or received one within the past 30 days; concomitant use is disallowed.

Examples of DMD-directed antisense oligonucleotides include golodirsen, casimersen, viltolarsen, and eteplirsen

Step Therapy / Concurrent Therapy Rules

Step	Requirement
{"text":"1","status":""},{"text":"No concurrent use of DMD-directed antisense oligonucleotide therapy (e.g., golodirsen, casimersen, viltolarsen, eteplirsen).","status":""}
{"text":"1","status":""},{"text":"No receipt of a DMD-directed antisense oligonucleotide within the past 30 days prior to ELEVIDYS administration.","status":""}

Quantity Limits

inv-15: ELEVIDYS dose per lifetime allowed

Dose per lifetimeOne single dose per lifetime (one kit based on patient weight).

Quantity limit unitLimit applied as a single course / one kit per patient lifetime.

DocumentationPA request must reflect kit selection based on patient weight and single-dose limitation.

Site of Care Requirements

Note

Maintain proximity to healthcare facility for 2 months post‑infusion

Prescriber must attest that the patient will maintain proximity to an appropriate healthcare facility for at least 2 months following ELEVIDYS infusion.

Applicable site(s) of care: infusion center or hospital outpatient setting.

Definitions

inv-11: Ambulatory defined as able to walk without assistive devices and not wheelchair dependent

DefinitionAmbulatory = able to walk without assistive devices and not wheelchair dependent.

RelevancePatient must be ambulatory to meet core eligibility for ELEVIDYS.

AssessmentAmbulatory status should be documented in clinical notes at time of PA submission.

inv-12: Preexisting liver impairment — defined as GGT >2x ULN or total bilirubin >ULN not due to Gilbert's syndrome

DefinitionPreexisting liver impairment = GGT more than 2x the upper limit of normal (ULN) or total bilirubin more than the ULN not due to Gilbert's syndrome.

Exclusion implicationPatients with this defined preexisting liver impairment are ineligible for ELEVIDYS per policy.

Background

ELEVIDYS (delandistrogene moxeparvovec-rokl) is an adeno‑associated virus vector‑based gene therapy indicated for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) aged 4 years and older who have a confirmed eligible mutation of the DMD gene. The therapy is intended as a one‑time intravenous infusion (one dose per lifetime, one kit based on patient weight) and requires baseline and ongoing monitoring for immune response, liver function, cardiac markers, and hematologic parameters per policy prior to and following infusion.