Pharmacy Prior Authorization Criteria

Elevidys (delandistrogene moxeparvovec-rokl) - PA, NF

Indications for Prior Authorization

Elevidys (delandistrogene moxeparvovec-rokl)

• For diagnosis of Duchenne Muscular Dystrophy (DMD)
  Indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age: 1) For patients who are ambulatory and have a confirmed mutation in the DMD gene, and 2) For patients who are non-ambulatory and have a confirmed mutation in the DMD gene.

  The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of Elevidys micro-dystrophin (noted hereafter as “micro-dystrophin”) in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Elevidys

Prior Authorization, Non Formulary

Length of Approval: 1 Time Authorization in Lifetime
For diagnosis of Duchenne Muscular Dystrophy (DMD)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Duchenne Muscular Dystrophy (DMD)
AND
• Submission of medical records (e.g., chart notes) confirming a mutation in the DMD gene
AND
• Submission of medical records (e.g., chart notes) confirming a deletion in exon 8 or exon 9 in the DMD gene is not present
AND
• Patient is at least 4 years of age
AND
• Submission of medical records (e.g., chart notes) confirming patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
AND
• Both of the following:
• Prescribed by a neurologist with expertise in the treatment of DMD at an authorized treatment center with expertise in gene therapy
AND
• Submission of medical records (e.g., chart notes) confirming that prescriber completed a shared decision-making conversation regarding the potential risks of treatment with Elevidys, including but not limited to acute serious liver injury
AND
• Submission of medical records (e.g., chart notes) confirming Anti-AAVrh74 total binding antibody titers are less than 1:400
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting that patient will receive a corticosteroid regimen prior to and following the administration of Elevidys in line with the FDA-approved recommendations in the labeling
AND
• Provider attests that patient does not have preexisting liver impairment, chronic hepatic condition or acute liver disease
AND
• Submission of medical records (e.g., chart notes) documenting results of all of the following baseline laboratory values and provider attests that these laboratory values will be monitored after administration according to the FDA-approved recommendations in the labeling:
• Liver function [i.e., clinical exam, GGT (gamma-glutamyl transferase), total bilirubin]
• Platelet counts
• Troponin-I
AND
• Provider attests that liver function (clinical exam, GGT, and total bilirubin) will be monitored weekly for the first 3 months following Elevidys infusion and monitoring will be continued thereafter if clinically indicated as per FDA-approved recommendations in the labeling
AND
• Submission of medical records (e.g., chart notes) confirming patient has a left ventricular ejection fraction of greater than or equal to 40 percent (%)
AND
• Provider attests that patient does not have clinical signs or symptoms of infection
AND
• Provider attests that patient will not receive exon-skipping therapies for DMD [e.g., Amondys (casimersen), Exondys 51 (eteplirsen), Viltepso (viltolarsen), Vyondys 53 (golodirsen)] concomitantly or following Elevidys treatment [2]
AND
• Provider attests that patient has never received Elevidys treatment in their lifetime

P & T Revisions

2025-08-25, 2025-07-31, 2025-07-31, 2025-06-20, 2024-09-16, 2024-08-08, 2023-11-30, 2023-09-06

References

1. Elevidys Prescribing Information. Sarepta Therapeutics, Inc. Cambridge, MA. June 2024.
2. Per clinical consult with pediatric neurologist. August 29, 2023.

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Revision History

• 2025-08-25: Updates to clinical criteria and addition of submission of medical records requirement throughout. Combined formulary and non formulary criteria into one section.
• 2025-07-31: Updated prescriber req in NF criteria.
• 2025-07-31: Updated prescriber requirement in line with May P&T approved language for the medical policy.
• 2025-06-20: Added criteria "Patient is ambulatory".
• 2024-09-16: 2024 Annual Review. Removed "pediatric" from the prescriber requirement.
• 2024-08-08: Update to PA and NF criteria due to new FDA-expanded indication
• 2023-11-30: Added drug-specific NF criteria.
• 2023-09-06: New program

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