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

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

• Diagnosis of Duchenne Muscular Dystrophy (DMD)
AND
• Mutation in the DMD gene has been confirmed
AND
• No deletion in exon 8 or exon 9 in the DMD gene is present
AND
• Patient is at least 4 years of age
AND
• Anti-AAVrh74 total binding antibody titers are less than 1:400
AND
• 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 all of the following laboratory values have been checked prior to therapy and will be monitored after administration according to the FDA-approved recommendations in the labeling:
• Liver function (i.e., clinical exam, GGT, total bilirubin)
• Platelet counts
• Troponin-I
AND
• Patient has a left ventricular ejection fraction of greater than or equal to 40 percent (%)
AND
• Patient does not have clinical signs or symptoms of infection
AND
• 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
• Prescribed by a neurologist with expertise in the treatment of DMD at an authorized treatment center with expertise in gene therapy
AND
• Patient has never received Elevidys treatment in their lifetime

Elevidys

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 mutation in the DMD gene
AND
• No deletion in exon 8 or exon 9 in the DMD gene is present
AND
• Patient is at least 4 years of age
AND
• Anti-AAVrh74 total binding antibody titers are less than 1:400
AND
• 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
• Submission of medical records (e.g., chart notes) documenting that all of the following laboratory values have been checked prior to therapy and will be monitored after administration according to the FDA-approved recommendations in the labeling:
• Liver function (i.e., clinical exam, GGT, total bilirubin)
• Platelet counts
• Troponin-I
AND
• Patient has a left ventricular ejection fraction of greater than or equal to 40%
AND
• Patient does not have clinical signs or symptoms of infection
AND
• 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
• Prescribed by a neurologist with expertise in the treatment of DMD at an authorized treatment center with expertise in gene therapy
AND
• Patient has never received Elevidys treatment in their lifetime

P & T Revisions

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

• 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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