Last Review Date: 08/05/2025 Date of Origin: 07/05/2023

Dates Reviewed: 07/2023, 07/2024, 01/2025, 03/2025, 08/2025

1. Length of Authorization

Coverage will be provided for one dose and may not be renewed.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• • 1 billable unit for one dose

3. Initial Approval Criteria ^1-10

          regimen pre- and post- infusion (refer to the package insert for recommended corticosteroid dosing during therapy); AND

• • Patient troponin-I levels will be monitored at baseline and subsequently as clinically indicated;

AND

• • Patient will have baseline liver function assessed prior to and following therapy for at least 3 months and as indicated; AND
  • In patients with acute liver disease, treatment will NOT be initiated until liver disease is resolved or controlled (NOTE: Treatment with Elevidys should be carefully considered in patients with preexisting liver impairment or chronic hepatic viral infection. These patients may be at increased risk of acute serious liver injury)¹; AND
  • Patient has a confirmed mutation of the DMD gene; AND
  • Patient is receiving physical and/or occupational therapy or will initiate therapy; AND
  • Patient must have a baseline anti-AAVrh74 total binding antibody titer of < 1:400 as measured by ELISA (Note: An FDA authorized test for the detection of AAVrh74 total binding antibodies is not currently available. Currently available tests may vary in accuracy and design.); AND
  • Patient does NOT have any deletion in exon 8 and/or exon 9 in the DMD gene

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria
   • Duration of authorization has not been exceeded (refer to Section I).

5. Dosage/Administration 1

6. Billing Code/Availability Information

HCPCS code:

• • J1413 – Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose; 1 billable unit = 1 therapeutic dose

NDC(s):

Elevidys kit sizes:

7. References

1. Elevidys [package insert]. Cambridge, MA; Sarepta Therapeutics, Inc.; August 2024. Accessed February 2025.
2. Topaloglu H, Gloss D, Moxley RT 3^rd, et al. Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 Jul 12;87(2):238.
3. Bushby K, Finkel R, Birnkrant DJ, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and pharmacological and psychosocial management. Lancet Neurol; 2010 Jan; 9(1):77‑93.
4. Bushby K, Finkel R, Birnkrant DJ, et al. Diagnosis and management of Duchenne muscular dystrophy, part 2: implementation of multidisciplinary care. Lancet Neurol; 2010 Jan; 9(2):177- 189.
5. Birnkrant DJ, Bushby K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol 2018; 17:251.
6. Birnkrant DJ, Bushby K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 2: respiratory, cardiac, bone health, and orthopaedic management. Lancet Neurol 2018; 17:347.
7. Moxley RT 3rd, Ashwal S, Pandya S, et al. Practice parameter: corticosteroid treatment of Duchenne dystrophy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology

Society. Neurology. 2005;64:13–20.

8. Gordon LB, Brown WT, Collins FS. Hutchinson-Gilford Progeria Syndrome. GeneReviews. https://www.ncbi.nlm.nih.gov/books/NBK1121/ Last Revision: October 19, 2023 (Accessed on June December 317, 2024).
9. Scott E, Eagle M, Mayhew A, et al. Development of a Functional Assessment Scale for Ambulatory Boys with Duchenne Muscular Dystrophy. Physiother. Res. Int. 17 (2012) 101–109.
10. Mercuri E, Coratti G, Messina S. et al. Revised North Star Ambulatory Assessment for Young Boys with Duchenne Muscular Dystrophy. PLoS ONE, 2016 Aug 5;11(8): e0160195.