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Elevidys® (delandistrogene moxeparvovec-rokl)

Policy Number: PH-0713

Intravenous

Last Review Date: 07/02/2024

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023, 07/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

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

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • 1 kit (based on weight chart below)
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 1 therapeutic dose (up to 70 vials [700 mL] based on weight chart below)
  1. Initial Approval Criteria 1-11

Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation related to diagnosis, step therapy, and clinical markers (i.e., genetic, and mutational testing) supporting initiation when applicable.  Please provide documentation via direct upload through the PA web portal or by fax.

Coverage is provided in the following conditions:

Duchenne Muscular Dystrophy (DMD) † Ф 1-11

  • Patient is at least 4 years of age; AND
  • Patient is not on concomitant therapy with DMD-directed antisense oligonucleotides (e.g., golodirsen, casimersen, viltolarsen, eteplirsen, etc.); AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Stable steroid regimen, unless not medically/clinically appropriate as per treating providers recommendations, and will be used concomitantly with a corticosteroid 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
  • Patient has a confirmed mutation of the DMD gene; AND
  • Patient is receiving physical and/or occupational therapy, or will be initiating 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

  1. Renewal Criteria

Coverage cannot be renewed.

  1. Dosage/Administration

Indication

Dose

Duchenne Muscular Dystrophy
  • For patients weighing less than 70 kg, the recommended dose is 1.33 × 1014 vector genomes per kilogram (vg/kg) of body weight (or 10 mL/kg body weight)

  • For patients weighing 70 kg or greater, the recommended dose is 9.31 × 1015 vector genomes (equal to 700mL/70 vials) as a total fixed dose*

Calculate the dose for patients weighing less than 70 kg as follows:

Elevidys dose (in mL) = patient body weight (in kilogram) x 10

The multiplication factor 10 represents the per kilogram dose (1.33 × 1014 vg/kg) divided by the amount of vector genome copies per mL of the Elevidys suspension (1.33 × 1013 vg/mL).

Number of vials needed = Elevidys dose (in mL) divided by 10 (round to the nearest number of vials).

*Note: There is limited safety data available in non-ambulatory patients weighing 70 kg or greater, who received the maximum dose of ELEVIDYS, 9.31 × 1015 vg, in clinical trials
  • Immune responses to the AAVrh74 vector can occur after administration of Elevidys. To reduce the risk associated with an immune response, corticosteroids should be administered starting 1 day prior to Elevidys infusion. Initiate a corticosteroid regimen following the appropriate schedule. This regimen is recommended for a minimum of 60 days after the infusion unless earlier tapering is clinically indicated. See the PI for the recommended corticosteroid regimen dose modification for patients with liver function abnormalities following Elevidys infusion. If acute serious liver injury is suspected, a consultation with a specialist is recommended.
  • For patients previously taking corticosteroids at baseline, taper off the additional peri-Elevidys corticosteroids (back to baseline corticosteroid dose) over 2 weeks, or longer as needed. For patients not previously taking corticosteroids at baseline, taper the added peri-Elevidys corticosteroids off (back to no corticosteroids) over 4 weeks, or longer, as needed, and the corticosteroids should not be stopped abruptly.
  • Elevidys is shipped frozen at ≤ -60 °C. Elevidys can be refrigerated but must be used within 14 days of receipt.DO NOT RE-FREEZE.
  • Elevidys is an adeno-associated virus vector-based gene therapy. Follow precautions for viral vector shedding for one month after the infusion.
  • For single-dose intravenous infusion only.
  1. Billing Code/Availability Information

HCPCS code:

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

NDC:

Elevidys kit sizes:

Patient Weight (kg)

Total Vials (and mL) per Kit

NDC

Patient Weight (kg)

Total Vials (and mL) per Kit

NDC

10.0 – 10.4

10 (100)

60923-0501-10

40.5 – 41.4

41 (410)

60923-0532-41

10.5 – 11.4

11 (110)

60923-0502-11

41.5 – 42.4

42 (420)

60923-0533-42

11.5 – 12.4

12 (120)

60923-0503-12

42.5 – 43.4

43 (430)

60923-0534-43

12.5 – 13.4

13 (130)

60923-0504-13

43.5 – 44.4

44 (440)

60923-0535-44

13.5 – 14.4

14 (140)

60923-0505-14

44.5 – 45.4

45 (450)

60923-0536-45

14.5 – 15.4

15 (150)

60923-0506-15

45.5 – 46.4

46 (460)

60923-0537-46

15.5 – 16.4

16 (160)

60923-0507-16

46.5 – 47.4

47 (470)

60923-0538-47

16.5 – 17.4

17 (170)

60923-0508-17

47.5 – 48.4

48 (480)

60923-0539-48

17.5 – 18.4

18 (180)

60923-0509-18

48.5 – 49.4

49 (490)

60923-0540-49

18.5 – 19.4

19 (190)

60923-0510-19

49.5 – 50.4

50 (500)

60923-0541-50

19.5 – 20.4

20 (200)

60923-0511-20

50.5 – 51.4

51 (510)

60923-0542-51

20.5 – 21.4

21 (210)

60923-0512-21

51.5 – 52.4

52 (520)

60923-0543-52

21.5 – 22.4

22 (220)

60923-0513-22

52.5 – 53.4

53 (530)

60923-0544-53

22.5 – 23.4

23 (230)

60923-0514-23

53.5 – 54.4

54 (540)

60923-0545-54

23.5 – 24.4

24 (240)

60923-0515-24

54.5 – 55.4

55 (550)

60923-0546-55

24.5 – 25.4

25 (250)

60923-0516-25

55.5 – 56.4

56 (560)

60923-0547-56

25.5 – 26.4

26 (260)

60923-0517-26

56.5 – 57.4

57 (570)

60923-0548-57

26.5 – 27.4

27 (270)

60923-0518-27

57.5 – 58.4

58 (580)

60923-0549-58

27.5 – 28.4

28 (280)

60923-0519-28

58.5 – 59.4

59 (590)

60923-0550-59

28.5 – 29.4

29 (290)

60923-0520-29

59.5 – 60.4

60 (600)

60923-0551-60

29.5 – 30.4

30 (300)

60923-0521-30

60.5 – 61.4

61 (610)

60923-0552-61

30.5 – 31.4

31 (310)

60923-0522-31

61.5 – 62.4

62 (620)

60923-0553-62

31.5 – 32.4

32 (320)

60923-0523-32

62.5 – 63.4

63 (630)

60923-0554-63

32.5 – 33.4

33 (330)

60923-0524-33

63.5 – 64.4

64 (640)

60923-0555-64

33.5 – 34.4

34 (340)

60923-0525-34

64.5 – 65.4

65 (650)

60923-0556-65

34.5 – 35.4

35 (350)

60923-0526-35

65.5 – 66.4

66 (660)

60923-0557-66

35.5 – 36.4

36 (360)

60923-0527-36

66.5 – 67.4

67 (670)

60923-0558-67

36.5 – 37.4

37 (370)

60923-0528-37

67.5 – 68.4

68 (680)

60923-0559-68

37.5 – 38.4

38 (380)

60923-0529-38

68.5 – 69.4

69 (690)

60923-0560-69

38.5 – 39.4

39 (390)

60923-0530-39

≥ 69.5

70 (700)

60923-0561-70

39.5 – 40.4

40 (400)

60923-0531-40

The total number of vials in each kit corresponds to the dosing requirement for the individual patient, based on the patient’s body weight. Each kit includes a specified number of Elevidys vials (with a minimum of 10 vials for a patient with 10.0 – 10.4 kg body weight range, and a maximum of 70 vials for a patient with body weight of 69.5 kg and above).
  1. References
  1. Elevidys [package insert]. Cambridge, MA; Sarepta Therapeutics, Inc.; June 2024. Accessed June 2024.
  2. Topaloglu H, Gloss D, Moxley RT 3rd, 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 17, 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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

G71.01

Duchenne or Becker muscular dystrophy

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC