Last Review Date: 01/04/2024

Date of Origin: 06/01/2023

Dates Reviewed: 06/2023, 01/2024

1. Length of Authorization

Coverage will be provided for 1 dose only

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Omisirge single-use culture containing at least 12 × 10⁸ live cells, which include CD34+ and CD3+ cells: 1 dose only

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

• 1 dose only (single-use culture containing at least 12 × 10⁸ live cells, which include CD34+ and CD3+ cells)

3. Initial Approval Criteria

Coverage is provided in the following conditions:

Umbilical cord blood transplantation (UCBT) following myeloablative conditioning in patients with hematologic malignancies to reduce the time to neutrophil recovery and incidence of infection † Ф ^1-3

• Patient is at least 12 years of age; AND
• Patient is eligible for allogeneic hematopoietic stem cell transplant (allo-HSCT) and has not received a prior allo-HSCT; AND 
• Patient has a diagnosis of a high-risk hematologic malignancy and is planned for an umbilical cord blood transplantation (UCBT) following myeloablative conditioning; AND
• Therapy is used to reduce the time to neutrophil recovery and incidence of infection; AND
• Patient will receive prophylactic and supportive therapies for prevention or treatment of transplant complications (e.g., GVHD, infections, etc.) according to institutional guidelines; AND
• Patient does not have a known allergy or hypersensitivity to any of the following:
  • Dimethyl Sulfoxide (DMSO)
  • Dextran 40
  • Gentamicin
  • Human serum albumin or bovine material; AND
• Patients has no readily available matched related donor (MRD), matched unrelated donor (MUD), mismatched (7/8 matched) unrelated donor (MMUD), or haploidentical (half HLA-matched) related donor

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

4. Renewal Criteria ¹

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS code:

• J3590 – Unclassified biologics
• C9399 – Unclassified drugs or biologicals

NDC(s):

• Omisirge single-use cryopreserved cell fractions culture containing at least 12 × 10⁸ live cells (At the time of cryopreservation, the CF contains a minimum of 8.0 × 10⁸ total viable cells with a minimum of 8.7% CD34+ cells and a minimum of 9.2 × 10⁷ CD34+ cells suspended in 20 mL of a cryopreservation solution containing 10% DMSO): 73441-0800-xx

7. References

1. Omisirge [package insert]. Boston, MA; Gamida Cell, Inc.; April 2023. Accessed December 2023.
2. Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719.
3. Kanate AS, Majhail NS, Savani BN, et al. Indications for Hematopoietic Cell Transplantation and Immune Effector Cell Therapy: Guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT). Transplantation and Cellular Therapy. Volume 26, Issue 7, P1247-1256, July 2020. DOI: https://doi.org/10.1016/j.bbmt.2020.03.002
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Cell Transplantation 3.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed December 2023.
5. Sivaraman S, Sajeev G, Song Y, et al. Clinical Outcomes Following Allogeneic Hematopoietic Cell Transplantation with Omidubicel or Other Donor Sources in Patients with Hematologic Malignancies: Comparison of Clinical Trial Results to Center for International Blood and Marrow Transplant Research Database Controls. Blood (2022) 140 (Supplement 1): 660–661. https://doi.org/10.1182/blood-2022-162439
6. Natasha Kekre, Joseph H. Antin; Hematopoietic stem cell transplantation donor sources in the 21st century: choosing the ideal donor when a perfect match does not exist. Blood 2014; 124 (3): 334–343. doi: https://doi.org/10.1182/blood-2014-02-514760 

Appendix 1 – Covered Diagnosis Codes

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/LCD/LCA): N/A