Description

Hematologic malignancies (blood cancers) are caused by abnormal cell growth in the bone marrow, where stem cells form into different types of blood cells. Hematopoietic stem cell transplantation (HSCT) is a potentially curative therapy for a variety of conditions, most commonly blood or bone marrow cancers, in which an individual cannot produce enough normal blood cells. It involves transplanting stem cells isolated from either the individual (autologous or auto-HSCT) or a donor (allogeneic or allo-HSCT), growing them in number, and transplanting them into an individual who lacks sufficient functional stem cells of their own.

A common treatment for blood cancers is stem cell transplantation from umbilical cord blood (UCB), the blood remaining in the umbilical cord and placenta following the birth of an infant. A major disadvantage of UCB is the low stem cell dose available for transplantation, compared to mobilized peripheral blood or bone marrow. This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes. The aim of ex vivo (outside the living body) expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo (inside the living body) neutrophil and platelet producing potential to enable successful transplantation.

Omisirge (omidubicel-only)

Omisirge (omidubicel-only) is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy, given as a single dose and one-time infusion. The infusion is a mixture of hematopoietic stem cells and differentiated immune cells, derived from a single unit of UCB.5 Omisirge purportedly enhances the treatment of an individual undergoing allo-HSCT who has no matched donor for bone marrow or peripheral blood. In addition, the therapy purports to restore blood and immune cells and improve resistance to infections and related complications efficiently and quickly.

Omisirge is indicated for use in adult and pediatric individuals, 12 years of age and older, with hematologic malignancies who are planned for UCB transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.9 The two components of cryopreserved cell therapy, a cultured fraction (CF) and a non-cultured fraction (NF), are derived from the same individual-specific cord blood unit (CBU).

• For CF: a minimum of 8.0 × 10⁸ total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 × 10⁷ CD34+ cells
• For NF: a minimum of 4.0 × 10⁸ total viable cells with a minimum of 2.4 × 10⁷ CD3+ cells

Coverage Determination

Refer all requests or questions regarding Omisirge (omidubicel-only) to the Corporate Transplant Department at 1-866-421-5663, Fax: 502-508-9300 or Email: transplant@humana.com.

Requests for Omisirge (omidubicel-only) require review by a medical director.

Omisirge (omidubicel-only) Effective Date: 06/22/2023 Revision Date: n/a Review Date: 06/22/2023 Policy Number: HUM-0621-000 Page: 3 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for Omisirge (omidubicel-only) when ALL the following criteria are met:

• Absence of a human leukocyte antigen (HLA) matched donor (with an 8/8 allele level HLA-matched and readily available related or unrelated donor); AND
• Absence of contraindications; AND
• Individual is 12 through 65 years of age AND diagnosed with a hematological malignancy (eg, acute lymphoblastic leukemia, acute myelogenous leukemia); AND
• Performance score greater than or equal 70% by Karnofsky/Lansky; AND
• Adequate organ function, as indicated by the following:
  • Cardiac: left ventricular ejection fraction of greater than or equal to 40% or left ventricular shortening fraction greater than or equal to 29%; AND
  • Hepatic: serum bilirubin less than 2.0 mg/dl; hepatic transaminases alanine transaminase and aspartate transaminase less than 3 times the upper limit of normal range; AND
  • Pulmonary: function tests demonstrating forced vital capacity (FVC) and forced expiratory volume (FEV1) of greater than 50% predicted for age and carbon monoxide diffusing capacity (cDLCO) greater than 50% of predicted; AND
  • Renal: creatinine clearance test greater than or equal to 60 mL/min; AND
• Individual will receive 1 dose per lifetime; AND
• Individual will receive Omisirge (omidubicel-only) at a certified treatment center

Omisirge (omidubicel-only) Effective Date: 06/22/2023 Revision Date: n/a Review Date: 06/22/2023 Policy Number: HUM-0621-000 Page: 4 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for Omisirge (omidubicel-only) for any indications other than those listed above including, but may not be limited to:

• Chronic lymphocytic leukemia (CLL); OR
• Myelodysplastic syndromes (MDS) or Chronic myelogenous leukemia (CML) with marked or 3+ fibrosis; OR
• Less than 21 days have elapsed since initiation of the individual’s last chemotherapy cycle and the initiation of the HSCT preparative regimen; OR
• Active malignancy other than that for which the UCB unit transplant was being performed; OR
• Evidence of donor-specific anti-HLA antibodies to the selected treatment CBU; OR
• Evidence of uncontrolled bacterial, fungal or viral infections or severe concomitant diseases; OR
• Individual is pregnant or breastfeeding; OR
• Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material; OR
• Positive for any of the following:
  • Active hepatitis B or C virus infection as determined by serology or polymerase chain reaction (PCR); OR
  • Human immunodeficiency virus (HIV) infection or HIV-positive serology; OR
• Presence of leukemic blasts in the central nervous system; OR
• Prior allogenic HSCT

Omisirge (omidubicel-only) Effective Date: 06/22/2023 Revision Date: n/a Review Date: 06/22/2023 Policy Number: HUM-0621-000 Page: 5 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Background

Omisirge (omidubicel-only) is only available at qualified treatment centers.

For more information, please visit https://omisirge.com.

Warnings and Precautions:

• Malignancies of donor origin: monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs after treatment with Omisirge, contact Gamida Cell at (844) 477-7478
• Transmission of rare genetic diseases: monitor individuals for rare genetic diseases
• Transmission of serious infections: monitor individuals closely for serious infections

Additional information about hematological cancers may be found from the following websites:

• National Library of Medicine
• National Organization for Rare Disorders
• US Food & Drug Administration

Medical Alternatives

Alternatives to Omisirge (omidubicel-only) include, but may not be limited to, the following:

• Allogeneic hematopoietic stem cell transplantation
• Pooled unexpanded cord blood transplantation
• Unexpanded cord blood transplantation

Physician consultation is advised to make an informed decision based on an individual's health needs.

Omisirge (omidubicel-only) Effective Date: 06/22/2023 Revision Date: n/a Review Date: 06/22/2023 Policy Number: HUM-0621-000 Page: 6 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.