Omidubicel-onlv (Omisirge®) - CAM 937HB

Background
Omisirge (omidubicel-onlv) is an FDA-approved, allogeneic hematopoietic progenitor cell therapy derived from cord blood. It's used to reduce the time to neutrophil recovery and the incidence of infection in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning. It's administered as a single intravenous infusion.

Policy:   
Omisirge is considered MEDICALLY NECESSARY when the following criteria are met:

  1. Patient has a hematologic malignancy [e.g., acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL), myeloproliferative diseases (MPH)], AND
  2. Patient is a candidate for umbilical cord blood transplantation following myeloablative conditioning, AND
  3. Patient does not have a readily available matched sibling or matched unrelated donor, AND
  4. Patient has not received a prior allogeneic hematopoietic stem cell transplantation

Continuation of Omisirge is considered NOT MEDICALLY NECESSARY. This treatment is one infusion per lifetime.

Covered Doses

Omisirge is a cell suspension for IV infusion.

A single dose of OMISIRGE consists of: a Cultured Fraction (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 × 107CD34+ cells, and a Non-cultured Fraction (NF): a minimum of 4.0 × 108 total viable cells with a minimum of 2.4 × 107 CD3+ cells

References

  1. Gamida Cell Ltd. OMISIRGE® (omidubicel-onlv) suspension for infusion, for intravenous use. Prescribing Information. Jerusalem, Israel: Gamida Cell: revised February 2024.
  2. Premera Blue Cross. (n.d.). 5.01.638 omisirge (omidubicel). Pharmacy / Medical Policy – 5.01.638 Omisirge (omidubicel) . https://www.premera.com/medicalpolicies-individual/5.01.638.pdf

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

Code

Number

Description

HCPCS

C9399

Unclassified drugs or biologicals (used to code Omisirge)

 

J3590

Unclassified biologics (used to code Omisirge)

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward

07/01/2025

New Policy

 

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