Pharmacy Prior Authorization Criteria

Omisirge (omidubicel-onlv) – PA, NF

Indications for Prior Authorization

Omisirge (omidubicel-onlv)

• For diagnosis of Hematologic Malignancies
  Indicated for the treatment of adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections.

• For diagnosis of Severe Aplastic Anemia
  Indicated for the treatment of adults and pediatric patients 6 years of age and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

Criteria

Omisirge

Prior Authorization, Non-Formulary

Length of Approval: 1 Time Authorization in Lifetime
For diagnosis of Hematologic Malignancies

• Submission of medical records (e.g., chart notes) confirming diagnosis of hematologic malignancy
AND
• Patient is 12 years of age or older
AND
• Prescribed by a physician with expertise in the treatment of hematologic malignancies at a center with expertise in hematopoietic stem cell transplants with shared decision-making regarding the potential risks of treatment with Omisirge
AND
• Provider attests that patient has never received Omisirge treatment in their lifetime

Omisirge

Prior Authorization, Non-Formulary

Length of Approval: 1 Time Authorization in Lifetime
For diagnosis of Severe Aplastic Anemia

• Submission of medical records (e.g., chart notes) confirming both of the following:
• Diagnosis of severe aplastic anemia
AND
• Both of the following:
• Bone marrow cellularity of less than 25%
AND
• Patient meets at least two of the following:
• Platelet count of less than 20,000/mcL
• Absolute neutrophil count of less than 500/mcL
• Absolute reticulocyte count of less than 60,000/mcL
AND
• Prescriber attests that other known causes of bone marrow failure (BMF) have been ruled out (e.g., immune thrombocytopenia [ITP], hodgkin lymphoma or non-hodgkin lymphoma, aplastic anemia associated with paroxysmal nocturnal hemoglobinuria [PNH]) [3]
AND
• Patient is 6 years of age or older
AND
• Prescribed by a physician with expertise in the treatment of severe aplastic anemia in a center with expertise in hematopoietic stem cell transplants with shared decision-making regarding the potential risks of treatment with Omisirge
AND
• Provider attests that patient has never received Omisirge treatment in their lifetime

P & T Revisions

2026-06-16

References

1. Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS clinicaltrials.gov NCT02730299
2. OMISIRGE- omidubicel-onlv Prescribing information Gamida Cell Inc. MA. Accessed March 2026
3. Kulasekararaj A, Cavenagh J, Dokal I, Foukaneli T, Gandhi S, Garg M, et al. Guidelines for the diagnosis and management of adult aplastic anaemia: A British Society for Haematology Guideline. Br J Haematol. 2024; 204(3): 784–804. https://doi.org/10.1111/bjh.19236
4. Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome. Clinicaltrials.gov NCT03173937
5. ASH Clinical Practice Guidelines: Diagnosis and Management of Severe and Very Severe Acquired Aplastic Anemia; a Pocket Guide for the Clinician 2026

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Revision History

• 2026-06-16: New Program for Omisirge

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