Anthem Blue Cross Connecticut MED.00147 Cellular Therapy Products for Allogeneic Stem Cell Transplantation Form

This document addresses stem cell therapy products such as omidubicel, (Omisirge ^®, Gamida Cell, Ltd. Boston, MA) for hematologic malignancies (blood cancers) which are amenable to stem cell transplantation. Omidubicel is the first U. S. Food and Drug Administration (FDA) approved stem cell therapy product for allogeneic stem cell transplantation.

Note: Please see the following related documents for additional information:

• TRANS.00016 Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation
• CG-TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies after Allogeneic Hematopoietic Progenitor Cell Transplantation

Note: For additional stem cell transplant information and criteria, see the applicable transplant document:

• TRANS.00023 Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Other Plasma Cell Dyscrasias
• TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome
• TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors
• TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma
• TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias
• TRANS.00030 Hematopoietic Stem Cell Transplantation for Germ Cell Tumors
• TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors
• TRANS.00034 Hematopoietic Stem Cell Transplantation for Diabetes Mellitus

Position Statement

Medically Necessary:

Use of ex-vivo expansion of cord blood stem cell products (for example, omidubicel) is considered medically necessary for individuals when the following criteria are met:

1. 12 years of age or older; and
2. Is a candidate for myeloablative allogeneic hematopoietic stem cell transplantation to treat a hematologic malignancy; and
3. The appropriate stem cell transplant criteria are met (see related policies above); and
4. Is eligible and planned for umbilical cord blood transplantation following myeloablative conditioning; and
5. Use is intended to reduce the time to neutrophil recovery and the incidence of infection.

Investigational and Not Medically Necessary:

Use of ex-vivo expansion of cord blood stem cell products (for example, omidubicel) is considered investigational and not medically necessary when the criteria above are not met and for all other indications.