CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Omisirge (omidubicel-onlv) — coverage criteria for umbilical cord blood transplantation

Policy governs coverage of Omisirge (intravenous) for patients planned for umbilical cord blood transplantation following myeloablative conditioning; applies to Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOmisirge (omidubicel-onlv) — coverage criteria for umbilical cord blood transplantation

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date06/01/2024

Next Review DateN/A

Key ActionObtain prior authorization; coverage is limited to a single dose meeting the product cell‑count specifications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseLength of authorization / max units

≥12 yrsMinimum patient age for coverage

Neutrophil recovery 12 vs 22dPrimary efficacy outcome (Omisirge vs UCB)

5/62 (8%)Manufacturing failure proportion in study

Boxed WarningSerious safety risks

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Coverage Criteria

Initial Approval

Covered when ALL of the following are met:

Initial Approval Criteria: 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 intended 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., graft‑versus‑host disease, infections) according to institutional guidelines; AND patient has no known allergy or hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, or human serum albumin/bovine material; AND patient has no readily available matched related donor (MRD), matched unrelated donor (MUD), mismatched (7/8 matched) unrelated donor (MMUD), or haploidentical related donor

Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

Coverage is limited to a single administration. Coverage cannot be renewed; authorization and benefit limits allow for only one dose of Omisirge per member for the indicated transplant episode.

Use of Omisirge for indications beyond the approved intent is not supported by available evidence. Specifically, the randomized study did not show statistically significant improvements in overall survival, relapse rate, disease-free survival, nonrelapse mortality, or GVHD, and therefore use to attempt to improve these outcomes is considered not medically necessary and is not supported by the study data.

Regimen	Composition / Minimum cell counts	Preparation & Administration notes	Coverage status
Single intravenous administration comprising cultured and non-cultured fractions	Cultured Fraction (CF): minimum 8.0 × 10^8 total viable cells, ≥8.7% CD34+ cells, and at least 9.2 × 10^7 CD34+ cells; Non‑cultured Fraction (NF): minimum 4.0 × 10^8 total viable cells with ≥2.4 × 10^7 CD3+ cells	CF and NF supplied cryopreserved separately in two bags; thaw immediately prior to use; dilute with two infusion solution (IS) bags (one per fraction); begin NF infusion within 1 hour after completion of CF infusion; intravenous use only; do not irradiate; do not use a leukodepleting filter; verify patient identity prior to thaw and prior to infusion; administration under supervision of physician experienced in hematologic malignancies at HSCT center	Covered with criteria

Coding

HCPCS codesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

NDCNDC

734410800-xx

Omisirge single-use cryopreserved cell fractions NDC

Covered Diagnosis CodesICD-10Covered

Z94.81

Bone marrow transplant status

inv-07: Product cell counts — single dose composition and cell count minimums

Single dose total live cellsSingle dose contains at least 12 × 10^8 live cells (single-use culture)

Cultured Fraction (CF) — total viable cells minimumMinimum 8.0 × 10^8 total viable cells

Cultured Fraction (CF) — CD34+ compositionAt least 8.7% CD34+ cells, and at least 9.2 × 10^7 CD34+ cells

Non‑cultured Fraction (NF) — total viable cells minimumMinimum 4.0 × 10^8 total viable cells

Non‑cultured Fraction (NF) — CD3+ cells minimumAt least 2.4 × 10^7 CD3+ cells

Provider Actions & Billing Requirements

Prior Authorization

Prior Authorization & Quantity Limitation

Prior authorization is required. Coverage is limited to a single dose per member (see max units). Requests for renewal will be denied because coverage is limited to one dose only.

Prior authorization required
Coverage limited to a single dose — renewal requests will be denied

Step Therapy

Step Therapy Exception for Medicare

Medicare members who have previously received this medication within the past 365 days are exempt from Step Therapy requirements. Document prior receipt date in the prior authorization request.

Step therapy exception applies only to Medicare members with prior dosing within 365 days

Definitions

inv-13: Single dose / product composition — Definition of a single dose and component minimums (cultured and non-cultured fractions).

Definition of a single doseA single dose is a single-use culture containing at least 12 × 10^8 live cells

Cultured Fraction (CF) compositionSupplied separately; minimum 8.0 × 10^8 total viable cells with ≥8.7% CD34+ (≥9.2 × 10^7 CD34+ cells)

Non‑cultured Fraction (NF) compositionSupplied separately; minimum 4.0 × 10^8 total viable cells with ≥2.4 × 10^7 CD3+ cells

Administration notes for fractionsCF and NF are cryopreserved separately, thawed and diluted in separate infusion solution bags; NF infusion should begin within 1 hour after completion of CF infusion

Additional handling restrictionsIntravenous use only; do not irradiate; do not use a leukodepleting filter; verify patient identity upon receipt; do not open metal cassettes until time of thaw

Background

Omisirge (omidubicel-onlv) is an expanded umbilical cord blood–derived hematopoietic progenitor cell product indicated to reduce the time to neutrophil recovery and the incidence of infection in adults and pediatric patients aged ≥ 12 years undergoing umbilical cord blood transplantation following myeloablative conditioning. In the pivotal randomized study (P0501), median time to neutrophil recovery was 12 days with Omisirge versus 22 days with standard UCB; however, Omisirge did not demonstrate statistically significant benefits for survival, relapse, or GVHD. The product carries a Boxed Warning for fatal infusion reactions, graft-versus-host disease, engraftment syndrome, and graft failure.

Line of Therapy

salvage

Salvage: Planned for umbilical cord blood transplantation following myeloablative conditioning; no prior allo‑HSCT; high‑risk hematologic malignancy

Intended as part of the transplant preparative regimen