CurrentBlue Cross Blue Shield - IowaPolicy 05.05.06

Omisirge (omidubicel-onlv) — Coverage Criteria for Umbilical Cord Blood Transplantation

Defines medical necessity criteria, dosing limits, and billing codes for coverage of Omisirge (omidubicel-onlv) for members 12 years and older undergoing umbilical cord blood transplantation following myeloablative conditioning. Applies to Wellmark Blue Cross and Blue Shield determinations of benefit coverage.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

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

Policy CodePolicy 05.05.06

Change TypeNo material changes

Effective DateAug 2, 2023

Next Review DateAug 2, 2025

Key ActionObtain prior authorization (limited to one treatment course per lifetime) for members 12 years and older who meet all listed criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 yrsminimum patient age

1treatment course per lifetime

12 vs 22 dmedian neutrophil recovery

39% vs 60%infections within 100 days

Coverage Criteria for Omisirge (omidubicel-onlv)

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Initial Therapy — Omidubicel-onlv

Omidubicel-onlv is considered medically necessary when ALL of the following are met:

Initial Approval Criteria: A. The member will receive umbilical cord blood transplantation; B. The requested medication is being used to reduce the time to neutrophil recovery and incidence of infection; C. The member will receive myeloablative conditioning; D. The member must not have a matched related donor (MRD), matched unrelated donor (MUD), mismatched unrelated donor (MMUD), or haploidentical donor readily available; E. The member has not received prior allogeneic hematopoietic stem cell transplant; F. The member will receive one treatment course per lifetime.

Authorization limited to one month for a single dose per policy text.

Continuation Therapy — Omidubicel-onlv

Continuation of therapy

Continuation: Approval is limited to one treatment course per lifetime.

Quantity limits: one treatment course per lifetime.

Members who do not meet the specified coverage criteria are not medically necessary for Omisirge (omidubicel-onlv).

Not medically necessary: Omisirge (omidubicel-onlv) is considered not medically necessary for members who do not meet the criteria set forth above.

Regimen	Coverage status	Authorized quantity / limit	Clinical rationale / expected effect
Omisirge (omidubicel-onlv) as a single treatment course (single dose)
Covered with criteria
One treatment course (single dose) per lifetime
Reduces median time to neutrophil recovery (12 vs 22 days) and lowers incidence of bacterial/fungal infections within 100 days (39% vs 60%) when used with umbilical cord blood transplantation after myeloablative conditioning; no statistically significant improvement in overall survival or GVHD in Study PO501.

Line of Therapy

first-line

Indication: Patients 12-65 years with high-risk hematologic malignancies who are candidates for myeloablative allogeneic HSCT and have no readily available matched sibling or matched unrelated adult donor; planned for umbilical cord blood transplantation following myeloablative conditioning.

Policy covers adults and pediatric patients 12 years and older per labeling.

Procedures, Billing Limits, and Codes

Procedures and HCPCS/ICD-10-PCS codesmixed

J3490	Unclassified drugs (When specified as [Omisirge] (omidubicel-onlv))
J3590	Unclassified biologics (when specified as [Omisirge] (omidubicel-onlv))
XW133C8	Transfusion of Omidubicel into Peripheral Vein, Percutaneous Approach; New Technology Group 8 (ICD-10-PCS eff 10/01/2022)
XW143C8	Transfusion Omidubicel into Central Percutaneous Approach, New Technology Group 8 (ICD-10-PCS eff 10/01/2022)

inv-06: treatment course limit — 1 treatment course per lifetime

Treatment course limit1 treatment course per lifetime

ScopeLimit applies to Omisirge (omidubicel-onlv) used with umbilical cord blood transplantation

Authorization implicationPrior authorization is required and limited to one treatment course per lifetime for eligible members 12 years and older

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and limited to one treatment course (single dose) per lifetime for members 12 years and older meeting all policy criteria.

Prior authorization required
Limit: one treatment course (single dose) per lifetime
Applies to members age ≥ 12 years

Documentation Required

Documentation Requirements

Documentation must demonstrate the member will receive umbilical cord blood transplantation after myeloablative conditioning and that no matched related donor (MRD), matched unrelated donor (MUD), mismatched unrelated donor (MMUD), or haploidentical donor is readily available. Documentation should also confirm the member has not received a prior allogeneic hematopoietic stem cell transplant.

Confirm planned umbilical cord blood transplantation
Confirm myeloablative conditioning
Confirm absence of MRD, MUD, MMUD, or haploidentical donor readily available
Confirm no prior allogeneic hematopoietic stem cell transplant

Denial Risk

Denial / Not Medically Necessary

Omisirge is considered not medically necessary for members who do not meet the criteria set forth above.

Definitions

inv-12: Definition of Omisirge — nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated to reduce time to neutrophil recovery and incidence of infection

Generic descriptionNicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood

Indication (age)For adults and pediatric patients 12 years and older

Intended useIndicated to reduce the time to neutrophil recovery and the incidence of infection when planned for umbilical cord blood transplantation following myeloablative conditioning

Product name (brand & generic)Omisirge (omidubicel-onlv)

Background

Umbilical cord blood transplantation is used as a source of hematopoietic stem cells for patients with hematologic malignancies who lack suitable adult donors but is associated with delayed hematopoietic recovery. Omisirge (omidubicel-onlv) is a nicotinamide‑modified allogeneic progenitor cell therapy derived from cord blood indicated to reduce time to neutrophil recovery and incidence of infection in patients 12 years and older planned for umbilical cord blood transplantation after myeloablative conditioning.

Clinical evidence (Study PO501) demonstrated that Omisirge shortened median time to neutrophil recovery (12 days vs 22 days) and reduced early bacterial/fungal infections (39% vs 60% within 100 days) compared with standard umbilical cord blood, though no statistically significant improvement in overall survival or graft‑versus‑host disease was observed.