CurrentMass General Brigham Health PlanPolicy 074

Omisirge (omidubicel-onlv)

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This policy governs medical necessity and prior authorization for Omisirge, a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. It applies differently across Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial or Qualified Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOmisirge (omidubicel-onlv)

Policy CodePolicy 074

Change TypeMaterial coverage and authorization update

Effective DateSeptember 1, 2026

Last ReviewSep 1, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization requests through the applicable plan-specific pathway before requesting Omisirge.

SourceLink

POLICY UPDATE CHANGES

The policy added the Medicare National Coverage Determination for stem cell transplantation as a coverage reference.

The policy expanded the FDA-approved indications and updated the Omisirge medical necessity criteria to include severe aplastic anemia following reduced intensity conditioning for patients age 6 years and older.

The policy added or clarified plan-specific prior authorization pathways for Mass General Brigham ACO, One Care and SCO, and Commercial and Qualified Health Plan members.

Age 12+Minimum age for hematologic malignancy indication

Age 6+

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CurrentMass General Brigham Health PlanPolicy 074

Omisirge (omidubicel-onlv)

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Policy Summary

PayerMass General Brigham Health Plan

PolicyOmisirge (omidubicel-onlv)

Policy CodePolicy 074

Change TypeMaterial coverage and authorization update

Effective DateSeptember 1, 2026

Last ReviewSep 1, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization requests through the applicable plan-specific pathway before requesting Omisirge.

SourceLink

POLICY UPDATE CHANGES

The policy added the Medicare National Coverage Determination for stem cell transplantation as a coverage reference.

The policy added or clarified plan-specific prior authorization pathways for Mass General Brigham ACO, One Care and SCO, and Commercial and Qualified Health Plan members.

Age 12+Minimum age for hematologic malignancy indication

Age 6+

Medical Necessity and FDA-Approved Indications

Medicare Advantage medical necessity

Covered for Medicare Advantage members when either of the following pathways is met.

Medicare Advantage pathways

Hematologic malignancy pathway
- Disease and conditioning
  - The member has a high risk hematologic malignancy treated with myeloablative conditioning.
- Age and donor availability
  - The member is at least 12 years old.>= 12 years
  - The member has no matched-related donor, matched-unrelated donor, or unrelated donor available.
Severe aplastic anemia pathway
- The member has severe aplastic anemia following reduced intensity conditioning.
- The member is 6 years of age or older.>= 6 years

FDA-approved indications

The FDA-approved indications addressed by this policy are:

Hematologic malignancy indication
- Adult and pediatric patients 12 years of age and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning, to reduce the time to neutrophil recovery and the incidence of infections.>= 12 years
Severe aplastic anemia indication
- Adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced intensity conditioning.>= 6 years

Authorized Coding and Age Requirements

Authorized CodeHCPCS

J3490	Unclassified drugs
J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals
J9999	Antineoplastic drugs, not otherwise classified
S2140	Cord blood harvesting for transplantation, allogeneic
S2142	Cord blood-derived stem-cell transplantation, allogeneic

Age for hematologic malignancy indication

Minimum age12 years of age and older

IndicationHematologic malignancies

Required transplant settingUmbilical cord blood transplantation following myeloablative conditioning

Age for severe aplastic anemia indication

Minimum age6 years of age and older

IndicationSevere aplastic anemia

Required conditioning

Prior Authorization and Review Pathways

Prior Authorization

Obtain Medicare Advantage authorization

Prior authorization is required for Omisirge for Medicare Advantage members. Medicare review uses applicable CMS guidance, FDA indications, and this policy’s criteria; because NCD 110.23 lacks sufficient specificity, the plan uses the NCD, FDA indications, and the criteria described in this policy.

Prior Authorization

Submit ACO requests to MassHealth DUR

Prior authorization is required for Omisirge for Mass General Brigham ACO members. Submit the request to the MassHealth Drug Utilization Review Program using the criteria in Table 72: Agents Not Otherwise Specified.

Prior Authorization

Follow the One Care/SCO review pathway

Prior authorization is required for Omisirge for One Care and Senior Care Options members. Medicare Advantage criteria are applied first; if those criteria are not met, MassHealth criteria are applied.

Therapy Overview

Omisirge (omidubicel-onlv) is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood. It is used for selected patients requiring umbilical cord blood transplantation for hematologic malignancies and for adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced intensity conditioning. For hematologic malignancies, the FDA-approved indication applies to patients 12 years of age and older planned for cord blood transplantation following myeloablative conditioning. In a pivotal randomized trial, Omisirge reduced median time to neutrophil engraftment compared with standard cord blood transplantation (12 versus 22 days) and increased engraftment success (96% versus 89%).

Key Terms

Omisirge (omidubicel-onlv)

TherapyNicotinamide-modified allogeneic hematopoietic progenitor cell therapy

SourceDerived from cord blood

Indicated useTreatment of hematologic malignancies in certain patients who require umbilical cord blood transplantation

SAA

AbbreviationSAA

MeaningSevere aplastic anemia

Policy indicationSevere aplastic anemia following reduced intensity conditioning in adults and pediatric patients 6 years of age and older

Hematopoietic Stem Cell Transplant Candidate Criteria

Hematopoietic stem cell transplant candidate criteria

For the Medicare Advantage transplant-related coverage pathway, one of the following candidate pathways must be met.

Hematopoietic stem cell transplant candidate pathways

Hematologic malignancy candidate
- The member has a high risk hematologic malignancy treated with myeloablative conditioning.
- The member is at least 12 years old.>= 12 years
- The member has no matched-related donor, matched-unrelated donor, or unrelated donor available.
Severe aplastic anemia candidate

Transplant and Conditioning Requirements

Documentation Required

Document the transplant and conditioning regimen

The requested transplant must be planned as an umbilical cord blood transplantation and must follow the applicable conditioning regimen: myeloablative conditioning for the hematologic malignancy indication or reduced intensity conditioning for severe aplastic anemia.