CurrentMass General Brigham Health PlanPolicy 074

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

This policy governs prior authorization and medical necessity criteria for Omisirge (omidubicel-onlv) for members of Mass General Brigham Health Plan and affiliated lines of business, specifying covered indications, age limits, and donor availability requirements.

Policy Summary

PayerMass General Brigham Health Plan

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

Policy CodePolicy 074

Change TypeAd hoc update — added OneCare/SCO variationprior auth table revised

Effective DateApr 1, 2024

Next Review Date

Key ActionObtain prior authorization for Omisirge for applicable lines of business (Prime Therapeutics manages prior authorization for Commercial and Qualified Health Plan members).

SourceLink

POLICY UPDATE CHANGES

Added variation for OneCare and Senior Care Options (SCO) members and updated prior authorization table.

MassHealth prior authorization process updated to direct requests to MassHealth Drug Utilization Review Program and Table 72.

>=12Minimum member age for coverage

Phase 3 RCTPivotal evidence

12 vs 22dMedian neutrophil engraftment

6 codes

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Billing codes (info)

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

Medical necessity criteria: Member is at least 12 years old.>= 12 years

Age requirement aligns with FDA-approved indication for Omisirge.

Medical necessity criteria: Diagnosis of a high-risk hematologic malignancy for which allogeneic umbilical cord blood transplantation is planned and the patient will undergo myeloablative conditioning.

Consistent with pivotal trial population and FDA labeling.

Medical necessity criteria: No suitable matched related donor, matched unrelated donor, or other unrelated donor is available.

Use when no appropriate alternative donor source is available for allogeneic transplantation.

first-line

Indication context: Omisirge is intended for patients planned for umbilical cord blood transplantation following myeloablative conditioning for hematologic malignancies when no suitable matched related or unrelated donor is available.

Aligned with FDA-approved indication and the pivotal Phase 3 trial population.

Patients with conditions that were excluded from the pivotal trial may be clinically inappropriate for Omisirge and are listed here as potential exclusions or limitations to coverage. The trial excluded patients with uncontrolled infections, organ dysfunction, a history of prior allogeneic transplantation, active CNS involvement of malignancy, or those concurrently enrolled in other investigational therapy trials; these factors should be considered when assessing medical eligibility for Omisirge.

Omisirge is covered only for the FDA‑labeled population and clinical context: patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning. Use of Omisirge outside the FDA indication (for example, patients younger than 12 years, patients not undergoing myeloablative conditioning, or situations where a suitable matched related or unrelated donor is available) is not supported by this policy.

Regimens and Administration

Regimen	Indication	Coverage status
Omisirge (omidubicel-onlv) administered as the allogeneic cord blood-derived product per FDA labeling and pivotal trial protocols.
Reduce time to neutrophil recovery and incidence of infection after myeloablative umbilical cord blood transplantation in eligible patients (patients ≥12 years with hematologic malignancies requiring allogeneic transplantation and no suitable matched related or unrelated donor).
Covered when ALL coverage criteria are met (see medical necessity criteria: age ≥12 years, myeloablative conditioning planned, no suitable matched related or unrelated donor).

Billing and Coding (Informational)

Informational codesHCPCS | CPT | mixed

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

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for Omisirge for applicable lines of business. Prime Therapeutics manages prior authorization for Omisirge for Commercial and Qualified Health Plan members. Prior authorization requests for Mass General Brigham ACO members should be submitted to the MassHealth Drug Utilization Review Program. For OneCare and Senior Care Options (SCO) members, prior authorization requests are managed by Mass General Brigham Health Plan.

Commercial and Qualified Health Plans: Prior authorization managed by Prime Therapeutics — see Prime Therapeutics policy for Omisirge.
Mass General Brigham ACO: Submit prior authorization requests to MassHealth Drug Utilization Review Program (Table 72).
OneCare and SCO: Managed by Mass General Brigham Health Plan; CMS and MassHealth guidance used for determinations.

Step Therapy

Step therapy requirements: None specified. There are no step therapy requirements identified for Omisirge in the source policy.

Key Definitions

Omisirge — product definition and indication summary

ProductOmisirge (omidubicel-onlv)

Therapeutic classNicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood

Indication (FDA)For adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection

Intended use contextUsed when patients require UCB transplantation and lack suitable matched related or unrelated donors

Age requirement>= 12 years

Neutrophil engraftment — pivotal trial primary endpoint and median times

Background and Clinical Context

Omisirge (omidubicel-onlv) is a nicotinamide‑modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood intended to reduce time to neutrophil recovery and the incidence of infection after myeloablative conditioning and umbilical cord blood transplantation. FDA approval was based on a pivotal Phase 3 randomized controlled trial that demonstrated a median time to neutrophil engraftment of 12 days with omidubicel versus 22 days with standard UCBT, and improved secondary outcomes including engraftment success and infection rates.

Policy Revision History

2026-01ad_hoc_updateLatest

Updated prior authorization table and added variation for OneCare and Senior Care Options (SCO) members; fixed code disclaimer.

2025-04annual_review

Annual review with a typo correction in the Medicare variation and MassHealth variation updated to include a new prior authorization process.

2025-03ad_hoc_update

Policy Summary

PayerMass General Brigham Health Plan

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

Policy CodePolicy 074

Change TypeAd hoc update — added OneCare/SCO variationprior auth table revised

Effective DateApr 1, 2024

Next Review Date

Key ActionObtain prior authorization for Omisirge for applicable lines of business (Prime Therapeutics manages prior authorization for Commercial and Qualified Health Plan members).

SourceLink

On This Page

Documentation Required

Program-specific Documentation Sources

Documentation and medical necessity determinations follow program-specific guidance. For Medicare Advantage and OneCare/SCO members, Mass General Brigham Health Plan uses CMS guidance (NCDs, LCDs, LCAs, Medicare manuals) as the basis for medical necessity determinations; when CMS guidance is not available, Mass General Brigham Health Plan medical policies are used. For MassHealth/ACO members, criteria and prior authorization processes follow MassHealth guidance (Table 72: Agents Not Otherwise Specified).

Medicare Advantage / OneCare / SCO: Use CMS NCDs, LCDs, LCAs and Medicare manuals. If no CMS guidance, use Mass General Brigham Health Plan policy.
MassHealth / ACO: Follow MassHealth Drug Utilization Review Program criteria (Table 72).

Denial Risk

Requests Without Required Prior Authorization May Be Denied

Requests submitted without the required prior authorization may be denied or delayed. Ensure you follow the line-of-business specific submission process (Prime Therapeutics for Commercial and Qualified Health Plans; MassHealth DUR for ACO; Mass General Brigham Health Plan for OneCare and SCO).

Missing or incomplete prior authorization may result in claim denial.
Check the applicable administrator (Prime Therapeutics, MassHealth DUR, or Mass General Brigham Health Plan) before submission.

Primary trial endpointMedian time to neutrophil engraftment

Omidubicel median time to neutrophil engraftment12 days (95% CI: 10-15)

Standard UCBT median time to neutrophil engraftment22 days (95% CI: 19-25)

Engraftment success rate96% with omidubicel vs 89% with standard UCBT

Evidence sourcePivotal Phase 3 randomized controlled trial (Horwitz et al. 2021)

Added a summary of evidence to the policy.

2024-04-01effective_date

Policy effective date established.