CurrentMass General Brigham Health PlanPolicy 074

Omisirge (omidubicel-onlv) coverage and prior authorization

Policy governs coverage and prior authorization requirements for Omisirge (omidubicel-onlv) as a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy for patients requiring umbilical cord blood transplantation for hematologic malignancies; applies to Mass General Brigham Health Plan commercial, MassHealth, and Medicare Advantage members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOmisirge (omidubicel-onlv) coverage and prior authorization

Policy CodePolicy 074

Change TypeMassHealth process updateevidence summary added

Effective DateApril 2024

Next Review DateN/A

Key ActionObtain prior authorization for Omisirge for Commercial, MassHealth, and Medicare Advantage members before treatment.

SourceLink

POLICY UPDATE CHANGES

MassHealth variation updated to include new authorization process.

Fixed a typo in the Medicare variation.

Summary of evidence was added in an ad hoc update.

>=12minimum patient age for coverage

12d vs 22dmedian time to neutrophil engraftment

96%neutrophil engraftment rate (trial)

63%estimated 3-yr overall survival

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Coverage criteria

Covered when ALL of the following are met:

Main coverage criteria: 1) Member is at least 12 years old; 2) High-risk hematologic malignancy treated with myeloablative conditioning; 3) No suitable matched-related or matched-unrelated donor available, requiring umbilical cord blood transplantation

Criteria aligned with FDA-approved indication and pivotal trial eligibility; applies to patients planned for UCB transplantation following myeloablative conditioning

Patients who were excluded from the pivotal Phase 3 trial (and who are therefore typically not eligible under this policy) included those with uncontrolled infections, significant organ dysfunction, a history of prior allogeneic transplantation, active CNS involvement of their malignancy, or those concurrently enrolled in other investigational therapy trials. These exclusion criteria reflect the trial population used to establish safety and efficacy and are used to guide routine coverage determinations.

Use of Omisirge (omidubicel-onlv) is considered medically necessary only for members who meet criteria similar to the pivotal trial and FDA labeling: patients aged >= 12 years with a high‑risk hematologic malignancy requiring myeloablative conditioning for allogeneic transplantation, who lack a suitable matched related or unrelated donor and therefore require umbilical cord blood transplantation. Use outside these indications or without meeting donor‑availability and conditioning criteria does not meet the policy's coverage criteria.

Salvage

Line of therapy: Patients indicated are those requiring allogeneic hematopoietic stem cell transplantation following myeloablative conditioning; specific line of therapy (e.g., salvage) is determined by underlying disease and transplant indication as per treating clinician and trial eligibility

Policy follows FDA labeling and pivotal trial population

Covered Regimens and Clinical Effect

Regimen	Indication / context	Key efficacy endpoints (trial results)
Omidubicel (Omisirge) allogeneic cord blood–derived hematopoietic progenitor cell therapy
Reduce time to neutrophil recovery and incidence of infection following myeloablative conditioning prior to umbilical cord blood transplantation in patients 12 years and older lacking suitable matched donors
Median time to neutrophil engraftment: 12 days (omidubicel) vs 22 days (standard UCBT); engraftment success rate 96% vs 89%; secondary endpoints (platelet engraftment, infections) favored omidubicel; pooled analysis estimated 3‑year overall survival ~63% and durable trilineage hematopoiesis

Billing Codes and Age Limitations

Authorized CPT/HCPCS Codes (informational)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

mixed

No codes listed

Minimum age

Minimum age for coverage>= 12 years

Supported FDA-approved indication age rangeAdults and pediatric patients 12 years and older

Pivotal trial eligible age rangeEligible patients in pivotal trial were between 12 and 65 years

Prior Authorization, Submission Instructions, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omisirge (omidubicel-onlv) for Commercial, MassHealth (including ACO members), and Medicare Advantage members. Requests may be denied if prior authorization is not obtained.

Affected plans: Commercial, MassHealth, Medicare Advantage
Affected codes: relevant HCPCS/CPT unclassified drug/biologic billing codes (check payer billing guidance)

Note

Submission Instructions and Guidance Sources

Submit prior authorization requests according to the member's plan: for MassHealth ACO members, route requests to the MassHealth Drug Utilization Review Program and reference Table 72: Agents Not Otherwise Specified. For Medicare Advantage members, follow CMS guidance when available; if CMS has no applicable NCD/LCD/LCA, Mass General Brigham Health Plan medical policy will be applied.

MassHealth ACO submission: MassHealth Drug Utilization Review Program; reference Table 72
Medicare Advantage: follow applicable CMS NCDs/LCDs/LCAs; otherwise use plan medical policy

Documentation Required

Provider Action — Documentation and Submission

Provider action: ensure documentation supports medical necessity per coverage criteria (member age, absence of suitable matched donor, high-risk hematologic malignancy with myeloablative conditioning) and include any CMS or MassHealth references relied upon for Medicare Advantage or MassHealth ACO submissions.

Include documentation of: member age (≥12 years), lack of matched-related or matched-unrelated donor availability, diagnosis of high-risk hematologic malignancy, and plan for myeloablative conditioning
For MassHealth ACO: include any information required by Table 72 submission guidance

Denial Risk

Denial Risk if Authorization Not Obtained

Failure to obtain prior authorization may result in denial of the request or claim. Follow payer-specific billing instructions and code reporting requirements; contact Mass General Brigham Health Plan provider services for coding/billing questions.

Denial risk if authorization not obtained (Commercial, MassHealth, Medicare Advantage)
Contact provider services for billing/coding guidance

Definitions and Key Terms

Omisirge (omidubicel-onlv)

Product name and codeOmisirge (omidubicel-onlv)

DefinitionNicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood

FDA-approved useIndicated to reduce time to neutrophil recovery and incidence of infection in patients planned for umbilical cord blood transplantation following myeloablative conditioning

Applicable patient populationPatients with high-risk hematologic malignancies lacking suitable matched donors and meeting trial-like eligibility

Standard UCBT

TermStandard UCBT (myeloablative umbilical cord blood transplantation)

Role in evidence baseUsed as the comparator arm in the pivotal Phase 3 randomized trial of omidubicel

Key comparative outcomeMedian time to neutrophil engraftment: 22 days for standard UCBT vs 12 days for omidubicel (p < 0.0001)

Engraftment rate in trialStandard UCBT engraftment rate 89% vs 96% with omidubicel

Background and Clinical Context

Omisirge (omidubicel-onlv) is a nicotinamide‑modified allogeneic hematopoietic progenitor cell therapy derived from cord blood developed to reduce the time to neutrophil recovery and decrease infections in patients undergoing myeloablative conditioning prior to umbilical cord blood transplantation. Pivotal evidence from a Phase 3 randomized trial demonstrated a median time to neutrophil engraftment of 12 days for omidubicel versus 22 days for standard UCBT and an engraftment success rate of 96%. A pooled analysis with longer follow‑up reported durable trilineage hematopoiesis and an estimated 3‑year overall survival of 63%, while noting ongoing questions about real‑world outcomes and cost‑effectiveness.

Policy Changes and Revision History

2025-04annual_reviewLatest

Annual review: MassHealth variation updated to include new authorization process and a typographical fix made to the Medicare variation.

2025-03ad_hoc_update

Ad hoc update adding a Summary of Evidence describing the pivotal Phase 3 trial results supporting FDA approval of omidubicel (Omisirge).

2024-04effective_date

Policy became effective in April 2024.