CurrentCareSourcePolicy N/A

Omisirge (omidubicel) — Prior Authorization and Coverage Criteria for Umbilical Cord Blood Transplantation

This policy governs prior authorization and medical benefit coverage of Omisirge (omidubicel) as a single-dose intravenous therapy to reduce time to neutrophil recovery and infection risk for patients undergoing umbilical cord blood transplantation after myeloablative conditioning; it applies to providers arranging transplant therapy for eligible members in North Carolina.

Policy Summary

PayerCareSource

PolicyOmisirge (omidubicel) — Prior Authorization and Coverage Criteria for Umbilical Cord Blood Transplantation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionObtain prior authorization with documentation showing FDA‑approved indication, patient age ≥ 12 years, hematologic malignancy diagnosis, and prescribing by or in consultation with a transplant specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single doseapproval provided per patient

6 monthsauthorization length

≥12minimum age

neutrophil 12dPhase III outcome

Coverage and Authorization Criteria

FDA‑Approved Indication for Omisirge

Covered when ALL of the following are met:

FDA‑Approved Indication: Patient is planning to undergo umbilical cord blood transplantation following myeloablative conditioning, and Omisirge is prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or a physician associated with a transplant center.

Based on FDA-approved indication; see dosing for single intravenous dose.

Age: Patient is ≥ 12 years of age.>= 12 years

Diagnosis: Patient has a hematologic malignancy (examples include acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia).

Policy Summary

PayerCareSource

PolicyOmisirge (omidubicel) — Prior Authorization and Coverage Criteria for Umbilical Cord Blood Transplantation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 11, 2024

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage of Omisirge (omidubicel) is not recommended for circumstances that are not explicitly listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available.

Transplant Candidate Eligibility

Transplant candidate criteria

Candidate must meet indication and age criteria

Transplant context: Planned umbilical cord blood transplantation following myeloablative conditioning.

Specialist involvement: Omisirge is prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or a physician associated with a transplant center.

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required — one dose, 6‑month approval

Prior authorization is recommended. Approvals are provided for one dose and the approval duration is 6 months to allow preparation and administration of the single dose. Requests for doses outside established dosing will be reviewed case‑by‑case by a clinician.

Approval covers preparation and administration timeframe (one dose; approval length 6 months).
Requests for non‑standard dosing considered case‑by‑case by Medical Director or Pharmacist.

Step Therapy

Step therapy: none specified

No step therapy requirements are specified in this policy.

Documentation Required

Required documentation to support approval

Submit documentation that the patient meets the FDA‑approved indication: undergoing umbilical cord blood transplantation after myeloablative conditioning, is ≥ 12 years of age, has a hematologic malignancy, and that Omisirge is prescribed by or in consultation with a hematologist, oncologist, transplant or transplant‑center clinician.

Evidence of age (≥ 12 years) and diagnosis (hematologic malignancy).
Documentation of prescribing clinician specialty or documented consultation with a hematologist/oncologist/transplant clinician or physician associated with a transplant center.

Denial Risk

Non‑listed indications are not recommended for approval

Requests for indications or circumstances not listed in the Recommended Authorization Criteria are not recommended for approval.

Coding and Age Limits

No codes listedmixed

No codes listed

inv-04: Minimum age

Minimum agePatient must be ≥ 12 years of age

Age scopeApplies to adults and pediatric patients ≥ 12 years

Policy sourcingAge requirement based on FDA‑approved indication in policy

Dose and Authorization Duration

inv-15: Single intravenous infusion of Omisirge (omidubicel)

Number of doses approvedApproval provided for a single intravenous dose (one dose) of Omisirge (omidubicel)

Approval durationAuthorization length up to 6 months to allow preparation and administration of the single dose

Prior authorizationPrior authorization is recommended for coverage; requests for doses outside established dosing reviewed case‑by‑case

Background and Drug Description

Omisirge (omidubicel) is a nicotinamide‑modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood. It is indicated to shorten the time to neutrophil recovery and reduce infection risk when used as a single intravenous dose in patients undergoing umbilical cord blood transplantation following myeloablative conditioning.

Definitions

inv-10: Omisirge (omidubicel) — key facts

Generic identityOmisirge (omidubicel), a nicotinamide‑modified allogeneic hematopoietic progenitor cell therapy derived from cord blood

Indication summaryIndicated to shorten time to neutrophil recovery and reduce infections for patients undergoing umbilical cord blood transplantation after myeloablative conditioning

Prescriber/settingMust be prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or physician associated with a transplant center

Dose formGiven as a single intravenous infusion; product provided in two separate cryopreserved bags (cultured and non‑cultured fractions)

Contraindications and Safety

No specific contraindications are listed in this policy text. Safety concerns noted in product labeling and considered by the policy include risks of infusion reactions, graft‑versus‑host disease (GvHD), engraftment syndrome, and graft failure.

Pre-Approval Evaluation Requirements

Note

Evaluation requirements — documentation only

No additional pre‑approval evaluation steps are required beyond submission of documentation showing indication, age, diagnosis, and prescribing/consultation by the appropriate specialist.

Policy does not list extra evaluation tests or steps prior to authorization beyond required documentation.

Transplant Center and Prescribing Requirements

Note

Center requirement — specialist prescribing/consultation

Prescription and administration should be associated with a transplant center; Omisirge must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or physician associated with a transplant center.