Prior Authorization Required

Prior authorization is required. Submit medical necessity documentation with the prior authorization request. Requests that do not include required medical record documentation (see items below) may be denied.

• Required documentation must be submitted with the prior authorization request: diagnosis, patient age, planned transplantation type (e.g., UCBT) and conditioning regimen (myeloablative or reduced-intensity), intent to reduce neutrophil recovery time and incidence of infection (when applicable), prior allo-HSCT history, details confirming lack of readily available matched donor (MRD/MUD/MMUD/haploidentical) when applicable, confirmation of prior SAA therapy (e.g., hATG + cyclosporine + eltrombopag) or contraindication to immunosuppressive therapy for SAA, eligibility for myeloablative allo-HSCT (for hematologic malignancy indication), planned prophylactic/supportive therapies (including G-CSF), prescriber specialty or consultation with a specialist, documentation of dosing within FDA-labeled limits and requested quantity, and documentation of any contraindications (e.g., known hypersensitivity to DMSO, Dextran 40, gentamicin, human serum albumin, or bovine material).
• Documentation examples: operative/transplantation plan, clinic notes, pathology or marrow reports (e.g., bone marrow cellularity, reticulocyte count), prior treatment records showing trial and inadequate response to standard immunosuppressive therapy for SAA, allergy/intolerance documentation, and institutional conditioning regimen orders.

Documentation Required

Medical record documentation is required and must be submitted with the request. Failure to provide the required records may result in denial of coverage.

• At minimum include: diagnosis and supporting clinical data (e.g., marrow cellularity, reticulocyte count), patient age, planned transplant type and conditioning intensity, documentation that the requested product will be used to reduce time to neutrophil recovery and infection (for UCBT indication), prior allo-HSCT status, lack of suitable donors (when applicable), prior SAA therapy and response (e.g., hATG + cyclosporine + eltrombopag) or contraindication to immunosuppression, prophylactic/supportive care plan (including G-CSF), prescriber specialty or consult, dosing and quantity justification within FDA limits, and any contraindication documentation.

Denial Risk — Missing Medical Record Documentation

Requests missing any of the required medical records or lacking documentation to support key eligibility criteria (diagnosis, planned UCBT/myeloablative or reduced-intensity conditioning, prior allo‑HSCT details, prior SAA therapy and response or contraindication, lack of suitable donors, or prescriber specialty/consultation) are at risk for denial.

• Common denial-risk omissions: absent marrow reports (cellularity), missing reticulocyte counts, no documentation of prior standard immunosuppressive therapy trial and inadequate response for SAA, no transplant plan or conditioning regimen documentation, and no documentation confirming absence of suitable donors.