CurrentBlue Cross Blue Shield - MassachusettsPolicy 028

Adjunct Medications to Support Hematopoietic Stem Cell Transplantation and its Complications

Governs prior authorization and medical necessity documentation for adjunct biologic medications (Omisirge/Omidubicel and Ryoncil/remestemcel-L) used to support HSCT and treat its complications for Blue Cross Blue Shield - Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAdjunct Medications to Support Hematopoietic Stem Cell Transplantation and its Complications

Policy CodePolicy 028

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit initial authorization requests using Authorization Manager (fax 888-973-0726 for out-of-network providers).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named drugs with specific criteria

one lifetimeOmisirge one-time infusion

2mo+ / 12yr+age thresholds specified

Authorization Managerauthorization system required

Coverage Criteria

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Omisirge (Omidubicel) coverage criteria

Covered when ALL of the following are met for Omisirge (one-time infusion, one course per lifetime):

Omisirge initial approval criteria: Individual is 12 years of age and older; has a diagnosis of hematologic malignancy planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; is a candidate for myeloablative allogeneic hematopoietic stem cell transplantation (HSCT); does not have any of the following: availability of HLA-identical, HLA-matched, or HLA-haploidentical donor; history of prior allogeneic HSCT; other malignancy or significant immunodeficiency disorder; active, uncontrolled HCV or HBV infection; and the medication is being prescribed by or in consultation with a hematologist/oncologist.one lifetime

One treatment course per lifetime specified for Omisirge

Ryoncil (remestemcel-L) coverage criteria

Covered when ALL of the following are met for Ryoncil (remestemcel-L):

Ryoncil initial approval criteria: Individual is 2 months of age and older; has a diagnosis of steroid-refractory acute graft-versus-host disease (SR-aGvHD); and the aGvHD progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or an equivalent corticosteroid prior to the request.

Donor availability and prior transplant history are key determinants of eligibility for Omisirge. The therapy is intended for individuals who are planned for umbilical cord blood transplantation following myeloablative conditioning and who are candidates for myeloablative allogeneic hematopoietic stem cell transplantation (HSCT). Patients who have an available HLA-identical, HLA-matched, or HLA-haploidentical donor are not appropriate candidates for Omisirge and should not receive authorization. Similarly, individuals with a history of prior allogeneic HSCT are excluded from approval. Ensure documentation clearly states donor search results and prior transplant history when submitting an authorization request.

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Providers must submit initial authorization requests using Authorization Manager. Authorization Manager (available 24/7) is the preferred method to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, requests must meet medical policy guidelines.

Enter the appropriate surgeon's NPI or provider ID as the servicing provider (not the billing group).
Enter the facility's NPI or provider ID for where services are being performed.

Prior Authorization

Prior Steroid Therapy Requirement (Ryoncil)

For Ryoncil (remestemcel-L-rknd) requests, document steroid-refractory acute graft-versus-host disease (SR-aGvHD). The patient must be 2 months of age or older and have a diagnosis of SR-aGvHD. Clinical documentation must show that the patient’s acute GVHD either progressed within 3 days or did not improve within 7 consecutive days of treatment with one of the following corticosteroid regimens: methylprednisolone 2 mg/kg/day or an equivalent corticosteroid.

Post-Transplant Coverage Notes

Omidubicel infusion — Omisirge lifetime course

Authorization statusOmisirge (Omidubicel) is authorized as a single treatment course per lifetime (one-time infusion)

IndicationFor individuals 12 years of age and older with hematologic malignancy planned for umbilical cord blood transplantation after myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection

Transplant candidacy requirementIndividual must be a candidate for myeloablative allogeneic hematopoietic stem cell transplantation (HSCT)

Donor availability exclusionNot eligible if an HLA-identical, HLA-matched, or HLA-haploidentical donor is available

Other exclusionsHistory of prior allogeneic HSCT, other malignancy or significant immunodeficiency disorder, or active uncontrolled HCV or HBV infection precludes approval

Definitions

Ryoncil definition — remestemcel-L (Ryoncil)

Proprietary name and active substanceRyoncil (remestemcel-L)

IndicationFor steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD)

Age thresholdIndividual is 2 months of age and older

Definition of steroid‑refractoryaGvHD progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent corticosteroid prior to request

Documentation requirementClinical documentation must confirm timing and dosing of high‑dose corticosteroid therapy prior to Ryoncil request

Evaluation Requirements

Note

Show steroid failure/progression with specified timing for Ryoncil

Demonstrate progression or lack of improvement on high‑dose corticosteroids with the required timing: aGvHD progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent.

Document dates of steroid initiation and the observed progression or non‑response window.
Document the corticosteroid dose (e.g., methylprednisolone 2 mg/kg/day) or equivalent used.

Contraindications

The policy specifies several contraindications that preclude use of Omisirge. Do not approve therapy for individuals with active, uncontrolled hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. A history of prior allogeneic HSCT is an exclusion, as is the availability of an alternate donor (HLA-identical, HLA-matched, or HLA-haploidentical). The presence of any other malignancy or significant immunodeficiency disorder listed in the clinical documentation also contraindicates approval. The medication must be prescribed by or in consultation with a hematologist/oncologist, and absence of these contraindications should be documented in the clinical submission.

Background

These adjunct biologic therapies support hematopoietic stem cell transplantation and related complications. Specifically, Omisirge (Omidubicel) is indicated in this policy for use in patients with hematologic malignancy who are planned for umbilical cord blood transplantation after myeloablative conditioning to reduce time to neutrophil recovery and the incidence of infection. The document requires that patients be 12 years of age and older for Omisirge and that the medication be prescribed by or in consultation with a hematologist/oncologist; supporting clinical details should be included in the authorization request.