BREYANZI (lisocabtagene maraleucel) 

OFFICE ADMINISTRATION– IV

Diagnosis considered for coverage:
  • Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
    • Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma
Coverage Criteria:

For diagnosis of relapsed or refractory large B-cell lymphoma:

  • Dose does not exceed 1 single-dose, AND
  • Patient is 18 years of age or older, AND
  • Patient has a diagnosis of relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B), AND
  • Prescribed by or in consultation with a hematologist/oncologist, AND
  • Disease is relapsed or refractory after two or more lines of systemic therapy (e.g., rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, cisplatin, cytarabine, etc.), AND
  • Approval already authorized for T cell collection, AND
  • Prophylacitc systemic corticosteroids will not be used as they may interfere with Breyanzi's activity, AND
  • Patient has not been previously treated with CAR-T therapy (e.g., Breyanzi, Kymriah®, Tecartus™, Yescarta®), AND
  • Patient has received lymphodepleting chemotherapy prior to infusion of Breyanzi, AND
  • Patient does not have an inflammatory disorder or active infection
Coverage Duration:
  • 1 dose
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • A single dose of Breyanzi contains 50 to 110 × 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in one to four single-dose vials
    • Dosing of Breyanzi is based on the number of chimeric antigen receptor (CAR)-positive viable T cells
  • Breyanzi is for autologous use only
  • Administer Breyanzi in a certified healthcare facility
  • Administer a lymphodepleting regimen of fludarabine and cyclophosphamide before infusion of Breyanzi. Premedicate with acetaminophen and an H1 antihistamine. Ensure that 2 doses of tocilizumab are available prior to infusion of Breyanzi
  • Black Box Warnings:
    • Cytokine Release Syndrome (CRS)
    • Neurologic Toxicities
    • Breyanzi REMS
  • Warnings:  hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and effects on ability to drive and use machines
  • Breyanzi is not recommended for women who are pregnant, and pregnancy after Breyanzi infusion should be discussed with the treating physician
Policy Updates:
  • 06/15/2021 – New policy approved by P&T
References:
  • Breyanzi Prescribing Information. Juno Therapeutics, Inc. Bothell, WA. February 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. v.3.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed March 16, 2021.

Last review date: June 15, 2021