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