BREYANZI (lisocabtagene maraleucel)

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.