TECARTUS (brexucabtagene autoleucel)

TECARTUS (brexucabtagene autoleucel)

OFFICE ADMINISTRATION - IV INFUSION

Indications for Prior Authorization:

• Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Coverage criteria:

For diagnosis of relapsed or refractory mantle cell lymphoma (MCL):

• Dose does not exceed 2 x 10⁶ CAR-positive viable T cells per kilogram (kg) body weight, with a maximum of 2 x 10⁸ CAR-positive viable T cells; AND
• Prescribed by or in consultation with a hematologist/oncologist; AND
• Patient has relapsed or refractory MCL disease; AND
• Patient has been previously been treated with both of the following:
  • At least one prior chemoimmunotherapy (e.g., RDHA+ platinum, RCHOP/RDHAP, NORDIC regimen, HyperCVAD, rituximab + bendamustine, VR-CAP, RCHOP, rituximab + lenalidomide, etc.)
  • At least one bruton’s tyrosine kinase inhibitor (BTKi) therapy (e.g., ibrutinib, acalabrutinib, zanubrutinib).

For diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL):

• Dose does not exceed 1 x 10⁶ CAR-positive viable T cells per kilogram (kg) body weight, with a maximum of 1 x 10⁸ CAR-positive viable T cells; AND
• Prescribed by or in consultation with a hematologist/oncologist; AND
• Patient has relapsed or refractory ALL disease

Coverage Duration:

• 1 year

Additional Information:

• Do not administer Tecartus to patients with active infection or inflammatory disorders.
• Tecartus is available only through a restricted program under Risk Evaluation and Mitigation Strategy (REMS).

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 Committee.

Review History:

• 09/16/2020 - Original review
• 05/27/2022 - Add new indication to treat ALL. Update dosing maximum. Update formatting.

References:

• Tecartus Prescribing Information. Kite Pharma, Inc. Santa Monica, CA. October 2021
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Acute Lymphoblastic Leukemia, version 1.2022 – April 4, 2022. NCCN Web site. Accessed May 6, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – B-Cell Lymphomas, version 3.2022 – April 25, 2022. NCCN Web site. Accessed May 6, 2021.