Last Review Date: 11/05/2024

Date of Origin: 08/04/2020

Dates Reviewed: 08/2020, 11/2020, 01/2021, 04/2021, 11/2021, 11/2022, 11/2023, 11/2024

1. Length of Authorization

Coverage will be provided for one treatment course (1 dose of Tecartus) and may not be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• 1 infusion bag of up to 200 million autologous anti-CD19 CAR-positive viable T cells

2. Max Units (per dose and over time) [HCPCS Unit]:

• 1 billable unit (1 infusion of up to 200 million autologous anti-CD19 CAR-positive viable T cells)

3. Initial Approval Criteria ^1-5

Coverage is provided in the following conditions:

• Patient is at least 18 years of age, unless otherwise specified; AND
• Healthcare facility must be enrolled in and comply with the requirements of the YESCARTA & TECARTUS REMS Program; AND
• Patient does not have a clinically significant active systemic infection or inflammatory disorder; AND
• Prophylaxis for infection will be followed according to local guidelines; AND
• Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during brexucabtagene autoleucel treatment and until immune recovery following treatment; AND
• Patient has been screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
• Used as a single agent (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture); AND
• Patient has an ECOG performance status of 0-1; AND
• Patient has not received prior CAR-T therapy; AND

Mantle Cell Lymphoma † ‡ Ф ^1,2,4

• Patient has relapsed or refractory disease; AND
• Used as subsequent therapy after prior covalent Bruton Tyrosine Kinase Inhibitor (BTKi) therapy; AND
  • Patient had no response or progressive disease following second-line therapy with covalent BTKi or other continuous treatment regimens (i.e., lenalidomide and rituximab); OR
  • Patient had partial response, no response, or progressive disease following second-line therapy with fixed-duration regimens; OR
  • Patient has relapsed or progressive disease that is in second or greater relapse

B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)* † ‡ Ф ^1,5

• Patient has relapsed or refractory disease; AND
• Patient has not received other anti-CD19 therapy, (e.g., blinatumomab, tafasitamab, loncastuximab tesirine, etc.) OR patient previously received other anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
  • Patient has Philadelphia chromosome (Ph)-positive disease; AND
    • Previous therapy has included tyrosine kinase inhibitors (TKIs) (e.g., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib); OR
  • Patient has Philadelphia chromosome (Ph)-negative disease

*May also be applicable to adolescent and young adult (AYA) patients 15 to 39 years of age, who are treated in the pediatric oncology setting.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• Q2053 – Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose; 1 billable unit = 200 million autologous anti-cd19 car positive viable t cells

NDC(s):

• Tecartus suspension for intravenous infusion (MCL); 1 infusion bag (~68 mL): 71287-0219-xx
• Tecartus suspension for intravenous infusion (ALL); 1 infusion bag (~68 mL): 71287-0220-xx

7. References

1. Tecartus [package insert]. Santa Monica, CA; Kite Pharma, Inc.; June 2024. Accessed October 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) brexucabtagene autoleucel. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2024.
3. Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
4. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.
5. Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021 Aug 7;398(10299):491-502. doi: 10.1016/S0140-6736(21)01222-8. Epub 2021 Jun 4.
6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed October 2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):  N/A