Last Review Date: 04/01/2021

Date of Origin: 08/04/2020

Dates Reviewed: 08/2020, 11/2020, 01/2021, 04/2021

1. Length of Authorization

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

2. Dosing Limits

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

• 1 infusion bag

B.  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 ^1,4

Coverage is provided in the following conditions:

• Patient aged 18 years or greater; AND
• Healthcare facility has enrolled in the YESCARTA & TECARTUS REMS and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities; AND
• Patient does not have a clinically significant active systemic infection or inflammatory disorder; AND
• Prophylaxis for infection has been followed according to local guidelines; AND
• Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel treatment, and will not receive live vaccines 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 single agent therapy (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture); AND
• Patient did not receive prior allogeneic hematopoietic stem cell transplantation (HSCT); AND
• Patient does not have central nervous system lymphoma, detectable cerebrospinal fluid malignant cells or brain metastases; AND

Mantle Cell Lymphoma †  Ф  ^1,2,4

• Patient’s has relapsed or refractory disease; AND
• Patient has at least one measurable lesion; AND
• Patient must have received previous systemic therapy which included at least one agent from each of the following categories:
  • Bruton tyrosine kinase (BTK) inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib)
  • Anti-CD20 monoclonal antibody (e.g., rituximab)
  • Anthracycline- OR bendamustine-containing chemotherapy

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

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS code:

• J9999 – Not otherwise classified, antineoplastic drugs (Discontinued on 04/01/21)
• 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 (Effective 04/01/21)
• C9073 – 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 (HOPPS-Hospital Outpatient Prospective Payment System Use Only) (Discontinued on 04/01/21)

NDC:

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

7. References

1. Tecartus [package insert]. Santa Monica, CA; Kite Pharma, Inc., July 2020. Accessed October 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) brexucabtagene autoleucel. National Comprehensive Cancer Network, 2020. 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 2020.
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.

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Articles (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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