Last Review Date: 08/04/2020

Date of Origin: 08/04/2020

Dates Reviewed: 08/2020

I. Length of Authorization

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

II. Dosing Limits

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

• N/A

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

• 1 infusion of up to 200 million autologous anti-cd19 CAR -positive viable T cells

III. Initial Approval Criteria 

Tecartus meets medical criteria for coverage for the treatment of relapsed or refractory Mantle Cell Lymphoma (MCL) when documentation is provided to support all of the following criteria:

• 18 years of age or older at the time of infusion; and
• Relapsed or refractory disease, as defined below:
  • Relapsed disease defined as progression after two or more lines of systemic therapy (which may or may not include therapy supported by autologous stem cell transplant); or
  • Refractory disease defined as not having achieved an initial complete remission after 2 cycles of standard chemotherapy regiment or in second or greater relapse; and 
• Received adequate prior therapy including, at a minimum, all of the following:
  • Anti-CD20 monoclonal antibody for CD20-positive tumor; and
  • An anthracycline containing chemotherapy regimen; and
• Have not received prior treatment with Tecartus or any other gene therapy or are being considered for treatment with any other gene therapy; and
• Have not received radiation therapy or systemic therapy within 2 weeks of leukapheresis or planned CAR-T infusion; and
• *ECOG performance status of 0-1; and
• Documentation of all of the following clinical findings within 2 weeks of planned leukapheresis:

• Absolute neutrophil count (ANC) ≥1000/µL; and
• Absolute lymphocyte count (ALC) >100/µL; and
• Platelet count ≥75,000/µL

• Tecartus will be given as a one-time, single administration treatment; and
• Have adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis, as evidence by, including, but not limited to the following:
  • Serum creatinine ≤ 1.5mg/dL
  • ALT/AST ≤ 5 times the upper limit of normal
  • Total bilirubin ≤ 2 mg/dL
  • Cardiac ejection fraction ≥45% confirmed by echocardiogram
  • No evidence of pericardial effusion as evident by echocardiogram
  • No clinically significant pleural effusion
  • Minimum level of pulmonary reserve defined as < Grade 1 dyspnea and pulse oxygenation > 91% on room air
• Do not have any of the following:
  • CNS lymphoma
  • Any central nervous system (CNS) disease (i.e., history or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, autoimmune disease with CNS involvement)
  • History of or active HIV, hepatitis B, or hepatitis C
  • Any uncontrolled infection requiring IV antimicrobials for management
  • Active inflammatory disorder (ongoing use of systemic corticosteroids or other immunosuppressive treatment).
  • Active autoimmune disease requiring systemic treatment in the previous 2 years (excluding replacement therapy)
  • History of malignancy except carcinoma in situ (e.g. skin, cervix)
  • History of other invasive malignancy (unless the patient is currently disease-free and in complete remission for > 5 years)
  • Autologous stem cell transplant within 6 weeks prior to request for CAR-T
  • History of allogeneic stem cell transplantation
  • Unstable angina and/or myocardial infarction within 6 months prior to screening
  • Cardiac arrhythmia not controlled with medical management
  • Taking oral anticoagulation medication
  • Investigational medicinal product or medical device product within the last 30 days prior to screening
  • Recent monoclonal antibody treatment including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody; whichever is longer.

IV. Renewal Criteria

Coverage cannot be renewed.

V. Dosage/Administration

VI. Billing Code/Availability Information

HCPCS code:

• J9999 – Not otherwise classified, antineoplastic drugs  

NDC:

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

VII. References

1. Tecartus [package insert]. Santa Monica, CA; Kite Pharma, Inc., July 2020. Accessed July 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 August 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