vp-0558
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Tecartus™ (brexucabtagene autoleucel) (Intravenous)

Policy Number: VP-0558

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
  1. 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

Indication

Dose

Mantle Cell Lymphoma

Lymphodepleting chemotherapy:

  • Administer cyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2 intravenously on the fifth, fourth, and third day before infusion of Tecartus.

Tecartus Infusion:

  • Premedicate with acetaminophen and diphenhydramine (or other H1-antihistamine) 30-60 minutes prior to infusion. Avoid prophylactic systemic corticosteroids which may interfere with Tecartus activity.
  • Infuse the entire contents of the Tecartus bag within 30 minutes by either gravity or a peristaltic pump. Tecartus is stable at room temperature for up to 3 hours once thawed.
  • Each single infusion bag of Tecartus contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells (for patients 100 kg and above).

Monitoring:

  • Monitor patients daily for at least 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS and neurologic toxicities.
  • Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion.

For autologous use only. For intravenous use only.

  • Tecartus is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure
  • One treatment course consists of lymphodepleting chemotherapy followed by a single infusion of Tecartus.
  • Confirm Tecartus availability prior to starting the lymphodepleting regimen.
  • Store infusion bag in the vapor phase of liquid nitrogen (less than or equal to minus 150°C). Thaw prior to infusion.
  • In case of manufacturing failure, a second manufacturing may be attempted.
  • Additional chemotherapy (not the lymphodepletion) may be necessary while the patient awaits the product.
  • Ensure that 2 doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
  • Tecartus contains human blood cells that are genetically modified with replication incompetent retroviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal.

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

ICD-10

ICD-10 Description

C83.10

Mantle cell lymphoma, unspecified site

C83.11

Mantle cell lymphoma, lymph nodes of head, face and neck

C83.12

Mantle cell lymphoma, intrathoracic lymph nodes

C83.13

Mantle cell lymphoma, intra-abdominal lymph nodes

C83.14

Mantle cell lymphoma, lymph nodes of axilla and upper limb

C83.15

Mantle cell lymphoma, lymph nodes of inguinal region and lower limb

C83.16

Mantle cell lymphoma, intrapelvic lymph nodes

C83.17

Mantle cell lymphoma, spleen

C83.18

Mantle cell lymphoma, lymph nodes of multiple sites

C83.19

Mantle cell lymphoma, extranodal and solid organ sites

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC