Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tecartus requires prior authorization.

2)    Tecartus is used to treat Large B-cell Lymphoma.

Initial Approval Criteria A. Mantle Cell Lymphoma* (must meet all):

*Only for initial treatment dose; subsequent doses will not be covered.

1. Diagnosis of relapsed or refractory MCL;

2. Prescribed by or in consultation with an oncologist or hematologist;

3. Age ≥ 18 years;

4. Recent (within the last 30 days) absolute lymphocyte count (ALC) ≥ 100 cells/μL;

5. Member has previously received 2 to 5 prior regimens that included all of the following (a, b, and c): a. Anthracycline (e.g., doxorubicin) or bendamustine-containing chemotherapy;

b. Anti-CD20 monoclonal antibody therapy (e.g., rituximab);

c. Bruton tyrosine kinase (BTK) inhibitor (e.g., Imbruvica®, Calquence®, Brukinsa™);

6. Member does not have a history of or current central nervous system (CNS) disease or CNS disorders (i.e., detectable cerebrospinal fluid malignant cells or brain metastases, CNS lymphoma, seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement);

7. Member does not have a history of allogeneic stem cell transplantation;

8. Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Kymriah™, Yescarta™);

9. Tecartus is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Kymriah, Yescarta);

10. Dose does not exceed 2 x 108 CAR-positive viable T cells/kg.

Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) at up to 800 mg per dose)

Codes Used In This BI:

1)    C9073  Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (code deleted & replaced by Q2053 eff 04/01/2021)

2)    Q2053  Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (new code eff 04/01/2021) 

1. Tecartus Prescribing Information. Santa Monica, CA: Kite Pharma, Inc.; July 2020. Available at: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf. Accessed July 27, 2020.

2. 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;382:1331-42.

3. National Comprehensive Cancer Network. B-cell Lymphomas Version 2.2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed July 27, 2020.

Addendum:

1)    Effective 01-01-2021: New code C9073.

2)    Effective 04/01/2021: Deleted code C9073 & replaced by Q2053