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INDEX:



Effective Date: 01/01/2021	Title: Yescarta (axicabtagene ciloeucel)
Revision Date:	Document: BI668:00
CPT Code(s): Q2041
Public Statement
*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) Yescarta requires prior authorization. 2) Yescarta is used to treat Large B-Cell Lymphoma.
Medical Statement
Initial Approval Criteria A. Large B-Cell Lymphoma* (must meet all): Only for initial treatment dose; subsequent doses will not be covered. 1. Diagnosis of LBCL; 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/μL; 5. Disease is refractory or member has relapsed after ≥ 2 lines of systemic therapy that includes rituximab and one anthracycline-containing regimen (e.g., doxorubicin); 6. Member does not have a history of or current CNS disease; 7. Dose does not exceed 2 x 108 chimeric antigen receptor (CAR)-positive viable T cells. Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) at up to 800 mg* per dose) Continued Therapy A. Large B-Cell Lymphoma 1. Continued therapy will not be authorized as Yescarta is indicated to be dosed one time only. Approval duration: Not applicable Codes Used In This BI: 1) Q2041
Limits
Limited to one dose per lifetime.
Reference
1. Yescarta Prescribing information. Santa Monica, CA: Kite Pharma, Inc.; May 2019. Available at www.yescarta.com. Accessed October 31, 2019. 2. Data on File. Kite Pharma - Yescarta: Primary Results of the Pivotal ZUMA-1 Phase 2 Study. MRC-00038. October 2017. 3. National Comprehensive Cancer Network. B-cell Lymphomas Version 5.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed October 31, 2019. 4. National Comprehensive Cancer Network Drug and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed October 31, 2019. 5. National Comprehensive Cancer Network. Central Nervous System Cancers Version 3.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed October 31, 2019. 6. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. NEJM 2017; 377: 2531-44. 7. Bennani NN, Maurer MJ, Nastoupil LJ, et al. Experience with Axicabtagene Ciloleucel (Axi-cel) in Patients with Secondary CNS Involvement: Results from the US Lymphoma CAR T Consortium. Blood (2019); 134 (Supplement_1): 763.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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