71287-0119-XX Yescarta SUSP (KITE PHARMA, INC.)
Axicabtagene ciloleucel is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare the product an individual’s own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. The anti-CD19 CAR T cells are expanded and infused back into the individual.
Axicabtagene ciloleucel binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
Axicabtagene ciloleucel for the treatment of large B-cell lymphoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Axicabtagene ciloleucel for the treatment of other conditions/diseases is considered investigational.
Axicabtagene ciloleucel is considered medically appropriate in the treatment of large B-cell lymphoma if ALL of the following criteria are met:
The individual is age 18 or older
Disease is relapsed or refractory after two or more lines of systemic therapy (i.e., prior systemic therapy must have included anthracycline as well as an anti-CD20 monoclonal antibody[unless tumor is CD20-negative]) NOTE: Relapsed defined as within 1 year after autologous hematopoietic stem cell transplantation, or refractory disease to most recent therapy)
Has CD 19-positive disease
Disease is ANY ONE of the following:
Diffuse large B-cell lymphoma not otherwise specified
Diffuse large B-cell lymphoma arising from follicular lymphoma
Primary mediastinal large B-cell lymphoma
High grade B-cell lymphoma
The individual has been screened for hepatitis B (HBV), Hepatitis C (HCV) and human immunodeficiency virus (HIV) prior to collection of cells (leukapheresis)
Absence of ALL of the following:
Primary central nervous system lymphoma
Prior allogeneic hematopoietic stem cell transplantation
The individual has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy and during treatment with axicabtagene ciloleucel will not receive live vaccines until immune recovery following treatment
The individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
The individual has not received prior CAR-T therapy
The healthcare facility has enrolled in the Yescarta REMS and training has been given to providers on the management of cytokine release syndrome and neurological toxicities
Axicabtagene ciloleucel is NOT considered medically appropriate for renewal.
DOSAGE & ADMINISTRATION
For autologous use only. For intravenous use only.
LENGTH OF AUTHORIZATION
Coverage will be provided for one treatment course (1 dose of Yescarta) and may not be renewed.
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BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
U. S. Food and Drug Administration. (2017, October). Center for Vaccines, Blood and Biologics. YESCARTA™ (axicabtagene ciloleucel). Retrieved October 20, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581226.pdf.
ORIGINAL EFFECTIVE DATE: 12/14/2017
MOST RECENT REVIEW DATE: 12/14/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit