00078-0846-XX KYMRIAH SUSP (NOVARTIS PHARMACEUTICALS)
Tisagenlecleucel (KYMRIAH™) is a CD19-directed genetically modified autologous T cell immunotherapy. Each dose is a customized treatment created using an individual’s own T-cells. The individual’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the individual. Upon binding to the CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination and persistence of the KYMRIAH™ cells.
Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Tisagenlecleucel for the treatment of other conditions/diseases is considered investigational.
Tisagenlecleucel is considered medically appropriate in the treatment of B-cell precursor acute lymphoblastic leukemia if ALL of the following criteria are met:
Individual is 3 to 25 years of age
Individual has CD19-positive disease
The individuals performance status (i.e., Karnofsky/Lansky) is equal to or greater than 50
Life expectancy greater than 12 weeks
Used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy)
Individual has not received prior CAR-T therapy
Prophylaxis for infection has been followed according to local guidelines
Healthcare facility has enrolled in the Kymriah REMS and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities
Disease is ANY ONE of the following:
In second or later relapse as exhibited by ANY ONE of the following:
Second or greater bone marrow relapse
Any bone marrow relapse after allogeneic stem cell transplantation
Primary refractory (not achieving a complete response after 2 cycles of standard chemotherapy)
Chemorefractory (not achieving a complete response after 1 cycle of standard chemotherapy for relapsed disease)
Individuals with Philadelphia chromosome positive disease have a contraindication, intolerance or have failed two prior lines of tyrosine kinase inhibitor therapy (e.g., imatinib, dasatinib, ponatinib)
The individual is not eligible for allogeneic stem cell transplantation
Absence of ALL of the following:
Hepatitis B virus, hepatitis C virus and human immunodeficiency virus
Live vaccination within two weeks prior to initiation of lymphodepleting chemotherapy
Tisagenlecleucel is NOT considered medically appropriate for renewal.
DOSAGE & ADMINISTRATION
B-Cell Precursor Acute lymphoblastic leukemia
For autologous use only. For intravenous use only
KYMRIAH is provided in a single-dose unit containing chimeric antigen receptor (CAR)-positive viable T cells* based on the patient weight reported at the time of leukapheresis:
*See the Certificate of Analysis (CoA) for the actual number of chimeric antigen receptor (CAR)-positive T cells in the product.
Store infusion bag in the vapor phase of liquid nitrogen (less than or equal to minus 120°C) in a temperature-monitored system. Thaw prior to infusion.
In case of manufacturing failure, a second manufacturing may be attempted.
Additional bridging chemotherapy may be necessary between leukapheresis and lymphodepleting chemotherapy.
Tocilizumab must be available on site prior to infusion if needed for the treatment of CRS (2 doses minimum)
Biosafety guidelines must be followed. Product contains human cells genetically modified with a lentivirus. Employ universal precautions when handling
LENGTH OF AUTHORIZATION
Coverage will be provided for one treatment course (1 dose) and may not be renewed
Click here to view DOSAGE LIMITS
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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, August). Center for Vaccines, Blood and Biologics. KYMRIAH™ (tisagenlecleucel). Retrieved September 5, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf.
ORIGINAL EFFECTIVE DATE: 10/14/2017
MOST RECENT REVIEW DATE: 10/14/2017
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit