00078-0846-XX KYMRIAH SUS (NOVARTIS PHARMACEUTICALS CORP)
00078-0958-XX KYMRIAH SUS (NOVARTIS PHARMACEUTICALS CORP)
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 tisagenlecleucel cells.
Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) and Large B-Cell Lymphoma 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 if ALL of the following criteria are met:
Individual has ALL of the following:
Freedom from active infection or inflammatory disorder including a screen for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis)
Life expectancy greater than 12 weeks
NOTreceived prior CAR-T therapy
NOTreceived prior anti-CD19 therapy, e.g., blinatumomab
NOTreceived live vaccines within six weeks prior to initiation of lymphodepleting chemotherapy and will not receive live vaccines until immune recovery following tisagenlecleucel treatment
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
Used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy)
Diagnosis of ANY ONE of the following:
B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) if ALL of the following:
Individual is 3 to 25 years of age
Disease is refractory or 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)
Individual is not eligible for allogeneic stem cell transplantation
Individual has performance status (i.e., Karnofsky/Lansky) is equal to or greater than 50
Large B-Cell Lymphoma if ALL of the following:
Individual is 18 years of age or older
ECOG performance status of 0-1
Diagnosis of ANY ONE of the following aggressive B-cell non-Hodgkin lymphomas:
Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
High grade B-cell lymphoma
DLBCL arising from follicular lymphoma (TFL)
Primary mediastinal large B-cell lymphoma
Disease is relapsed or refractory and is defined as ANY ONE of the following:
Relapse after autologous hematopoietic stem cell transplantation (HSCT)
Refractory disease to the most recent therapy
Individual does NOT have diagnosis of primary central nervous system lymphoma
Treatment will be used as ANY ONE of the following:
After two or more lines of systemic therapy, which included an anthracycline and an anti-CD20 monoclonal antibody, e.g., rituximab (unless the tumor is CD20-negative)
Additional therapy for patients with intention to proceed to high-dose therapy who have partial response following second line therapy for relapsed or refractory disease
Treatment of disease that is in second or greater relapse
Tisagenlecleucel is NOT considered medically appropriate for renewal
DOSAGE & ADMINISTRATION
B-Cell Precursor Acute lymphoblastic leukemia
o For individuals ≤ 50 kg: administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight.
For individuals > 50 kg: administer 0.1 to 2.5 x 108 CAR-positive viable T cells
For autologous use only. For intravenous use only.
|*See the Certificate of Analysis (CoA) for the actual number of chimeric antigen receptor (CAR)-positive T cells in the product|
LENGTH OF AUTHORIZATION
Coverage will be provided for one treatment course (1 dose) and may not be renewed
Refer to DOSAGE LIMITS below
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).
No controlled studies were found in the published literature that validate the use of tisagenlecleucel for the treatment or prevention of other conditions or diseases.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2018). Adoptive immunotherapy (8.01.01). Retrieved September 7, 2018 from BlueWeb.
Maude, S. L., Laetsch, T.W., Buechner, J. Rives, S., Boyer, M., Bittencourt, H., et al. (2018). Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. The New England Journal of Medicine, 378 (5), 439-448.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, June). Tisagenlecleucel. Retrieved December 6, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Tisagenlecleucel. Retrieved December 6, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, May). Center for Vaccines, Blood and Biologics. Kymriah™ (tisagenlecleucel). Retrieved December 6, 2018 from https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf.
ORIGINAL EFFECTIVE DATE: 10/14/2017
MOST RECENT REVIEW DATE: 4/2/2019
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