BlueCross BlueShield of Tennessee Medical Policy Manual

Tisagenlecleucel

NDC CODE(S)

00078-0846-XX KYMRIAH SUSP (NOVARTIS PHARMACEUTICALS)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

B-Cell Precursor Acute lymphoblastic leukemia

For autologous use only. For intravenous use only

  • Kymriah is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure

  • One treatment course consists of lymphodepleting chemotherapy followed by a single infusion of Kymriah

Lymphodepleting chemotherapy:

  • Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2 intravenous daily for 2 days starting with the first dose of fludarabine).

  • Delay the infusion of Kymriah after lymphodepleting chemotherapy for unresolved serious adverse reactions from preceding chemotherapies (including pulmonary toxicity, cardiac toxicity, or hypotension), active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden

Kymriah Infusion:

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:

  • Infuse 2 to 14 days after completion of lymphodepleting chemotherapy

  • For individuals 50 kg or less; administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.

  • For individuals above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.

*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

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

SOURCE

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

ID_MRxEx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

Maximum Units

B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)

1 infusion (up to 250 million car-positive viable t-cells) of Kymriah only