BlueCross BlueShield of Tennessee Medical Policy Manual

Tisagenlecleucel

NDC CODE(S)

00078-0846-XX KYMRIAH SUS (NOVARTIS PHARMACEUTICALS CORP)

 

00078-0958-XX KYMRIAH SUS (NOVARTIS PHARMACEUTICALS CORP)

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 tisagenlecleucel cells.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

B-Cell Precursor Acute lymphoblastic leukemia

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).

Kymriah Infusion:

  • Infuse 2 to 14 days after completion of lymphodepleting chemotherapy

  • 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:

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.

  • 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

  • Confirm availability of Kymriah prior to starting the lymphodepleting regimen.

  • 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.

*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

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.

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).

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.

SOURCES

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

ID_MRx

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 billable unit (1 infusion of up to 250 million CAR-positive viable T-cells)

Large B-Cell Lymphoma

3 billable units (1 infusion of up to 600 million CAR-positive viable T-cells)