BlueCross BlueShield of Tennessee Medical Policy Manual

Ado-Trastuzumab Emtansine

NDC CODE(S)

50242-0088-xx Kadcyla 100 MG SOLR (GENENTECH)

 

50242-0087-xx Kadcyla 160 MG SOLR (GENENTECH)

DESCRIPTION

Ado-trastuzumab emtansine is an antibody-drug conjugate.  It consists of the anti-HER2 IgG1 antibody trastuzumab covalently linked to the drug DM1 via the stable thioether linker MCC.  DM1 is a maytansine derivative.  

Maytansine, an ansamycin antibiotic, is a potent microtubule inhibitor which has not been found to have a clinical use due to severe side effects and lack of tumor specificity. The term emtansine references both the source drug and the covalent linker of the small molecule complex MCC-DM1.

In the body, ado-trastuzumab emtansine binds to the HER2 receptor on cancer cells.  It is then internalized into the cell where it causes lysosomal degradation resulting in the intracellular release of DM1-containing cytotoxic catabolites.  These bind to tubulin causing disruption of the cellular microtubule network resulting in cell cycle arrest and apoptotic cell death.  Ado-trastuzumab emtansine additionally appears to inhibit HER2 receptor signaling, mediate antibody-dependent cell-mediated cytotoxicity and inhibit shedding of the HER2 extracellular domain in human breast cancer cells that overexpress HER2, as is found with trastuzumab.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*HER2 positive overexpression criteria
  • Immunohistochemistry (IHC) assay 3+

  • Fluorescence in situ hybridization (FISH) assay ≥2.0 (HER2/CEP17 ratio)

  • Average HER2 copy number ≥ 6 signals/cell

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle)

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may 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 

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 validates the use of ado-trastuzumab emtansine for the treatment or prevention of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Ado-trastuzumab emtansine (trastuzumab-DM1) for treatment of HER2-positive malignancies (5.01.22). Retrieved February 23, 2018 from BlueWeb.

Lexi-Comp Online. (2017, March). AHFS DI. Ado-trastuzumab emtansine. Retrieved February 23, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, February). Ado-trastuzumab emtansine. Retrieved February 23, 2018 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Ado-trastuzumab emtansine. Retrieved February 23, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Kadcyla® (ado-trastuzumab emtansine) for injection, for intravenous use. Retrieved February 23, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/8/2013

MOST RECENT REVIEW DATE:  5/8/2018

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  1 billable unit = 1 mg

DIAGNOSIS

MAXIMUM UNITS

All indications

480 billable units every 21 days