50242-0088-XX Kadcyla 100 MG SOLR (GENENTECH)
50242-0087-XX Kadcyla 160 MG SOLR (GENENTECH)
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
Ado-trastuzumab emtansine for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Non-Small Cell Lung Cancer
Ado-trastuzumab emtansine for the treatment of other conditions/diseases is considered investigational.
Ado-trastuzumab emtansine is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individuals disease is human epidermal growth factor receptor 2 (HER2)-positive*
Baseline left ventricular ejection fraction (LVEF) within normal limits
Used as single agent therapy
Diagnosis of ANY ONE of the following:
Breast cancer and ANY ONE of the following:
Used as adjuvant therapy in individuals with residual disease after preoperative therapy
Individual was previously treated with trastuzumab and a taxane (separately or in combination) for metastatic or recurrent disease
Non-Small Cell Lung Cancer
|*HER2 positive overexpression criteria defined as ANY ONE of the following:|
Ado-trastuzumab emtansine is considered medically appropriate for renewal therapy if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response is indicated with stabilization of disease or decrease in size of tumor
Absence of unacceptable toxicity from the drug, e.g., hepatotoxicity; left ventricular dysfunction; pulmonary toxicity (i.e. pneumonitis); thrombocytopenia; neurotoxicity; infusion-related and hypersensitivity reactions; hemorrhage; extravasation at infusion site; etc.
Left ventricular ejection fraction (LVEF) is >45% OR LVEF is ≥40% and absolute decrease is <10% from baseline (results must be less than 3 months old)
Use for adjuvant treatment of breast cancer treatment is limited up to 42 weeks on
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Adjuvant therapy of HER2-positive breast cancer after preoperative systemic therapy
|3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) for up to 14 cycles.|
All other indications
|3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity|
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Use as adjuvant treatment of HER2-positive disease in individuals with residual disease after preoperative therapy will be limited up to 14 cycles.
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).
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. (2019, February). AHFS DI. Ado-trastuzumab emtansine. Retrieved April 16, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, April). Ado-trastuzumab emtansine. Retrieved April 16, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium™. Ado-trastuzumab emtansine. Retrieved April 16, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Kadcyla® (ado-trastuzumab emtansine) for injection, for intravenous use. Retrieved April 16, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125427s096lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/8/2013
MOST RECENT REVIEW DATE: 8/30/2019
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