Ado-trastuzumab emtansine (Kadcyla)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019


Ado-trastuzumab emtansine (Kadcyla®) is a human epidermal growth factor receptor 2 (HER2) targeted antibody-drug conjugate comprised of trastuzumab and emtansine. Ado-trastuzumab emtansine (Kadcyla) is an antagonist of HER2 that is intended as treatment for individuals with HER2-overexpressing cancer.


Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the website.

Human epidermal growth factor receptor 2 (HER’s-2) protein over expression must be verified by ANY ONE of the following FDA approved diagnostic tests:

  • An immunohistochemical (IHC) assay with a result of 3+ (positive); or
  • A positive fluorescence in situ hybridization (FISH) test (ratio greater than 2.2); or
  • In situ hybridization (ISH) positive by ANY of the following:
    • Single-probe in situ hybridization (ISH) test with average HER2 copy number greater than or equal to 6.0 signals/cell; or
    • Dual-probe ISH test: HER2/CEP17 (chromosome enumeration probe 17) ratio greater than or equal to 2.0; or
    • HER2/CEP17 ratio less than 2.0 and average HER2 copy number greater than or equal to 6.0 signals/cell.

Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for adult individuals for the following indications:

Food and Drug Administration (FDA) Indications:

Breast Cancer:

  • As single agent therapy for treatment of HER2-positive metastatic breast cancer:
    • In individuals who previously received trastuzumab and a taxane, separately or in combination; and
    • Individual has received prior therapy for metastatic disease or developed disease recurrence during or within six months of completed adjuvant therapy; or
  • As single agent therapy for treatment of HER2-positive early breast cancer in individuals who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment; or

National Comprehensive Cancer Network (NCCN) Recommendations:

Breast Cancer:

  • As adjuvant systemic therapy for individuals with HER2-positive invasive breast cancer and ANY of the following clinical stages:
    • T1-3, N0-1, M0; or
    • T0-3, N1, M0 disease; or
    • ANY of the locally advanced clinical stages following completion of planned chemotherapy if residual disease are preoperative therapy:
      • T0-4, N1-3, M0; or
      • T2-4, N0, M0; or
  • As single agent therapy for recurrent or stage IV HER2-positive invasive breast cancer for either hormone receptor negative or hormone receptor positive disease; or

Non-Small Cell Lung Cancer

  • In individuals with non-small cell lung cancer with HER2-positive mutations.

The use of ado-trastuzumab emtansine (Kadcyla) is considered experimental/investigational in all other situations, and therefore non-covered. There is insufficient evidence in the peer reviewed published literature regarding its effectiveness and safety.

 Procedure Codes


Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

C33 C34.00 C34.01 C34.02 C34.10 C34.11 C34.12
C34.2 C34.30 C34.31 C34.32 C34.80 C34.81 C34.82
C34.90 C34.91 C34.92 C50.011 C50.012 C50.019 C50.021
C50.022 C50.029 C50.111 C50.112 C50.119 C50.121 C50.122
C50.129 C50.211 C50.212 C50.219 C50.221 C50.222 C50.229
C50.311 C50.312 C50.319 C50.321 C50.322 C50.329 C50.411
C50.412 C50.419 C50.421 C50.422 C50.429 C50.511 C50.512
C50.519 C50.521 C50.522 C50.529 C50.611 C50.612 C50.619
C50.621 C50.622 C50.629 C50.811 C50.812 C50.819 C50.821
C50.822 C50.829 C50.911 C50.912 C50.919 C50.921 C50.922
C50.929 Z85.118 Z85.3