Description

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.

Criteria

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 www.fepblue.org 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