When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
Ado-trastuzumab emtansine (Kadcyla®) is considered medically necessary and, therefore, covered for the indication(s) identified below in individuals who meet the applicable criteria, and whose tumors have human epidermal growth factor receptor 2 (HER2) protein overexpression verified as a positive result by one of the following US Food and Drug Administration (FDA)--approved diagnostic tests:
Confirmatory tests should be performed for borderline results as follows:
- Immunohistochemical (IHC) assay with a result of 3+
- Fluorescence in situ hybridization (FISH) test (ratio greater than 2.0)
- Single-probe in situ hybridization (ISH) test with average HER2 copy number 6.0 signals/cell or greater
- Dual-probe ISH test HER2/CEP17 (chromosome enumeration probe 17) ratio 2.0 or greater; or HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 6.0 signals/cell or greater
ADJUVANT SYSTEMIC THERAPY
Ado-trastuzumab emtansine (Kadcyla®) is considered medically necessary and, therefore, covered when all of the following criteria are met:
- If IHC assay has a result of 2+, confirm with ISH test of the same sample or a new test with IHC or ISH (if new sample available).
- If FISH test has a HER2 gene/chromosome 17 ratio of 1.8-2.0, confirm with FISH re-test; additional cell counting and recalculation of the ratio; or IHC assay.
- If single-probe ISH assay has an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with dual-probe ISH or with IHC (if same sample), or with a new ISH or IHC (if new sample available).
- If dual-probe ISH assay has a HER2/CEP17 ratio less than 2.0 and an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with one of the following: IHC (if same sample), alternative ISH chromosome 17 probe, or order a new test with ISH or IHC (if new sample available).
RECURRENT OR METASTATIC BREAST CANCER
Ado-trastuzumab emtansine (Kadcyla®) is considered medically necessary and, therefore, covered as a single agent for individuals with HER2 positive, recurrent or stage IV (M1) breast cancer (verified by one of the FDA-approved diagnostic tests listed above), who meet the following criteria:
- For individuals with HER2-positive early breast cancer, who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
- The individual has left ventricular ejection fraction of 50 percent or greater.
- For individuals with HER2-positive tumors and locally advanced clinical stage ≥T2, M0 or ≥N1, M0 disease, as (NCCN preferred) therapy, and all of the following:
- The individual completed planned chemotherapy and following mastectomy or lumpectomy with surgical axillary staging if:
- ypT1-4N0 or residual disease
- ypN≥1 or node-positive
- The individual has a left ventricular ejection fraction of 50 percent or greater.
NON-SMALL CELL LUNG CANCER
Ado-trastuzumab emtansine (Kadcyla®) is considered medically necessary and, therefore, covered for individuals with adenocarcinoma (with mixed subtypes), Large cell carcinoma, Squamous cell carcinoma, who meet the following criteria:
- The individual has a documented history of receiving trastuzumab (Herceptin®) and a taxane (separately or in combination)
- The individual has received prior therapy for metastatic disease OR has developed disease recurrence during or within six months of completing adjuvant therapy
- The individual has a left ventricular ejection fraction of 50% or greater
- The individual is hormone receptor negative or hormone receptor positive
All other uses for ado-trastuzumab emtansine (Kadcyla®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
NOT MEDICALLY NECESSARY
- The individual has documented HER2 mutations
- The individual has a left ventricular ejection fraction of 50 percent or greater
When FDA-approved diagnostic tests do not reveal HER2 protein overexpression, for the indication of breast cancer, Emtansine (Kadcyla®) is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of those diseases.
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.