In certain cancers, the human epidermal growth factor receptor 2 (HER2) gene is amplified and overexpressed. Trastuzumab (Herceptin®) is a humanized monoclonal antibody, HER2 receptor antagonist, used for the treatment of various cancers including breast and metastatic gastric or gastroesophageal junction adenocarcinoma works by halting the out-of-control growth prompted by an overabundance of the HER2/neugene.
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.
The use of trastuzumab (Herceptin) may be considered medically when the presence of the HER2-overexpression is confirmed by the following:
HER2-overexpression 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 2.0); or
- Single-probe in situ hybridization (ISH) test with average HER2 copy number 6.0 signals/cell or greater; or
- 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.
Confirmatory tests should be performed for borderline results as follows:
- 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); or
- 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; or
- If single-probe ISH assay has an average HER2 copy number result ); or 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); or
- 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).
Trastuzumab (Herceptin) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indications
- For adjuvant treatment of HER2-overexpressing node positive or node negative (estrogen receptor/progesterone [ER/PR] receptor negative or with one high risk feature) breast cancer in ANY of the following:
- As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or
- As part of a treatment regimen with docetaxel and carboplatin; or
- As a single agent following multi-modality anthracycline based therapy; or
- For metastatic breast cancer in ANY of the following:
- In combination with paclitaxel for first-line treatment of HER2-ovrexpressing metastatic breast cancer; or
- As a single agent for treatment of HER2-overexpressing breast cancer in individuals who have received one or more chemotherapy regimens for metastatic disease; or
Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- For treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in combination with cisplatin and capecitabine or 5-fluorouracil in individuals who have not received prior treatment for metastatic disease.
The use of trastuzumab (Herceptin) for any other indication listed above is considered experimental/investigational, and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.