BRCA1 and BRCA2 Testing
Genetic testing for BRCA1 or BRCA2 germline variants may be considered medically necessary to predict treatment response to PARP inhibitors (eg, olaparib [Lynparza] and talazoparib [Talzenna]) for human epidermal receptor 2 (HER2)-negative metastatic and early stage, high-risk breast cancer (see Policy Guidelines).
Genetic testing of BRCA1 or BRCA2 germline or somatic variants in individuals with breast cancer for guiding therapy is considered investigational in all other situations.
PIK3CA Testing
PIK3CA testing may be considered medically necessary to predict treatment response to alpelisib (Piqray) in individuals with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who have progressed on or after an endocrine-based regimen (see Policy Guidelines).
When tumor tissue is available, use of tissue for testing is preferred but is not required (see Circulating Tumor DNA Testing below).
PIK3CA testing of tissue in individuals with breast cancer is considered investigational in all other situations.
Ki-67 Testing
Ki-67 testing to predict treatment response to abemaciclib (Verzenio) in individuals with breast cancer is considered investigational.
RET Testing
RET testing to predict treatment response to selpercatinib (Retevmo) in individuals with breast cancer is considered investigational.
BRAF Testing
BRAF testing to predict treatment response to dabrafenib (Tafinlar) plus trametinib (Mekinist) in individuals with breast cancer is considered investigational.
Circulating Tumor DNA Testing (Liquid Biopsy)
PIK3CA testing using FoundationOne Liquid CDx may be considered medically necessary to predict treatment response to alpelisib (Piqray) in individuals with hormone receptor-positive, HER2 negative advanced or metastatic breast cancer who have progressed on or after an endocrine-based regimen (see Policy Guidelines).
When tumor tissue is available, use of tissue for testing is preferred but is not required.
ESR1 testing using Guardant360 CDx may be considered medically necessary to predict treatment response to elacestrant (Orserdu) in individuals with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy (see Policy Guidelines).
Circulating tumor DNA testing in individuals with breast cancer is considered investigational in all other situations.
Circulating Tumor Cell Testing
Analysis of circulating tumor cells to select treatment in individuals with breast cancer is considered investigational.
Other
Testing for other variants may become available between policy updates.
