The use of the 21-gene reverse transcriptase-polymerase chain reaction (RT-PCR) assay (ie, Oncotype DX), EndoPredict, the Breast Cancer Index, MammaPrint, or Prosigna to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node-negative breast cancer meeting all of the following characteristics:
unilateral tumor (see Policy Guidelines);
hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);
human epidermal growth factor receptor 2-negative;
tumor size 0.6 to 1 cm with moderate or poor differentiation or unfavorable features OR tumor size larger than 1 cm;
node-negative (lymph nodes with micrometastases [≤2 mm in size] are considered node-negative for this policy statement);
who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);
when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND
when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.
The use of the MammaPrint assay to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node positive breast cancer meeting all of the following characteristics:
unilateral tumor;
hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);
human epidermal growth factor receptor 2-negative;
stage T1 or T2 or operable T3 at high clinical risk (see Policy Guidelines);
1 to 3 positive nodes (N1);
no distant metastases;
who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);
eligible for a chemotherapy regimen containing a taxane, an anthracycline, or both;
when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND
when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.
The use of Oncotype Dx to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node positive breast cancer meeting all of the following characteristics:
postmenopausal (defined as previous bilateral oophorectomy or more than 12 months since the last menstrual period and no previous hysterectomy);
unilateral tumor;
hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);
human epidermal growth factor receptor 2-negative;
stage T1 or T2 or operable T3 at high clinical risk (see Policy Guidelines);
1 to 3 positive nodes (N1);
no distant metastases;
who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);
eligible for a chemotherapy regimen containing a taxane, an anthracycline, or both;
when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND
when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.
The use of Oncotype Dx to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy in premenopausal women (defined as lass than 6 months since the last menstrual period) with primary, invasive, node positive breast cancer is considered investigational (see Policy Guidelines).
The use of EndoPredict, the Breast Cancer Index, and Prosigna to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy in individuals with primary, invasive, node positive breast cancer is considered investigational.
The Oncotype DX, EndoPredict, the Breast Cancer Index, MammaPrint, and Prosigna assays should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (ie, the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician-patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.
For patients who otherwise meet the above characteristics but who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted for testing. It is not necessary to test each tumor; treatment is based on the most aggressive lesion (see Policy Guidelines).
All other indications for the 21-gene RT-PCR assay (ie, Oncotype DX), EndoPredict, the Breast Cancer Index, MammaPrint, and Prosigna, including to consider the length of treatment with endocrine therapy, repeat testing with same test, or combination testing with various tests, are considered investigational.
Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (ie, Oncotype DX® Breast DCIS Score) to inform treatment planning after excisional surgery is considered investigational.
Use of the DCISion RT assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ to inform treatment planning after excisional surgery is considered investigational.
The use of BluePrint in conjunction with MammaPrint or alone is considered investigational.
The use of Insight TNBCtype to aid in making decisions regarding chemotherapy in women with triple-negative breast cancer is considered investigational.
Use of gene expression assays in men with breast cancer is considered investigational.
