Reviewer #3:

This is a female with node negative ER+ HER 2 negative breast cancer. Prosigna Breast Cancer Prognostic Gene Signature Assay was performed and is under review.

The peer reviewed scientific literature does not support a result of improvement in health outcome for the Prosigna gene testing. The test is FDA approved; however, the Prosigna Breast Cancer Gene Assay does not have valid positive outcome data and is not recommended by the NCCN Guidelines. The patient is not a good candidate for the gene assay.

The NCCN (2019) states referring to the Oncotype Dx multigene test: "The NCCN Panel members acknowledge that many assays have been clinically validated for prediction of prognosis. However, based on the currently available data, the panel believes that the 21-gene assay has been best validated for its use as a prognostic test as well as in predicting who is most likely to respond to systemic chemotherapy."

According to Losk, K., Freedman, R. A., Lin, N. U., et al. (2017), "Wait times in the treatment of breast cancer have increased over the past 20 years, in part as a result of the growing complexity of breast cancer management, including additional testing conducted to help guide treatment decisions. Among patients with early-stage estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer, the Oncotype DX Recurrence Score (RS; Genomic Health, Redwood City, CA), a multigene diagnostic test that provides 10-year estimates for risk of breast cancer recurrence and the potential benefit of chemotherapy, is used by oncologists to assist in adjuvant treatment decisions and is included in all major breast cancer clinical guidelines."

The Prosigna gene assay is not likely to be more beneficial than any of the standard treatments for breast cancer (such as Oncotype DX). The carrier's denial of coverage for the Prosigna Breast Cancer Prognostic Gene Assay should be upheld.