Diagnosis: Gleason 3+3 adeno carcinoma

Treatment: Oncotype DX Prostate Cancer Assay

The insurer denied coverage for Oncotype DX Prostate Cancer Assay. The denial is upheld.

This patient is a male with a prostate-specific antigen (PSA) of 2.5, who underwent a prostate biopsy for further evaluation. The patient was diagnosed with Gleason 3+3 adeno carcinoma in 1/12 biopsy cores, Gleason grade group 1. The patient then had on Oncotype Dx PCA test ordered for further risk stratification. The patient's genomic prostate score (GPS) score was 17, indicating very low risk prostate cancer.

While the National Comprehensive Cancer Network (NCCN) guidelines state that men who have a NCCN low risk or favorable intermediate risk prostate cancer and at least a 10 year life expectancy should consider the usage of tissue based genomic biomarkers; they also note the absence of randomized prospective trials. The American Urological Association (AUA) guidelines are not so positive on the usage of biomarker testing. The AUA states that the "tissue based genomic biomarker tests (such as Oncotype Dx PCA) have not shown a clear role in active surveillance for localized prostate cancer, and are not necessary for follow-up." Based on the review of the literature guidelines, the impact of tissue based gene expression tests, such as Oncotype Dx PCA, on clinical practice and long term patient outcomes remains to be empirically demonstrated. There is insufficient evidence to support that the prospective studies of these tests yield a true clinical benefit when implemented in clinical practice. It is not yet clear which patient population this test benefits and fits into the algorithm of the diagnosis and/or management of prostate cancer.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the Oncotype DX Prostate Cancer Assay is not substantiated. The insurer's denial is upheld.