Cancer
Genetic Testing

Diagnosis: Prostate Cancer
Treatment: genetic testing
The insurer denied genetic testing. The health plan's determination is upheld.

The patient is a male who underwent a prostate biopsy for an elevated prostate-specific antigen (PSA). The biopsy showed Gleason 6 adenocarcinoma in 5 out of 15 cores. The clinical stage was T1c. An OncotypeDx test was ordered on the biopsy specimens. Medical necessity of the test is under review.

The Genetic Testing is not medically necessary for this patient. The Oncotype DX Prostate Cancer Assay is a real time polymerase chain reaction (RT-PCR) assay designed for analysis of prostate core needle biopsies. The assay measures the expression of 17 genes to calculate a Genomic Prostate Score (GPS). A lower GPS score more favorable biology and less aggressive disease. This test may be utilized to counsel men regarding the best course of therapy (active surveillance versus (vs). treatment) in newly diagnosed low or low-intermediate prostate cancer. The American Urological Association (AUA) Guidelines on Clinically Localized Prostate Cancer, 2017 states, "Among most low-risk localized prostate cancer patients, tissue based genomic biomarkers have not shown a clear role in the selection of candidates for active surveillance. Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up."

While Oncotype Dx may eventually have a role in making treatment decision about patients with prostate cancer, there is limited data on clinical outcomes to currently support routine use. Hence, it is not considered a generally acceptable standard of care for management of patients with a diagnosis of prostate cancer.