preview

Prostate Cancer: A Case Study

Decent Essays

The records have been reviewed. The member is an adult male with a birth date of 03/10/1960. He has a diagnosis of prostate cancer. His treating provider, Samuel Torres, MD, recommended the Oncotype DX Prostate Cancer Assay, which was performed on 12/30/2015.

The carrier has denied coverage of Oncotype DX Prostate Cancer Assay as experimental and/or investigational and not medically necessary. A letter from the carrier to the provider, dated 06/22/2016, states in part:

“Claim number 201602083184074 (Genomic Health Inc.) was denied as services that are experimental/investigational are not a covered benefit. According to Humana's medical coverage policy, while the Oncotype DX assay may eventually have a role in making treatment decisions about …show more content…

Boyter was proposed a variety of options regarding how best to treat his cancer. His biopsy and PSA level indicated that he had low risk of disease. These characteristics are helpful, but often are not reflective of the extent of the tumor within the prostate. Thus, a physician cannot fully determine whether a patient has low risk prostate cancer that can be managed with active surveillance (AS), a clinically acceptable course of conservative management for men with low risk cancers, or whether he has aggressive prostate cancer and would benefit from surgery or radiation therapy without the results of an Oncotype DX Prostate Cancer Assay, he and his physician did not have a complete understanding of the biology of his …show more content…

The biopsy revealed Gleason score 6 adenocarcinoma in 3 cores. The clinical stage was T1c. An OncotypeDx Prostate test was ordered on the biopsy specimens; this was performed on 12/30/2015. The Health Plan considers the testing experimental/investigational and has denied coverage. Medical necessity of the testing is under review.

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 has a more favorable biology and less aggressive disease. This test may be utilized to counsel men regarding the best course of therapy (active surveillance vs. treatment) in newly diagnosed low or low-intermediate prostate cancer.

Two recent studies have suggested that Oncotype Dx can predict adverse pathology and unfavorable outcomes after radical prostatectomy. In both of these studies, multiple authors are either employed by the manufacturer of the test or have a financial interest. These studies are recently published and need continued validation prior to widespread clinical use. The medical literature is still insufficient to conclude that the use of this test for decision making after prostate biopsy yields improved

Get Access