Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer. 
Treatment: Oncotype Dx Prostate. 

The insurer denied the Oncotype Dx Prostate. 
The determination is upheld. 

The patient underwent a prostate biopsy for an elevated prostate-specific antigen (PSA). The biopsy showed Gleason 6 adenocarcinoma in 3 out of 15 cores. The clinical stage was T1c. An Oncotype Dx test was ordered on the biopsy specimens. At issue is the medical necessity for the Oncotype Dx test. 

The Oncotype Dx Prostate Cancer Assay not medically necessary for this patient. A biopsy showed Gleason 6 adenocarcinoma in 3 out of 15 cores. The clinical stage was T1c.  Oncotype Dx 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 treatment) in newly diagnosed low or low-intermediate prostate cancer. 

Recent studies have suggested that Oncotype Dx can predict adverse pathology and unfavorable outcomes after radical prostatectomy. These studies have financial conflicts of interest, are recently published and need continued validation from a widespread clinical use. In addition, it is difficult to ascribe clinical utility of Oncotype Dx Prostate in patients planning to undergo active surveillance as all patients in the above studies, regardless of clinical criteria, elected radical prostatectomy within 6 months of diagnostic biopsy. Moreover, the validity of using different degrees of tumor pathology as "markers" to extrapolate the risk of progression of a tumor in vivo is unclear. 

The National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer 2020 states, "Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed men considering active surveillance and in treated men considering adjuvant therapy or treatment for recurrence. No randomized controlled trials have studied the utility of these tests. These molecular biomarker tests have been developed with extensive industry support, guidance, and involvement, and have been marketed under the less rigorous Food and Drug Administration (FDA) regulatory pathway for biomarkers. Although full assessment of their clinical utility requires prospective randomized clinical trials, which are unlikely to be done, the panel believes that men with low or favorable intermediate disease may consider the use of Decipher, Oncotype DX Prostate, Prolaris, or ProMark during initial risk stratification. Men with unfavorable intermediate-and high-risk disease and life expectancy greater than or equal to (>=) 10 years may consider the use of Decipher and Prolaris tumor-based molecular assays." 

The European Association of Urology (EAU) Guidelines on Prostate cancer, 2019 states the following about Prolaris and Oncotype Dx test, "The results of prospective multicentre studies are awaited before a recommendation can be made regarding their routine application." 

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."
The American Society for Clinical Oncology (ASCO) Guideline on Molecular Biomarkers in Localized Prostate Cancer, 2019 states "Tissue-based molecular biomarkers (evaluating the sample with the highest volume of the highest Gleason pattern) may improve risk stratification when added to standard clinical parameters, but the Expert Panel endorses their use only in situations in which the assay results, when considered as a whole with routine clinical factors, are likely to affect a clinical decision. These assays are not recommended for routine use as they have not been prospectively tested or shown to improve long-term outcomes-for example, quality of life, need for treatment, or survival."
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. Therefore, it is not considered a generally acceptable standard of care for management of patients with a diagnosis of prostate cancer and is not medically necessary for this patient.