Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer. 
Treatment: Cancer Screening. 
The insurer denied: OncotypeDx test. 
The denial is upheld in whole.

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.
The subject under review is whether the test is medically necessary in this case.

The health plan's determination is upheld in whole.

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 indicates 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.

Recent studies have suggested that OncotypeDx 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 OncotypeDx 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.

National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer 2019 state, "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."

While OncotypeDx may eventually have a role in making treatment decisions 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, and therefore is not considered medically necessary.