Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer 
Treatment: Cancer Screening 

The insurer denied the Oncotype DX testing. 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 2 out of 12 cores. The clinical stage was T1c. An Oncotype Dx test was ordered on the biopsy specimens. The subject under review is the medical necessity for the testing. 

The health plan's determination is upheld. 

The Oncotype DX Prostate Cancer Assay is not medically necessary for this patient. 

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. 

National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer 2020 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 y may consider the use of Decipher and Prolaris tumor-based molecular assays." 

American Society for Clinical Oncology 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. Hence, it is not considered a generally acceptable standard of care for management of patients with a diagnosis of prostate cancer.