Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cancer. 
Treatment: Cancer Screening.
The insurer denied Oncotype DX Prostate. 
The denial 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 2 out of 12 cores. The clinical stage was T1c. An Oncotype DX test was ordered on the biopsy specimens.
At issue is whether the proposed health service Oncotype DX Prostate is likely to be more beneficial than any standard treatment for the patient's disease.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Oncotype DX prostate is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
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 means 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.
These studies have financial conflicts of interest, are recently published, and need continued validation from a widespread clinical use. 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. 
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."
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."
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."
Therefore, the proposed health service or treatment Oncotype DX prostate is not likely to be more beneficial than any standard treatment or treatments for this patient.