Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: oncology (prostate) messenger ribonucleic acid gene expression profiling of 22 content genes. 
The insurer denied oncology (prostate) messenger ribonucleic acid gene expression profiling of 22 content genes. 

The determination is upheld.

The patient underwent a prostate biopsy. A biopsy showed Gleason 3+4, clinical T1c, prostate-specific antigen (PSA) 4.64, intermediate risk prostate cancer. At issue is whether oncology (prostate) messenger ribonucleic acid gene expression profiling of 22 content genes is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

No. This 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 patient has a diagnosis of prostate cancer. The 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 years may consider the use of Decipher and Prolaris tumor-based molecular assays."
European Association of Urology (EAU) Guidelines on Prostate cancer, 2019 state the following about Prolaris and Oncotype DX test, "The results of prospective multicenter 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 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 Decipher 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.

The health plan's determination is upheld.