Diagnosis: Prostate Cancer.
Treatment: OncotypeDx Prostate Cancer Assay (0047U).

The insurer denied the OncotypeDx Prostate Cancer Assay (0047U).
The denial is upheld.

The patient is a male with expected life expectancy of greater than (>) ten years with history of prostate specific antigen (PSA) 4.57 a few years ago with 11% free prostate specific antigen (PSA), increase in prostate specific antigen to 5.1. The patient's magnetic resonance image (MRI) obtained demonstrated prostate imaging reporting and data system (PI-RADS) IV and three lesions, 30 centimeter (cm) prostate. There was no prior history of prostate biopsy.

The patient underwent prostate biopsy with results of Gleason 3+3=6 in three of 16 cores involving, five percent in two cores and ten percent in one core. The patient had OncotypeDx obtained with result of Genomic Prostate Score (GPS) of 13, very low risk. The patient was on active surveillance.

The requested service, OncotypeDx, was denied in the final adverse determination stating "the peer reviewed literature doesn't support the use of test for the diagnosis of prostate cancer thus the service is not considered safe and effective".

No, the health plan should not cover the proposed OncotypeDx Prostate Cancer Assay (0047U).

The requested service, OncotypeDx in this patient with National Comprehensive Cancer Network (NCCN) low risk prostate cancer is not supported by the American Urologic Association guidelines on clinically localized prostate cancer and the American Society of Clinical Oncology guidelines on protein biomarkers in prostate cancer. The American Urologic Association (AUA) / American Society of Clinical Oncology (ASCO) / Society of Urologic Oncology (SUO) guidelines on clinically localized prostate cancer note that "amongst 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".

There is lack of comparative trials and the impact of the requested service on health outcomes is not well established.

The National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer note "the panel believes that patients with low or favorable intermediate risk disease and life expectancy > 10 years may consider use of decipher, OnctoypeDx prostate or prolaris during initial risk stratification. Future comparative effectiveness research may allow these tests and others like them to gain additional evidence regarding their utility for better risk stratification of patients with prostate cancer.

The American Society of Clinical Oncology (ASCO) guidelines on molecular biomarkers in localized prostate cancer note "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".

Cucchiara et al concluded "despite progress made in discovering suitable biomarker candidate few have been used in a clinical setting. Large-scale and multi-institutional studies are required to validate the efficacy and cost utility of these new technologies."

Thus as the current guidelines do not indicate that the requested service is necessary for the evaluation and management of the patient's low risk prostate cancer and the guidelines and medical literature support that further studies are needed to determine the impact of the requested service on health outcomes, the requested service would not be considered medically necessary.