NEW YORK – Decipher Biosciences announced on Tuesday that Medicare Administrative Contractor Palmetto GBA has issued a final local coverage determination (LCD) for the use of the company's Decipher Prostate Biopsy test in men diagnosed with favorable or unfavorable intermediate-risk prostate cancer.
Decipher Prostate Biopsy is indicated for men with localized prostate cancer at diagnosis, the company said. It's a clinical-grade whole-transcriptome assay, measuring the expression of over 1.4 million RNAs, performed on formalin-fixed paraffin embedded (FFPE) prostate cancer tumor tissue from diagnostic biopsy needle cores. The assay results are reported as a genomic classifier score based on gene expression using a machine-learning algorithm. The molecular pathways represented include proliferation/cell death, invasion and metastasis, androgen signaling, immune activity and response, growth and differentiation, angiogenesis, and metabolism functions.
The test can be used to provide a continuous score and a categorization of that score into low, average, or high risk with associated probabilities of high-grade disease, five-year metastatic risk, and 10-year prostate cancer specific mortality.
The company's second test, Decipher Prostate RP, is indicated for men after prostate-removal surgery. Both assays are meant to help guide physicians in the selection of appropriate therapies for specific patients.
The Medicare LCD, "Decipher Biopsy Prostate Cancer Classifier Assay for Men with Intermediate Risk Disease," will become effective on Jan. 6, 2020. Decipher also said it has effective Medicare coverage for use of Decipher Prostate in men with very low and low-risk prostate cancer as well as men with adverse pathological findings after surgical removal of the prostate.
According to the Palmetto LCD, the test will be covered when several criteria are met, including a needle biopsy with localized adenocarcinoma of prostate, but no clinical evidence of metastasis or lymph node involvement; FFPE prostate biopsy specimen with at least 0.5 mm of cancer length, and favorable or unfavorable intermediate risk disease as defined in the most recent available NCCN guideline; an estimated life expectancy for the patient of greater than or equal to 10 years; a possibility for the patient to undergo definitive therapy; if the result of the test can be used to determine treatment among definitive therapy modalities or observation; that the patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy; and that the patient is monitored for disease progression according to established standard of care.
"The recommendation to treat intermediate risk men, particularly those with unfavorable intermediate risk disease, is based in part on Level I evidence showing survival benefit from definitive therapy. However, the intensity of treatment appropriate in this risk stratum remains ambiguous despite further stratification of the intermediate risk disease category," Palmetto wrote in its coverage guidelines. "The broad range of recommended interventions for intermediate risk men is reflective of the heterogeneous metastatic potential of disease classified as intermediate risk and the increased morbidity of intensified therapy. In all cases, treatment intensification appears most appropriate in men that are at elevated risk of disease progression. As such, a clinical tool that is able to enhance risk stratification would be expected to allow for more informed decisions regarding treatment selection."
In a statement, Decipher President and CEO Tina Nova noted that the use of Decipher Prostate Biopsy in intermediate-risk men with prostate cancer can help to match the selection and intensity of treatment with the metastatic potential of the tumor, reducing the chances of over- or under-treatment, and improving outcomes.