Medicare Expands Coverage of Prolaris, Genetic Test for Prostate Cancer Aggressiveness

Medicare Expands Coverage of Prolaris, Genetic Test for Prostate Cancer Aggressiveness

Medicare coverage for Prolaris genetic test, a tool developed by  Myriad Genetics to help predict the aggressiveness of prostate, cancer has been expanded to include patients with favorable intermediate-risk cancer.

Men with low- and very low-risk disease are already covered by Medicare for this test, and the recent decision means the Prolaris test will now be available to 70 percent of Medicare beneficiaries with prostate cancer.

The announcement comes after Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the test.

“We are excited that the MolDX program has expanded Prolaris coverage to the thousands of Medicare beneficiaries with favorable intermediate risk prostate cancer,” Mark C. Capone, president and CEO of Myriad Genetics, said in a recent press release.  “The coverage decision is another important step to make sure the Prolaris test is broadly accessible to the patients who need it.”

About 20 percent of newly diagnosed prostate cancer patients have intermediate risk disease. Prolaris is a genomic test that aids clinicians in predicting the aggressiveness of prostate cancer  when used in combination with Gleason score and PSA.

It works to measure the molecular biology of patients’ prostate cancer, by measuring the expression levels of 46 genes involved in cancer cell proliferation and aggressiveness. Prolaris has been validated to predict 10-year prostate cancer-specific mortality in untreated patients, the company states in the release.

At diagnosis, the test can help doctors to identify patients with less aggressive disease who may be candidates for active surveillance, lowering both their risk of side effects and care costs. Prolaris can also identify patients who seem to be at low-risk disease, but have a more aggressive prostate cancer requiring more extensive treatment.

“It is clinically challenging to determine how best to treat men with favorable intermediate risk prostate cancer. Our goal is to provide physicians with genetic information and help them tailor treatments based on patients’ individual risk profiles,” said Michael Brawer, MD, senior vice president of urology, Myriad Genetic Laboratories. “The Prolaris test accurately measures the aggressiveness of prostate cancer and gives both the patient and physician the confidence to make appropriate medical management decisions.”