This decision follows a final LCD decision from Palmetto GBA on January 15, 2015.
The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website with an effective date of October 15, 2015 and provides Medicare coverage for prostate cancer patients defined as low and very low risk by the National Comprehensive Cancer Network (NCCN).
The Medicare coverage decision extends reimbursement for testing to the approximately 60,000 patients diagnosed each year with localized prostate cancer in the United States who meet the criteria of a Gleason score =6 and serum prostate specific antigen (PSA) level <10 ng/ml.
"We are excited that Noridian has issued a final LCD for Prolaris, providing coverage for Medicare beneficiaries with localized prostate cancer," said Mark Capone, president and CEO, Myriad Genetics.
"The decision is an important step in providing Medicare reimbursement for this life-saving test and will significantly increase patient access to Prolaris testing in the United States."
More than 220,000 new cases are diagnosed and 30,000 men will die from the disease each year, making prostate cancer the second leading cause of cancer death among men in the United States.
In Dec. 2014, Myriad presented data at the Society of Urological Oncology meeting that showed Prolaris could save the healthcare system $6 billion over a ten-year time period. Also, data from the recently completed PROCEDE 1000 clinical utility study demonstrated that physicians changed their treatment decisions in 48 percent of cases based on results from the Prolaris test.
Of these treatment changes, 73 percent were reductions in treatment, while 27 percent were increases in treatment.
"At last, doctors who care for men with prostate cancer have an objective test to accurately measure the aggressiveness of their patients’ cancer," said Michael Brawer, M.D., vice president of Urology, Myriad Genetic Laboratories. "Physicians can use this information to tailor treatments based on patients’ individual risk."
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth.
Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy.
