NEW YORK (360Dx) – Opko Health announced today that Medicare administrator Novitas Solutions has issued a draft local coverage determination of non-coverage of the company's 4Kscore test.
Opko said it plans to submit comments on the proposed LCD by the end of the comment period, ending July 5.
The proposal is the latest development in Opko's efforts to get a positive LCD for the test, which uses four prostate-specific biomarkers to measure the risk of aggressive prostate cancer. Medicare contractor Novitas originally issued a positive LCD for the test in May of 2016, but withdrew that determination after another Medicare contractor, Palmetto issued a conflicting LCD not to cover the test.
Opko today pointed out that the 4Kscore test has been included in the National Comprehensive Cancer Network Guidelines since 2015, and the European Association of Urology Prostate Cancer Guidelines since 2016. Both guidelines recommend that the 4Kscore test can be used as an aid in decision-making before a first or repeat prostate biopsy in men with elevated PSA or other clinical symptoms, according to the company.
Opko added that the 4Kscore test has a 95 percent sensitivity and a 93 percent negative predictive value for identification of aggressive prostate cancer in the patient population recommended by NCCN. The 4Kscore has been ordered by more than 9,000 physicians worldwide, and studies of the test, involving more than 25,000 patients collectively, has been presented in 18 peer-reviewed scientific publications, according to the company.
In one study published in March, researchers reported that 4Kscore could identify patients who had elevated PSA levels but were at low risk of dying from prostate cancer over the next 20 years.
During Opko's first quarter conference call last week, Opko reported that 4Kscore test utilization in the recently completed quarter was up 13 percent from the year-ago period. In Q1, there were approximately 21,000 4Kscore tests performed, according to Opko Executive Vice President, Administration Steven Rubin.
Results of five new studies of the 4Kscore test will be presented at the American Urological Association's 2018 annual meeting in San Francisco this weekend, including the second study demonstrating the 4Kscore test's ability to predict prostate cancer mortality in men with elevated PSA, Opko said. In June, a study will also be presented at the American Society of Clinical Oncology meeting demonstrating that the 4Kscore test has clinical utility for management decisions of men diagnosed with low- and intermediate-risk prostate cancer due to its strong association with radical prostatectomy pathology outcome, the company said.
The 4Kscore test uses levels of four kallikrein protein markers — total prostate specific antigen, free PSA, intact PSA, and hK2 — combined with patient age and digital rectal exam results to determine the likelihood of a patient having aggressive prostate cancer. The test also provides clinicians with a score based on the patient's risk of having an aggressive cancer.
The test aims to address the issue of the overdiagnosis of prostate cancer by prostate-specific antigen tests. Some organizations, such as the American Academy of Family Physicians has recommended against the use of PSA tests for prostate cancer screening due to the overdiagnosis issue.
Last week, the US Preventive Services Task Force released its recommendations for prostate cancer screening, saying men between the ages of 55 and 59 should decide with their clinicians whether to pursue PSA-based cancer screening. The panel also recommended against PSA-based screening for prostate cancer in men 70 years and older.