NEW YORK – Medicare administrative contractor Novitas has issued a proposed limited local coverage determination for Opko Health's 4Kscore, changing course from a previously issued non-coverage determination, the company said today.
The 4Kscore test measures blood levels of four kallikrein protein markers — total prostate specific antigen (PSA), free PSA, intact PSA, and hK2 — and combines this data with patient age, digital rectal exam results, and prior biopsy history to assess a man's risk for having aggressive prostate cancer and refine patient selection for biopsies so as to reduce unnecessary prostate biopsies.
The proposed LCD, which opened for comments yesterday and will remain open until Aug. 11, states that 4Kscore will be considered medically reasonable and necessary in men 45 years of age and older, prior to an initial biopsy or following a negative biopsy, who have a confirmed moderately elevated PSA, and when there is no other relative indication for biopsy and no other relative contraindication for biopsy. In addition, the proposed LCD stipulates the presence of shared decision-making between the ordering physician and patient.
Earlier this year Novitas issued a notice of future non-coverage determination, after originally issuing a positive LCD in May 2016 but later withdrawing it after another MAC, Palmetto GBA, issued a conflicting LCD. Novitas has now changed its stance after Opko submitted additional comments and evidence including published studies supporting the test's utility.
Novitas serves as the MAC for a jurisdiction that includes New Jersey, where Opko's BioReference Laboratories is located, and where all 4Kscore test samples are processed. Opko said last week that it submitted a de novo request to the US Food and Drug Administration for regulatory clearance of 4Kscore. Opko has offered the test since 2014 in the US, Europe, and elsewhere.
In mid-afternoon trading on Nasdaq, Opko's shares were up around 7 percent to $2.38.