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Novitas Announces Future Non-Coverage of Opko's 4Kscore Prostate Cancer Test

NEW YORK (360Dx) – Opko Health announced that Medicare administrator Novitas Solutions has issued a notice of future non-coverage determination for the company's 4Kscore prostate cancer test.

The non-coverage determination, scheduled to take effect March 20, appears identical to the draft non-coverage determination released by Novitas on May 18, 2018, according to Opko. The company is evaluating options for appealing the decision and will try to work with the Centers for Medicare & Medicaid Services in an effort to have the determination rescinded or reversed.

Novitas had originally issued a positive local coverage determination for the test in May of 2016, but withdrew that determination after Medicare contractor Palmetto issued a conflicting LCD.

After the draft non-coverage determination was released last year, Steven Rubin, Opko's executive vice president administration, said during a quarterly conference call that the company had submitted comments to Novitas aimed at reversing the decision, including published studies supporting the effectiveness of the test. Eight urologists also spoke to Novitas about the usefulness of the test, he said.

The 4Kscore test uses levels of four kallikrein protein markers – total prostate specific antigen (PSA), free PSA, intact PSA, and hK2 – combined with patient age and digital rectal exam to determine the likelihood of a patient having aggressive prostate cancer. The test, which aims to address the issue of overdiagnosis of prostate cancer by PSA tests, provides clinicians with a score of the patient's risk for having aggressive prostate cancer.

In announcing the future non-coverage determination, Opko pointed out that the test has been included in the National Comprehensive Cancer Network (NCCN) guidelines since 2015, and the European Association of Urology Prostate Cancer guidelines since 2016. The test has 95 percent sensitivity and 93 percent negative predictive value for the identification of aggressive prostate cancer in the patient population recommended by NCCN, according to the company.

"The 4Kscore test is proven to offer significant benefits to patients. It can identify men at higher risk of aggressive prostate cancer who will benefit from a prostate biopsy, while also helping to avoid biopsies in men who are at low risk," said Phillip Frost, chairman and CEO of Opko, in a statement. "We remain committed to our goal of widespread and affordable access to 4Kscore."

More than 200,000 4Kscore tests have been ordered by more than 12,000 practicing physicians worldwide, according to the company. Utilization of the 4Kscore was around 18,700 tests for third quarter 2018, the most recent quarter reported, down from 18,900 tests ordered in the same quarter the prior year.

Novitas serves as the Medicare Administrative Contractor for a jurisdiction that includes New Jersey, where Opko's BioReference Laboratories is located, and where all 4Kscore test samples are processed.

Shares of Opko were down around 5 percent on the Nasdaq at $3.51 in Friday morning trade.