Novitas Issues Favorable LCD Criteria for OPKO Prostate Cancer Test

Novitas has posted a local coverage determination for Florida-based OPKO Health’s predictive prostate cancer blood test, 4Kscore® Test, opening up the door for it eventually being covered by the Medicare program.

According to the Novitas LCD, the test would be considered reasonable and necessary for any patient with prostate-specific antigen (PSA) levels of three or above who have not undergone a biopsy, or three or above with at least one prior negative biopsy but considered to be at higher risk for contracting prostate cancer.

The LCD criteria appears generous for OPKO. The National Cancer Institute (NCI) notes on its website that a PSA score of up to four is considered normal, and any score above that would be abnormal and predictive of a higher prostate cancer risk. However, the NCI also noted recent studies citing incidence of prostate cancer in patients with a PSA score of four or below.

An OPKO spokesperson said that if the cutoff were as low as 1.5, virtually no aggressive prostate cancer would go undetected.

In addition to diagnosing cancer or predicting a patient’s risk, the test can also provide insights about the potential aggression of any current or future cancers.

“This first MAC determination is a major milestone for the 4Kscore Test as it expands access to a potentially life-saving tool,” said Phillip Frost, M.D., OPKO’s chief executive officer. “We believe this decision by Novitas will help accelerate further coverage decisions by other payers, and will encourage adoption of the 4Kscore Test by physicians and patients. More importantly, it will allow broader access to this important test, which can assist patients and physicians in further defining a patient’s risk of having a high-grade prostate cancer that requires immediate or aggressive treatment.”

The test is seen as a way of avoiding an invasive prostate cancer biopsy, which usually ranges in price from the low to mid four figures. In some instances, the patients are placed under general anesthesia, increasing the risk for complications. A study published earlier this year in the journal Reviews in Urology concluded the 4Kscore test substantially cut down on the use of the procedure across all risk categories of patients.

OPKO has seen the 4Kscore as a potential blockbuster assay for the company, which is trying to find its footing after its acquisition last year of the much larger Bio-Reference Laboratory.

Marion Janic, an OPKO spokesperson, said that the company had also received coverage from some commercial payers at around 50 percent of the test’s retail price of $1,900.

“We expect to obtain broad reimbursement by the end of the year,” Janic said in an email. He added that the Medicare price continued to be under negotiation. Medicare pricing tends to be significantly below that of commercial reimbursement.

For the first quarter of 2016, OPKO reported a loss of $12 million on revenue of $291 million. That compares to the first quarter of 2015, when the pre-merger OPKO lost $118 million on revenue of $30 million.

Takeaway: OPKO appears to have scored a victory on Novitas’ LCD for its predictive prostate cancer test.