Prostate Cancer Test Shows Role of 'Clinical Utility'

How Can Molecular Diagnostic Companies Show Value if Insurers Won't Pay?

FOR IMMEDIATE RELEASE FEBRUARY 20, 2014

Prostate Cancer Test Shows Role of ‘Clinical Utility’

How Can Molecular Diagnostic Companies Show Value if Insurers Won’t Pay?

PLAINSBORO, N.J. — A test that could determine whether a man with signs of prostate cancer needs a second biopsy seems a no-brainer, correct? Not unless the insurer paying for it is convinced that his doctor’s decision will turn on the outcome of that test.

Welcome to the world of clinical utility, the new bar that molecular diagnostic testing companies must meet as insurance companies, Medicare and Medicaid strive to hold down costs, just as the possibilities of personalized medicine seem boundless. A story in the current issue of Evidence-Based Oncology, a news publication of The American Journal of Managed Care, explores how the demand for proof of clinical utility has affected the marketing of MDxHealth’s promising new epigenetic test for prostate cancer, called Confirm MDx. Peer-reviewed research pegs the test’s savings at $500,000 a year for a commercial plan of 1 million members.

The standard of clinical utility, versus the old standard of clinical validity — which meant the test was accurate – came into vogue around 2011, after the concept appeared in the literature and a white paper by United Healthcare estimated that the payer spent 14 percent more on genetic and diagnostic testing per patient in 2010 than it did in 2008.

Payers’ concerns about molecular diagnostics stem from fears that for all their promise, such tests do not always change the ways doctors practice medicine. Payers want to know that the tests are actually preventing extra costly procedures, not just providing additional information. Thus, payers are demanding evidence of that the tests are changing physician behavior. But testing companies say such proof is hard to come by if insurers won’t pay for the tests in the first place, because a lack of reimbursement can essentially deny access for many patients.

For the full story, click here.

CONTACT: Mary Caffrey (609) 716-7777 x 144

mcaffrey@ajmc.com

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