Clinical Utility in Prostate Cancer Testing

Belgian cancer testing group MDxHealth recently announced an agreement with US health organization Prime Health Services to extend access to its prostate cancer test to 144 million insured people. MDxHealth suggests that collaboration will permit faster reimbursement for cancer testing. As well, the group's promising new epigenetic prostate test, ConfirmMDx, can reduce the number of false negatives in testing.

A story in the current issue of Evidence-Based Oncology, a news publication of The American Journal of Managed Care (AJMC), adds that the demand for proof of clinical utility has affected the marketing of ConfirmMDx. 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% 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.

A release from AJMC states:

The full article can be viewed here.

Around the Web

Belgium's MDxHealth Signs U.S. Deal for Prostate Cancer Test [Reuters]