5:24 PM
 | 
Jun 05, 2018
 |  BioCentury  |  Product Development

Second (Ex)act

Why Exact Sciences expects smooth reimbursement path for its HCC test

Armed with Phase II data for its second DNA methylation test, Exact Sciences Corp. expects a repeat performance of the rapid launch trajectory its Cologuard colorectal cancer screening assay has enjoyed. Cologuard beat expectations for a molecular diagnostic thanks in part to a parallel review that allowed it to launch with a national coverage determination from CMS.

The company isn’t saying whether it expects to get an NCD upon launch of its new hepatocellular carcinoma (HCC) screening test. But it says relationships with payers it has built since launching Cologuard, combined with data suggesting much better performance than standard of care in a population at high risk for HCC should lead to reimbursement at least as fast as Cologuard’s.

“We now have deeper relationships with commercial payers than we did before we launched Cologuard,” Chairman and CEO Kevin Conroy told BioCentury. “And we have one of the largest, if not the largest cancer diagnostic commercial team of any company in the space.”

For most molecular diagnostics, uptake is slow because of a reimbursement environment that is notoriously slow and fickle. Companies often must tack on local coverage decisions one by one. This is time consuming, costly and difficult because different regional payers have different evidence requirements. These requirements can translate into the need for additional postmarket studies, delaying uptake.

Cologuard was an exception. Participating in FDA and CMS’ parallel review pilot provided Exact with an NCD at the time of approval...

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