Roche Diagnostics' newly approved NT-proBNP test for congestive heart failure will enjoy a substantially higher reimbursement rate beginning in January.

Natriuretic peptide tests will be reimbursed at $47.43 under the 2003 Medicare clinical laboratory fee schedule effective Jan. 1. The tests were previously reimbursed at $17.89 under a generic immunoassay code, according to competitor Biosite, which markets the Triage BNP test.

The Triage, cleared in November 2000, has until now been the only BNP test for use in congestive heart failure diagnosis available in the U.S. Abbott Labs is also developing a BNP test and intends to submit a 510(k) in 2003. Bayer Diagnostics also has a BNP test in development.

The Roche assay was cleared via 510(k) Nov. 19 as an aid in diagnosing congestive heart failure. Roche has indicated it expects the test to list for less than the Triage, which costs $29. Roche is touting the assay as the first fully automated test for CHF as a potential advantage over the Biosite Triage. Using the Roche test, "laboratories can have results ready to report to physicians in as few as 18 minutes," the company noted in a Nov. 20 release.

The NT-proBNP will generate $120 mil. in worldwide sales over the next three years, Roche projects. The assay has been available in Europe since October 2001.

The assay, run on Roche's Elecsys family of analyzers, works by detecting blood levels of NT-prohormone. In contrast, the Triage measures only the active strand, not the pro-form of B-type natriuretic peptide (BNP), Roche says. The pro-form is stable at room temperature for days and is less prone to short-term acute effects than the hormone's active BNP counterpart, the company maintains.

In addition, "the Elecsys proBNP assay gives the physician an accurate reading of elevated NT-proBNP due to CHF without interference from certain drug therapies," Roche claims. The Roche 510(k) was supported by data from a 16-center, 2,000-patient study that demonstrated a relationship between "the severity of the symptoms of congestive heart failure and the levels of NT-proBNP," according to an FDA "talk paper."

Roche CHF Test Will Benefit From Reimbursement Advantages In 2003

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