VANCOUVER, B.C.—The federal government’s new system of bundled payments for end-stage renal disease (ESRD) care—which went into effect in January—may be stifling development of new ESRD therapies, according to investigators.

Mahesh Krishnan, MD, MBA, MPH, and collaborators at DaVita Clinical Research in Minneapolis found that the number of registrational clinical trials for therapeutic agents to treat ESRD patients has been declining. In 2005, 11 trials of ESRD-related medications were registered with the FDA. The number rose to 15 in 2006 and 20 in 2007, then decreased to 10 in 2008, rose to 14 in 2009, and dropped to five in 2010, the researchers reported at the World Congress of Nephrology.

Although many factors may be responsible for the decline, the investigators concluded, the anticipated introduction of the new payment system may inhibit the economic viability of large-scale investments in ESRD-related pharmaceuticals.

Continue Reading

“Innovation is costly,” the authors observed. “Industry will focus research and development in therapeutic areas with potential for investor return.”