CareDx Inc (NASDAQ:CDNA) received notice that the Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA has set AlloSure reimbursement at $2,840.75, which is same reimbursement as AlloMap in 2017.
Shares of CareDx reacted to the news, rising nearly 26% to $4.21 as of 12:00PM EDT.
AlloSure will be reimbursed for kidney transplant patients covered by Medicare across the United States starting October 9, 2017, the effective date of the Palmetto local coverage determination. Approximately 80% of kidney transplant patients are covered by Medicare. Payments will be made by Noridian, which has implemented the MolDX Program and is the Medicare administrator in CareDx’s jurisdiction.
Medicare reimbursement for AlloSure follows a rigorous technical assessment by the MolDX Program. Evidence in support of the AlloSure test included a clinical trial in 14 leading transplant centers and 400 patients with follow-up over 18 months. A prospective observational cohort study will begin in early 2018 to provide additional data on longer term outcomes, as part of a coverage under data development commitment.
A study of over 110,000 patients from the United States Renal Data System showed a 500% increase in cost burden for patients with renal transplant failure. Twenty percent of annual kidney transplants are re-transplants, so a test to accurately measure probability of rejection has been a major medical need. “We are pleased to see Medicare reimburse AlloSure at the same level as AlloMap, highlighting the value of advanced diagnostic tests to measure organ health for transplant recipients. AlloSure testing provides the precision medicine approach needed for individual transplant recipient clinical management,” said Sasha King, Chief Commercial Officer at CareDx.
CareDx, Inc. operates as a commercial stage company, which engages in developing, marketing, and delivering a diagnostic surveillance solution. Its product includes AlloMap, which aids clinicians in identifying heart transplant recipients with stable allograft function.