XDx said this week that Aetna has determined that its AlloMap noninvasive gene expression test is “medically necessary” for monitoring rejection in heart transplant patients more than a year after a heart transplant.
In line with the decision, Aetna has added the test to its clinical policy bulletin for heart transplantation.
The decision means that "Aetna has decided to pay for AlloMap as a matter of policy," an XDx spokesperson said. Prior to the policy decision, "Aetna would require medical justification for each test to consider whether or not to pay" for it.
AlloMap is a PCR-based test that measures the expression levels of 20 genes associated with the probability of acute cellular rejection after heart transplant. The test, which the company runs in its CLIA-certified laboratory, was launched in 2005 and was cleared by the US Food and Drug Administration in 2008.
Last year, researchers from XDx, Stanford University, and members of the Invasive Monitoring Attenuation through Gene Expression (IMAGE) study group published a study in the New England Journal of Medicine that found the test to be non-inferior to standard methods of identifying which heart transplant recipients are likely to experience rejection (PGx Reporter 4/28/2010).
Currently, heart transplant patients are monitored via endomyocardial biopsy, an extremely resource-intensive invasive process in which patients are biopsied up to 12 times a year following transplant surgery.
The estimated cost for endomyocardial biopsy is approximately $50,000 to $60,000 per patient per year, according to Hannah Valentine, professor of cardiovascular medicine at Stanford, who presented information about the test at last week's Future of Genomic Medicine conference hosted by the Scripps Translational Research Institute.
Valentine, a co-author of the NEJM study, noted that the majority of patients in the study who received AlloMap required either no biopsy or one biopsy following a heart transplant, while the overall number of biopsies in the AlloMap arm of the study was a third of the level of the biopsy-only arm.
XDx said this week that Aetna's decision presents "the opportunity to expand the reach of AlloMap to more patients, potentially improving heart transplant patients’ quality of life by reducing the number of invasive biopsies they have to undergo to monitor for post-transplant rejection."
According to estimates provided by XDx, there are about 2,100 heart transplants in the US each year and approximately 20,000 living recipients of heart transplants.