With spending on diagnostics alone for cardiovascular disease likely to be a major challenge for insurers amid the baby boom wave, Aetna is turning to an emerging option as part of a strategy to avoid invasive tests and treatments.
Members of Aetna and its Coventry subsidiary now have access to a gene expression blood test that helps diagnose obstructive coronary artery disease, a condition often investigated with stress testing, electrocardiograms, CT scans, dye-based angiography or catheterizations.
Under Aetna's new clinical policy, a coronary artery disease (CAD) gene expression test sold by the company CardioDX will be covered as medically necessary for non-diabetic adult members experiencing chest pain or similar symptoms without a history of CAD.
Each year, some 3 million non-diabetic Americans go to primary care doctors with symptoms suggestive of obstructive CAD, leading to about $6.7 billion in spending on cardiac work-ups, according to a study in Population Health Management.
At the same time, those symptoms "often can be ambiguous and overlap with many other highly prevalent conditions," said Lee Herman, MD, in a media release. Lee is a Georgia-based primary care practitioner who co-authored a CardioDX-funded study on primary care doctors' CAD diagnostic strategies.
Measuring the expression levels of 23 genes linked to the development and response of atherosclerosis, the test can rule out obstructive CAD and help clinicians avoid further tests, according CardioDX. The California-based company says the test has a 96 percent negative predictive value for ruling out obstructive CAD, based on two large clinical studies.
One, led by Eric Topol, MD, examining 4,000 patients, found that the company's algorithm-based scores correlated with the extent of the disease, though only in non-diabetics, and had a negative predictive value of 83 percent.
The second study found that the test had a higher sensitivity and was more predictive than myocardial perfusion imaging and that 96 percent of patients with low scores did not have obstructive CAD.
Not long ago, CAD could only be diagnosed through cardiac catheterization and invasive coronary angiography, and more recently stress tests have been used for initial assessments, although according on one study, stress testing with imaging can have false positives and false negative rates as high as 20 percent.
CardioDX's test was approved by Medicare in August 2012 and the company is now "actively pursuing additional third-party payer reimbursement."
The obstructive CAD expression test is one of many new genetic- and molecular-based diagnostic tests coming to the market in cardiology, oncology and other clinical areas, promising more accurate and less invasive options for patients and lower-cost alternatives for payers.