HeartFlow Announces Positive Medical Coverage Decisions On Non-Invasive Heartflow FFRct Analysis From Anthem Blue Cross Blue Shield, Blue Shield Of California And Blue Cross And Blue Shield Of Alabama

Nearly 80 Million Americans Will Have Access to HeartFlow Analysis

REDWOOD CITY, Calif.--(BUSINESS WIRE)--HeartFlow, Inc. today announced that Anthem Blue Cross Blue Shield, Blue Shield of California, and Blue Cross and Blue Shield of Alabama have each issued a positive medical policy for the HeartFlow^® FFRct Analysis, a first-of-its-kind noninvasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). These three health plans, which provide health insurance for a total of 44 million people, assessed the technical performance, diagnostic accuracy, clinical utility and clinical benefits of the HeartFlow FFRct Analysis. After reviewing the evidence, they each determined that, when necessary, the use of HeartFlow’s noninvasive FFRct technology following a coronary computed tomography (CT) angiogram is considered medically necessary for its members with stable chest pain.

“We are seeing increasing momentum in the number of national and regional commercial payors that are covering the HeartFlow FFRct Analysis for their members – based on the evidence demonstrating that it reduces the need for both non-invasive and invasive tests and procedures and lowers healthcare costs”

CAD, which today affects 16.8 million Americans,¹ develops when the coronary arteries narrow, reducing blood flow to the heart and causing angina (chest pain), myocardial infarction (heart attack) and death. The HeartFlow FFRct Analysis is the first and only commercially available non-invasive technology to provide insight into both the extent of CAD and the impact of the disease on blood flow to the heart.

“We are seeing increasing momentum in the number of national and regional commercial payors that are covering the HeartFlow FFRct Analysis for their members – based on the evidence demonstrating that it reduces the need for both non-invasive and invasive tests and procedures and lowers healthcare costs,” said John H. Stevens, M.D., president and chief executive officer of HeartFlow. “With the growing number of health plans covering our technology, even more patients with suspected CAD will benefit by receiving a definitive personalized treatment plan based on the HeartFlow Analysis.”

Anthem provides healthcare coverage to 35 million people, Blue Shield of California to 4 million people, and Blue Cross and Blue Shield of Alabama to more than 3 million people. Several other commercial payers have issued positive coverage decisions for the HeartFlow FFRct Analysis, including Aetna, which covers more than 23 million lives, and additional Blue Cross Blue Shield companies that provide health insurance for nearly 5.5 million people. In June, Evidence Street, which conducts healthcare technology evaluations for the Blue Cross Blue Shield Association, a national federation of 36 independent Blue Cross and Blue Shield companies, issued its review supporting HeartFlow FFRct Analysis. Evidence Street determined that the technology provides a meaningful improvement in net health outcome in patients with stable chest pain.

The National Institute for Health and Care Excellence (NICE) of the U.K.’s National Health Service, which covers 59 million lives, also issued positive guidance, recommending the HeartFlow FFRct Analysis to help determine the cause of stable chest pain. Additionally, the American College of Cardiology (ACC) and American Heart Association (AHA) recently released updated Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease. These criteria include the use of HeartFlow FFRct Analysis in determining the appropriateness of revascularization in many clinical scenarios.

About the HeartFlow FFRct Analysis
Clinicians diagnosing someone with suspected CAD want to know as definitively as possible if the individual has a significant blockage in their coronary arteries. They also want to know the impact of that blockage on blood flow so they can best determine which treatment pathway is appropriate (e.g., medical management, stenting or coronary artery bypass grafting).

Data from a patient’s non-invasive coronary CT angiogram are securely uploaded from the hospital’s system to the cloud. HeartFlow leverages deep learning to create a personalized, digital 3D model of the patient’s coronary arteries. It then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. The HeartFlow FFRct Analysis results are provided via a secure web interface to offer actionable information on the optimal course of treatment. To date, more than 13,000 patients have benefitted from the HeartFlow FFRct Analysis.

This technology has been demonstrated to reduce unnecessary and invasive diagnostic coronary angiography procedures, which can be associated with bleeding, stroke, major blood vessel damage and other serious complications. It also significantly reduces healthcare costs for hospitals.²

About HeartFlow, Inc.
HeartFlow, Inc. is transforming the way cardiovascular disease is diagnosed and treated. The company’s HeartFlow^® FFRct Analysis is the first available non-invasive solution that enables a physician to more appropriately evaluate whether an individual has significant coronary artery disease (CAD) based on both anatomy and physiology. The HeartFlow FFRct Analysis, which leverages deep learning to create a personalized 3D model of the patient’s arteries, is well positioned to become an integral part of the standard of care for patients who are at risk for CAD because of its potential to improve both clinical outcomes and the patient experience while reducing the cost of care. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. For more information visit www.heartflow.com.

¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787400/.

² Douglas PS, DeBruyne B, Pontone G., Patel MR, et al. One-year outcomes of FFRCT-guided care in patients with suspected coronary disease: The PLATFORM Study. J Am Coll Cardiol. 2016;68(5),435-45.