HeartFlow Announces Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on Non-Invasive HeartFlow® FFRct Analysis for Coronary Artery Disease

Each Concludes HeartFlow FFRct Analysis is Medically Necessary to Guide Decisions About Use of Invasive Procedures

REDWOOD CITY, Calif.--()--HeartFlow, Inc. today announced that Horizon Blue Cross Blue Shield of New Jersey (Horizon BCBSNJ), Blue Cross Blue Shield of Arizona, Blue Cross of Idaho and Blue Cross Blue Shield of Kansas City 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). Each of the four health plans assessed the technical performance, diagnostic accuracy, clinical utility and clinical benefits of the HeartFlow FFRct Analysis and determined that the use of noninvasive FFRct following a positive coronary computed tomography (CT) angiogram is considered medically necessary to guide decisions about the use of invasive coronary angiography for its members with stable chest pain (i.e., those with suspected or presumed stable ischemic heart disease).

CAD, which today affects 16.8 million Americans,i 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 non-invasive technology to provide insight into both the extent of CAD and the impact of the disease on blood flow to the heart. It is designed to help enable clinicians design a definitive, personalized treatment plan for each patient and reduce the need for additional invasive or noninvasive testing.

“These new coverage decisions add to the growing number of payers that have reviewed evidence from clinical trials demonstrating that the HeartFlow FFRct Analysis helps improve clinical outcomes, reduces unnecessary invasive diagnostic procedures, and reduces healthcare costs.ii These payers have made the decision to cover HeartFlow’s noninvasive technology because they recognize the benefit it can provide to patients with suspected CAD,” said John H. Stevens, M.D., chief executive officer of HeartFlow. “Together with the American Medical Association’s decision to issue a set of Category III CPT codes for HeartFlow FFRct Analysis, we are seeing increasing acceptance and adoption of our non-invasive technology by clinicians and top medical centers throughout the United States and around the world. The HeartFlow FFRct Analysis is helping physicians determine which patients with suspected CAD have clinically significant disease and how they should be optimally treated.”

Horizon BCBSNJ, the state’s oldest and largest health insurer, manages the health insurance needs of approximately 3.8 million people in New Jersey. Blue Cross Blue Shield Arizona provides health insurance for 695,000 people within the state of Arizona. Blue Cross of Idaho, with approximately one quarter of the state's population enrolled in its programs, covers an estimated 500,000 individuals. Blue Cross Blue Shield of Kansas City provides health insurance to approximately 500,000 individuals. Their assessments of the HeartFlow FFRct Analysis concluded the available evidence supports that selective addition of the HeartFlow FFRct Analysis following coronary CT angiography results in meaningful improvements in net health outcomes, particularly by limiting unnecessary invasive testing.

Several other payers have also issued positive coverage decisions, including Aetna, which covers more than 23 million lives. In June, Evidence Street, which provides healthcare technology evaluations for the Blue Cross Blue Shield Association, a national federation of 36 independent Blue Cross and Blue Shield companies that collectively provide healthcare coverage for 105 million Americans, issued a review supporting the HeartFlow FFRct Analysis and indicating an expected improvement in net health outcomes. Earlier this year, the National Institute for Health and Care Excellence (NICE) of the U.K.’s National Health Service, which covers 59 million lives, 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, which 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, and then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow in the model 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 HeartFlow FFRct Analysis.

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.

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

ii 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.

Contacts

HeartFlow, Inc.
Chris B. Ernst, 415-710-9445
cernst@heartflow.com

Contacts

HeartFlow, Inc.
Chris B. Ernst, 415-710-9445
cernst@heartflow.com