Redwood City, California-based digital health company HeartFlow has reached a major milestone in its international expansion efforts after Japan’s health ministry approved the reimbursement of its technology to analyze arterial blood flow.
Traditionally the test for arterial blood flow consists of an invasive procedure that places a wire directly into the artery. HeartFlow’s cheaper and less invasive approach ingests CT scans to create an accurate 3D model of coronary blood flow and uses advanced algorithms to measure the impact of blockages.
The company claims that using its technology allows doctors to make more cost-efficient and safer clinical care decisions for people with suspected coronary artery disease (CAD) by avoiding the risk factors like bleeding, bruising and infection associated with catheterization.
“As we launch in Japan, our general strategy is to make the HeartFlow Analysis available to as many physicians and patients with suspected coronary artery disease as possible,” HeartFlow CEO John Stevens said in an email.
“CAD is the leading cause of death worldwide yet it is one of the hardest conditions to diagnose as symptoms can be vague – such as feelings of indigestion to breathlessness – or there may simply be no apparent symptoms. Missing the diagnosis of CAD can result in a lost opportunity for life-saving treatment for patients.”
The new Japanese reimbursement policy will go into effect on Dec. 1 and follows positive coverage decisions by Medicare and the United Kingdom’s National Health Services. According to the company, clinicians have used the HeartFlow Analysis to aid diagnosis of heart disease for more than 25,000 patients.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Outside of government payers, HeartFlow has also made progress with commercial health plans including UnitedHealthcare which recently extended access to the company technology to its beneficiaries across the country.
HeartFlow says that more than 235 million people in the U.S. now have access to the company’s technology through their insurer.
Stevens highlighted Japan as a great expansion market because the medical community has promoted CT coronary angiogram as the initial diagnostic for patients suspected of having coronary arty disease. This feeds directly into the data source for HeartFlow’s analysis.
“When a patient presents with symptoms suggesting CAD, we want to be able to quickly and effectively diagnose patients while reducing the need for unnecessary tests or invasive procedures,” said Wakayama Medical University cardiologist Takashi Akasaka, in a statement.
“In clinical studies, we were able to see firsthand how the HeartFlow Analysis can help improve patient management and avoid invasive procedures in some patients. The reimbursement approval will enable more physicians and patients to benefit from this ground-breaking technology.”
The company, which was founded in 2007 by Stanford University scientists Charles Taylor and Chris Zarins has raised more than $475 million from investors, most recently at a $1.5 billion valuation.
Stevens who said in a previous interview he would be surprised if HeartFlow is a private company by the end of 2019 is still playing coy about the exact timeline for the company’s public offering, but alluded to it definitely being on the horizon.
“It’s an exciting time to be at HeartFlow. At some point, we anticipate becoming a public company. But for now, our focus is to make the HeartFlow Analysis available to as many physicians and patients possible, continue to innovate, and maintain our commitment to bringing the very best in clinical research to our patients, physicians and partners,” Stevens said.
Photo: BrianAJackson, Getty Images
