A technology that can ease the treatment burden for patients is good, but one that can improve outcomes is better. Throw in cost savings too, and you have a winner. All three claims are made for HeartFlow Medical’s FFRCT diagnostic technology, and the first two appear to be supported by data from the Platform study presented at the European Society of Cardiology meeting today.
The third claim is supported by a modelling exercise, HeartFlow’s chief executive, John Stevens, told EP Vantage. “In the average Medicare patient there was an average price reduction of about 30%, and that includes the HeartFlow price,” he said. If HeartFlow can indeed pull this off, when it begins full worldwide commercial launch of FFRCT next year, the private company could see significant success.
The current standard for assessing the extent and impact of coronary artery narrowing is fractional flow reserve (FFR), an invasive procedure that involves insertion of a wire into the coronary artery. HeartFlow’s technology uses computer simulations based on CT scans to calculate blood flow noninvasively, reducing the use of catheterisation procedures.
FFRCT is CE marked and received FDA clearance under the de novo pathway last autumn. The company is just starting to release a beta phase version at around 10 sites, in the US, Japan and the EU.
HeartFlow is expecting more widespread utilisation in the coming year if it obtains reimbursement coverage – and this is where the data from the Platform trial come in.
Platform for change
The Platform data showed that among patients evaluated using standard methods, including CT scans, and who were sent for further diagnostic evaluation using invasive coronary angiography as a result, 73% were found to have no significant blockage or obstruction. Among patients initially evaluated using FFRCT, 12% had no significant blockages when examined using diagnostic angiography.
In other words, HeartFlow’s technology was able to detect that many patients did not in fact require further assessment, and to reduce the number of unnecessary procedures performed.
There was no difference between the two groups in the rate of revascularisation procedures, such as stenting and coronary artery bypass surgery, suggesting that those patients who did require treatment got it.
Presenting the results, Dr Pamela Douglas of Duke University School of Medicine said there were no adverse events at all at the 90-day point among the patients who had angiography procedures cancelled after FFRCT indicated that these were unnecessary. It thus appears that the technology can reduce the number of invasive procedures without putting patients at risk.
This reduction in angiography is where the cost savings come in. Mr Stevens said that in the modelling exercise the price factored in for FFRCT was $1,500 per patient, the implication being that the elimination of many unnecessary angiographies can more than compensate for this, resulting in an overall cost reduction.
That said, a definite price for the technology has yet to be settled on. An economic analysis of the Platform trial will be presented at the TCT meeting in October; more clarity on pricing ought to emerge then.
And, after that, reimbursement. “In the next 18 months it will be in place,” said Mr Stevens. “This Platform trial will be instrumental in helping get some payers over the finish line.”
As for the future of HeartFlow as a company, Mr Stevens refused to be drawn. He said the group does not yet know how big a sales force FFRCT will need, though its potential cost savings mean that it will have global appeal.
“It won’t be a huge sales force as it doesn’t require in-cath lab training or mentoring like they do with a new stent or atherectomy catheter.”
Investors, he said, look for three things in a technology: “improving the experience of care for the patient, improving outcomes for the patient, and doing both of those things while reducing the overall cost of care.”
He conceded that these same factors could also appeal to potential acquirers.