TCT.14: A case of reimbursement blues and how to avoid them

WASHINGTON, D.C.—When choosing a device-based treatment for patients with peripheral artery disease, physicians may find themselves in a quandary. A cost-effectiveness model found that the best deal from a payer’s perspective was the worst option for the provider, according to a presentation Sept. 13 at the Transcatheter Cardiovascular Therapeutics scientific session.

A physician who opens a free-standing cath lab must offset overhead costs with a profit to remain viable, Michael R. Jaff, DO, chair of the Massachusetts General Hospital Institute for Heart, Vascular and Stroke Care in Boston, told Cardiovascular Business. “If the device reimburses well, obviously it would be of value to a physician who is taking on all that risk,” he said. “If the device reimburses poorly, then it would not be a first choice, even though it might potentially be the most savings type of technology for the system.”

At the conference, Jaff shared results from a cost-effectiveness analysis on therapies for hypothetical patients with intermittent claudication from femoropopliteal disease. The study combined U.S. and German data to assess the economic impact on the payer and the provider of four different endovascular strategies: percutaneous transluminal angioplasty, bare-metal stents, drug-eluting stents and drug-coated balloons. The latter three have lower rates of target lesion revascularization and the drug-coated balloon also avoids risks associated with stenting.

He and his colleagues calculated that at 24 months after the index procedure, the drug-coated balloon offered the greatest savings to Medicare, at a cost of $5,598 vs. almost $11,000 for a bare-metal stent procedure. The bare-metal stent gave the provider the biggest profit, at nearly $9,000 while a drug-coated balloon brought in $3,659.

“What is right for the system may not be right for you and that puts a challenge [on] what you will be able to offer your patients,” he told the audience.

In reality, it may not be so dire, Jaff explained in the interview. Drug-coated balloons have yet to be approved in the U.S. so the researchers applied the reimbursement rate for a bare balloon. “We took the most conservative route,” he said.

They determined that the number needed to treat to avoid target lesion revascularization for drug-coated balloon vs. angioplasty was four while for angioplasty vs. drug-coated balloon it was about seven. A second economic analysis based on data from the first-in-human ILLUMINATE trial showed similar number-needed-to-treat results. ILLUMINATE, funded by Covidien, is designed to evaluate the safety and efficacy of the Stellarex drug-coated balloon.

Jaff stressed to the audience the need to incorporate a cost-effectiveness component in trials to provide evidence to payers that extra spending will bring long-term savings.

“In this day and age, if every trial doesn’t include some prospective analysis of how it fits into a payment scale, everybody will be in for a rude awakening,” Jaff told Cardiovascular Business. “Every trial needs to build in a value-based decision process to their analysis.”