|Supera stent--Courtesy of Abbott|
Abbott ($ABT) is promoting the health economics of its Supera Stent for peripheral artery disease, pointing to a yet-to-be-published study which found that the device is cost-effective because it reduces the need for interventions compared to competing therapies, like Medtronic's ($MDT) Protégé bare-metal peripheral stent and In.Pact Admiral drug-coated balloon.
Among 100 patients, implantation of the Supera is estimated to result in 7 additional reinterventions over three years (for a total of 107), researcher Dr. Brian DeRubertis of UCLA's division of Vascular Surgery said in an interview. In contrast, balloon angioplasty alone is expected to result in 51 additional interventions, while bare-metal stents produce 33 reinterventions, drug-coated balloons produce 28 and drug-eluting stents produce 22.
These estimates were determined by performed calculations based on the failure rates of the various treatment modalities in their IDE clinical trials for FDA approval.
The three-year time frame is not surprising, for makers of innovative devices prefer to focus on longer-term (or lifecycle) costs and benefits, which they say compensate for the higher up-front cost of their products.
Abbott's Supera stent was compared to compared to Cook Medical's Zilver PTX's drug-eluting peripheral stent, drug-coated balloons made by Medtronic and Bard (the In.Pact Admiral and Lutonix, respectively) and various other bare-metal peripheral stents for the thigh's superficial artery including Medtronic's Protégé.
The IDE trials also provided the failure rate of balloon angioplasty (also known percutaneous transluminal angioplasty, or PTA) alone. It was the control arm in the various trials, for all of the other modalities are performed subsequent to the procedure.
The study found that using bare-metal stents as the "index" or first procedure actually produces the most reimbursement for hospitals over three years (estimated at $1.32 million per 100 patients) due to the need for subsequent interventions.
The Supera is estimated in to result in $1.07 million in reimbursement per 100 patients.
But if you consider the reimbursement per procedure, Supera is the most economical choice for hospitals, DeRubertis said. That's because the Supera results in fewer reinterventions, driving down overall reimbursement, but earning more for each procedure, he explained.
It produces an estimated $9,978 in reimbursement per intervention, compared to $9,937 for bare-metal stents and about $9,400 when drug-eluting stents are used as the original treatment modality. Angioplasty balloons and drug-coated balloons resulted in a little more than $8,500 in reimbursement per intervention when used as the original intervention.
Makers of the other devices could easily turn the argument on its head and say that their devices result in a lower cost to payers and the overall healthcare system on a per procedure basis. But it is the hospitals that buy the devices. Moreover, the higher cost per procedure can be justified if it provides benefits to patients in the form of fewer reinterventions.
However, hospitals may still be tempted to purchase bare-metal stents in order to earn revenue from the high volume of reinterventions that result. In an attempt to discourage hospitals from picking lower quality devices that result in a higher volume of procedures to correct failures, the Centers for Medicaid & Medicare Services is promoting various incentives that reward hospitals for quality outcomes rather than just the volume of procedures performed, DeRubertis said.
He was not aware of a specific incentive program that applies to devices to treat PAD though. CMS is implementing the Hospital Readmission Reduction Program to penalize hospitals with high rates of readmission, but it does not take into account readmitted PAD patients, though the list of conditions the program includes in its calculation has been steadily expanding.
On the PAD front, CMS does offer bonus-reimbursement to cover the higher costs of drug-coated balloons, in recognition of their innovative nature and strong outcomes.
Medtronic has touted the clinical and economic benefits of its drug-coated balloon by pointing out they reduce the need for implantation of peripheral stents, citing statistics showing that doctors are more likely to opt to forgo them following use of the In.Pact. Peripheral stents are generally believed to be less effective than those placed in the coronary artery in part due to the constant movement of the legs, which puts stress on the devices, resulting in a higher failure rate.
DeRubertis said the Supera's unique design makes it more resistant to compression than traditional bare-metal stents, which are cut out of nitinol tubes. In contrast, he said the non-drug-eluting Supera is made of 6 interwoven nitinol wires that are attached at the ends.
DeRubertis is aiming to get the study published in a journal in 6 to 9 months. It was presented at the recent Vascular Interventional Advances (VIVA) conference in Las Vegas.
The study assumed that patients could receive up to two reinterventions over the three years following implantation. The reinterventions were assumed to be a combination of the various modalities, based on the prevailing clinical practices.
DeRubertis is a practicing vascular surgeon and said he is or has been a paid consultant for Abbott, Medtronic, Boston Scientific ($BSX) and Cook Medical.
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