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CoreValve cost effective for high-risk patients undergoing TAVR
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WASHINGTON — In the CoreValve US High Risk Study, transcatheter aortic valve replacement improved quality of life at 1 month and survival at 12 months relative to surgical aortic valve replacement, according to results of a cost-effectiveness analysis presented at TCT 2014.
“Previous studies have consistently shown that TAVR is a reasonable value in patients not suitable for surgical AVR. However, there is less consensus regarding the cost effectiveness of TAVR vs. surgery in high-risk patients, especially internationally,” Matthew R. Reynolds, MD, MSc, director of economics and quality-of-life research at Harvard Clinical Research Institute, said during a press conference.
For the new cost-effectiveness analysis, Reynolds and colleagues evaluated the comparative costs of TAVR and surgical AVR in high-risk patients from the CoreValve US High Risk Study. The analysis included 747 patients from the as-treated population of the trial. The researchers collected inpatient and outpatient medical resource utilization for all patients in order to quantify cost effectiveness. They acquired hospital bills for 80% of index hospitalizations and measured health state utilities through the EQ-5D questionnaire at 1, 6 and 12 months.
The primary effectiveness measure of the study was quality-adjusted life years (QALY). Reynolds and colleagues made two key assumptions: an estimated $32,000 commercial cost of the CoreValve device and no further survival benefit to TAVR beyond 12 months.
Costs of TAVR vs. surgical AVR
According to results presented, TAVR was associated with a $23,661 higher per-patient mean cost for the initial valve implant procedure compared with surgical AVR ($37,920 vs. $14,258; P<.001) in the as-treated population. However, TAVR was associated with a 4.4-day decrease in the initial hospital length of stay compared with surgical AVR (8.1 days vs. 12.5 days; P<.001). TAVR also reduced the need for rehabilitation services at discharge by almost half (23.1% vs. 43.7%; P<.001), according to Reynolds.
TAVR was associated with approximately $11,000 higher initial hospital costs, including physician fees ($69,592 vs. $58,332). The per-patient projected lifetime cost of TAVR was approximately $13,700 higher than surgical AVR.
In other results, patients assigned TAVR had significantly better self-reported quality of life at 1 month compared with patients assigned surgical AVR; however, the improvement in quality of life was not sustained at 6 or 12 months. It was estimated that patients who underwent TAVR would gain 0.24 life years and 0.2 QALYs relative to surgical AVR over a lifetime. TAVR was also associated with projected lifetime incremental cost-effectiveness ratios of approximately $67,000 per QALY gained and $57,000 per life year gained.
Patients eligible for iliofemoral access (n=623) had slightly better results, with cost-effectiveness ratios of $55,500 per QALY gained and $48,300 per life year gained. Patients not suitable for iliofemoral access (n=124) had a cost-effectiveness ratio of approximately $118,000 per QALY gained and $98,000 per life year gained.
“However, this subgroup was small, and the results were uncertain,” Reynolds said.
A sensitivity analysis indicated that a $2,000 to $4,000 per-patient decrease in the cost of initial TAVR hospitalization would reduce the cost-effectiveness ratios to less than $50,000 per QALY or life year.
Implications discussed
During the press conference, discussant Zoltan G. Turi, MD, said the cost-effectiveness data are important and relevant for the use of TAVR in clinical practice.
“[The data] affect us in the day-to-day operations of doing TAVR,” he said. “There is a lot of pressure for hospital administrators to bring the costs under control, but there is also pressure to do more of these procedures, because there is a need.”
Reynolds discussed new diagnosis-related groups (DRGs) that are expected for TAVR in October.
“On Oct. 1, there will be a new reimbursement scheme in the United States for TAVR,” he said. “Until now, TAVR has been paid for by the surgical DRG, but starting in October there will be new DRGs specifically for TAVR, and I’m told the reimbursement will be a little bit more. This will help to the extent that some programs have had a gap between reimbursement and cost.” – by Jennifer Byrne
For more information:
Reynolds MR. Plenary session V: Late-breaking clinical trials #1. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.
Disclosure: Reynolds reports receiving grant/research support from Edwards Lifesciences and Medtronic and consulting fees/honoraria from Medtronic.
Perspective
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Chandan Devireddy, MD, FACC, FSCAI
One of the major criticisms of TAVR is that although it is a catheter-based procedure, physicians and payers aren’t certain as to whether cost effectiveness is achieved, because the device is very expensive and a lot of these patients, especially high-risk ones, still require considerable acute care in the hospital. Cost-effectiveness studies are always tricky in that measuring quality and defining the relevant variables can greatly influence the outcome. In this analysis, 747 patients from the as-treated population of the trial were included. The investigators made two key assumptions — an estimated $32,000 commercial cost of the CoreValve device and no further survival benefit to TAVR beyond 12 months — which I think were reasonable, but perhaps conservative. Patients receiving TAVR gained 0.24 life years and 0.2 quality-adjusted life years (QALY) compared with surgical AVR over a lifetime.
As operators continue to gain experience with commercial TAVR and because of the tremendous cost pressure on TAVR centers, we’re actively searching for ways to deliver these new therapeutic tools in a way that is cost effective, in order to maximize the viability of TAVR as a reasonable treatment option. In terms of cost and length of stay, our site, as an example, has been implementing novel techniques to perform TAVR in a minimalist fashion outside the operating room so that patients may potentially leave the hospital as soon as the next day. The fact that this study demonstrates cost effectiveness with the CoreValve device during the initial US study experience should portend a lot of hope for the use of these catheter-based approaches. Our ability to deliver this care is only going to get better over time in ways that are going to lower cost, and which hopefully influence payers, policy makers and hospitals to look at this procedure in a favorable light.
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