MitraClip Pricey but ‘Acceptable’ in COAPT Cost-Efficacy Analysis

SAN FRANCISCO, CA—Earlier results from the COAPT trial have established that use of a MitraClip (Abbott) on top of guideline-directed medical therapy (GDMT) cuts mortality and heart failure hospitalizations and improves quality of life, but new data show, unsurprisingly, that this comes at a cost. Even though follow-up costs are significantly lower after clip implantation, the upfront costs of the device as well as hospital costs mean that the cumulative 2-year costs outstrip those of a drug-based strategy.

The cost per quality-adjusted life-year (QALY) gained, however, falls within the “acceptable economic value,” according to the authors of this analysis, led by Suzanne J. Baron, MD (Lahey Hospital and Medical Center, Burlington, MA and Saint Luke‘s Mid America Heart Institute, Kansas City MO). Baron presented the cost-efficacy analysis during the final day of late-breaking clinical trials at TCT 2019; the results were published simultaneously in Circulation.

“For symptomatic heart-failure patients with 3 to 4+ symptomatic mitral regurgitation, [transcatheter mitral valve repair (TMVr)] increases quality-adjusted life-expectancy compared with GDMT at an incremental cost per QALY gained consistent with intermediate-to-high economic value based on currently accepted US thresholds,” Baron said. “Future studies are needed to examine the durability of TMVr benefit in this population and to evaluate the cost-effectiveness of TMVr compared with other available and emerging mitral valve therapies.”

COAPT’s Track Record

As previously reported by TCTMD, COAPT showed that transcatheter mitral valve repair using the percutaneous clip procedure in patients with heart failure (HF) and severe functional mitral regurgitation (MR) significantly reduced not only the primary endpoint of HF rehospitalizations but also mortality (a powered secondary endpoint) at 2 years. An analysis released earlier this year showed that patients felt better, with higher quality-of-life scores, if treated with the MitraClip on top of standard care rather than GDMT alone.

This third piece of the puzzle, an analysis of cost-efficacy, used patient-level data to show that mean costs of the TMVr procedure itself were $35,755 while index hospitalization costs were $48,198. Over the subsequent 2 years of follow-up, medical care costs (based on resource use) were higher for patients initially randomized to GDMT than to GDMT plus clip ($38,345 vs $26,654), but that difference was not enough to cancel out the initial upfront costs in the MitraClip-treated patients. Overall, 2-year costs were $73,416 in the MitraClip group versus $38,345 in the GDMT group.

Baron and colleagues did further analyses to calculate projected survival beyond the trial’s follow-up period and estimated future healthcare costs, using a regression model that was derived from observed costs between 1 year and the end of the trial at 2 years. Three different analyses were done in order to take into account the unknown durability of TMVr’s effects: one assumed that the benefits were stable over the long term, one assumed that these declined between year 2 and year 5, and the third assumed that the benefits did not extend beyond 2 years. Finally, investigators also tried to factor in varying costs over time, including the possibility of the device’s price coming down and even—hypothetically—the device costing nothing at all.

“When the observed in-trial results were projected over a lifetime horizon, TMVr was associated with substantial gains in life expectancy and quality-adjusted life expectancy at an incremental cost of ~$45,000 per patient,” the researchers note. Even when other types of projected benefit and costs were used, “there were no patient subgroups or alternative scenarios in which TMVr would be considered to be of low economic value,” Baron et al conclude. 

But there also was no scenario in which the cost of MitraClip would actually be cheaper than a medical strategy, and that comes down to the fact that patients live longer if they undergo TMVr.

“With the cost of these technologies, we’re going to automatically be in the hole once we start,” Baron told TCTMD. “The reality is that though we see costs offset, we can’t make all of that cost up and the reason for that is that staying alive is expensive. We actually did a sensitivity analysis that looked to see whether this procedure would be cost-saving if the device itself was free. Even with it costing zero dollars, this procedure still is not cost-saving, because people stay alive longer.”

Moreover, these costs are in keeping with other technologies that have emerged in recent years, she noted.

“The big thing I want to get across is that the cost-efficacy of the MitraClip in this particular population is at least of intermediate value if not high economic value and its comparable to what we’ve seen for other technologies in this patient population, and similar to what we’ve seen in TAVR for the inoperative population,” Baron told TCTMD.

Money Talk

Similar discussions took place following Baron’s Main Arena presentation today.

“Costs are much more complicated than the cost of the device,” noted session co-chair Clyde Yancy, MD (Northwestern Memorial Hospital, Chicago, IL), who asked Baron if there were other ways that costs could come down.

In response, she pointed out that nonprocedural costs were approximately $8,000 in the MitraClip group. “A lot of that is related to, where do we put patients after they have this procedure? ICU care is a big determinant of that, so if these are patients that can go to a [postanesthesia care unit], then just to the ward and then home the next day, that will decrease costs as well.”

Baron and colleagues are already planning additional analyses, particularly given the new 3-year data presented yesterday at this meeting, that as she pointed out already show that some of their modelling assumptions—for example, that the benefit of MitraClip would attenuate with time—have proved “wrong.”

They will also need to take into account newer heart failure medications, like sacubitril/valsartan (Entresto; Novartis), many of which have proved highly effective but also very expensive, Baron noted.

Panelist Anita Asgar, MD (Institut Cardiologie de Montréal, Canada), picked up on this point during the Main Arena discussion. “When we are talking about Entresto, and we’re talking about expensive technology to treat MR, perhaps we need to put that a little bit in perspective,” she said. “There was a cost-effectiveness analysis of Entresto in the PARADIGM-HF trial and the incremental cost-effectiveness ratio was $51,000 for Entresto, so with the MitraClip, we’re really not that far off the mark. . . . Technology tends to get dinged because we have that high upfront cost, but there is not that much difference between these therapies.”

Asgar elaborated on this point later with TCTMD, pointing out that this is not a question of either/or for drugs versus devices. Instead, Asgar noted, the cost-effectiveness analyses for MitraClip in the COAPT trial took into account the fact that the device costs are on top of GDMT, which included sacubitril/valsartan. “It is not a choice to have one therapy or the other, but rather to understand that the costs are additive and put into perspective that the costs of device therapy and long-term drug therapy are not that different,” she said.