An economic analysis of COAPT data suggests edge-to-edge transcatheter mitral valve repair (TMVR) with the MitraClip device is a more affordable long-term treatment option than guideline-directed medical therapy (GDMT) alone for patients with severe secondary mitral regurgitation (SMR)—but the steep cost of an index TMVR procedure might eclipse that benefit.
COAPT has boasted strong, positive results for the MitraClip over the past two years, and at TCT 2019 in San Francisco the investigative team reported a further survival benefit with Abbott’s device. Two years into the study, 66.6% of patients randomized to maximally tolerated GDMT and 44.5% of patients randomized to GDMT plus the MitraClip intervention met COAPT’s primary endpoint of heart failure hospitalization or death; by three years, those numbers were 88.1% and 58.8%, respectively.
But for most heart patients in the U.S., procedural success isn’t the only variable that counts. Price is a big component in healthcare decision-making, and TMVR doesn’t come cheap.
“Given the rising cost of healthcare, it is essential to understand the cost-effectiveness of new therapies, especially when the technology involved is costly and the target population is large and characterized by significant comorbidities,” Suzanne J. Baron, MD, MSc, and colleagues wrote in Circulation, where they published their economic analysis of COAPT Sept. 29. “Since patients with severe SMR often experience poor clinical outcomes and high rates of healthcare resource utilization, whether TMVR can provide meaningful health benefits to this population at an acceptable cost is particularly important.”
Drawing on COAPT data, Baron and co-authors found that initial costs of the TMVR procedure and index hospitalization were $35,755 and $48,198, respectively. While follow-up costs were much lower with TMVR than with GDMT ($26,654 and $38,345, respectively), cumulative two-year costs remained higher for TMVR due to the baseline procedure’s $73,416 average price tag.
Modeling costs, health utilities and in-trial survival over a lifetime horizon, the authors reported TMVR was projected to increase life expectancy by 1.13 years and quality-adjusted life years (QALYs) by 0.82 years at a cost of $45,648. That’s a lifetime incremental cost-effectiveness ratio (ICER) of $40,361 per life-year gained and $55,600 per QALY gained.
They’re big numbers, but Baron et al. maintained the long-term cost of TMVR “represents acceptable economic value based on currently accepted U.S. thresholds.” Placing COAPT in the context of other CV therapies used to treat valvular heart disease and heart failure, the statistics make more sense—in the PARTNER 1B trial, for instance, investigators found the ICER for transcatheter aortic valve replacement (TAVR) versus medical therapy was $61,889 per QALY gained.
“The cost-effectiveness of TMVR is also comparable to that for other commonly used technologies for the treatment of heart failure, including implantable cardiac defibrillators for the prevention of sudden cardiac death and bi-ventricular pacing, and is substantially more cost-effective than continuous-flow left ventricular assist devices used for destination therapy,” the authors wrote.
Still, it’s also important to note that this analysis was generalized, Baron and colleagues said. The cost-effectiveness of TMVR will vary according to individual patients, ranging from a best-case scenario ICER of $27,000 per QALY to a worst-case scenario ICER of $70,000 per QALY.
The bottom line is that TMVR using the MitraClip improved both life expectancy and quality-adjusted life expectancy compared with GDMT alone, the authors wrote, at an incremental cost per QALY that represents an “acceptable” economic value in the U.S. The team called for future studies to further examine the durability of TMVR’s benefit in the COAPT population.