SAN FRANCISCO--Transcatheter aortic valve implantation (TAVI) has the potential to be cost effective at thresholds accepted by U.K. National Institute for Health and Clinical Excellence (NICE) perspective, which modeled the PARTNER A trial data. These findings were presented Nov. 8 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
“In healthcare today, we are presented with myriad choices. It is no longer enough to simply evaluate the clinical outcomes of a new therapy or device, but also the cost-effectiveness of treatments,” said the study’s lead author, James Eaton, MSc, an employee of Oxford Outcomes, an Icon company that conducts health economic and outcomes research on behalf of pharmaceutical and medical devices companies. “Whether the payor is private or public as in the U.K. with the National Health Service (NHS), we need to consider the economic value.”
However, NICE has not conducted a cost-effectiveness analysis of TAVI yet. He and his colleagues determined the incremental cost-effectiveness ratio, which calculates the difference in costs, and the difference in benefits between those two treatments.
Eaton explained that TAVI in high-risk patients with severe aortic stenosis (AS) should undergo a cost-effectiveness model analysis because the procedure costs are high and front loaded and all the benefits (life years gained, quality-adjusted life years [QALY], etc.) accrue over time.
Also, since these high-risk patients are likely to be either old or infirm, he questioned whether they will they live long enough to accrue enough benefit to overcome all upfront costs. Also, in high-risk operable patients eligible for surgical aortic valve replacement [SAVR], the acquisition cost for valves is much lower, so it’s unclear whether TAVI can be cost-effective. “Hence, it is necessary to capture lifetime costs and benefits in an economic model to inform reimbursement decisions,” he said.
The researchers used the PARTNER A data to inform their analysis from a U.K. perspective. One limitation that stems from using these data is that the patient follow-up only goes out to 24 months, and they had to extrapolate to extend throughout the life of the patient to capture the relevant costs and benefits, which is where the mathematical modeling came into play.
The model examined a lifetime of 20 years with a patient age of 84, and applied the NHS discount rate of 3.5 percent. Using the PARTNER A data, they determined the minimum length of ICU stay was three days for TAVI, compared with five days for SAVR. Also, based on PARTNER A, the proportion of TAVI patients that received a pacemaker was 3.8 percent, compared 3.6 percent in those SAVR patients.
Finally, the total cost of the TAVI operation (including device and implantation costs) was £15,750 ($25,348 U.S.), compared with £3,906 ($6,286 U.S.) for the total costs associated with SAVR (including device and implantation costs).
Eaton also said that the procedure cost per-hour was £574 ($925 U.S.), the daily cost in the ICU was £1,394 ($2,243 U.S.), based on a recent study by Raikou et al (J Med Econ 2011;14;47-52). In the model, they used £1,830 ($2,944 U.S.) as the cost of SAVR valve and £14,800 as the cost of the TAVI valve.
Eaton said that TAVI has the potential to be cost-effective at a threshold of £30,000 ($48,266 U.S.) per QALY. They found that TAVI was associated with lifetime costs of £29,042 ($46,726 U.S.), while SAVR was associated with the lifetime costs of £9,874 ($15,889 U.S.). TAVI was associated with life years gained over SAVR of 0.6 life years gained and 0.39 of QALYs. Even with a higher number of pacemaker implantations, TAVI remained cost-effective.
Eaton concluded that from a U.K. perspective, TAVI has the potential to be cost-effective at thresholds accepted by NICE.
“As more devices come to market, the competition could drive down the cost of the valves, and therefore, the highest upfront costs would be reduced, and the device could be even more cost-effective in the future,” he added.
This project was funded by Medtronic, but Eaton said that no influence was exerted on the design of the model or presentation of the results.