In a Belgian cost-utility analysis, TAVI yielded an ICER >€750,000/QALY in high-risk operable patients and €44,900/QALY in inoperable patients compared to standard care.
Is TAVI cost-effective compared to surgical valve replacement or standard therapy in high-risk or inoperable patients with severe aortic stenosis in Belgium?
TAVI is not cost-effective for high-risk operable patients in Belgium, but may be cost-effective for inoperable patients, particularly those with anatomically prohibitive conditions.
Effect estimate: ICER €44,900/QALY (inoperable); >€750,000/QALY (high-risk operable)
BACKGROUND: Patients with severe aortic stenosis and coexisting non-cardiac conditions may be at high risk for surgical replacement of the aortic valve or even be no candidates for surgery. In these patients, transcatheter aortic valve implantation (TAVI) is suggested as an alternative. Results of the PARTNER (Placement of AoRTic TraNscathetER Valve) trial comparing the clinical effectiveness of TAVI with surgical valve replacement and standard therapy were published. The authors assessed the cost-effectiveness of TAVI in Belgium. METHODS: A Markov model of incremental costs, effects (survival and quality of life) and incremental cost-effectiveness of TAVI was developed. The impact on survival, number of events and quality of life was based on the PARTNER trial. Costs per event were context specific. RESULTS: In high-risk operable patients, even if the minor differences in 30-day and 1-year mortality are taken into account, the incremental cost-effectiveness ratio (ICER) remains on average above €750 000 per quality-adjusted life-year (QALY) gained (incremental cost: €20 400; incremental effect: 0.03 QALYs). In inoperable patients, an ICER of €44 900 per QALY (incremental cost: €33 200; incremental effect: 0.74 QALYs) is calculated, including a life-long extrapolation of the mortality benefit. This result was sensitive to the assumed time horizon. The subgroup of anatomically inoperable patients had better outcomes than medically inoperable patients, with ICERs decreasing more than €10 000/QALY. CONCLUSIONS: It is inappropriate to consider reimbursement of TAVI for high-risk operable patients. Reimbursing TAVI in inoperable patients in essence is a political decision. From an economic perspective, it would be prudent to first target patients that are inoperable because of anatomical prohibitive conditions. In the search for evidence, the authors identified non-published negative results from a randomised controlled TAVI trial. The study sponsor should be more willing to share this information to allow balanced evaluations and policy recommendations. Payers should require these data before taking reimbursement decisions.
Neyt et al. (Sun,) conducted a other in Severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) vs. Surgical valve replacement and standard therapy was evaluated on Incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained (ICER €44,900/QALY (inoperable); >€750,000/QALY (high-risk operable)). In a Belgian cost-utility analysis, TAVI yielded an ICER >€750,000/QALY in high-risk operable patients and €44,900/QALY in inoperable patients compared to standard care.