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.
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.
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.
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.
To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) for Belgian patients.
In high-risk operable patients, surgical aortic valve replacement and TAVI are associated with similar mortality rates at 1 year. However, there is a twice as high rate of stroke after TAVI. From an economic point of view, the less invasive nature of the TAVI procedure does not weigh against the extra costs of about €20 000 per patient.
In inoperable patients, TAVI significantly reduces the rate of death from any cause as compared with a non-surgical approach. The ICER is about €45 000 per QALY gained. Nevertheless, a distinction should be made between inoperability for anatomic versus medical reasons. TAVI offers more value for money in the former patient group with ICERs decreasing more than €10 000 per QALY.
If policy makers are willing/able to pay the relative high price for TAVI, it is advised to focus in the first place on the anatomic inoperable patients.
Strengths and limitations of this study
Hospital billing data of 183 Belgian patients treated with the Edwards SAPIEN valve were at our disposal for cost calculations.
Next to the published pivotal PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a non-published randomised controlled trial (RCT) with TAVI was identified. This Continued Access trial was performed according to the same study protocol of the pivotal PARTNER trial. The mortality outcomes of this Continued Access RCT, disfavouring TAVI, were included in our analysis.
An unbalance in patient characteristics was observed in the inoperable patients of the PARTNER trial, favouring the TAVI group. A subgroup analysis showed a greater improvement for anatomic inoperable patients versus those inoperable for medical reasons.
The most important limitation of our analysis is the non-availability of all relevant study outcomes, especially for the negative non-published Continued Access RCT. The study sponsor should be willing to reveal this information in due time. Payers should require access to these non-published data before deciding on reimbursement.