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Abstract
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.
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Footnotes
To cite: Neyt M, Van Brabandt H, Devriese S, et al. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population. BMJ Open 2012;2:e001032. doi:10.1136/bmjopen-2012-001032
Contributors MN carried out the economic analysis and drafted the paper. HVB provided medical advice and performed a medical literature review in search for relevant data. SD and SVDS analysed the Belgian data. All authors participated in revising the draft paper and approved the version to be published. MN is guarantor for the paper.
Funding There was no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Individual patient data are not available. Aggregated data are published in ‘Neyt M, Van Brabandt H, Van de Sande S, Devriese S. Health Technology Assessment. Transcatheter Aortic Valve Implantation (TAVI): a Health Technology Assessment Update. Health Technology Assessment (HTA). Brussels: Belgian Health Care Knowledge Centre (KCE), 2011.’ which is publicly available at http://www.kce.fgov.be/publication/report/transcatheter-aortic-valve-implantation-tavi-a-health-technology-assessment-updat