Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients

Abstract

Objective: Transcatheter aortic valve implantation (TAVI) has become the therapy of choice for treating severe aortic stenosis in patients at high-risk for surgery or where it is considered too risky to attempt. This uptake varies across geographies however, and its cost or value has frequently been cited as the reason for this. We sought to evaluate the potential cost and clinical impact of TAVI in intermediate risk patients from a French collective perspective. Materials and methods: The analysis was performed using a novel Markov model with data derived from the PARTNER II randomized controlled trial for survival, clinical event rates, and quality-of-life. The simulated time horizon was 15 years, costs were from French sources and presented in 2016 Euros. Discounting of all outcomes was at 4% annually and the effect of uncertainty in model parameters was explored by deterministic and probabilistic sensitivity analysis (PSA). Results: In comparison to surgery, TAVI resulted in improved clinical outcomes (life expectancy and quality-adjusted life expectancy) and lower costs over a lifetime time horizon. The base case results showed increases of 0.42 years and 0.41 QALYs with lifetime cost savings of e439 for TAVI compared to surgery. PSA results showed a >50% likelihood of cost-effectiveness at e0 willingness-to-pay and a 100% likelihood at $e15,000. Limitations: Clinically, survival projections are based on limited follow-up data and introduce uncertainty into the outcomes from the model. Economically, procedure costs are derived from a heterogeneous mix of patient risk groups, although this is much more likely to bias against TAVI and underestimate overall cost savings. Conclusions: In our analyses of intermediate risk patients, TAVI is associated with superior clinical outcomes compared to surgery and is cost saving. It could be expected that cost savings are conservative and likely to increase over time.

Cost-Effectiveness Analysis of SAPIEN 3 Transcatheter Aortic Valve Implantation Procedure Compared With Surgery in Patients With Severe Aortic Stenosis at Low Risk of Surgical Mortality in France

“…Models in patients at moderate or high risk of surgical mortality comprised Markov models based around complications or New York Heart Association class. 16,17 The New York Heart Association class was not judged granular enough to capture the differences between treatments in patients at low risk of surgical mortality, and thus, a model based around complications was used.…”

The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups

“…The results from the present analysis are consistent with those obtained in the few studies available related to the last generation devices. Indeed, four recent studies evaluated the CE of TAVI versus sAVR in intermediate-risk patients [24,[37][38][39]. Three of them showed TAVI being dominant considering the payer perspective and a lifetime horizon in the US [37], France [24] and Australia [39], while, accounting for the perspective of the National Health System in Canada, Tarride et al [38] found that TAVI was cost-effective (ICER being 28,154 Canadian dollars/QALY).…”

“…Transition probabilities (related to disease progression or improvement), risk of relevant clinical events and survival were derived from the Placement of Aortic Transcatheter Valves (PARTNER) trials [7,[21][22][23] and extrapolation from them all over the time horizon of the analysis as previously detailed in Goodall et al [24]; particularly, linear extrapolation was used to extend mortality data, while for complications, the last available data were assumed constant for the rest or the time period. Details of inputs for the incidence of events used in the analysis over the different risk groups and references for them are reported in Table 1.…”

Tratamento da Estenose Aórtica do Idoso no Brasil: Até Quando Podemos Esperar?

“…Despite the fact that TAVI has already been evaluated and accepted in the health care systems of several countries with evidence of cost-effectiveness even in individuals at intermediate operative risk, 3 the Ministry of Health, based on a position stand from the National Commission for Incorporation of Technologies in the SUS (Conitec), established in 2013, in response to a request by the Brazilian Society for Hemodynamics and of Interventional Cardiology (SBHCI) acting as the petitioner, considered that there was no convenience in incorporating this therapy in Brazil. Conitec, at the time, based on the opinion of a reviewer and disregarding the opinion of prestigious national universities presented in a public consultation on the subject, recommended against the incorporation of the procedure, justifying this decision on three points: a) TAVI would not be a safe and effective procedure due to an allegedly high incidence of stroke within the first 30 days after the procedure, b) the budgetary impact of incorporating TAVI into the SUS would approach 1 billion reais per year, and c) methodological inaccuracies could have affected the economic model presented by the petitioner and the PARTNER B study, which served as the main background for the incorporation of this procedure by all health technology assessment agencies in the world that have requested the incorporation of this technology.…”