Authors' objectives: The aim of this report is to assess the cost-effectiveness and budget impact of TAVI for patients with severe aortic stenosis and intermediate surgical risk compared with open surgery, and evaluate the intervention against the priority criteria (benefit, resource use and severity) applicable in Norway.

Authors' results and conclusions: The cost-utility analysis indicated that TAVI was slightly more effective (incremental effectiveness: 0.07 QALYs) and more costly (incremental costs: 71 000 Norwegian kroner) than the open surgery. The incremental cost-effectiveness ratio (ICER) was about 1.04 million Norwegian kroner per QALY in analysis with two-years perspective, falling to about 800 000 kroner per QALY in life time perspective. The results of sensitivity analysis of our model analysis showed that cost parameters related to the TAVI procedure had the greatest impact on the results. The calculated absolute shortfall for patients with severe aorta stenosis and intermediate surgical risk is equal to 3.6 QALYs. The budget impact analysis based on the results of the cost-effectiveness analysis, and some conservative assumptions about expansion in the use of TAVI indicates that the incremental annual total cost of this expansion will reach 32.5 million Norwegian kroner in the course of five years. Conclusion: The results of our cost-utility analysis indicate that TAVI for patients with aortic stenosis and intermediate surgical risk compared with open surgery offers modest health gains (incremental effectiveness: 0.07 QALYs), at higher costs (incremental costs: 71 000 Norwegian kroner). The calculated incremental cost-effectiveness ratio is equal to 1.04 million Norwegian kroner per QALY gained in the base case scenario. The calculated absolute shortfall for patients with severe aortic stenosis and intermediate surgical risk receiving standard treatment is equal to 3.6 QALYs, categorising these patients into severity class 1, which is the least severe of the six classes suggested by the Magnussen group. These findings can help decision makers appraise the intervention against the official priority setting criteria in health care sector applicable in Norway.

Authors' methods: We performed a cost-utility analysis (CUA) comparing TAVI with open surgery, where all relevant cost and health outcomes related to both procedures were accounted for. The relevant costs were expressed in 2018 Norwegian kroner (NOK), and effects in quality-adjusted life-years (QALYs). The results were expressed as mean incremental cost-effectiveness ratio (ICER). The Markov model was developed and analysed in TreeAge Pro ® 2018. The uncertainty in model parameters were handled by performing probabilistic sensitivity analyses (PSA). The analyses were performed from the healthcare perspective. Both costs and effects were discounted using an annual discount rate of 4%. In accordance with the Government White Paper about priority setting, (Meld. St. 34 2015–2016)(2), and its recommendations related to quantification of the severity criterion, we estimated absolute shortfall for patients with severe aorta stenosis and intermediate surgical risk. Premised on assumptions based on registry data about adoption rates for TAVI as well as cost data derived from the Markov model, we calculated likely budgetary consequences of introduction of TAVI as a routine treatment for patients with severe aortic stenosis and intermediate surgical risk.

Project Status: Completed

Year Published: 2019

URL for published report: https://www.fhi.no/en/publ/2019/Transcatether-aortic-valve-implantation-as-treatment-of-patients-with-severe-aortic-stenosis-and-intermediate-surgical-risk/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo