Original Title: Análisis coste-efectividad del recambio valvular aórtico mediante prótesis valvular percutánea frente al tratamiento quirúrgico habitual

Authors' objectives: The objective of the study is to conduct a cost-effectiveness analysis, in which transcatheter aortic valve implantation (TAVI) is compared with aortic valve replacement (AVR) in high-risk patients with severe, symptomatic aortic stenosis.

Authors' results and conclusions: The result of the economic evaluation for the baseline case (deterministic model) indicated that the TAVI alternative was more costly than AVR and more effective in terms of QALYs. The mean cost for the TAVI procedure was € 39,861 compared to € 30,789 for AVR and quality-adjusted life years were 1.66 versus 1.58. The mean incremental cost (mean cost of TAVI minus mean cost of AVR) was € 9,072 and the mean incremental QALY (mean QALY of TAVI minus mean QALY of AVR) was 0.08. Regarding life years gained, the AVR procedure was superior to the TAVI, with 2.65 versus 2.31 life years gained. The incremental cost-effectiveness ratio of TAVI versus AVR was € 119,575/QALY, i.e. one would have to be willing to pay € 119,575 per QALY gained with TAVI compared to the AVR procedure. The cost-effectiveness acceptability curve indicates that for an acceptability threshold of € 30,000/QALY, the standard usually accepted in Spain, the probability of obtaining an incremental net benefit greater than zero for the TAVI alternative compared to AVR is 39%. Conclusions From the economic evaluation, it can be concluded that for the baseline case and an acceptability threshold of € 30,000/QALY, transcatheter aortic valve implantation (TAVI) versus aortic valve replacement (AVR) in symptomatic patients with severe aortic stenosis considered high risk for AVR, is not cost-effective. These findings can not be extended to other populations with different ages, surgical risks and clinical characteristics. Given the uncertainty in the long-term data, national data collection is considered to be of importance in order to confirm these results

Authors' methods: From the perspective of the National Health System and for the timeframe of a patient’s lifetime, an analytic decision-making model was developed to estimate the costs, life years gained and quality-adjusted life years (QALY) of the TAVI procedure compared to AVR. The model consists of a decision tree in the short term and a Markov model in the long term. In the decision tree, patients face the risk of dying during the procedure or of surviving with or without (major or minor) events. They can be re-operated for implantation of a new valve or converted to AVR, for patients having undergone TAVI. In the Markov model, for cycles of 12 months, three states are distinguished: functional recovery, no functional recovery and death. Patients in the functional recovery state may stay in the same state, die or move to the no functional recovery state, as a result of having suffered serious late events. Patients in the no functional recovery state may stay in the same state or die. Clinical data for filling the model were obtained mainly from the PARTNER trial, cohort A. Given the perspective adopted in the economic analysis, the direct costs related to the analysed procedures were evaluated: costs of the TAVI and AVR procedure, cost of (major or minor) events arising during the procedure, cost of reoperation, cost of drugs, and costs associated with health states over time. The costs were obtained mainly from the analytical accounts of the Cruces University Hospital, which is part of the Osakidetza Basque Health Service. The cost of drugs was obtained from the Pharmacy Department of the Basque Government’s Department of Health. The mean utility value corresponding to the patients in the functional recovery state, after 30 days and 1 year, was obtained from the PARTNER assay (cohort A), whereas the value for the patients in the no functional recovery state was obtained by allocating to the proportion of patients in each of the NYHA scales (data obtained from the Cruces University Hospital patient records), the utility score attributed to each of them, according to the results of the Spanish INCA study. The incremental cost-effectiveness ratio was calculated, which indicates the mean incremental cost associated with TAVI compared to AVR, per mean incremental QALY gained and a probabilistic sensitivity analysis was performed, by means of a second-order Monte Carlo simulation, to assess the uncertainty of the model variables and the robustness of the obtained data. The results of the sensitivity analysis are expressed through the costeffectiveness plane and the acceptability curve.

Project Status: Completed

Year Published: 2014

URL for published report: https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=051588&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>