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Evidencia del coste-efectividad de la implantación transcatéter de la prótesis valvular aórtica (TAVI) Edwards SAPIEN en pacientes de alto riesgo con estenosis aórtica sintomática en España: resultados preliminares

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PharmacoEconomics Spanish Research Articles

Resumen

Objetivos

La implantación transcatéter de la prótesis valvular aórtica (Transcatheter Aortic Valve Implantation, TAVI) es una técnica mínimamente invasiva con la que se obtienen mejores resultados que con el tratamiento médico conservador (estudio aleatorio PARTNER US) en pacientes con alto riesgo quirúrgico. El objetivo de este estudio es estimar la relación coste-efectividad de TAVI en comparación con el tratamiento médico conservador en España.

Métodos

Se empleó un modelo económico (árbol de decisión), longitudinal, adaptado para España para predecir los resultados clínicos y económicos al tratar pacientes con estenosis valvular aórtica (EVA) severa, con TAVI por vía transapical (TA TAVI), transfemoral (TF TAVI), o con tratamiento médico conservador. La información clínica empleada procedió del registro SOURCE (SAPIEN Aortic Bioprosthesis European Outcomes) para TAVI, mientras que para el tratamiento médico conservador se usaron datos de la bibliografía y de un registro español de 62 pacientes con EVA, no tratados quirúrgicamente, con un seguimiento (medio) de 332 días. Se buscó el consenso de expertos cuando la información necesaria no estaba disponible. Los resultados se expresaron en costes/paciente tratado y costes/año de vida ajustado por calidad (AVAC) desde la perspectiva del sistema nacional de salud (SNS). Se aplicó una tasa de descuento anual del 3 % a los costes y los beneficios.

Resultados

Durante el periodo de 3 años analizado, se logró un incremento en años de vida por paciente de 2,12 con TA TAVI, de 2,31 con TF TAVI, y de 1,51 con tratamiento médico conservador, lo que representa una ganancia de 1,24, 1,38 y 0,74 AVAC por paciente, respectivamente. Los costes directos (sanitarios) estimados de tratar a un paciente fueron de €37.311 con TA TAVI, €35.689 con TF TAVI y €23.103 con tratamiento médico conservador. El coste/AVAC adicional fue de €28.003 para TA TAVI y de €19.499 para TF TAVI, situándose ambos valores muy por debajo del umbral aceptado para España. El impacto del coste de los dispositivos sobre el procedimiento con TAVI fue ampliamente compensado en el tiempo por el menor número de reingresos hospitalarios de origen cardiaco.

Conclusiones

En comparación con el tratamiento médico conservador, TAVI con prótesis Edwards SAPIEN presenta mejores resultados en términos de mortalidad y es coste-efectivo en el ámbito sanitario español para pacientes inoperables con EVA severa y sintomática de alto riesgo. El análisis de sensibilidad demostró la solidez de los resultados.

Abstract

Aims

Transcatheter aortic valve implantation (TAVI) represents an innovative technology superior to medical management (PARTNER study, US) in inoperable patients with severe aortic valve stenosis (AVS). This study aims to estimate the cost-effectiveness of TAVI compared to conservative medical management in symptomatic AVS patients in Spain.

Methods

An economic longitudinal cohort model was used to predict clinical and economic outcomes of symptomatic AVS patients treated with either transapical (TA) or transfemoral (TF) TAVI, or medical management alone (MEDICAL). Clinical model input data for TAVI was derived from the real-world SOURCE registry, and for MEDICAL from literature and a registry of 62 untreated Spanish AVS patients followed up for 332 days. Health utilities as well as resource use and unit costs utilized for modelling are representative for Spain. Missing information was substituted by expert estimates. Economic results are expressed as cost per quality-adjusted life year (QALY) gained. Perspective is that of the national health system (NHS). Benefits and costs were discounted at 3 % per year.

Results

Over the 3-year analysis period, 2.12 life years per patient were achieved with TA TAVI, 2.31 with TF TAVI, and 1.51 with conservative medical care, representing 1.24, 1.38, and 0.74 QALYs, respectively. Cumulative direct costs were predicted to amount to €37,311 and €35,689 with TA and TF TAVI, respectively, and to €23,103 with conservative care. Cost/QALY gained was €28,003 for TA TAVI and €19,499 for TF TAVI; both ratios remaining well below the accepted willingness-to-pay threshold for Spain. The substantial cost of the TAVI procedure was largely offset over time mainly by savings related to prevented hospital readmissions for cardiac reasons.

Conclusions

Compared to conservative management, TAVI is a life-saving and cost-effective treatment for high-risk or inoperable patients with symptomatic aortic valve stenosis in Spain. Sensitivity analyses indicated these findings to be robust.

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Authors and Affiliations

  1. Unidad de Epidemiología, Hemodinámica y Servicio de Cirugía Cardiaca del Área del Corazón, Hospital Vall d’Hebron, Barcelona, España

    Ignacio Ferreira-González, Vicente Serra, Omar Abdul, Aida Ribera, Carlos Sureda, Alberto Igual, Bruno García del Blanco, Juan Ángel, David García-Dorado & Pilar Tornos

  2. CIBER de Epidemiología y Salud Pública (CIBERESP), Passeig Vall d’Hebron, 119-129, 08035, Barcelona, España

    Ignacio Ferreira-González, Vicente Serra, Omar Abdul, Aida Ribera, Carlos Sureda, Alberto Igual, Bruno García del Blanco, Juan Ángel, David García-Dorado & Pilar Tornos

  3. Outcomes’10, Parc Cientific Tecnológic i Empresarial, Universitat Jaume I, Edificio ESPAITEC II, Campus Sec, Avda Sos Baynat s/n, 12071, Castellón, España

    Silvia Paz

  4. Outcomes’10, Parc Cientific Tecnológic i Empresarial, Universitat Jaume I, Edificio ESPAITEC I, Campus del Riu Sec, Avda Sos Baynat s/n, Passeig Vall d’Hebron, 119-129, 08035, Barcelona, España

    Luis Lizan

  5. Outcomes International, Malzgasse 9, 4052, Basilea, Suiza

    Kurt Banz

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  1. Ignacio Ferreira-González
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  2. Vicente Serra
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  3. Omar Abdul
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Corresponding author

Correspondence to Silvia Paz.

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Este estudio ha sido patrocinado por Edwards LifeSciences.

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Ferreira-González, I., Serra, V., Abdul, O. et al. Evidencia del coste-efectividad de la implantación transcatéter de la prótesis valvular aórtica (TAVI) Edwards SAPIEN en pacientes de alto riesgo con estenosis aórtica sintomática en España: resultados preliminares. PharmacoEcon Span Res Artic 10, 1–13 (2013). https://doi.org/10.1007/s40277-013-0001-z

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