Skip to main content
SpringerLink
Log in

Análisis coste-efectividad de rivaroxabán en la prevención de la enfermedad tromboembólica venosa en España

  • Artículo de Investigacón Original
  • Published:
PharmacoEconomics Spanish Research Articles

Resumen

Introducción: La enfermedad tromboembólica venosa (ETV) es una enfermedad frecuente y grave que causa un gran impacto sobre el Sistema Nacional de Salud (SNS). El objetivo del presente estudio ha sido realizar un análisis coste-efectividad de rivaroxabán frente a enoxaparina en la prevención de la ETV en pacientes sometidos a cirugía ortopédica mayor en España, desde la perspectiva del SNS.

Métodos: Un modelo farmacoeconómico de rivaroxabán frente a enoxaparina permitió replicar los resultados de los estudios RECORD y modelar los costes y efectos a 5 años de la ETV en dos cohortes de pacientes: pacientes sometidos a artroplastia total de cadera (ATC) y pacientes sometidos a artroplastia total de rodilla (ATR). El análisis tomó la perspectiva del SNS, expresando los costes en € de 2008, y descontando costes y efectos al 3% anual.

Resultados: Rivaroxabán fue más efectivo que enoxaparina (16 y 29 episodios sintomáticos de ETV menos por cada 1.000 pacientes en ATC y ATR, respectivamente), lo que se tradujo en una moderada ganancia en términos de años de vida ajustados por calidad (AVAC) (11 y 22 AVA C ganados por cada 1.000 pacientes tratados en ATC y ATR, respectivamente). Rivaroxabán presentó un coste total menor que enoxaparina (ahorro por paciente de 30 € y 151 €, en ATC y ATR, respectivamente). Los resultados del análisis de sensibilidad probabilístico mostraron la robustez del análisis a cambios en los parámetros principales del modelo.

Conclusiones: La reducción de la incidencia de la ETV, con consecuencias económicas importantes a corto y medio plazo, hace que rivaroxabán sea una opción no sólo más efectiva sino también menos costosa que enoxaparina.

Abstract

Introduction: Venous thromboembolic disease (VTE) is a common and serious disease that causes a great impact on the National Health System (NHS). The aim of this study was to perform a cost-effectiveness analysis of rivaroxaban versus enoxaparin in preventing VTE in patients undergoing major orthopedic surgery in Spain from the perspective of the NHS.

Methods: A decision analytic model of rivaroxaban versus enoxaparin was used to replicate the short-term results of the RECORD studies and to model the 5-year costs and outcomes of VTE in two cohorts of patients: patients undergoing total hip replacement (THR) and patients undergoing total knee replacement (TKR). The analysis was conducted from the perspective of the NHS. All costs were in euros of 2008. Costs and effects were discounted at a rate of 3% annually.

Results: Rivaroxaban was more effective than enoxaparin (16 and 29 fewer symptomatic events per 1,000 patients in THR and TKR, respectively), which resulted in a moderate gain in terms of quality-adjusted life year (QALY) (11 and 22 QALYs gained per 1000 patients treated in THR and TKR, respectively). The lower incidence of complications also resulted in a lower total cost for rivaroxa-ban over enoxaparin, showing cost savings of € 30 and € 151 (for THR and TKR respectively). The results of the probabilistic sensitivity analysis showed the robustness of the analysis when changing the main parameters of the model.

Conclusions: Reducing the incidence of VTE, with major economic consequences in the short and medium term, makes rivaroxaban an option not only more effective but also less costly compared with enoxaparin.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Referencias

  1. Jaffer AK. An overview of venous thromboembolism: impact, risks, and issues in prophylaxis. Cleve Clin J Med 2008;75(Suppl 3):S3–6.

    Article  PubMed  Google Scholar 

  2. Calvo Romero JM, Arevalo Lorido JC, Romero Requena J, Pérez Alonso JL, Ortiz Descane C, Gutiérrez Montaño C, et al. Enfermedad tromboembólica venosa en un área rural del sur de Extremadura (España). An Med Interna 2005;22:465–8.

    Google Scholar 

  3. Guijarro R, San Roman CM, Perelló JI, Nuño E. A study of hospital discharges for venous thromboembolism in the south of Spain. An analysis of 19,170 cases from a regional database from 1998 to 2001. Eur J Intern Med 2005;16:279–86.

    Article  PubMed  Google Scholar 

  4. Cohen AT, Agnelli G, Anderson FA, Arceluis JI, Bergqvist D, Brecht, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost 2007;98:756–64.

    PubMed  CAS  Google Scholar 

  5. Monreal M, Peidró L, Resines C, Garcés C, Fernández JL, Garagorri E, González JC. Limited diagnostic workup for deep vein thrombosis after major joint surgery. Findings from a prospective, multicentre, cohort study. Thromb Haemost 2008;99:1112–15.

    PubMed  CAS  Google Scholar 

  6. Botella, G. Reflexiones sobre la enfermedad tromboembólica venosa. An Med Interna (Madrid) 2003;20:447–450.

    Google Scholar 

  7. Ministerios de Sanidad y Consumo (MSC). 2005. Registro de Altas Hospitalarias del Sistema Nacional de Salud. CMBD (Conjunto Mínimo Básico de Datos). Disponible en http://www.msc.es/estadEstudios/estadisticas/cmbd.htm

    Google Scholar 

  8. Deitelzweig S, Jaff MR. Medical management of venous thromboembolic disease. Tech Vasc Interv Radiol 2004;7:63–7.

    Article  PubMed  Google Scholar 

  9. National Institute for Health and Clinical Excellence (NICE). Venous thromboembolism. Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. NICE clinical guideline 46. April 2007.

    Google Scholar 

  10. Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178–85.

    Article  PubMed  CAS  Google Scholar 

  11. Monreal M (Coordinador). Registro Informatizado de Pacientes con Enfermedad TromboEmbólica (R.I.E.T.E.). Accedido en www.riete.org en Enero de 2011.

    Google Scholar 

  12. Skedgel C, Goeree R, Pleasance S, Thompson K, O’brien B, Anderson D. The cost-effectiveness of extended-duration antithrombotic prophylaxis after total hip arthroplasty. J Bone Joint Surg Am 2007;89:819–28.

    Article  PubMed  Google Scholar 

  13. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765–75.

    Article  PubMed  CAS  Google Scholar 

  14. Kakkar AK, Brenner B, Dahl O, Eriksson BI, Mouret P, Muntz J, et al. Extended duration rivaroxaban versus shortterm enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008;372:31–9.

    Article  PubMed  CAS  Google Scholar 

  15. Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358:2776–86.

    Article  PubMed  CAS  Google Scholar 

  16. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673–80.

    Article  PubMed  CAS  Google Scholar 

  17. Diamantopoulos A, Forster F, Lees M, Gilmour L, Ashley D. Cost-effectiveness of rivaroxaban versus enoxaparin for thromboprophylaxis after total hip replacement in the UK. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 11th Annual European Congress, 2008 Abstract PHC9.

    Google Scholar 

  18. White RH, Romano PS, Zhou H, Rodrigo J, Bargar W. Incidence and time course of thromboembolic outcomes following total hip or knee arthroplasty. Arch Intern Med 1998;158:1525–31.

    Article  PubMed  CAS  Google Scholar 

  19. Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica 1997;82:423–8.

    PubMed  CAS  Google Scholar 

  20. Lenert LA, Soetikno RM. Automated computer interviews to elicit utilities: potential applications in the treatment of deep venous thrombosis. J Am Med Inform Assoc 1997;4:49–56.

    Article  PubMed  CAS  Google Scholar 

  21. Räsänen P, Paavolainen P, Sintonen H, Koivisto AM, Blom M, Ryynanen OP, Roine RP. Effectiveness of hip or knee replacement surgery in terms of quality-adjusted life years and costs. Acta Orthop 2007;78:108–15.

    Article  PubMed  Google Scholar 

  22. Haentjens P, De Groote K, Annemans L. Prolonged enoxa-parin therapy to prevent venous thromboembolism after primary hip or knee replacement. A cost-utility analysis. Arch Orthop Trauma Surg 2004;124:507–17.

    Article  PubMed  Google Scholar 

  23. Highland KB, Strange C, Mazur J, Simpson KN. Treatment of pulmonary arterial hypertension: a preliminary decision analysis. Chest 2003;124:2087–92.

    Article  PubMed  Google Scholar 

  24. Brosa Riestra M, Rubio-Terrés C, Nadipelli V, Casado Collado A, Martínez Brotons F. Cost-effectiveness analysis of enoxaparin for the prophylaxis of venous thromboembolism in major orthopedic surgery patients. Farm Hosp 2003;27:210–8.

    Google Scholar 

  25. Páramo JA, Feliu J, Iglesias R, Ruiz de Gaona E, Lecumberri R. Profilaxis del tromboembolismo venoso: recomendaciones en pacientes médicos y sistema de alarma electrónica en pacientes hospitalizados. Rev Med Univ Navarra 2006;50:17–23.

    Google Scholar 

  26. García Vidal R, Berga Fauria C, Martín Paredero V. Trombosis venosa profunda: nuevos fármacos y futuras perspectivas terapéuticas. Rev Clin Esp 2006;206:281–3.

    Article  Google Scholar 

  27. Honorato J, Gómez-Outes A, Navarro-Quilis A, Martínez-González J, Rocha E, Planès A. Pharmacoeconomic analysis of bemiparin and enoxaparin as prophylaxis for venous thromboembolism in total knee replacement surgery. Pharmacoeconomics 2004;22:885–94.

    Article  PubMed  CAS  Google Scholar 

  28. Gisbert R, Brosa M. E-Salud. Base de Datos de Costes Españoles. 2008. Oblikue Consulting. Disponible en: http://www.oblikue.com/bddcostes/

    Google Scholar 

  29. Nuijten MJ, Villar FA, Kosa J, Nadipelli V, Rubio-Terrés C, Suarez C. Cost-effectiveness of enoxaparin as thromboprophylaxis in acutely ill medical patients in Spain. Value Health 2003;6:126–36.

    Article  PubMed  CAS  Google Scholar 

  30. Galiè N, Torbicki A, Barst R, Dartevelle P, Haworth S, Higenbottam T, et al. Guidelines on diagnosis and treatment of pulmonary arterial hypertension. The Task Force on Diagnosis and Treatment of Pulmonary Arterial Hypertension of the European Society of Cardiology. Eur Heart J 2004;25:2243–78.

    Article  PubMed  Google Scholar 

  31. Wlodarczyk JH, Cleland LG, Keogh AM, McNeil KD, Perl K, Weintraub RG, Williams TJ. Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia: cost effectiveness and risk sharing. Pharmacoeconomics 2006;24:903–15.

    Article  PubMed  Google Scholar 

  32. Sacristán JA, Oliva J, Del Llano J, Prieto L, Pinto JL. ¿Qué es una tecnología sanitaria eficiente en España? Gac San 2002;16:334–43.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. c/Josep Irla i Bosch, 5–7 Primera Planta, 08034, Barcelona, España

    Max Brosa (Oblikue Consulting)

  2. Servicio de Medicina Interna, Hospital Germans Trias i Pujol. Badalona, Barcelona, España

    Manuel Monreal

  3. Bayer Healthcare, Barcelona, España

    Carme Piñol

Authors
  1. Max Brosa
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Manuel Monreal
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Carme Piñol
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Max Brosa.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Brosa, M., Monreal, M. & Piñol, C. Análisis coste-efectividad de rivaroxabán en la prevención de la enfermedad tromboembólica venosa en España. Pharmacoecon. Span. Res. Artic. 9, 35–46 (2012). https://doi.org/10.1007/BF03320872

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF03320872

Palabras clave

Keywords

Search

Navigation