RESUMO
BACKGROUND: Patients with venous thromboembolism (VTE) commonly have an underlying genetic predisposition. However, genetic tests nowadays in use have very low sensitivity for identifying subjects at risk of VTE. Thrombo inCode(®) is a new genetic tool that has demonstrated very good sensitivity, thanks to very good coverage of the genetic variants that modify the function of the coagulation pathway. OBJECTIVE: To conduct an economic analysis of risk assessment of VTE from the perspective of the Spanish National Health System with Thrombo inCode(®) (a clinical-genetic function for assessing the risk of VTE) versus the conventional/standard method used to date (factor V Leiden and prothrombin G20210A). METHODS: An economic model was created from the National Health System perspective, using a decision tree in patients aged 45 years with a life expectancy of 81 years. The predictive capacity of VTE, based on identification of thrombophilia using Thrombo inCode(®) and using the standard method, was obtained from two case-control studies conducted in two different populations (S. PAU and MARTHA; 1,451 patients in all). Although this is not always the case, patients who were identified as suffering from thrombophilia were subject to preventive treatment of VTE with warfarin, leading to a reduction in the number of VTE events and an increased risk of severe bleeding. The health state utilities (quality-adjusted life-years [QALYs]) and costs (in 2013 EUR values) were obtained from the literature and Spanish sources. RESULTS: On the basis of a price of EUR 180 for Thrombo inCode(®), this would be the dominant option (more effective and with lower costs than the standard method) in both populations. The Monte Carlo probabilistic analyses indicate that the dominance would occur in 100 % of the simulations in both populations. The threshold price of Thrombo inCode(®) needed to reach the incremental cost-effectiveness ratio (ICER) generally accepted in Spain (EUR 30,000 per QALY gained) would be between EUR 3,950 (in the MARTHA population) and EUR 11,993 (in the S. PAU population). CONCLUSION: According to the economic model, Thrombo inCode(®) is the dominant option in assessing the risk of VTE, compared with the standard method currently used.
Assuntos
Análise Custo-Benefício , Predisposição Genética para Doença , Testes Genéticos/economia , Medição de Risco/economia , Tromboembolia Venosa/economia , Tromboembolia Venosa/genética , Adulto , Idoso , Idoso de 80 Anos ou mais , Árvores de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Valor Preditivo dos Testes , Medição de Risco/métodos , Sensibilidade e Especificidade , Espanha , Tromboembolia Venosa/etiologiaRESUMO
We estimated the predictive values of activated protein C resistance in the diagnosis of women who are carriers of factor V Leiden. When the prevalence of factor V Leiden is 2%, the positive predictive value is 44% and the cost of preventing one thromboembolic death is $44,180,000. Thus the activated protein C resistance assay is not cost-effective in ruling out factor V Leiden in this population.