Search

Introduction and Aims: To project the long-term cost-effectiveness of treating non-valvular atrial fibrillation (AF) patients for stroke prevention with rivaroxaban compared to warfarin in Portugal. Methods: A Markov model was used that included health and treatment states describing the management and consequences of AF and its treatment. The model's time horizon was set at a patient's lifetime and each cycle at three months. The analysis was conducted from a societal perspective and a 5% discount rate was applied to both costs and outcomes. Treatment effect data were obtained from the pivotal phase III ROCKET AF trial. The model was also populated with utility values obtained from the literature and with cost data derived from official Portuguese sources. The outcomes of the model included life-years, quality-adjusted life-years (QALYs), incremental costs, and associated incremental cost-effectiveness ratios (ICERs). Extensive sensitivity analyses were undertaken to further assess the findings of the model. As there is evidence indicating underuse and underprescription of warfarin in Portugal, an additional analysis was performed using a mixed comparator composed of no treatment, aspirin, and warfarin, which better reflects real-world prescribing in Portugal. Results: This cost-effectiveness analysis produced an ICER of €3895/QALY for the base-case analysis (vs. warfarin) and of €6697/QALY for the real-world prescribing analysis (vs. mixed comparator). The findings were robust when tested in sensitivity analyses. Conclusion: The results showed that rivaroxaban may be a cost-effective alternative compared with warfarin or real-world prescribing in Portugal. Resumo: Introdução e objetivos: Estimar o rácio custo-efetividade a longo-prazo associados à utilização de rivaroxabano na prevenção de acidente vascular cerebral em doentes com fibrilhação auricular (FA) não-valvular relativamente a varfarina em Portugal. Métodos: Foi utilizado um modelo de Markov que representa os estádios representativos da progressão da FA e do seu tratamento. O horizonte temporal modelizado descreve o tempo de vida dos doentes e cada ciclo tem a duração de três meses. A análise foi desenvolvida na perspetiva da sociedade, tendo sido aplicada uma taxa de atualização de cinco por cento para custos e consequências. Os efeitos do tratamento foram obtidos no ensaio clínico de fase III ROCKET AF. Adicionalmente, no modelo foram incluídos valores de utilidade provenientes da literatura e estimativas de custos nacionais. Os outcomes avaliados no modelo incluem anos de vida incrementais, anos de vida ajustados pela qualidade de vida incrementais (AVAQ), custos incrementais e rácio custo-efetividade incremental (RCEI). Foram desenvolvidas análises de sensibilidade com o objetivo de avaliar os resultados do modelo. A evidência existente indica subutilização e subprescrição de varfarina em Portugal e, por esta razão, foi desenvolvida uma análise adicional com um comparador misto, constituído por não tratamento, ácido acetilsalicílico e varfarina, o que reflete melhor o «mundo real de prescrição». Resultados: RCEI obtido varia entre 3 895€/AVAQ para o cenário-base (relativamente varfarina) e 6 697€/AVAQ para o «mundo real de prescrição» (relativamente comparador misto). As análises de sensibilidade demonstraram que os resultados são robustos. Conclusão: Os resultados sugerem que rivaroxabano pode constituir uma alternativa custo-efetiva comparativamente a varfarina ou «mundo real de prescrição» em Portugal. Keywords: Atrial fibrillation, Cost-effectiveness, Portugal, Rivaroxaban, Stroke, Palavras-chave: Fibrilhação Auricular, Custo-efetividade, Portugal, Rivaroxabano, AVC

Introduction: Venous thromboembolism is a burden on healthcare systems. The aim of this analysis was to project the long-term costs and outcomes for rivaroxaban compared to standard of care (enoxaparin/warfarin) in Portugal for the treatment and secondary prevention of venous thromboembolism. Material and Methods: A Markov model was developed using event rates extracted from the EINSTEIN trials supplemented with literature-based estimates of longer-term outcomes. Core outcomes included per patient costs and quality-adjusted life years reported separately per treatment arm and incrementally, as well as cost per quality-adjusted life years gained. The deep vein thrombosis and pulmonary embolism indications were analysed separately. The analyses were conducted from the Portuguese societal perspective and over a 5-year time horizon. Costs and outcomes were discounted at a 5% annual rate. Several scenario analyses were undertaken to explore the impact on results of varying key modeling assumptions. Results: Rivaroxaban treatment was associated with cost-savings for the treatment of deep vein thrombosis and was both cost-saving and more effective for the treatment of pulmonary embolism, compared with enoxaparin/warfarin. Discussion: The results of the sensitivity and scenario analyses further supported that rivaroxaban is a cost-effective alternative to standard of care treatment. The use of an expert panel to derive some input values and the lack of Portuguese specific utilities were the main limitations. Conclusion: Rivaroxaban represents an efficient alternative to using enoxaparin/warfarin in Portugal, as it’s associated with lower costs (for both indications) and greater quality adjusted life years (for the pulmonary embolism indication). Keywords: Venous Thrombosis; Pulmonary Embolism; Rivaroxaban; Venous Thromboembolism.