Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.

Predictors for total hospital and cardiology cost claims among patients with atrial fibrillation initiating dabigatran or acenocoumarol in The Netherlands.

AIMS: The prevalence of atrial fibrillation (AF) has increased over the past years due to aging of the population, and healthcare costs associated with AF reflect a significant financial burden. The aim of this study was to explore predictors for the real-world AF-related in-hospital costs in patients that recently initiated anticoagulation with acenocoumarol or dabigatran. METHODS: Predictors for claimed total hospital care costs and cardiology costs in AF patients were explored by using hospital financial claims data from propensity score matched patient groups in a large Dutch community hospital. This study analyzed the total dataset (n = 766) and carried out a secondary analysis for all matched pairs of anticoagulation naïve AF patients (n = 590) by ordinal regression. RESULTS: Dabigatran was a predictor for significantly lower cardiology and total hospital care costs (Odds Ratio [OR] = 0.43, 95% confidence interval (CI) = 0.33-0.57; and OR = 0.60, 95% CI = 0.46-0.79, respectively). Female gender was a predictor for lower total hospital care costs. Predictors for an increase in total hospital care costs were the occurrence of stroke or systemic embolism, major bleeding, and minor bleeding. The costs predictors were comparable when limiting the analysis to patients that were anticoagulation naïve. Age and CHA2DS2-VASc were not predictors for either cardiology or total hospital care costs in both analyses. CONCLUSION: Dabigatran treatment was as a predictor for lower cardiology costs and lower total hospital care costs in AF patients that initiated oral anticoagulation.

Latin American Clinical Epidemiology Network Series - Paper 2: Apixaban was cost-effective vs. acenocoumarol in patients with nonvalvular atrial fibrillation with moderate to severe risk of embolism in Chile.

OBJECTIVE: Nonvalvular atrial fibrillation (NVAF) is a risk factor for ischemic stroke and systemic embolism. New oral anticoagulants are currently available. The objective of this study was to assess the incremental cost-utility ratio (ICUR) for apixaban vs. acenocoumarol in patients treated in Chile's public health system. STUDY DESIGN AND SETTING: We assessed cost-utility from the payer perspective with a lifetime Markov model. Epidemiologic characteristics, costs, and utilities were obtained from a Chilean cohort; data were completed with information from international literature. RESULTS: Incremental costs when using apixaban vs. acenocoumarol over a lifetime are CH$2,108,600 with an incremental effectiveness of 0.173 years of life gained (YLG) and 0.182 quality-adjusted life-year (QALY). The ICUR of apixaban vs. acenocoumarol was CH$12,188,439 per YLG and CH$11,585,714 per QALY. One to 3 times gross domestic product (GDP) per capita threshold is acceptable based on World Health Organization (WHO) norms. Chilean GDP per capita was CH$7,797,021 in 2013. The sensitivity analysis shows that these results are sensitive to the ischemic stroke risk with apixaban, and the intracranial hemorrhage risk due to the use of acenocoumarol. CONCLUSION: The use of apixaban in patients with NVAF in moderate-to-high risk of stroke is cost-effective, considering the payment threshold suggested by WHO.

Economic evaluation of a pharmacogenetic dosing algorithm for coumarin anticoagulants in The Netherlands.

AIM: To investigate the cost-effectiveness of a pharmacogenetic dosing algorithm versus a clinical dosing algorithm for coumarin anticoagulants in The Netherlands. MATERIALS & METHODS: A decision-analytic Markov model was used to analyze the cost-effectiveness of pharmacogenetic dosing of phenprocoumon and acenocoumarol versus clinical dosing. RESULTS: Pharmacogenetic dosing increased costs by €33 and quality-adjusted life-years (QALYs) by 0.001. The incremental cost-effectiveness ratios were €28,349 and €24,427 per QALY gained for phenprocoumon and acenocoumarol, respectively. At a willingness-to-pay threshold of €20,000 per QALY, the pharmacogenetic dosing algorithm was not likely to be cost effective compared with the clinical dosing algorithm. CONCLUSION: Pharmacogenetic dosing improves health only slightly when compared with clinical dosing. However, availability of low-cost genotyping would make it a cost-effective option.

[Dabigatran versus acenocumarol for the prevention of stroke in atrial fibrillation: budget impact analysis in one health department in Spain]. / Dabigatrón versus acenocumarol para la prevención del ictus en la fibrilación atrial: análisis de impacto presupuestario en un departamento sanitario.

BACKGROUND: To Estimate, in the context of a Health Department of the Valencia Health Agency, the budgetary impact of the widespread use of dabigatran at doses of 110 and 150 mg in patients with non-valvular atrial fibrillation (AF), regarding the current scenario with acenocoumarol therapy. METHODS: Budget impact analysis of three scenarios of oral anticoagulation use in AF: a) current treatment with acenocoumarol, b) widespread replacement of acenocoumarol for Dabigatran 110 mg and, c) idem at doses of 150 mg. The analysis was conducted from the perspective of the Valencia Health Agency with a time horizon of one year (2009). The effectiveness and adverse effects were extrapolated from the RE-LY study, while prevalence and cost data correspond to the Health Department estimates in 2009. RESULTS: We included 5889 patients (2.4% of the population > 18 years) diagnosed with AF, of which 3726 (63.2%) were treated with acenocoumarol. The total costs of each scenario were € 1,119,412 (€ 300 patient/year) for acenocoumarol, € 4,985,095 (€ 1,337 patient/year) for dabigatran 110 and € 4,981,226 (€ 1,336 patient/year) for dabigatran 150, with a budget impact of 1,037 euros/year per patient shifted from acenocumarol to dabigatran-150. CONCLUSIONS: The high budgetary impact of moving to a scenario of widespread substitution of warfarin for Dabigatran supports the restriction of this therapeutic strategy to subgroups of patients at high risk or difficult control.