Rivaroxaban for non-valvular atrial fibrillation and venous thromboembolism in the Netherlands: a real-world data based cost-effectiveness analysis

Abstract

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) have been included in international guidelines as important alternatives to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE) and stroke prevention in non-valvular atrial fibrillation (NVAF). Meanwhile, in the Netherlands, NOACs are widely used next to VKAs. The objective of this study is to estimate the cost-effectiveness of treatment with rivaroxaban compared to VKAs in NVAF and VTE patients in the Netherlands, using data from international prospective observational phase IV studies. Methods: Two models were developed to represent NVAF and VTE patients, populated with patients from the XANTUS (NCT01606995) and XALIA (NCT01619007) international prospective observational studies. The 1-year cost-effectiveness of rivaroxaban use, compared to VKAs, was explored in a population consisting of NVAF and VTE patients (base case) as well as for four scenarios with sub-populations: NVAF patients only, VTE patients only, NVAF patients with unstable international normalized ratio (INR), and NVAF patients using an INR self-measuring device. Results: In the base case, rivaroxaban saved e72,350 and gained 21 quality-adjusted life-years (QALYs) in a simulation of 2,000 patients over the use of VKAs. Ergo, rivaroxaban was dominant over VKAs. The probabilistic sensitivity analysis showed a probability of 85% for rivaroxaban being dominant and 100% at a willingness-to-pay threshold of e20,000/QALY. Rivaroxaban appeared to be dominant in all scenarios as well, except for the NVAF-patients-only scenario where the incremental cost-effectiveness ratio (ICER) was e157/QALY. Conclusions: In patients with NVAF or VTE, rivaroxaban treatment is likely to be cost-effective and a potentially cost-saving alternative to VKA in the Netherlands. ARTICLE HISTORY

Real-world cost-effectiveness of rivaroxaban compared with vitamin K antagonists in the context of stroke prevention in atrial fibrillation in France

“…In the latter, uncertainty around RCT data used for NOACs was specifically highlighted, suggesting the need to validate the results in a French real-life context. Other published models considered RWE to document effectiveness [39][40][41][42], but none considered a meta-analysis with RWE only.…”

Safety and feasibility of rivaroxaban in deferred workup of patients with suspected deep vein thrombosis

“…A disadvantage is system and patient cost, albeit subject to varying legislation between countries. [19][20][21] However, the main potential disadvantage is risking bleeding complications in patients without DVT. The favorable safety profile demonstrated in this and similarly designed studies applying LMWH or unfractionated heparin for deferred workup, all yielding no major bleedings, 3-9 support the use of empiric anticoagulation in prolonged workup of DVT.…”

Big Data and Real-World Data based Cost-Effectiveness Studies and Decision-making Models: A Systematic Review and Analysis

“…However, there were still several studies from a societal perspective that did not include indirect costs ( Aarnio et al, 2015 ; van Leent et al, 2015 ; Dor et al, 2018 ; de Jong et al, 2019a ; de Jong et al, 2019b ; Voermans et al, 2019 ). Although none of these studies focusing on malignant diseases that can cause serious damage to the patient’s productivity or infectious diseases that can infect others ( Aarnio et al, 2015 ; van Leent et al, 2015 ; Dor et al, 2018 ; de Jong et al, 2019a ; de Jong et al, 2019b ; Voermans et al, 2019 ), ignoring indirect costs to some extent underestimates the total costs and the benefits of productivity that could accrue to patients from more effective interventions ( Drummond and McGuire, 2005 ). When using society as a research perspective of cost, opportunity cost instead of acquisition cost should be measured as the cost of interventions or programs.…”

“…When using society as a research perspective of cost, opportunity cost instead of acquisition cost should be measured as the cost of interventions or programs. However, in all the studies that we included using society as the perspective, the costs were directly used acquisition costs, and there was no discussion why these costs were not adjusted into opportunity costs ( Lindgren et al, 2009 ; Lekander et al, 2010 ; Yang et al, 2010 ; Lekander et al, 2013 ; Aarnio et al, 2015 ; Zhao et al, 2016 ; Tanaka et al, 2017 ; Vassall et al, 2017 ; Dor et al, 2018 ; de Jong et al, 2019a ; de Jong et al, 2019b ; Behan et al, 2019 ; Lin et al, 2019 ; Voermans et al, 2019 ; Wang et al, 2019 ; Arrobas et al, 2021 ). This might lead to the overestimation of costs and ICER.…”