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

Abstract

ObjectiveThe objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective.Funding: LF, CC and PL received honorarium from Bayer AG for critical input into study design and results analysis. Bayer Plc. provided support in the form of salaries for author KB; Bayer AG provided support in the form of salaries for author JBB. Bayer AG sponsored the study, and Bayer AG as well as Bayer Plc had a role in the study design, ConclusionsAlthough there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective. Introduction/BackgroundAtrial fibrillation (AF) is a cardiac arrhythmia with structural and/or electrophysiological abnormalities that induce remodelling in the atria; it is the most common cardiac arrhythmia [1][2][3]. Worldwide, an estimated 3% of adults aged 20 years or older suffer from AF, approximately 20.9 million men and 12.6 million women [2]. Due to the aging of the population, the worldwide prevalence is predicted to at least double in many countries during the next several decades [4,5].AF is associated with substantial morbidity and mortality [2]. Compared to otherwise healthy individuals, men and women with AF are at a 1.5-fold and 2-fold increased risk for allcause mortality, respectively [2], and the risk for strokes increased by 2-to-7-fold [4]. Strokes are associated with significant financial burden [6]; in 2015, the total costs of stroke care in the European Union (EU) was estimated to be €45 billion euros [7]. It is expected that between 2015 and 2035, there will be a 34% increase in total number of stroke events in the European Union [7].Oral anticoagulants including vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban, have been established as a cornerstone of management in patients with AF and to reduce stroke incidence and mortality [2] in randomized clinical trials (RCTs) [2].Many uncertainties remain regarding the relevance of the results of RCTs in a real-world setting. Real-world evidence (RWE) may provide additional information to decision-makers [8]. Indeed, RWE sample size is not limited as it is the case of RCTs. RCTs have to respect inclusion/exclusion criteria regarding population selection. Also, RWE can offer long-term outcomes while the timeframe of RCT is usually shorter with only a few outcomes [9].A meta-analysis comparing NOACs with VKAs and reporting effectiveness, safety, and persistence using RWE has recently been published [10]. It confirmed the findings of rivaroxaban pivotal RCT [11] and concluded that rivaroxaban is a suitable alternative to VKAs in routine clinical practice. Health Technology Assessment (HTA) agencies are frequently requesting manufacturers to prove the benefits of their hea...

Real-world cost-effectiveness of rivaroxaban and apixaban vs VKA in stroke prevention in non-valvular atrial fibrillation in the UK

“…This confirms previous results submitted to NICE [12,13], but also results published later, in the UK in particular [46], but also in France [15]. This latter paper used a similar approach for rivaroxaban, considering only RWE inputs (characteristics, clinical event rates, treatment effect, discontinuation, switch rates, utility, resource use and unit costs for all events), and led to a similar conclusion.…”

“…As described elsewhere [ 15 ], the model comprises a series of health states based on potential complications of NVAF (stable AF, acute and post-major ischaemic stroke [IS], acute and post-minor IS, acute and post-myocardial infarction [MI], acute and post-intracranial haemorrhage [ICH] and gastrointestinal [GI] bleed), and the absorbing state of death ( Figure 1 ). Patients transition through the model in cycles of 3 months, accumulating quality-adjusted life years (QALYs) associated with each health state, together with the costs of treatment, events and subsequent monitoring.…”

Real-World Data of Anticoagulant Treatment in Non-valvular Atrial Fibrillation

“…Using real-world data (RWD), the impact of anticoagulant therapy has been analyzed using different sources (9)(10)(11)(12)(13)(14)(15). Electronic health records (EHRs) collect a large amount of information, including data about prevalence, disease control, risk factors, treatments, modifying conditions, and information for surveillance programs (16,17). All of these can aid in evaluating treatment performance outside of the controlled environment of clinical trials.…”

Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation

“…Previous studies found that DOACs tend to be more cost-effective than VKAs for the treatment of AF. [ 19 – 23 ] One of these studies suggest that rivaroxaban is cost-effective compared to VKA, although the type of AVK and the dose thereof are not specified. [ 23 ] A comparative study of the cost-utility of the first 3 DOACs to be marketed in Spain (apixaban, dabigatran and rivaroxaban), [ 24 ] found dabigatran to be the most cost-useful.…”

“…[ 19 – 23 ] One of these studies suggest that rivaroxaban is cost-effective compared to VKA, although the type of AVK and the dose thereof are not specified. [ 23 ] A comparative study of the cost-utility of the first 3 DOACs to be marketed in Spain (apixaban, dabigatran and rivaroxaban), [ 24 ] found dabigatran to be the most cost-useful. [ 25 ] However, the most recent study carried out in Spain does not show significant differences between dabigatran and AVKs.…”