Cost-Effectiveness of Betrixaban Compared with Enoxaparin for Venous Thromboembolism Prophylaxis in Nonsurgical Patients with Acute Medical Illness in the United States

Abstract

Background Studies show that the risk of venous thromboembolism (VTE) continues post-discharge in nonsurgical patients with acute medical illness. Betrixaban is the first anticoagulant approved in the United States (US) for VTE prophylaxis extending beyond hospitalization. Objective The aim was to establish whether betrixaban for VTE prophylaxis in nonsurgical patients with acute medical illness at risk of VTE in the US is cost-effective compared with enoxaparin. Methods A cost-effectiveness analysis was conducted, estimating the cost per quality-adjusted life-year (QALY) gained with betrixaban (35-42 days) compared with enoxaparin (6-14 days) from a US payer perspective over a lifetime horizon. A decision tree (DT) estimated primary VTE events, thrombotic events, and treatment complications in the first 3 months based on data from the phase III Acute Medically Ill VTE Prevention with Extended Duration Betrixaban study. A Markov model estimated recurrent events and long-term complication risks from published literature. EuroQoL-5 Dimensions utility data and costs inflated to 2017 US dollars (US$) were from published literature. Results were discounted at 3.0% per annum. Deterministic and probabilistic sensitivity analyses explored uncertainty. Results Betrixaban dominated enoxaparin, with savings of US$784 and increased QALYs of 0.017 per patient. In addition, betrixaban dominated enoxaparin across all sensitivity analyses, but was most sensitive to utilities and DT probabilities. Furthermore, probabilistic sensitivity analysis found that betrixaban was more cost-effective than enoxaparin at all willingness-to-pay thresholds. Conclusion Betrixaban can be considered cost-effective for nonsurgical patients with acute medical illness at risk of VTE, requiring longer VTE prophylaxis from hospitalization through post-discharge. Key Points for Decision MakersProphylaxis of venous thromboembolism (VTE) from hospitalization through post-discharge is a new option for acute medically ill patients at high risk of thromboembolic events.In the US, a 35-42-day regimen with betrixaban, from hospitalization through post-hospital-discharge, was found to accrue more quality-adjusted life-years (QALYs) and less costs compared with a 6-14-day prophylaxis with enoxaparin, due to a reduced incidence of thromboembolic events and lower associated costs, for nonsurgical patients with acute medical illness at risk of VTE.Betrixaban dominated enoxaparin, with 0.017 additional QALYs accrued and cost savings of US$784 per patient.Electronic supplementary material The online version of this article (https ://doi.

Estimation of Acutely Ill Medical Patients at Venous Thromboembolism Risk Eligible for Extended Thromboprophylaxis Using APEX Criteria in US Hospitals

“…7,8,10,11 These data may serve as a basis to estimate the related economic impact of this strategy. 16 The major limitation was that the number of patients eligible for extended thromboprophylaxis described here is an overestimation and actually reflects a "maximum case scenario." Indeed, many reasons, including exclusion criteria from the APEX trial, especially risk factors for bleeding or polypharmacy with strong P-glycoprotein inhibitors, or costs, might preclude the actual prescription of extended betrixaban.…”

“…7,8,10,11 These data may serve as a basis to estimate the related economic impact of this strategy. 16…”

Current Opinion on the use of Direct Oral Anticoagulants for the Prophylaxis of Venous Thromboembolism among Medical Inpatients

“…As stated by the author, betrixaban administration was associated with saving 784 US dollars, as well as an increase of 0.017 in the quality-adjusted life year index per patient. 44 Despite the favorable cost-effectiveness, betrixaban has been discontinued and withdrawn from the market for independent business reasons from the manufacturer.…”

Current and Emerging Direct Oral Anticoagulants: State-of-the-Art

“…22 A subsequent substudy showed that betrixa-ban not only decreased the risk of VTE compared with enoxaparin in patients with a prior positive history for VTE (RR, 0.57; 95% CI, 0.38-0.86; p ¼ 0.006), but was also more effective than enoxaparin in significantly preventing VTE recurrence throughout the end of the trial (HR, 0.54; 95% CI, 0.36-0.81; p ¼ 0.004). Very recently, Guy and colleagues concluded a cost-effectiveness analysis aimed at assessing the cost per quality-adjusted life-year (QALY) of 35 to 42 days of betrixaban therapy compared with 6 to 14 days of enoxaparin treatment, 23 and concluded that the DOAC offset enoxaparin by generating overall saving of 784 U.S.$ and enhanced 0.017 QALYs for single patient. Interestingly, adaptation of commercial chromogenic anti-FXa assays has already been described for enabling routine laboratory monitoring of betrixaban in clinical laboratories, 24 although its true clinical availability may be questionable given that betrixaban has been cleared for use only in the United States, and that the described methods have not been cleared for use by the FDA.…”