Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

Abstract

Objective: Venous thromboembolism (VTE) is associated with almost 300,000 deaths per year in the United States. Novel oral anticoagulants (NOACs) offer an alternative to warfarin-based therapy without monitoring requirements and with fewer drug and food interactions. Edoxaban, a direct Xa inhibitor, is approved by the Food and Drug Administration (FDA), based upon results of the Hokusai-VTE Phase 3 trial. The trial demonstrated that edoxaban administered once daily after initial treatment with heparin was non-inferior in reducing the risk of VTE recurrence and caused significantly less major and clinically relevant non-major (CRNM) bleeding compared to warfarin. The objective of this study was to evaluate the cost-effectiveness of edoxaban versus warfarin for the treatment of adults with VTE. Methods: A cost-effectiveness model was developed using patient-level data from the Hokusai-VTE trial, clinical event costs from real-world databases, and drug acquisition costs for warfarin of $0.36 and edoxaban of $9.24 per tablet. Results: From a U.S. health-care delivery system perspective, the incremental cost-effectiveness ratio (ICER) was $22,057 per quality adjusted life year (QALY) gained. Probabilistic sensitivity analysis showed that edoxaban had an ICER <$50,000 per QALY gained relative to warfarin in 67% of model simulations. The result was robust to variation in key model parameters including the cost and disutility of warfarin monitoring. Conclusion: Despite its higher drug acquisition cost, edoxaban is a cost-effective alternative to warfarin for the treatment of VTE.

Cost-effectiveness of edoxaban compared to warfarin for the treatment and secondary prevention of venous thromboembolism in the UK

“…The model was developed using patient-level data from the Hokusai-VTE trial, with clinical events costs from a real-world database. Edoxaban was found to be a cost-effective alternative to warfarin in VTE patients in the USA with an ICER of $22,057 per QALY [30]. The high ICER in the US study compared to our study partly resided in a greater difference in the daily drug costs between edoxaban and warfarin ($9.24 vs. $0.36 in the US, against £1.75 vs. £0.04 in the UK).…”

Cost‐effectiveness analysis of low‐dose direct oral anticoagulant (DOAC) for the prevention of cancer‐associated thrombosis in the United States

“…Additional drug cost analysis was performed using the Federal Supply Schedule as a sensitivity analysis. Adverse event costs (each cycle) for initial and recurrent VTE events as well as bleeding episodes were obtained from the report by Preblick et al, in which the cost‐per‐stay estimates were derived from the Premier Hospital Database and a post‐hoc analysis of the DOAC arm of the Hokusai‐VTE study . For postcomplication states, the monthly cost (each cycle) was estimated from the appropriate publications for post‐ICH, PTS, and CTEPH .…”

“…We first estimated the baseline utility weight for patients with cancer as the product of cancer‐specific utility weight from various studies and the proportion of cancer subtype from the RCTs (see Supporting Table 4). We then calculated the disutility from general medical patients with VTE, bleeding, ICH, PTS, and CTEPH and subtracted the disutility from the baseline utility weight to determine the adjusted weight for each outcome state . For the primary utility measures of VTE and bleeding, we used the data published by Hogg et al, who that used a standard gamble method from 216 ambulatory patients with a history of DVT or PE …”

“…Adverse event costs (each cycle) for initial and recurrent VTE events as well as bleeding episodes were obtained from the report by Preblick et al, in which the cost-per-stay estimates were derived from the Premier Hospital Database and a post-hoc analysis of the DOAC arm of the Hokusai-VTE study. 24 For postcomplication states, the monthly cost (each cycle) was estimated from the appropriate publications for post-ICH, PTS, and CTEPH. [25][26][27] All cost estimates were inflated to May 2019 US dollars using the US Consumer Price Index for all urban consumers' medical care.…”

Use of novel oral anticoagulant agents in venous thromboembolism

“…A perceived downside of NOAC use is the cost of individual NOACs for the patient when compared to warfarin, yet several studies have suggested that individual NOACs are a more cost-effective option for the health care system, offer more value in quality-adjusted measures for users, reduce length-of-stay for hospitalization for VTE when compared to enoxaparin plus warfarin, and reduce the utilization of the inpatient health care system due to fewer major bleeding events than warfarin (47)(48)(49)(50).…”