The cost-utility of dabigatran etexilate compared with warfarin in treatment and extended anticoagulation of acute VTE in the UK

Abstract

The relative efficacy and safety of dabigatran etexilate and warfarin have been evaluated in two head-to-head, phase III, treatment of acute venous thromboembolism (VTE) trials, and one extended prophylaxis trial, in patients with high risk of recurrent VTE. Dabigatran etexilate demonstrated similar efficacy to warfarin, and was associated with a reduced risk of major or clinically relevant bleeds. Based on results of these trials, and real-life disease prognosis following discontinuation of anticoagulation treatment, we evaluated the cost-utility of dabigatran etexilate compared with warfarin in six months anticoagulation, and in extended, up to 24 months anticoagulation, in patients with acute VTE, acute deep-vein thrombosis (DVT) or acute, symptomatic, pulmonary embolism (PE). Costs were analysed from the perspective of the National Health Services (NHS) and Public Social Services (PSS) in England and Wales. Outcomes were quantified in quality-adjusted life years (QALY). The estimated incremental, lifetime cost/QALY gain following acute, symptomatic VTE (DVT or PE) was £1,252/QALY when dabigatran etexilate or warfarin were administered for up to six months treatment. In treatment of acute, symptomatic PE and in DVT respective ratios were £1,767/QALY and £1,075/QALY. In extended, up to 24 months anticoagulation, dabigatran etexilate projected costs/QALY of £8,242/QALY, when compared with warfarin. Results obtained herein were robust across a number of sensitivity analyses and suggest dabigatran etexilate to be a cost-effective alternative to current standard of care when evaluated in six months treatment and in extended anticoagulation following acute VTE (DVT and/or PE).

Extended anticoagulation for the secondary prevention of venous thromboembolic events: An updated network meta-analysis

“…While apixaban, edoxaban, and rivaroxaban have a better safety profile over VKA for the acute management [39–42], DOAC were only associated with trends for reduced MB and their net clinical benefit were similar during extended anticoagulation compared to VKA. Pharmacoeconomic studies also suggested that apixaban, dabigatran and rivaroxaban were cost-effective alternatives to VKA for extended anticoagulation following acute VTE in Canada, United Kingdom, and United States of America [47–51], although these studies were funded by pharmaceutical companies. Ultimately, the choice of treatment for extended anticoagulation thus likely relies on patients’ preference and individual risk factors for adverse events with VKA and DOAC.…”

American Society of Hematology 2020 Guidelines for Management of Venous Thromboembolism: Treatment of Deep Vein Thrombosis and Pulmonary Embolism

“…All of them suggested that DOACs are costeffective relative to VKA. 100,[104][105][106][107][108][109][110][111][112][113][114][115][116] Finally, we considered DOACs to be acceptable and feasible to implement in most scenarios. However, given their cost, some patients might not be able to afford them.…”

Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis

“…The company assumed that all bleeds were major, stating that no studies were identified that reported the proportion of bleeds classified as major or minor following an elective invasive procedure in this population, and that minor bleeds would be expected to have a minor impact on costs and QALYs. Therefore, a disutility associated with a major bleeding event of 0.397 for a duration of 1 week was adopted from Jugrin et al 84 For thrombus-related AEs, the company incorporated a disutility of 0.029, applied over 1 week, estimated by Jugrin et al 84 for related thrombotic events (index deep-vein thrombosis and index pulmonary embolism).…”

“…Disutilities for bleeding events and thrombotic events were also identified from the literature by Shionogi. Disutilities of 0.397 for major bleeding events and of 0.122 for clinically relevant non-major bleeding events were identified from Jugrin et al 84 The AG base-case model included only bleeding AEs of ≥ grade 3, which were assumed to be equivalent to major bleeding events. Therefore, the disutility of 0.397 for major bleeds was incorporated into the model base case, with a duration of 1 week.…”