Abstract
BackgroundPrior analyses beyond clinical trials are yet to evaluate the projected lifetime benefit of apixaban treatment compared to low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) for treatment of venous thromboembolism (VTE) and prevention of recurrences. The objective of this study is to assess the cost-effectiveness of initial plus extended treatment with apixaban versus LMWH/VKA for either initial treatment only or initial plus extended treatment.MethodsA Markov cohort model was developed to evaluate the lifetime clinical and economic impact of treatment of VTE and prevention of recurrences with apixaban (starting at 10 mg BID for 1 week, then 5 mg BID for 6 months, then 2.5 mg BID for an additional 12 months) versus LMWH/VKA for 6 months and either no further treatment or extended treatment with VKA for an additional 12 months. Clinical event rates to inform the model were taken from the AMPLIFY and AMPLIFY-EXT trials and a network meta-analysis. Background mortality rates, costs, and utilities were obtained from published sources. The analysis was conducted from the perspective of the United Kingdom National Health Service. The evaluated outcomes included the number of events avoided in a 1000-patient cohort, total costs, life-years, quality-adjusted life-years (QALYs), and cost per QALY gained.ResultsInitial plus extended treatment with apixaban was superior to both treatment durations of LMWH/VKA in reducing the number of bleeding events, and was superior to initial LMWH/VKA for 6 months followed by no therapy, in reducing VTE recurrences. Apixaban treatment was cost-effective compared to 6-month treatment with LMWH/VKA at an incremental cost-effectiveness ratio (ICER) of £6692 per QALY. When initial LMWH/VKA was followed by further VKA therapy for an additional 12 months (i.e., total treatment duration of 18 months), apixaban was cost-effective at an ICER of £8528 per QALY gained. Sensitivity analysis suggested these findings were robust over a wide range of inputs and scenarios for the model.ConclusionsIn the UK, initial plus extended treatment with apixaban for treatment of VTE and prevention of recurrences appears to be economical and a clinically effective alternative to LMWH/VKA, whether used for initial or initial plus extended treatment.
Highlights
Prior analyses beyond clinical trials are yet to evaluate the projected lifetime benefit of apixaban treatment compared to low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) for treatment of venous thromboembolism (VTE) and prevention of recurrences
Base-case analysis (Table 4) The evaluation in the current study predicted that, compared to 6 months of LMWH/Vitamin K antagonists (VKA) followed by no treatment, initial plus extended treatment with apixaban would lead to 62 fewer recurrent VTEs and VTE-related deaths, 13 fewer major bleeds, and 28 fewer Clinically relevant non-major (CRNM) bleeds over the lifetimes of 1000 treated patients
Compared to initial plus extended treatment with LMWH/VKA, apixaban was projected to lead to 26 fewer major bleeds and 111 fewer CRNM bleeds but, an additional 6 recurrent VTEs and VTE-related deaths
Summary
Prior analyses beyond clinical trials are yet to evaluate the projected lifetime benefit of apixaban treatment compared to low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) for treatment of venous thromboembolism (VTE) and prevention of recurrences. The only available and recommended anticoagulants for use in VTE were heparins (e.g., lowmolecular-weight heparin [LMWH]) or fondaparinux to initiate treatment, and vitamin K antagonists (VKAs) such as warfarin or acenocumerol to continue treatment and subsequent prevention of recurrence [8]. Use of these drugs is limited and complicated by their narrow therapeutic range and the burdensome requirement to monitor their anticoagulant effect by regularly measuring the international normalized ratio of the prothrombin time [9].
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