Abstract

Background: Clinical complications of long-term anticoagulation in patients with atrial fibrillation cause significant morbidity and have a substantial economic impact on the healthcare system. Objective: To assess the cost-benefit by implementing patient self-testing (PST) in German patients anticoagulated with vitamin K antagonists (VKA) compared to treatment with the new oral anticoagulant drugs (NOAC) apixaban, dabigatran, edoxaban, and rivaroxaban. Methods: A deterministic decision-analytic model was developed simulating the number of major bleedings, ischemic strokes, and hemorrhagic strokes and their associated costs by utilizing PST compared to those of treatment with NOAC. Data on the rates of these adverse events in both groups during the 1st year of treatment was taken from the NOAC approval studies. Direct costs were evaluated from the perspective of the Statutory Health Insurance (SHI) considering the use of resources directly related to PST testing and costs incurred by hospital treatment of the adverse events. Univariate sensitivity analysis was performed to examine the extent to which our calculations were affected by varying the parameters considered in our model within plausible extremes. To capture the interactions between multiple inputs, we also provided a probabilistic sensitivity analysis (PSA). Results: When achieving an average time in therapeutic range (TTR) of 78%, implementing PST in VKA patients reduces cost per patient compared to NOAC treatment between €603.38 [USD 681.52] (edoxaban) and €762.64 [USD 861.40] (rivaroxaban) during the 1-year observation period. In line with the TTR increase, the initially higher number of adverse events per VKA patient compared to NOAC-treated patients in the approval studies becomes largely aligned; the difference in associated hospital costs per patient in the NOAC groups is then only €1.03 [USD 1.16] (in favor of dabigatran), €23.41 [USD 26.44] (in favor of apixaban), €0.53 [USD 0.60] (in favor of edoxaban) and €52.62 [USD 59.43] (in favor of VKA anticoagulation in the rivaroxaban group). In PSA, implementation of self-management results on average in a cost saving between €619.20 [USD 699.39] and €785.24 [USD 886.93] per VKA patient in favor of the SHI. Under all reasonable assumptions, PST remains constantly less expensive irrespective of which NOAC is administered. Conclusion: Implementing PST in German VKA patients may significantly reduce SHI expenditures compared to utilizing NOAC.

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