Abstract
BackgroundClinical complications of long-term anticoagulation in patients with atrial fibrillation cause significant morbidity and have a substantial economic impact on the healthcare system.ObjectiveTo 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.MethodsA 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).ResultsWhen 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 NOACtreated 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.ConclusionImplementing PST in German VKA patients may significantly reduce SHI expenditures compared to utilizing NOAC.
Highlights
When achieving an average time in therapeutic range (TTR) of 78%, implementing patient self-management (PST) in vitamin K antagonists (VKA) patients reduces cost per patient compared to non-vitamin K oral anticoagulants (NOAC) treatment between €603.38 [USD 681.52] and €762.64 [USD 861.40] during the 1-year observation period
In line with the TTR increase, the initially higher number of adverse events per VKA patient compared to NOACtreated patients in the approval studies becomes largely aligned; the difference in associated hospital costs per patient in the NOAC groups is only €1.03 [USD 1.16], €23.41 [USD 26.44], €0.53 [USD 0.60] and €52.62 [USD 59.43]
Implementing PST in German VKA patients may significantly reduce Statutory Health Insurance (SHI) expenditures compared to utilizing NOAC
Summary
Atrial fibrillation (AF) increases the risk of stroke by a factor of 4–5 and accounts for almost 15% of all ischemic strokes. One in four middle-aged adults in Europe and the US is expected to develop AF, and by 2030, up to 7 million AF patients are anticipated in the European Union. Several studies have demonstrated that the risk of stroke is reduced by oral anticoagulant therapy with vitamin K antagonists (VKA), especially warfarin and phenprocoumon, which were the only oral anticoagulants available until a few years ago for primary and secondary prevention of thromboembolic events.Currently, the non-vitamin K oral anticoagulants (NOAC) dabigatran, rivaroxaban, apixaban, and edoxaban are approved as potential alternatives of VKA treatment. As some metaanalyses suggest superiority of NOAC treatment versus VKA with respect to reduction of thromboembolisms and bleeding complications, the use of NOAC is recommended in the 2016 European Society of Cardiology (ESC) guidelines as first line therapy for anticoagulation in atrial fibrillation.1one major point of criticism as stated by the Drug Commission of the German Medical Association is the unexpected short mean “time in therapeutic range” (TTR) of the International Normalized Ratio (INR), a standardized value to measure the required prolongation of prothrombin time, in the warfarin control groups of all NOAC approval studies. the higher rates of adverse vascular events in VKA patients investigated in those studies may partly be explained by the low mean TTR ranging between 55% (rivaroxaban) and 66% (edoxaban). As some metaanalyses suggest superiority of NOAC treatment versus VKA with respect to reduction of thromboembolisms and bleeding complications, the use of NOAC is recommended in the 2016 European Society of Cardiology (ESC) guidelines as first line therapy for anticoagulation in atrial fibrillation.. The higher rates of adverse vascular events in VKA patients investigated in those studies may partly be explained by the low mean TTR ranging between 55% (rivaroxaban) and 66% (edoxaban). Those VKA patients who utilize patient self-management (PST) during their VKA treatment usually have a significantly higher TTR of about 78%.9. Clinical complications of long-term anticoagulation in patients with atrial fibrillation cause significant morbidity and have a substantial economic impact on the healthcare system
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