What Influences the Cost Effectiveness of Dabigatran versus Warfarin for Stroke Prevention in Atrial Fibrillation: A Systematic Review.

Objectives The introduction of new oral anticoagulants for the prevention of stroke in atrial fibrillation (AF) has changed the clinical management of AF. To inform decision making around dabigatran by identifying factors influencing cost-effectiveness results, we undertook a systematic review of economic evaluations of dabigatran versus warfarin for the prevention of stroke in AF patients. Methods A systematic literature search of Ovid Medline and Embase, Wiley's Cochrane Library, HEED, PubMed databases and grey literature was carried out for primary economic evaluations comparing dabigatran versus warfarin in patients with AF. Data on study characteristics, model inputs and results, and sensitivity analyses were abstracted and synthesized qualitatively. Results Twenty-three economic evaluations were identified and RE-LY was cited in 52% of studies as the source of the efficacy data. Twenty evaluations used Markov modelling, 2 performed discrete event simulation, and 1 was a trial-based evaluation. Eighty-two percent reported base case incremental cost-effectiveness ratios (ICERs) of less than $50,000 USD/QALY. Key variables, including international normalized ratio (INR) control, the cost of monitoring, risk of stroke and bleeding, and age were found to alter the conclusions in only a few studies. Less commonly explored factors included time horizon and cost of long-term care follow-up. Conclusions Several factors should be considered when interpreting the results of economic analyses which are based on randomized clinical trial evidence. Real-world data are needed to further assess the clinical and economic consequences of dabigatran relative to warfarin for the prevention of stroke in AF.