OBJECTIVES : To assess the comparative health and budget impact of low-dose dabigatran indicated for non-valvular atrial fibrillation (AF) population versus reduced doses of apixaban and rivaroxaban in the Netherlands.

METHODS : A budget impact model was developed in accordance with ISPOR guidelines. A 3-year-time horizon was applied and analyses were conducted from a Dutch healthcare perspective. The model applies published data to local AF-epidemiology, allowing calculations based on clinical events (strokes and hemorrhages) and costs. The clinical events are based on real-world outcomes from patients with non-valvular atrial fibrillation filling a first direct oral anticoagulant (DOAC) prescription for low-dose dabigatran (110 mg) and reduced dose of apixaban (2.5 mg) or rivaroxaban (15 mg). The modelled results are based on an indirect comparison and applying propensity score analysis to account for population differences. Two scenarios of switching treatments from one to another DOAC (e.g. from apixaban or rivaroxaban to dabigatran) were modeled to assess the number of events and costs. Sensitivity analyses were used to explore the uncertainty around input parameters (+/- 5%), costs variations (price reductions in 2nd and 3rd year after dabigatran’s patent expiry), as well as population data (assuming 1% of the total population having AF and assuming switch of 30%, 60% and 100% in year 1, 2 and 3).

RESULTS : For the Netherlands, 3-years outcomes of switching patients form apixaban or rivaroxaban to dabigatran resulted in a potential reduction of 7714 or 5325 events (ischemic stroke, systemic embolism, any bleeding, major bleeding and hemorrhagic stroke) with respective event-costs-savings of €50 or €22 million. Cost-savings per 100 patient years were estimated at €77 or €110 thousand accordingly. The various sensitivity analyses reflected consistent cost-savings.

CONCLUSIONS : Switching non-valvular AF-patients to low-dose dabigatran has the potential to reduce healthcare payer’s budget expenditures based on comparative effectiveness and safety versus apixaban and rivaroxaban.