The cost-effectiveness and monetary benefits of dabigatran in the prevention of arterial thromboembolism for patients with non-valvular atrial fibrillation in the Netherlands

Abstract

Background: Atrial fibrillation (AF) causes a significant health and economic burden to the Dutch society. Dabigatran was proven to have at least similar efficacy and a similar or better safety profile when compared to vitamin K antagonists (VKAs) in preventing arterial thromboembolism in patients with AF.

Objective: To evaluate the cost-effectiveness and monetary benefit of dabigatran vs VKAs in Dutch patients with non-valvular AF. Value-based pricing considerations and corresponding negotiations on dabigatran will be explicitly considered.

Methods: The base case economic analysis was conducted from the societal perspective. Health effects and costs were analysed using a Markov model. The main model inputs were derived from the RE-LY trial and Dutch observational data. Univariate, probabilistic sensitivity, and various scenario analyses were performed.

Results: Dabigatran was cost saving compared to VKAs. A total of 4,552 QALYs were gained, and €13,892,288 was saved in a cohort of 10,000 AF patients. The economic value of dabigatran was strongly related to the costs of VKA control that are averted. Notably, dabigatran was cost saving compared to VKAs if annual costs of VKA control exceeded €159 per person, or dabigatran costs were below €2.81 per day.

Conclusion: Dabigatran was cost saving compared to VKAs for the prevention of atrial thromboembolism in patients with non-valvular AF in the Netherlands. This result appeared robust in the sensitivity analysis. Furthermore, volume based reduction of the price in the Netherlands will further increase the monetary benefits of dabigatran.

Keywords:

• Cost-effectiveness
• value based pricing
• dabigatran
• atrial fibrillation
• warfarin
• acenocoumarol
• fenprocoumon

Transparency

Declaration of funding

Boehringer Ingelheim paid personal fees to MVH to conduct this study.

Declaration of financial/other relationships

MVH reports grants from Bayer and personal fees from Boehringer Ingelheim during the conduct of the study. RGT reports grants and personal fees from Boehringer Ingelheim and personal fees from Bayer and Pfizer/Bristol Meyer Squibb, all outside the submitted work. BK is an employee of Boehringer Ingelheim. MJP received grants and honoraria from various pharmaceutical companies, inclusive of those developing, producing, and marketing new oral anti-coagulants (NOACs). JS and MSJ have no relevant or other relationships to disclose. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation

Presented as a poster at the Dutch Federation for Innovative Drug Research (FIGON), The Netherlands, October 2016.