Cost-effectiveness analysis of dabigatran versus rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation using real-world evidence in elderly US Medicare beneficiaries

Abstract

Objective: Dabigatran and rivaroxaban have been approved by the US FDA to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients. Newly published real-world evidence based on the US population found that elderly Medicare patients with NVAF treated with rivaroxaban experienced statistically significant increases in intracranial hemorrhage (ICH) and major extracranial bleeding, and statistically nonsignificant decreases in thromboembolic stroke and acute myocardial infarction (AMI) compared with dabigatran. This study assessed the cost-effectiveness of dabigatran vs. rivaroxaban for the treatment of US Medicare NVAF patients.

Methods: A previously published Markov model was adapted to compare dabigatran and rivaroxaban. The model considered thromboembolic stroke, bleeding events, and AMI based on the published real-world event risks. Model outputs included clinical event rates, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results: Dabigatran patients experienced fewer ICH and major extracranial bleeding events than rivaroxaban patients, but more stroke and AMI events. Dabigatran was found to yield lower costs and higher QALYs than rivaroxaban, with incremental costs of −$3534 and incremental QALYs of 0.004. Results remained consistent in sensitivity analyses, with a positive net monetary benefit (willingness-to-pay thresholds of $50,000 and $100,000 per QALY) for dabigatran over rivaroxaban for all model inputs tested.

Conclusions: In this study using US Medicare real-world data, dabigatran was found to dominate rivaroxaban. The analyses were limited by the short follow-up period of the real-world data and results may not be generalizable to other patient populations.

Keywords:

• Atrial fibrillation
• anticoagulants
• cost–benefit analysis
• dabigatran
• rivaroxaban
• stroke
• Medicare

Transparency

Declaration of funding

Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany, the manufacturer of Pradaxa (dabigatran etexilate) provided the funding for this project and for the development of the manuscript. Evidera received funding from Boehringer Ingelheim GmbH for their work on the project. The sponsor of this study, Boehringer Ingelheim GmbH, played no role in the design and interpretation of the study, beyond assigning its three employees, Anastasia Ustyugova, Pranav Gandhi, and Cheng Wang, to work on the project and manuscript.

Author contributions: S.P., K.A.D., N.Q. and A.R.K. worked on all aspects of the project and manuscript: conception, design, and implementation of the model; analysis and interpretation of the data; and drafting and revision of the manuscript. A.U., P.G. and C.W. participated in data interpretation, and the drafting and revisions of the manuscript. All authors have read and approved the final version of this paper, and agreed to be accountable for all aspects of the work.

Declaration of financial/other relationships

A.U. has disclosed that she is an employee of Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany. P.G. and C.W.C. have disclosed that they are employees of Boehringer-Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. All three are minor shareholders of the company. S.P., K.A.D. and A.R.K. have disclosed that they are employees of Evidera, which provides consulting and other research services to the biopharmaceutical industry. In their salaried positions, they work with a variety of companies and clients, and are precluded from receiving payment or honoraria directly from these organizations for services rendered. N.Q. has disclosed that she was an Evidera employee at the time the work was done.

A peer-reviewer on this manuscript has served as a consultant to and received honoraria from Bayer, Boehringer Ingelheim and Sanofi.

Acknowledgements

The authors thank Sonja Sorensen for her valuable contributions to conceptualizing and implementing the original model and analysis, and Janet Dooley for her editorial and production assistance in the submission of this article.