Cost-effectiveness of dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation. Applying RE-LY to clinical practice in Denmark

Abstract

Objective:

To estimate the economic implications of introducing dabigatran etexilate (‘dabigatran’) for anti-coagulation therapy in Danish patients with non-valvular atrial fibrillation based on results of the RE-LY trial.

Methods:

The lifetime cost and outcomes of dabigatran and warfarin were estimated using a previously published cost-effectiveness model. The model utilizes the data from the RE-LY study to estimate the costs and outcomes of stroke prevention in atrial fibrillation. Cost estimates were based on official Danish tariffs and prices, and published literature on the cost of stroke. In the base-case analysis a conservative approach was adopted applying tariffs from the lowest range for the cost of International Normalized Ratio (INR) monitoring associated with warfarin. The effectiveness measure of the analysis was quality-adjusted life-years (QALY).

Results:

The model estimated that the mean cost per patient for the remaining life-time is €16,886 treated with warfarin and €18,752 treated with dabigatran. This was associated with mean QALYs per patient of 8.32 with warfarin and 8.59 with dabigatran. The resulting incremental cost-effectiveness ratio (ICER) of ∼€7000 per QALY gained is regarded as cost-effective by Danish standards. This conclusion was seen to be robust to realistic variations in input parameters, including adjustment for the RE-LY centres achieving the best INR monitoring quality. Threshold analysis revealed that dabigatran would be cost-saving in settings where the cost of warfarin monitoring exceeds €744 per year.

Limitations:

The analysis does not include all aspects of Danish clinical practice anti-coagulation that will influence cost-effectiveness of dabigatran, e.g., this study did not attempt to model quality of anticoagulation monitoring and under-utilization in clinical practice.

Conclusions:

Based on the outcomes observed in the RE-LY trial, dabigatran represents a cost-effective alternative to warfarin in Denmark for all patients with atrial fibrillation within the licensed indication of dabigatran.

Key words::

• Anti-coagulation
• Dabigatran etexilate
• Warfarin
• Atrial fibrillation
• Cost-effectiveness
• Denmark

Transparency

Declaration of funding

The project was funded by Boehringer Ingelheim, Denmark.

Declaration of financial/other relationships

Lars K. Langkilde was a paid consultant for Boehringer Ingelheim for this project. Mikael Bergholdt Asmussen and Mikkel Overgaard are employees of Boehringer Ingelheim Denmark.

Acknowledgements

Sonja V. Sorensen and Anuraag R. Kansal from United BioSource Corporation developed the initial model15,16 and kindly provided us access to the model and a detailed description of methods and assumptions. Furthermore, we thank Steen Husted, MD PhD, Regional Hospital West Jutland, Jens Flensted Lassen, MD PhD, Aarhus University Hospital, and Anna-Marie Münster, MD PhD, Aalborg Hospital, for acting as advisors on clinical practice in anti-thrombotic management in Denmark and giving valuable input on the analysis plan and interpretation of results.