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Cost-Effectiveness of Dabigatran Compared to Vitamin-K Antagonists for the Treatment of Deep Venous Thrombosis in the Netherlands Using Real-World Data.

van Leent MW, Stevanović J, Jansman FG, Beinema MJ, Brouwers JR, Postma MJ - PLoS ONE (2015)

Bottom Line: Furthermore, a formal cost-effectiveness analysis of dabigatran compared to VKAs for DVT treatment was performed, using these estimates.Cost savings or favorable cost-effectiveness were robust in sensitivity and scenario analyses.Our results warrant confirmation in other settings and locations.

View Article: PubMed Central - PubMed

Affiliation: Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands.

ABSTRACT

Background: Vitamin-K antagonists (VKAs) present an effective anticoagulant treatment in deep venous thrombosis (DVT). However, the use of VKAs is limited because of the risk of bleeding and the necessity of frequent and long-term laboratory monitoring. Therefore, new oral anticoagulant drugs (NOACs) such as dabigatran, with lower rates of (major) intracranial bleeding compared to VKAs and not requiring monitoring, may be considered.

Objectives: To estimate resource utilization and costs of patients treated with the VKAs acenocoumarol and phenprocoumon, for the indication DVT. Furthermore, a formal cost-effectiveness analysis of dabigatran compared to VKAs for DVT treatment was performed, using these estimates.

Methods: A retrospective observational study design in the thrombotic service of a teaching hospital (Deventer, The Netherlands) was applied to estimate real-world resource utilization and costs of VKA monitoring. A pooled analysis of data from RE-COVER and RE-COVER II on DVT was used to reflect the probabilities for events in the cost-effectiveness model. Dutch costs, utilities and specific data on coagulation monitoring levels were incorporated in the model. Next to the base case analysis, univariate probabilistic sensitivity and scenario analyses were performed.

Results: Real-world resource utilization in the thrombotic service of patients treated with VKA for the indication of DVT consisted of 12.3 measurements of the international normalized ratio (INR), with corresponding INR monitoring costs of €138 for a standardized treatment period of 180 days. In the base case, dabigatran treatment compared to VKAs in a cohort of 1,000 DVT patients resulted in savings of €18,900 (95% uncertainty interval (UI) -95,832, 151,162) and 41 (95% UI -18, 97) quality-adjusted life-years (QALYs) gained calculated from societal perspective. The probability that dabigatran is cost-effective at a conservative willingness-to pay threshold of €20,000 per QALY was 99%. Sensitivity and scenario analyses also indicated cost savings or cost-effectiveness below this same threshold.

Conclusions: Total INR monitoring costs per patient were estimated at minimally €138. Inserting these real-world data into a cost-effectiveness analysis for patients diagnosed with DVT, dabigatran appeared to be a cost-saving alternative to VKAs in the Netherlands in the base case. Cost savings or favorable cost-effectiveness were robust in sensitivity and scenario analyses. Our results warrant confirmation in other settings and locations.

No MeSH data available.


Related in: MedlinePlus

Tornado diagram illustrating the impact on the ICER from sensitivity analyses for dabigatran vs. vitamin-K antagonists.Light grey bars denote influence of the high value of the 95% confidence interval range and dark grey bars denote influence of the low value for parameters investigated. The solid vertical line represents the base case incremental costs per QALY for dabigatran compared to VKA. Horizontal bars indicate the range of incremental costs per QALY obtained by setting each variable to the values shown while holding all other values constant. ICER, incremental cost-effectiveness ratio; INR, international normalized ratio; PE, pulmonary embolism; rDVT, recurrent deep vein thrombosis; VKA, vitamin K antagonist; CRNM, clinically relevant non-major.
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pone.0135054.g002: Tornado diagram illustrating the impact on the ICER from sensitivity analyses for dabigatran vs. vitamin-K antagonists.Light grey bars denote influence of the high value of the 95% confidence interval range and dark grey bars denote influence of the low value for parameters investigated. The solid vertical line represents the base case incremental costs per QALY for dabigatran compared to VKA. Horizontal bars indicate the range of incremental costs per QALY obtained by setting each variable to the values shown while holding all other values constant. ICER, incremental cost-effectiveness ratio; INR, international normalized ratio; PE, pulmonary embolism; rDVT, recurrent deep vein thrombosis; VKA, vitamin K antagonist; CRNM, clinically relevant non-major.

Mentions: The results of univariate sensitivity analyses for the top 15 parameters by the order of influence they have to the ICER, incremental costs and effects are presented in the form of tornado diagrams (Figs 2–4). The uncertainty around the level of utility associated with INR monitoring, and with dabigatran use, price of INR monitoring, the price of dabigatran, probabilities of major bleeding and nonfatal PE with dabigatran and, the costs due to productivity loss showed the highest impact on uncertainty in the estimated ICERs, incremental costs and effects. Results from the PSA were plotted in the cost-effectiveness plane (Fig 5) and transformed into a CEAC. The CEAC of the base case analysis shows that dabigatran is a cost-effective alternative compared to VKA at a willingness-to-pay threshold of €20,000/QALY in 99% of the simulations and cost saving in 74% of simulations (Fig 6).


Cost-Effectiveness of Dabigatran Compared to Vitamin-K Antagonists for the Treatment of Deep Venous Thrombosis in the Netherlands Using Real-World Data.

van Leent MW, Stevanović J, Jansman FG, Beinema MJ, Brouwers JR, Postma MJ - PLoS ONE (2015)

Tornado diagram illustrating the impact on the ICER from sensitivity analyses for dabigatran vs. vitamin-K antagonists.Light grey bars denote influence of the high value of the 95% confidence interval range and dark grey bars denote influence of the low value for parameters investigated. The solid vertical line represents the base case incremental costs per QALY for dabigatran compared to VKA. Horizontal bars indicate the range of incremental costs per QALY obtained by setting each variable to the values shown while holding all other values constant. ICER, incremental cost-effectiveness ratio; INR, international normalized ratio; PE, pulmonary embolism; rDVT, recurrent deep vein thrombosis; VKA, vitamin K antagonist; CRNM, clinically relevant non-major.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4524689&req=5

pone.0135054.g002: Tornado diagram illustrating the impact on the ICER from sensitivity analyses for dabigatran vs. vitamin-K antagonists.Light grey bars denote influence of the high value of the 95% confidence interval range and dark grey bars denote influence of the low value for parameters investigated. The solid vertical line represents the base case incremental costs per QALY for dabigatran compared to VKA. Horizontal bars indicate the range of incremental costs per QALY obtained by setting each variable to the values shown while holding all other values constant. ICER, incremental cost-effectiveness ratio; INR, international normalized ratio; PE, pulmonary embolism; rDVT, recurrent deep vein thrombosis; VKA, vitamin K antagonist; CRNM, clinically relevant non-major.
Mentions: The results of univariate sensitivity analyses for the top 15 parameters by the order of influence they have to the ICER, incremental costs and effects are presented in the form of tornado diagrams (Figs 2–4). The uncertainty around the level of utility associated with INR monitoring, and with dabigatran use, price of INR monitoring, the price of dabigatran, probabilities of major bleeding and nonfatal PE with dabigatran and, the costs due to productivity loss showed the highest impact on uncertainty in the estimated ICERs, incremental costs and effects. Results from the PSA were plotted in the cost-effectiveness plane (Fig 5) and transformed into a CEAC. The CEAC of the base case analysis shows that dabigatran is a cost-effective alternative compared to VKA at a willingness-to-pay threshold of €20,000/QALY in 99% of the simulations and cost saving in 74% of simulations (Fig 6).

Bottom Line: Furthermore, a formal cost-effectiveness analysis of dabigatran compared to VKAs for DVT treatment was performed, using these estimates.Cost savings or favorable cost-effectiveness were robust in sensitivity and scenario analyses.Our results warrant confirmation in other settings and locations.

View Article: PubMed Central - PubMed

Affiliation: Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands.

ABSTRACT

Background: Vitamin-K antagonists (VKAs) present an effective anticoagulant treatment in deep venous thrombosis (DVT). However, the use of VKAs is limited because of the risk of bleeding and the necessity of frequent and long-term laboratory monitoring. Therefore, new oral anticoagulant drugs (NOACs) such as dabigatran, with lower rates of (major) intracranial bleeding compared to VKAs and not requiring monitoring, may be considered.

Objectives: To estimate resource utilization and costs of patients treated with the VKAs acenocoumarol and phenprocoumon, for the indication DVT. Furthermore, a formal cost-effectiveness analysis of dabigatran compared to VKAs for DVT treatment was performed, using these estimates.

Methods: A retrospective observational study design in the thrombotic service of a teaching hospital (Deventer, The Netherlands) was applied to estimate real-world resource utilization and costs of VKA monitoring. A pooled analysis of data from RE-COVER and RE-COVER II on DVT was used to reflect the probabilities for events in the cost-effectiveness model. Dutch costs, utilities and specific data on coagulation monitoring levels were incorporated in the model. Next to the base case analysis, univariate probabilistic sensitivity and scenario analyses were performed.

Results: Real-world resource utilization in the thrombotic service of patients treated with VKA for the indication of DVT consisted of 12.3 measurements of the international normalized ratio (INR), with corresponding INR monitoring costs of €138 for a standardized treatment period of 180 days. In the base case, dabigatran treatment compared to VKAs in a cohort of 1,000 DVT patients resulted in savings of €18,900 (95% uncertainty interval (UI) -95,832, 151,162) and 41 (95% UI -18, 97) quality-adjusted life-years (QALYs) gained calculated from societal perspective. The probability that dabigatran is cost-effective at a conservative willingness-to pay threshold of €20,000 per QALY was 99%. Sensitivity and scenario analyses also indicated cost savings or cost-effectiveness below this same threshold.

Conclusions: Total INR monitoring costs per patient were estimated at minimally €138. Inserting these real-world data into a cost-effectiveness analysis for patients diagnosed with DVT, dabigatran appeared to be a cost-saving alternative to VKAs in the Netherlands in the base case. Cost savings or favorable cost-effectiveness were robust in sensitivity and scenario analyses. Our results warrant confirmation in other settings and locations.

No MeSH data available.


Related in: MedlinePlus