Comparison of Medical Costs Avoided When New Oral Anticoagulants Are Used for the Treatment of Patients with Atrial Fibrillation and Venous Thromboembolism in the U.S

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2181-2181
Author(s):  
Alpesh N Amin ◽  
Amanda Bruno ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Medical Cost ◽  
Oral Anticoagulants ◽  
Medical Costs ◽  
Nonvalvular Atrial Fibrillation ◽  
Equity Ownership ◽  
Acute Venous Thromboembolism ◽  
Event Rates

Abstract Introduction: Clinical trials have demonstrated that the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, and apixaban are either superior or non-inferior to standard therapies/placebo for the treatment of nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). This study estimated and compared the medical costs from a U.S. payer perspective that may be potentially avoided when NOACs are used instead of standard therapies/placebo for the treatment of patients with NVAF or VTE. Methods: Event rates of efficacy and safety clinical endpoints as defined in clinical trials (Table), were obtained from published trial data. Medical cost avoidances associated with NOAC usage vs. standard therapies/placebo for NVAF patients, acute VTE treatment patients, and extended VTE treatment patients were derived from previous publications. All costs were inflation adjusted to 2013 cost level. A hypothetical health plan population with 1 million members in 2014 was used to estimate and compare the NVAF and VTE combined medical cost avoidances for patients treated with NOACs vs. standard therapies/placebo. Prevalence rates of NVAF and VTE were derived from published literature. The same usage rate for each NOAC was assumed for comparison purpose. The medical cost avoidances are also projected in the years 2015-2018 and compared among the NOACs. Results: In 2014, in the hypothetical population of one million insured lives, the medical costs were projected to be reduced by -$3.0, -$2.1, and -$7.3 million for NVAF patients treated with dabigatran, rivaroxaban, and apixaban, respectively; by -$0.7, -$2.2, and -$4.1 million for patients treated for acute VTE with dabigatran, rivaroxaban, and apixaban, respectively; and by -$6.3, -$6.6, -$9.6, and -$9.5 million for VTE patients treated for extended periods with dabigatran, rivaroxaban, 2.5 mg apixaban, and 5.0 mg apixaban, respectively (2 arms with different apixaban dosages were included in extended VTE treatment trial). In 2014, for the combined NVAF and VTE patient populations, within the hypothetical population of one million insured lives, medical costs were projected to be reduced by -$10.0, -$10.9, -$21.0, and -$21.0 million for dabigatran, rivaroxaban, 2.5 mg apixaban, and 5.0 mg apixaban, respectively. In the model, the reductions in medical costs associated with usage of the NOACs were projected to steadily increase in the years 2015 to 2018 (Figure). Conclusions: Medical costs are reduced, when any of the three NOACs are used instead of standard therapy/placebo for the treatment of NVAF or VTE. Apixaban is associated with the greatest reduction in medical costs, which is driven by medical cost reductions associated with both efficacy and safety endpoints among patients with NVAF or VTE. Further evaluation may be needed to validate these results in the real-world setting. Table 1 Clinical Trials from which Clinical Event Rates were Obtained Trial Drug Indication RE-LY Dabigatran Nonvalvular atrial fibrillation ROCKET-AF Rivaroxaban Nonvalvular atrial fibrillation ARISTOTLE Apixaban Nonvalvular atrial fibrillation RE-COVER I Dabigatran Acute venous thromboembolism RE-COVER II Dabigatran Acute venous thromboembolism EINSTEIN-Pooled Rivaroxaban Acute venous thromboembolism AMPLIFY Apixaban Acute venous thromboembolism RE-SONATE Dabigatran Extended venous thromboembolism EINSTEIN-EXT Rivaroxaban Extended venous thromboembolism AMPLIFY-EXT Apixaban Extended venous thromboembolism Figure 1 Figure 1. Disclosures Amin: Bristol-Myers Squibb, Pfizer: Consultancy. Off Label Use: Apixaban for the indication of VTE.. Bruno:Bristol-Myers Squibb: Employment, Equity Ownership. Trocio:Pfizer: Employment, Equity Ownership. Lin:Bristol-Myers Squibb, Pfizer: Consultancy, Research Funding. Lingohr-Smith:Bristol-Myers Squibb, Pfizer: Consultancy, Research Funding.

scholarly journals Dabigatran, Rivaroxaban, or Apixaban versus Warfarin in Patients with Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Subgroups

Thrombosis ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-18 ◽  
Author(s):  
Antonio Gómez-Outes ◽  
Ana Isabel Terleira-Fernández ◽  
Gonzalo Calvo-Rojas ◽  
M. Luisa Suárez-Gea ◽  
Emilio Vargas-Castrillón
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Hemorrhagic Stroke ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Random Effect ◽  
Geographic Region ◽  
Nonvalvular Atrial Fibrillation ◽  
Relative Risks ◽  
Study Characteristics

Background. New oral anticoagulants (NOAC; rivaroxaban, dabigatran, apixaban) have become available as an alternative to warfarin anticoagulation in non-valvular atrial fibrillation (NVAF). Methods. MEDLINE and CENTRAL, regulatory agencies websites, clinical trials registers and conference proceedings were searched to identify randomised controlled trials of NOAC versus warfarin in NVAF. Two investigators reviewed all studies and extracted data on patient and study characteristics along with cardiovascular outcomes. Relative risks (RR) and 95% confidence intervals (CI) were estimated using a random effect meta-analysis. Results. Three clinical trials in 50,578 patients were included. The risk of non-hemorrhagic stroke and systemic embolic events (SEE) was similar with the NOAC and warfarin (RR=0.93; 95% CI=0.83–1.04), while the risk of intracranial bleeding (ICB) with the NOAC was lower than with warfarin (RR = 0.46; 95% CI = 0.33–0.65). We found differences in the effect size on all strokes and SEE depending on geographic region as well as on non-hemorrhagic stroke, SEE, bleeding and mortality depending on time in therapeutic range. Conclusion. The NOAC seem no more effective than warfarin for prevention of nonhemorrhagic stroke and SEE in the overall NVAF population, but are generally associated with a lower risk of ICB than warfarin.

Abstract 249: Medical Cost Avoidance among the General and Elderly Atrial Fibrillation Populations Differs According to Specific Anticoagulant Use, Based on the ARISTOTLE and RE-LY Trials

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Steve Deitelzweig ◽  
Yonghua Jing ◽  
Dinara Makenbaeva ◽  
Daniel Wiederkehr ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Major Bleeding ◽  
Medical Cost ◽  
Elderly Population ◽  
The Elderly ◽  
Medical Costs ◽  
Cost Avoidance ◽  
Weighted Averages ◽  
Event Rates

Introduction: The randomized ARISTOTLE and RE-LY clinical trials demonstrated that the new oral anticoagulants (NOACs) apixaban and dabigatran were effective and safe options for stroke prevention among non-valvular atrial fibrillation (AF) patients. It is unclear how the use of NOACs for the treatment of AF affects total medical costs. Hypothesis: This study evaluates the hypothesis that medical costs associated with the use of apixaban and dabigatran vs. warfarin are different among the general and elderly AF populations. Methods: Clinical event rates in patients receiving warfarin, apixaban, and dabigatran were estimated for the general and elderly (age ≥ 75 years) AF patient populations. Event rates associated with warfarin were calculated as weighted averages from NOAC trials among AF patients; NOAC rates were estimated by adjusting trial hazard ratios to these weighted averages. Annual incremental costs among patients with clinical events from the US payer perspective were obtained from published literature and inflation adjusted to 2010 cost levels. Medical cost avoidance was evaluated for each NOAC vs. warfarin. Results: Compared to warfarin, apixaban-mediated total medical cost reductions (Table) in both populations were driven by decreased major bleeding excluding hemorrhagic stroke (MBEHS) and stroke and systemic embolism (SSE). Dabigatran use reduced costs for the general population and increased costs for the elderly population; cost reduction in the general population was primarily due to reduced SSE while cost increase in the elderly population was primarily due to increased MBEHS. MI, PE or DVT, and non-major bleeding each made smaller contributions to the cost differences among both populations. Conclusions: Compared to warfarin, apixaban use may be associated with reduced medical costs in both general and elderly AF populations. Dabigatran use may be associated with a reduction of medical costs in the general AF population, but increased medical costs among the elderly.

Abstract 301: Evaluation Of Net Clinical Benefits Of New Oral Anticoagulants Used For Acute Venous Thromboembolism Treatment vs. Standard Therapy

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Yonghua Jing ◽  
Jeffrey Trocio ◽  
Jay Lin ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Standard Therapy ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Primary Efficacy ◽  
Clinical Benefits ◽  
Recurrent Vte ◽  
Event Rates

Background: Venous thromboembolism (VTE) is a significant healthcare burden, but is a preventable and treatable condition. The new oral anticoagulants (NOACs), apixaban, rivaroxaban, dabigatran, and edoxaban have all been shown in phase III trials to be noninferior in efficacy to standard therapies for acute VTE treatment, although there may be some differences in the bleeding rates among the NOACs. This study evaluated the net clinical benefits (NCB) of NOACs vs. standard therapies based on the AMPLIFY, EINSTEIN-Pooled analysis, RECOVER-1, RE-COVER II, and Hokusai-VTE trial results. Methods: Event rates of the primary efficacy and safety outcomes, as defined in each original trial, among VTE patients during trial periods were obtained from the published clinical trial data. Data from RECOVER-I and -II trials were combined to represent the findings for dabigatran since the two trials were of similar design. EINSTEIN-pooled (DVT and PE combined) data were used to represent findings for rivaroxaban. The combinations of rates for the primary efficacy endpoint, representing recurrent VTE or death and major bleedings (MB) were evaluated and defined as the NCB of each NOAC. Additionally, the number of VTE patients needed to treat (NNT) to avoid one event (e.g. VTE or MB) with each NOAC was also determined. Results: For patients treated in the VTE clinical trials, the differences in event rates of recurrent VTE or death for apixaban, rivaroxaban, dabigatran, and edoxaban vs. standard therapy were -0.43%, -0.23%, 0.20%, and -0.34%, respectively. The differences in event rates of MB for apixaban, rivaroxaban, dabigatran, and edoxaban vs. standard therapy were -1.26%, -0.78%, -0.43%, and -0.24%, respectively. The NCB improved for all NOAC treated patients, with those treated with apixaban (-1.69%) vs. standard therapy having the greatest NCB, followed by those treated with rivaroxaban (-1.01%), edoxaban (-0.58%), and dabigatran ( -0.23%) (Table 1). Conclusions: All NOACs were shown to be non-inferior to standard VTE treatments in clinical trials; however, apixaban may provide the optimal NCB with the lowest NNT. How these results translate into real-world outcomes or medical cost reductions will require further evaluation.

Association Between Age and Bleeding Events of Different Severities Among Patients with Nonvalvular Atrial Fibrillation in a Managed Care Population

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4238-4238
Author(s):  
Steven Deitelzweig ◽  
Brett Pinsky ◽  
Erin Buysman ◽  
Michael Lacey ◽  
Yonghua Jing ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Emergency Department ◽  
Older Patients ◽  
Claims Data ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Employment Equity ◽  
Equity Ownership ◽  
Event Rates

Abstract Abstract 4238 Background: Risk of bleeding is an important consideration among patients with nonvalvular atrial fibrillation (NVAF) due to the need for stroke prevention through anticoagulation. Older patients may be at risk for more frequent or more severe bleeding events. Objective: To describe the incidence of bleeding events in various age groups of patients with NVAF. Methods: Administrative claims data were used for this retrospective study. Adults with healthcare claims data related to atrial fibrillation (ICD-9-CM 427.31) between Jan 2005 and Jun 2009 but no evidence of valvular disease were included. Patients were followed until the earliest of death, disenrollment from the health plan, or 30 Jun 2010. Bleeding events in the follow-up period were categorized as major, serious non-major, or minor. A bleeding event was considered major if it was associated with any of the following: inpatient care, blood transfusion, decreased hemoglobin or hematocrit, physician guided medical or surgical treatment, intracranial bleed, or death. Serious non-major events were those involving vascular injury or critical site bleeding and were associated with outpatient hospital care or an emergency department visit. Minor bleeds were those associated with noncritical anatomical sites and an emergency department, outpatient hospital, or office visit. Patients were grouped based on their age as of the first atrial fibrillation diagnosis: younger than 65 years or 65 years and older; bleeding events in the subgroup of patients aged 75 years and older were also examined. Results: The mean (SD) age of the study sample (N=48,260) was 67 (13) years and 62.2% of the patients were male. Mean (SD) follow-up duration was 802 (540) days (median 673 days). Event rates for major bleeds were 5.2 events per 100 patient-years for patients aged younger than 65 years and 13.9 major bleeds per 100 patient-years for patients aged 65 years and older. Patients aged 75 and older had 15.6 major bleeds per 100 patient-years. Approximately 38.9% of all bleeding events experienced by patients aged 65 years and older were major. Approximately 23.3%, 33.6%, and 35.8% of major bleeds among patients younger than 65 years, 65 years and older, and 75 years and older, respectively, were associated with a hospitalization. Corresponding event rates for incident bleeds associated with an inpatient stay were 4.7 bleeding events per 100 patient-years for patients aged younger than 65 years, 12.0 events per 100 patient-years for patients aged 65 years and older, and 13.6 events per 100 patient-years for patients aged 75 years and older. Conclusions: Increasing age was associated with increased rate of any type of bleeding. The increase in rate with increasing age was particularly notable for major bleeds. Disclosures: Deitelzweig: Bristol-Myers Squibb/OptumInsight: Research Funding, Speakers Bureau. Pinsky:OptumInsight: Employment. Buysman:OptumInsight: Employment. Lacey:OptumInsight: Employment. Jing:Bristol-Myers Squibb: Employment, Equity Ownership. Wiederkehr:Pfizer: Employment, Equity Ownership. Graham:Bristol-Myers Squibb: Employment, Equity Ownership.

Evaluation of Differences in Medical Costs Associated with Venous Thromboembolism Prophylaxis with Desirudin Vs. Low Molecular Weight Heparin Among Patients Undergoing Total Hip Replacement Surgery

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4852-4852
Author(s):  
Steven Deitelzweig ◽  
Edith A Nutescu ◽  
James Meyer ◽  
Jay Lin ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Monte Carlo ◽  
Venous Thromboembolism ◽  
Medical Cost ◽  
Research Funding ◽  
Medical Costs ◽  
Efficacy And Safety ◽  
Vte Prophylaxis ◽  
Cost Offset ◽  
Event Rates ◽  
Cost Differences

Abstract Introduction: Total hip replacement (THR) surgery is effective in returning patients to function and improves health-related quality of life. However, venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a frequent complication of THR surgery that can be life threatening. Anticoagulation with low molecular weight heparin (LMWH) has been shown to be efficacious for lowering the risk of VTE among patients undergoing THR surgery. However, LMWH has biological limitations, such as the inability to inhibit clot-bound thrombin. Desirudin is a highly potent, selective, irreversible inhibitor of thrombin and inactivates both free and clot-bound thrombin. In the phase III, randomized, double-blind, clinical trial that compared the efficacy and safety of desirudin to LMWH among patients undergoing THR surgery, desirudin significantly reduced the overall rate of VTE relative to LMWH. Based on differences in event rates in the trial, this study estimated and compared the medical costs of THR surgery patients treated with desirudin vs. patients treated with LMWH for VTE prophylaxis. Methods: Event rates of efficacy and safety endpoints, including VTE defined as the overall rate of DVT, PE, or death related to thromboembolism, major bleeding (MB), clinically relevant non-major bleeding (CRNMB), and other minor bleeding, were obtained from published trial data. Incremental annual medical costs among patients with clinical events from a U.S. payer perspective were obtained from published literature. Costs were inflation adjusted to 2013 levels. Differences in total annual medical costs associated with clinical endpoints for desirudin vs. LMWH were then estimated. One-way and Monte Carlo multivariable sensitivity analyses were additionally carried out. Results: Desirudin treatment was associated with a 6.9% lower rate of VTE among patients undergoing THR surgery. As a result of the reduction in VTE event rate, annual medical costs were reduced by $1,250 per patient treated with desirudin in comparison to that of a patient treated with LMWH (Table). Univariate (one-way) sensitivity analysis showed that rates of VTE and MB had the greatest impact on the medical cost differences between desirudin and LMWH. The results of the 10,000 cycles of Monte Carlo multivariable analysis showed that the medical cost offset of desirudin vs. LMWH had a 95% interval range of -$562 to -$1,955, with 100% of the cycles showing a cost reduction <$0 (Figure). Conclusions: According to the estimate from this economic model, among patients undergoing THR surgery, VTE prophylaxis with desirudin is associated with reduced medical costs resulting from better efficacy in preventing VTE than LMWH. The efficacy and safety profile of desirudin and the estimated cost offset compared to LMWH make desirudin a good option for VTE prophylaxis among THR surgery patients in the U.S. Further evaluation may be needed to validate the economic model results in the real-world setting. Estimated Medical Cost Differences Among Patients who Undergo THR Surgery Treated with Desirudin vs. LMWH Table Outcome Desirudin vs. LMWH($/patient-year) Venous Thromboembolism -$1,299 Major Bleedings $52 Clinically Relevant Non-major Bleedings $0 Other Minor Bleedings -$4 Total Medical Cost -$1,250 Negative numbers indicate a cost reduction vs. LMWH Distribution of Total Medical Cost Differences from 10,000 Cycles of Monte Carlo Simulation: Desirudin vs. LMWH Figure 1 Figure 1. Disclosures Deitelzweig: 3-D Medical Services, Marathon Pharma: Consultancy, Research Funding. Nutescu:Marathon Pharma, Janssen, Anticoagulation Forum, American College of Clinical Pharmacy, National Blood Clot Alliance, NHLBI: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Meyer:Marathon Pharma: Employment. Lin:Marathon Pharma: Consultancy, Research Funding. Lingohr-Smith:Marathon Pharma: Consultancy, Research Funding. Amin:Marathon Pharma, Pfizer, BMS , J&J, Boeheinger-Ingelheim, Otsuka: Research Funding, Speakers Bureau.

scholarly journals Practical Considerations for the Nonvitamin K Antagonist Oral Anticoagulants

Cardiology ◽  
2016 ◽  
Vol 136 (2) ◽  
pp. 115-124 ◽  
Author(s):  
Rahul Trikha ◽  
Peter R. Kowey
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Heart Valves ◽  
Randomized Clinical Trials ◽  
Treatment Guidelines ◽  
Oral Anticoagulants ◽  
Treatment Guideline ◽  
Nonvalvular Atrial Fibrillation ◽  
Onset Of Action ◽  
Meta Analyses

Objectives: Dabigatran, rivaroxaban, apixaban, and edoxaban are nonvitamin K antagonist oral anticoagulants (NOACs) approved for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Phase-3 clinical trials demonstrated NOACs were as effective as warfarin in the prevention of stroke or systemic embolism and associated with decreased incidences of intracranial bleeding. Additionally, NOACs provide quicker onset of action, simpler dosing, more predictable pharmacokinetic profiles, and decreased food and drug interactions compared with warfarin. Despite the advantages of NOACs, the lack of knowledge may limit their use in clinical practice. Methods: A search was performed on the terms ‘atrial fibrillation' and ‘dabigatran', ‘apixaban', ‘edoxaban', or ‘rivaroxaban' to identify relevant papers; large randomized clinical trials, meta-analyses, and treatment guideline recommendations were given preference. Searches to identify registries, treatment guidelines, and meta-analyses relevant to patient subgroups were also employed. Results: Dosing recommendations, initiation of treatment, and applications in patients who undergo NVAF procedures, have mechanical heart valves, or experience other cardiovascular conditions such as myocardial infarction, previous stroke, and valvular heart disease are summarized. The NOAC-specific reversal approaches are also discussed. Conclusions: Several important factors should be considered regarding the adequate use of NOACs, especially in patients with renal impairment or cardiovascular conditions other than NVAF.

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