Abstract 16741: The Cost-Effectiveness of Apixaban versus Warfarin in Patients With Atrial Fibrillation: Insights From the ARISTOTLE Study Group

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Patricia A Cowper ◽  
Shubin Sheng ◽  
Kevin J Anstrom ◽  
Judith A Stafford ◽  
Renato D Lopes ◽  
...  

Background: In Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE), apixaban (vs. warfarin) significantly reduced stroke, death, and major bleeding in 18,201 patients with atrial fibrillation (AF). We assessed the cost-effectiveness of apixaban vs. warfarin from the perspective of the US health care system. Methods: Resource use (service dates, intensive care days, days on drug) was obtained from ARISTOTLE case report forms. Unit costs for components of hospital-based care of AF patients were estimated with generalized linear models using the national Premier database. Daily cost of anticoagulants was based on current acquisition cost (apixaban=$9.49; warfarin=$0.09) for 10 years, after which time apixaban was valued at projected costs of generic substitutes ($1.89). Physician services and anticoagulant monitoring were valued using Medicare fees. Within-trial costs were estimated using inverse probability weighting for differential follow-up. Survival was modeled with patient-level ARISTOTLE data using a two stage approach that combined a time-based Cox model for the within-trial period and an age-based Cox model for extrapolation. Uncertainty surrounding estimates of cost, life expectancy and cost/per life year gained was characterized with bootstraps and sensitivity analyses. Results: After 2 years, costs in the US cohort (n=3417) excluding study drug and monitoring averaged $306 less with apixaban than warfarin ($6257 vs. $6563). This difference was more than offset by higher apixaban anticoagulation costs ($6160 vs. $1181), resulting in an overall increase of $4673/patient. Over a lifetime, gains in life expectancy with apixaban (9.92 vs. 9.69; p<.001) were achieved at an additional cost of $17,564 ($29,447 vs. $11,883; p<.001), yielding a cost-effectiveness ratio (ICER) of $76,365/life year gained (85% likelihood of meeting $110,000 willingness to pay threshold). Cost-effectiveness was most sensitive to cost of apixaban. Conclusions: Reductions in mortality, stroke, and bleeding observed in ARISTOTLE translate to significant increases in life expectancy. At an estimated ICER of $76,365/life year gained, apixaban is a cost-effective alternative to warfarin.

2021 ◽  
Author(s):  
Youwen Zhu ◽  
Huabin Hu ◽  
Dong Ding ◽  
Shuosha Li ◽  
Mengting Liao ◽  
...  

Abstract Background:The phase III clinical trial Keynote-604 indicated that pembrolizumab plus chemotherapy could generate clinical benefits in Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). We aim to evaluate the cost-effectiveness of pembrolizumab plus chemotherapy as the first-line treatment of ES-SCLC from the United States (US) payers’ perspective.Methods: A synthetical Markov model was used to evaluate cost and effectiveness of pembrolizumab plus platinum-etoposide (EP) versus EP in first-line therapy for ES-SCLC from the data of Keynote-604. Lifetime costs life-years (LYs), quality adjusted LYs (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated. One-way and probabilistic sensitivity analyses were performed. In addition, We also considered subgroup cost-effectiveness.Results: Pembrolizumab plus EP resulted in additional 0.18 QALYs (0.32 LYs) and corresponding incremental costs $113,625, resulting an ICER of $647,509 per QALY versus EP. The most influential factor in this model was the cost of pembrolizumab. Probabilistic sensitivity analysis showed there was 0% probability that pembrolizumab combination chemotherapy was cost-effective at willingness-to-pay (WTP) values of $150,000 per QALY in the US. The results of subgroup probabilistic sensitivity analyses suggested that all subgroups were not cost-effective.Conclusion: From the perspective of the US payer, pembrolizumab plus EP is not a cost-effective option as first-line treatment for patients with ES-SCLC at a WTP threshold of $150,000 per QALY.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258605
Author(s):  
Qiao Liu ◽  
Chongqing Tan ◽  
Lidan Yi ◽  
Xiaomin Wan ◽  
Liubao Peng ◽  
...  

Background The phase III KEYNOTE-604 study confirmed the benefit of pembrolizumab combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC). Taken into account the clinical benefits of pembrolizumab and its high cost, this study aimed to assess the cost-effectiveness of adding pembrolizumab to standard first-line etoposide-platinum (EP) for patients with ES-SCLC from the US payer perspective. Methods A Markov model was developed to compare the cost and quality-adjusted life-year (QALY) of pembrolizumab plus EP and placebo plus EP over a 10-year time horizon. Clinical efficacy and safety data were pooled from the KEYNOTE-604 trial. Utilities were obtained from published resources. Costs were mainly collected from Medicare in 2020. Sensitivity analyses were performed to examine the robustness of our model. Results Adding pembrolizumab to standard first-line EP resulted in the better effectiveness than EP chemotherapy alone for ES-SCLC by 0.22 QALYs. Pembrolizumab plus EP was dominated economically by placebo plus EP, leading to an incremental cost-effectiveness ratio (ICER) of $334,373/ QALY. Deterministic sensitivity analyses indicated that the uncertainty in model parameters exerted no substantial effect on our results. Probability sensitivity analysis indicated that probabilities for pembrolizumab plus EP being cost-effective within a wide range of willingness to pay were modest. Conclusion From the US payer perspective, the first-line treatment for ES-SCLC with pembrolizumab plus EP was not cost-effective compared with placebo plus EP. Although pembrolizumab combination chemotherapy was beneficial to the survival of ES-SCLC, price reduction may be the necessary to improve its cost-effectiveness.


2021 ◽  
Vol 9 ◽  
Author(s):  
Peng-Fei Zhang ◽  
Dan Xie ◽  
Qiu Li

Background: The aim of this study is to evaluate the pharmacoeconomic profile of adding enzalutamide to first-line treatment for metastatic, hormone-sensitive prostate cancer (mHSPC) from the US and Chinese payers' perspectives.Materials and Methods: A Markov model with three health states: progression-free survival (PFS), progressive disease (PD), and death, was constructed. All patients were assumed to enter the model in the PFS state and transit according to the transition structure. Efficacy data were derived from the ENZAMET trial and Weibull distribution curves were modeled to fit the survival curves. Costs in the model included cost of drugs, best-supportive care (BSC), follow-up, tests, and adverse events (AEs)-related treatments. The primary endpoint of the study was incremental cost-effectiveness ratio (ICER). In addition, the impact of several key parameters on the results of the cost-effectiveness analysis was tested with one-way sensitivity analyses and probabilistic sensitivity analyses.Results: Overall, ICERs were $430,933.95/QALY and $225,444.74/QALY of addition of enzalutamide to androgen deprivation therapy (ADT) vs. ADT from the US and Chinese payers' perspective, respectively. The most influential factors were the utility for the PFS state and the cost of enzalutamide. At the willingness-to-pay (WTP) thresholds of $100,000.00/QALY in the US and $28,988.40/QALY in China, the probability of adding enzalutamide to first-line treatment being a cost-effective option for mHSPC was 0%.Conclusions: Based on the data from the ENZAMET trial and the current price of enzalutamide, adding enzalutamide to first-line treatment is not cost-effective for patients with mHSPC from the US and Chinse payers' perspectives.


2020 ◽  
Vol 36 (2) ◽  
pp. 145-151
Author(s):  
Laurence W. Busse ◽  
Gina Nicholson ◽  
Robert J. Nordyke ◽  
Cho-Han Lee ◽  
Feng Zeng ◽  
...  

BackgroundPatients with distributive shock who are unresponsive to traditional vasopressors are commonly considered to have severe distributive shock and are at high mortality risk. Here, we assess the cost-effectiveness of adding angiotensin II to the standard of care (SOC) for severe distributive shock in the US critical care setting from a US payer perspective.MethodsShort-term mortality outcomes were based on 28-day survival rates from the ATHOS-3 study. Long-term outcomes were extrapolated to lifetime survival using individually estimated life expectancies for survivors. Resource use and adverse event costs were drawn from the published literature. Health outcomes evaluated were lives saved, life-years gained, and quality-adjusted life-years (QALYs) gained using utility estimates for the US adult population weighted for sepsis mortality. Deterministic and probabilistic sensitivity analyses assessed uncertainty around results. We analyzed patients with severe distributive shock from the ATHOS-3 clinical trial.ResultsThe addition of angiotensin II to the SOC saved .08 lives at Day 28 compared to SOC alone. The cost per life saved was estimated to be $108,884. The addition of angiotensin II to the SOC was projected to result in a gain of .96 life-years and .66 QALYs. This resulted in an incremental cost-effectiveness ratio of $12,843 per QALY. The probability of angiotensin II being cost-effective at a threshold of $50,000 per QALY was 86 percent.ConclusionsFor treatment of severe distributive shock, angiotensin II is cost-effective at acceptable thresholds.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3605-3605 ◽  
Author(s):  
Gregory F. Guzauskas ◽  
Anthony Masaquel ◽  
Carolina Reyes ◽  
Kenneth Wilhelm ◽  
Tania Krivasi ◽  
...  

Abstract Background. Obinutuzumab (G) was recently approved for the treatment of follicular lymphoma (FL) in patients who relapsed after or are refractory to a rituximab (R)-containing regimen. In the phase III open label GADOLIN study of patients with rituximab-refractory iNHL, patients received either bendamustine (B, 120 mg/m2, d1+2, c1-6) alone, or obinutuzumab (G 1000 mg (d1, 8, 15 c1, d1 c2-6) for up to six 28d cycles) plus B (90 mg/m2, d1+2, c1-6) followed by G monotherapy (100 mg every 2 mo for up to 2 years). The net clinical benefit and economic value of G+B vs. B in R-refractory patients and the larger relapse patient population have not been formally evaluated. The objective of this study was to estimate the cost-effectiveness of G plus B followed by G monotherapy vs. B monotherapy based on results of the phase III GADOLIN trial in rituximab-refractory FL patients as well as model results for a refractory/relapse population. Methods. We developed a Markov model that utilized the GADOLIN trial's progression-free (PFS), and pooled G+B and B post-progression survival (PPS) through 4.5 years to model long-term patient PFS, progression, and death. We fit parametric curves to trial PFS and PPS data; PPS was used in lieu of immature overall survival (OS) data to model transitions to death from the progressed state. We used a U.S. registry of FL patients to inform the PFS and OS curves beyond the trial follow-up time to reflect a refractory/relapse patient population. The National LymphoCare Study is a disease-specific, prospective registry that enrolled more than 2,700 patients with newly diagnosed FL from 2004 to 2007 from more than 200 practice sites in the U.S. Drug utilization and adverse events were based on trial data, and costs were based on Medicare reimbursements and drug wholesale acquisition costs in 2016. Utility estimates were derived from the literature. Sensitivity analyses were conducted to assess uncertainty in the results. Results. Treatment with G+B followed by G monotherapy led to an increase in quality-adjusted life years (QALYs) relative to B-mono (1.23, 95% CR: -0.01, 2.38). The total cost of G+B was $114,815 and B-mono was $62,034, resulting in an incremental cost of $52,781. The average total cost was greater for G+B due primarily to increased drug and administration costs ($106,053 for G+B vs. $50,104 for B-mono), however this was offset by cost-savings for disease progression of -$4268 ($5,558 for G+B vs. $9,826 for B-mono). Adverse event costs were higher for G+B ($3,204) vs. B-mono ($2,103). The incremental cost-effectiveness ratio was $43,000 per QALY gained. In probabilistic sensitivity analyses, there was a 89% probability that G+B followed by G monotherapy was cost-effective versus B-mono at the $100,000 per QALY threshold. Conclusions. Our US-based analysis suggests that treatment with G+B followed by G monotherapy compared to B-mono is cost-effective in patients with FL who relapsed/refractory to a rituximab containing regimen. These findings are driven by the improvement in PFS with G+B treatment that lead to a projected increase in survival and decreased cost of treating disease progression. There was a high probability G+B was cost effective even when all parameters in the model were varied. In conclusion, G+B vs. B monotherapy in follicular lymphoma patients who relapse after or are refractory to a R-containing regimen is very likely cost effective in the US. Disclosures Guzauskas: Genentech, Inc.: Consultancy. Masaquel:Roche: Equity Ownership; Genentech: Employment. Reyes:Genentech: Employment; Roche: Equity Ownership. Wilhelm:Genentech: Employment; Roche: Equity Ownership. Krivasi:F. Hoffman-La Roche Ltd.: Employment. Veenstra:Genentech, Inc.: Consultancy.


2020 ◽  
Author(s):  
Lihui Zhou ◽  
Ye Cao ◽  
Bei Gao ◽  
Wenli Lu ◽  
Yuan Wang

Abstract Objectives: To evaluate the cost-effectiveness of community-based Atrial fibrillation (AF) screening by 12-lead electrocardiogram (ECG) in Chinese healthcare setting.Methods: A Markov state transition model was used to simulate the costs and effects on a 55/65/75-year-old cohort under routine care and AF screening by 12-lead ECG. The circle length was 1 year, and people were simulated until 90 years old. The cost-effectiveness analysis was perform using a societal perspective. Transition probability, costs, and utility data were derived from open dataset and published literature. One-way and probabilistic sensitivity analyses were performed to exam the uncertainty of the results. Results: Annual AF screening in 65/75-year-old cohort was highly cost-effective with the incremental cost-effectiveness ratio (ICER) Chinese Yuan Renminbi (CNY) 64147/49736 per quality-adjusted life year (QALY) gained. Annual AF screening in 65/75-year-old cohort was associated with 535/492 prevented ischemic strokes and 174/163 more intracerebral hemorrhages, and the anticoagulation rate increased from the assumed 10% on routine care to 61.5%. Probabilistic sensitivity analysis indicated that these two strategies have 55% and 78% chances of being cost-effective at a willingness-to-pay (WTP) threshold of 1× gross domestic product per capita of China in 2019, US $10635 QALY.Conclusion: Annual community-based screening of population aged 65 years and older in China is likely to be cost-effective at conventional willingness-to-pay thresholds to reduce the unnecessary burden of strokes.


Author(s):  
Nayyereh Ayati ◽  
Lora Fleifel ◽  
Mohammad Ali Sahraian ◽  
Shekoufeh Nikfar

Background: Cladribine tablets are the foremost oral immune-reconstitution therapy for high disease activity relapsing multiple sclerosis (HDA-RMS). We aimed to assess the cost-effectiveness of cladribine tablets compared to natalizumab in patients with HDA-RMS in Iran. Methods: A 5-year cohort-based Markov model was developed with 11 expanded disability status score (EDSS) health states, including patients with HDA-RMS as on and off-treatment. All costs were identified from the literature and expert opinion and were measured in Iranian Rial rates, changed to the 2020 USD rate and were discounted by 7.2%. Quality adjusted life years (QALY), discounted by 3.5%, and life years gained (LYG) were adopted to measure efficacy. The final results were presented as incremental cost-effectiveness ratio that was compared to a national willingness to pay (WTP) threshold of 1 to 3 gross domestic product (GDP) per capita. Deterministic and probabilistic sensitivity analyses (D/PSA) were employed to evaluate uncertainty. Results: Cladribine tablets dominated natalizumab and yielded 6,607 USD cost-saving and 0.003 additional QALYs per patient. LYG was comparable. The main cost component was drug acquisition cost in both arms. DSA indicated the sensitivity of the results to the cost discount rates and also the patients’ body weight; while they were less sensitive to the main clinical variables. PSA indicated that cladribine tablets were cost-effective in Iran, with a probability of 57.5% and 58.6% at lower and higher limits of threshold, respectively. Conclusion: Cladribine tablets yielded higher QALYs and lower costs compared to natalizumab, in patients with HDA-RMS in Iran.


Author(s):  
Brendan L Limone ◽  
William L Baker ◽  
Craig I Coleman

Background: A number of new anticoagulants for stroke prevention in atrial fibrillation (SPAF) have gained regulatory approval or are in late-stage development. We sought to conduct a systematic review of economic models of dabigatran, rivaroxaban and apixaban for SPAF. Methods: We searched the Medline, Embase, National Health Service Economic Evaluation Database and Health Technology Assessment database along with the Tuft’s Registry through October 10, 2012. Included models assessed the cost-effectiveness of dabigatran (150mg, 110mg, sequential), rivaroxaban or apixaban for SPAF using a Markov model or discrete event simulation and were published in English. Results: Eighteen models were identified. All models utilized a lone randomized trial (or an indirect comparison utilizing a single study for any given direct comparison), and these trials were clinically and methodologically heterogeneous. Dabigatran 150mg was assessed in 9 of models, dabigatran 110mg in 8, sequential dabigatran in 9, rivaroxaban in 4 and apixaban in 4. Adjusted-dose warfarin (either trial-like, real-world prescribing or genotype-dosed) was a potential first-line therapy in 94% of models. Models were conducted from the perspective of the United States (44%), European countries (39%) and Canada (17%). In base-case analyses, patients typically were at moderate-risk of ischemic stroke, initiated anticoagulation between 65 and 73 years of age, and were followed for or near a lifetime. All models reported cost/quality-adjusted life-year (QALY) gained, and while 22% of models reported using a societal perspective, no model included costs of lost productivity. Four models reported an incremental cost-effectiveness ratio (ICER) for a newer anticoagulant (dabigatran 110mg (n=4)/150mg (n=2); rivaroxaban (n=1)) vs. warfarin above commonly reported willingness-to-pay thresholds. ICERs (in 2012US$) vs. warfarin ranged from $3,547-$86,000 for dabigatran 150mg, $20,713-$150,000 for dabigatran 110mg, $4,084-$21,466 for sequentially-dosed dabigatran and $23,065-$57,470 for rivaroxaban. In addition, apixaban was demonstrated to be an economically dominant strategy compared to aspirin and to be dominant or cost-effective ($11,400-$25,059) vs. warfarin. Based on separate indirect treatment comparison meta-analyses, 3 models compared the cost-effectiveness of these new agents and reported conflicting results. Conclusions: Cost-effectiveness models of newer anticoagulants for SPAF have been extensively published. Models have frequently found newer anticoagulants to be cost-effective, but due to the lack of head-to-head trial comparisons and heterogeneity in clinical characteristic of underlying trials and modeling methods, it is currently unclear which of these newer agents is most cost-effective.


2021 ◽  
Author(s):  
Xueyan Luo ◽  
Wei Xu ◽  
Quan Yuan ◽  
Han Lai ◽  
Chunji Huang

BACKGROUND Mobile health (mhealth) technology is increasingly used in disease management. Using mhealth tools to integrate and streamline care was found to improve atrial fibrillation (AF) patients’ clinical outcomes. OBJECTIVE This study aimed to investigate the potential clinical and health economic outcomes of mhealth-based integrated care for AF from the perspective of a public healthcare provider in China. METHODS A Markov model was designed to compare outcomes of mhealth-based care and usual care in a hypothetical cohort of AF patients in China. The time horizon was 30 years with monthly cycles. Model outcomes measured were direct medical cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to examine the robustness of base-case results. RESULTS In the base-case analysis, mhealth-based care gained higher QALYs of 0.0818 with an incurred cost of USD1,778. Using USD33,438 per QALY (three times gross domestic product) as the willingness-to-pay threshold, mhealth-based care was cost-effective, with an ICER of USD21,739 per QALY. The one-way sensitivity analysis found compliance to mhealth-based care had the greatest impact on the ICER. In probabilistic sensitivity analysis, mhealth-based care was accepted as cost-effective in 80.91% of 10,000 iterations. CONCLUSIONS This study suggested that the use of mhealth technology in streamlining and integrating care for AF patients was cost-effective in China.


2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii46-ii46
Author(s):  
J Rosen ◽  
G Ceccon ◽  
E K Bauer ◽  
J M Werner ◽  
C Kabbasch ◽  
...  

Abstract BACKGROUND In light of increasing healthcare costs, higher medical expenses should be justified socio-economically. Therefore, we calculated the effectiveness and cost-effectiveness of PET using the radiolabeled amino acid O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) compared to conventional MRI for early identification of responders to adjuvant temozolomide chemotherapy. A recent study in IDH-wildtype glioma patients suggested that after two cycles, FET-PET parameter changes predicted a significantly longer survival while MRI changes were not significant. MATERIALS AND METHODS To determine the effectiveness and cost-effectiveness of serial FET-PET imaging, we analyzed published clinical data and calculated the associated costs in the context of the German healthcare system.Based on a decision-tree model, FET-PET and MRI’s effectiveness was calculated, i.e., the probability to correctly identify a responder as defined by an overall survival ≥15 months. To determine the cost-effectiveness, the incremental cost-effectiveness ratio (ICER) was calculated, i.e., the cost for each additionally identified responder by FET-PET who would have remained undetected by MRI. The robustness of the results was tested by deterministic and probabilistic (Monte Carlo simulation) sensitivity analyses. RESULTS Compared to MRI, FET-PET increases the rate of correctly identified responders to chemotherapy by 26%; thus, four patients need to be examined by FET-PET to identify one additional responder. Considering the respective cost for serial FET-PET and MRI, the ICER resulted in €4,396.83 for each additional correctly identified responder by FET-PET. The sensitivity analyses confirmed the robustness of the results. CONCLUSION In contrast to conventional MRI, the model suggests that FET PET is cost-effective in terms of ICER values. Concerning the high cost of temozolomide, the integration of FET-PET has the potential to avoid premature chemotherapy discontinuation at a reasonable cost.


Sign in / Sign up

Export Citation Format

Share Document