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Objective: To quantify the economic burden of bacterial antimicrobial resistance in Thailand and estimate potential savings from improving the rate of appropriate empiric treatment, where effective coverage is provided within the first days of infection., Design: Cost-of-illness study., Methods: A cost-calculator, decision-tree model was developed using published data and records from 3 Thai hospitals for patients hospitalized with antimicrobial-resistant infections between 2015 and 2019. Direct and indirect costs of antimicrobial-resistant infections were assessed over a 5-year time horizon, with outcomes derived separately for cases having received appropriate empiric treatment versus inappropriate empiric treatment. In a real-world scenario, outcomes were estimated using actual rates of inappropriate empiric treatment, and in a hypothetical scenario, outcomes were estimated using decreased rates of inappropriate empiric treatment., Results: Over 5 years, in-hospital antimicrobial-resistant infections produced costs of approximately Thai baht (THB) 66.4 billion (USD 2.1 billion) in the real-world scenario and THB 65.8 billion (USD 2.1 billion) in the hypothetical scenario (0.9% cost savings relative to the real-world scenario). Most costs were attributable to income loss due to in-hospital mortality (real world: THB 53.7 billion [USD 1.7 billion]; 80.9% of costs; hypothetical: THB 53.2 billion [USD 1.7 billion]; 80.8% of costs) and hospitalization (real world: THB 10.3 billion [USD 330.8 million]; 15.5% of costs; hypothetical: THB 10.2 billion [USD 328.9 million]; 15.5% of costs)., Conclusions: In-hospital antimicrobial-resistant infections produced a substantial economic toll in Thailand. This public health burden could be reduced with a strategy aimed at decreasing the rate of patients receiving inappropriate empiric treatment., Competing Interests: A.A.T., C.P., P.S., and N.K. are or have been employees of Pfizer and may own Pfizer stock. E.T. and TK are employees of Evidera, which received financial support from Pfizer. in connection with the study and the development of this manuscript. K.K. is an employee of University of Phayao and received financial support from Pfizer in connection with the study and the development of this manuscript., (© The Author(s) 2023.)

Objectives: Paediatric growth hormone deficiency (pGHD) manifests as growth failure associated with inadequate growth hormone (GH) production. Daily injections of recombinant human GH (dGH) [somatropin] is the current standard of care, which has been shown to be well tolerated and effective, but associated with suboptimal adherence, leading to reduced effectiveness. Somatrogon, a once-weekly injectable long-acting human GH, has demonstrated clinical non-inferiority and significantly lower life interference (i.e. treatment burden) vs. somatropin in two Phase 3 studies. This work evaluated cost-effectiveness and cost-utility of somatrogon vs dGHs from an Irish payer perspective., Methods: A Markov model was developed for patients starting somatrogon or dGHs treatment at 3-12 years and continuing up to achievement of near adult height (NAH), with growth driven by trial-based height velocity (HV) and treatment-specific adherence. Patients could discontinue treatment at the end of Year 1 (4%). DGH adherence (95.3%-65% over treatment duration) and adherence-growth relationship were based on published evidence. Higher Year 1 adherence of 4%, tapering over time, for somatrogon vs. dGHs was based on clinical consultation. Treatment costs, monitoring costs and costs due to different wastage types (device setting and adherence) were sourced from local data. Health utilities based on height and injection frequency were derived from published literature. Scenario analysis, deterministic and probabilistic sensitivity analysis were performed., Results: Somatrogon treatment led to 1.87-3.66 cm greater NAH gain and 0.21-0.50 higher quality adjusted life years (QALYs) vs. dGHs, across the base case and scenarios evaluated. Somatrogon treatment was associated with cost savings of €5,699-€21,974 and lower cost per cm gained vs. dGHs (€197-€527), per patient. Somatrogon was cost-effective vs. dGHs, with the result consistent across the sensitivity analyses conducted., Conclusion: Somatrogon weekly injections were estimated to result in higher NAH, higher QALYs, lower overall costs and lower costs per cm gained than dGHs, in pGHD.

Aim: Screening for non-valvular atrial fibrillation (NVAF) is key in identifying patients with undiagnosed disease who may be eligible for anticoagulation therapy. Understanding the economic value of screening is necessary to assess optimal strategies for payers and healthcare systems. We evaluated the cost effectiveness of opportunistic screening with handheld digital devices and pulse palpation, as well as targeted screening predictive algorithms for UK patients ≥75 years of age., Methods: A previously developed Markov cohort model was adapted to evaluate clinical and economic outcomes of opportunistic screening including pulse palpation, Zenicor (extended 14 days), KardiaMobile (extended), and two algorithms compared to no screening. Key model inputs including epidemiology estimates, screening effectiveness, and risks for medical events were derived from the STROKESTOP, ARISTOTLE studies, and published literature, and cost inputs were obtained from a UK national cost database. Health and cost outcomes, annually discounted at 3.5%, were reported for a cohort of 10,000 patients vs. no screening over a time horizon equivalent to a patient's lifetime, Analyses were performed from a UK National Health Services and personal social services perspective., Results: Zenicor, pulse palpation, and KardiaMobile were dominant (providing better health outcomes at lower costs) vs. no screening; both algorithms were cost-effective vs. no screening, with incremental cost-effectiveness ratios per quality-adjusted life-year (QALY) of £1,040 and £1,166. Zenicor, pulse palpation, and KardiaMobile remained dominant options vs. no screening in all scenarios explored. Deterministic sensitivity analyses indicated long-term stroke care costs, prevalence of undiagnosed NVAF in patients 75-79 years of age, and clinical efficacy of anticoagulant on stroke prevention were the main drivers of the cost-effectiveness results., Conclusions: Screening for NVAF at ≥75 years of age could result in fewer NVAF-related strokes. NVAF screening is cost-effective and may be cost-saving depending on the program chosen.

Background: Contemporary guidelines recommend opportunistic screening for atrial fibrillation (AF)., Objective: The objective of this study was to assess the cost-effectiveness of single time point opportunistic AF screening for patients 65 years and older by using the single-lead electrocardiogram., Methods: An established Markov cohort model was adapted by updating the background mortality estimates, epidemiology, screening efficacy, treatment patterns, resource use, and cost inputs to reflect a Canadian health care setting. Inputs were derived from a contemporary prospective screening study performed in Canadian primary care settings (screening efficacy and epidemiology) and the published literature (unit costs, epidemiology, mortality, utility, and treatment efficacy). The impact of screening and oral anticoagulant treatment on the cost and clinical outcomes was analyzed. A Canadian payer perspective over lifetime was used for analysis, with costs expressed in 2019 Canadian dollars., Results: Among the estimated screening-eligible population of 2,929,301 patients, the screening cohort identified an additional 127,670 AF cases compared with the usual care cohort. The model estimated avoidance of 12,236 strokes and incremental quality-adjusted life-years of 59,577 (0.02 per patient) over lifetime in the screening cohort. Cost savings were substantial because of improved health outcomes, reflecting screening being the dominant strategy (affordable and effective). Model results were robust across sensitivity and scenario analyses., Conclusion: Single time point opportunistic screening of AF using a single-lead electrocardiogram device in Canadian patients 65 years and older without known AF may provide improved health outcomes with cost savings from the perspective of a single payer health care environment., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Background/objective: AUGUSTUS trial demonstrated that, for patients with atrial fibrillation (AF) having acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), an antithrombotic regimen with apixaban and P2Y12 resulted in less bleeding, fewer hospitalizations, and similar ischemic events than regimens including a vitamin K antagonist (VKA), aspirin, or both. This study objective was to evaluate long-term health and economic outcomes and the cost-effectiveness of apixaban over VKA, as a treatment option for patients with AF having ACS/PCI., Methods: A lifetime Markov cohort model was developed comparing apixaban versus VKA across multiple treatment strategies (triple [with P2Y12 + aspirin] or dual [with P2Y12] therapy followed by monotherapy [apixaban or VKA]; triple followed by dual and then monotherapy; dual followed by monotherapy). The model adopted the Spanish healthcare perspective, with a 3-month cycle length and costs and health outcomes discounted at 3%., Results: Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA (net difference, LYs: 0.13; QALYs: 0.11). Bleeding and ischemic events (per 100 patients) were lower with apixaban than VKA (net difference, -13.9 and -1.8, respectively). Incremental net monetary benefit for apixaban was €3,041, using a willingness-to-pay threshold of €20,000 per QALY. In probabilistic sensitivity analysis, apixaban was dominant in the majority of simulations (92.6%), providing additional QALYs at lower costs than VKA., Conclusions: Apixaban was a dominant treatment strategy than VKA from both the Spanish payer's and societal perspectives, regardless of treatment strategy considered., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AK is an employee and holds stock from BMS. CP is an employee and holds stock from BMS. MDF is an employee and owner of stock at Pfizer Inc. DD is an employee and holds stock from BMS. JS is an employee and owner of stock at Pfizer Inc. MS is a Pfizer Inc. employee and owns stocks of Pfizer Inc. SR, TK, and AS are salaried employees of Evidera and are not allowed to accept remuneration from any clients for their services. Evidera received funding from BMS/Pfizer Inc. to conduct the study and develop this manuscript. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Background: A recent community-based disease management (CBDM) pilot study reported a 20.5% prevalence of hypertension and a 0.5 and 3.6% prevalence of stroke and coronary heart disease (CHD), respectively, in an elderly population (mean age 65 years) in the Xin Jiang autonomous region of China. The CBDM was initiated in 2013 as an essential public health service; however, the potential long-term impact of CBDM on cardiovascular (CV: CHD and stroke) events is unknown. The objective of the study was to understand the long-term impact of CBDM interventions on CV risk factors using disease-model simulation based on a single-arm experimental study., Methods: A discrete event simulation was developed to evaluate the impact of CBDM on the long-term CV risk among patients with hypertension, in China's Xin Jiang autonomous region. The model generated pairs of identical patients; one receives CBDM and one does not (control group). Their clinical courses were simulated based on time to CV events (CHD and strokes), which are estimated using published risk equations. The impact of CBDM was incorporated as improvement in systolic blood pressure (SBP) based on observations from the CBDM study. The simulation estimated the number of CV events over patients' lifetimes., Results: During a 2-year follow up, the CBDM led to an average reduction of 8.73 mmHg in SBP from baseline, and a 42% reduction in smoking. The discrete event simulation showed that, in the control group, the model estimated incidence rates of 276, 1789, and 616 per 100,000 individuals for lifetime CHD, stroke, and CV-related death, respectively. The impact of CBDM on SBP translated into reductions of 8, 28, and 23% in CHD, stroke, and CV-related deaths, respectively. Taking into account CBDM's reduction of both SBP and smoking, deaths from CHD, stroke, and CV-related deaths were reduced by 12, 30, and 26%, respectively., Conclusions: The implementation of CBDM in China's Xinjiang autonomous region is expected to significantly reduce incidences of CHD, strokes, and CV-related deaths.

Purpose: Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose combination antibiotic approved in Europe and the United States for patients with hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP). The economic benefits of a new drug such as CAZ-AVI are required to be assessed against those of available comparators, from the perspective of health care providers and payers, through cost-effectiveness and cost-utility analyses. The objective of this analysis was to compare the cost-effectiveness of CAZ-AVI versus meropenem in the empirical treatment of appropriate hospitalized patients with HAP/VAP caused by gram-negative pathogens, from the perspective of publicly funded health care in Italy (third-party perspective, based on the data from the REPROVE (Ceftazidime-Avibactam Versus Meropenem In Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia) clinical study; ClinicalTrials.gov NCT01808092)., Methods: A patient-level, sequential simulation model of the HAP/VAP clinical course was developed using spreadsheet software. The analysis focused on direct medical costs. The time horizon of the model selected was 5 years, with an annual discount rate of 3% on costs and quality-adjusted life-years (QALYs). Clinical inputs for treatment comparisons were mainly obtained from the REPROVE clinical study data. In addition to clinical outcomes observed in the trial, the model incorporated impact of resistance pathogens, based on data from published studies and expert opinion. Certain assumptions were made for some model parameters due to a lack of data., Findings: The analysis demonstrated that the intervention sequence (CAZ-AVI followed by colistin + high-dose meropenem) versus the comparator sequence (meropenem followed by colistin + high-dose meropenem) provided a better clinical cure rate (+13.52%), which led to a shorter hospital stay (-0.40 days per patient), and gains in the number of life-years (+0.195) and QALYs (+0.350) per patient. The intervention sequence had an estimated net incremental total cost of €1254 ($1401) per patient, and the estimated incremental cost-effectiveness ratio was €3581 ($4000) per QALY gained, well below the willingness-to-pay threshold of €30,000 ($33,507) per QALY in Italy., Implications: The model results showed that CAZ-AVI is expected to provide clinical benefits in hospitalized patients with HAP/VAP in Italy at an acceptable cost compared to meropenem., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose antibiotic approved in Europe and the United States for treating (in combination with metronidazole) cIAI in adult hospitalised patients who have limited or no alternative treatment options. The approval was based on the results of RECLAIM, a Phase III, parallel-group, comparative study (RECLAIM 1 [NCT01499290] and RECLAIM 2 [NCT01500239]). The objective of our study was to assess the cost-effectiveness of CAZ-AVI plus metronidazole compared with 1) ceftolozane/tazobactam plus metronidazole and 2) meropenem, as an empiric treatment for the management of cIAI in Italy., Methods: A sequential, patient-level simulation model, with a 5-year time horizon and 3% annual discount rate (applied to both costs and health benefits), was developed using Microsoft Excel® to demonstrate the clinical course of the disease. The impact of resistant pathogens was included as an additional factor., Results: In the base-case analysis, the CAZ-AVI sequence (CAZ-AVI plus metronidazole followed by a colistin + tigecycline + high-dose meropenem combination after treatment failure), when compared to sequences for ceftolozane/tazobactam (ceftolozane/tazobactam plus metronidazole followed by colistin + tigecycline + high-dose meropenem after treatment failure) and meropenem (meropenem followed by colistin + tigecycline + high-dose meropenem after treatment failure), had better clinical outcomes with higher cure rates (93.04% vs. 91.52%; 92.98% vs. 90.24%, respectively), shorter hospital stays (∆ = - 0.38 and ∆ = - 1.24 days per patient, respectively), and higher quality-adjusted life years (QALYs) gained per patient (4.021 vs. 3.982; 4.019 vs. 3.960, respectively). The incremental cost effectiveness ratio in the CAZ-AVI sequence was €4099 and €15,574 per QALY gained versus each comparator sequence, respectively, well below the willingness-to-pay threshold of €30,000 per QALY accepted in Italy., Conclusions: The model results demonstrated that CAZ-AVI plus metronidazole could be a cost-effective alternative when compared with other antibiotic treatment options, as it is expected to provide better clinical benefits in hospitalised patients with cIAI in Italy., Competing Interests: Competing interestsTK and ET are employees of Evidera, which received funding from Pfizer in connection with conducting the study, developing this manuscript, and medical writing. RDV, NBP, and CC are employees of Pfizer, and hold Pfizer stock and/or stock options. CE is an employee of Klinikum Peine, Academic Hospital of Medical University Hannover, (Hannover, Germany), and MB is an employee of University of Genoa, Genoa and Hospital Policlinico San Martino – IRCCS, Genoa (Italy), each of which received research funding from Pfizer. Outside the submitted work, MB has received funding for scientific advisory boards, travel and speaker honoraria from Angelini, AstraZeneca, Bayer, Cidara, Cepheid, Cubist, Pfizer, Menarini, MSD, Nabriva, Paratek, Roche, Shionogi, Tetraphase, The Medicine Company and Astellas Pharma Inc., (© The Author(s). 2019.)

Objective: To estimate the budget impact of introducing avelumab as a second-line (2L) treatment option for patients with locally advanced or metastatic urothelial cancer (mUC) from the perspective of a US third-party payer (commercial and Medicare)., Methods: A budget impact model (BIM) with a three-year time horizon was developed for avelumab. Efficacy and safety data were sourced from published literature and US package inserts. The analysis was conducted in collaboration with a specialist oncologist who validated clinical assumptions. Costs were based on the number of eligible patients, time-to-treatment failure, overall survival, adverse events (AEs), and projected market shares of various treatments., Results: In a hypothetical commercial health plan of 30,000,000 members, 884 patients were estimated to be eligible for 2L treatment over a three-year time period. Without avelumab, the total cost for treating patients with mUC was estimated to be US$70,268,035. The introduction of avelumab increased total costs by $73,438 (0.10% increase). In a hypothetical Medicare health plan of 30,000,000 beneficiaries, a total of 4,705 patients were estimated to be eligible for 2L treatment. Without avelumab, the total cost for treating patients with mUC was estimated to be $292,923,098 from a Medicare perspective; however, with avelumab, there was an increase of $719,324 (0.25% increase) in total costs. Results of the sensitivity analyses demonstrated a cost-neutral impact across all tested scenarios from both perspectives., Conclusion: The BIM estimated that avelumab would have a cost-neutral impact within a US commercial and a Medicare health plan. Overall, avelumab can be an affordable and valuable treatment option for patients with locally advanced or mUC in the 2L setting. These findings demonstrate a consistently favorable budget impact in both populations. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding avelumab to the treatment armamentarium of 2L mUC., Competing Interests: T. Kongnakorn and A. Benedict are employees of Evidera. T. Kongnakorn reports grants from Merck Healthcare KGaA, Darmstadt, Germany, outside the submitted work. M. Kearney is an employee of Merck Healthcare KGaA, Darmstadt, Germany. M. Bharmal, A. Bhanegaonkar and H. Phatak are employees of EMD Serono, Rockland, MA (a business of Merck KGaA). M. Galsky is an employee of Icahn School of Medicine at Mount Sinai, New York, NY, and reports a consulting/advisory role with Genentech, Bristol-Myers Squibb, Merck, AstraZeneca, EMD Serono, Pfizer, and Astellas and received research funding from Merck, Pfizer, AstraZeneca, Bristol-Myers Squibb, Roche/Genentech, and Seattle Genetics, outside the submitted work. The authors report no other conflicts of interest in this work., (© 2019 Kongnakorn et al.)

Ceftazidime/avibactam (CAZ-AVI) is a novel, fixed-dose combination antibiotic that has been approved in Europe and the United States for patients with complicated urinary tract infections (cUTIs) based on results of a Phase III, randomized, comparative study (RECAPTURE study). The present analysis evaluated cost-effectiveness of CAZ-AVI as an empirical treatment for hospitalized patients with cUTIs from the Italian publicly funded healthcare (third-party payer) perspective. A sequential, patient-level simulation model was developed that followed the clinical course of cUTI and generated 5000 pairs of identical patients (CAZ-AVI or imipenem as empirical treatment). The model included additional impact of resistant pathogens; patients who did not respond to empirical treatment were switched to second-line treatment of colistin+high dose carbapenem in both groups. The time horizon of the model was five years, with an annual discount rate of 3% applied to both costs and quality-adjusted life-years (QALYs). The analysis demonstrated that an intervention sequence (CAZ-AVI followed by colistin+high dose carbapenem) compared with a comparator sequence (imipenem followed by colistin+high dose carbapenem) was associated with a net incremental cost of €1015 per patient but provided better health outcomes in terms of clinical cure (97.65% vs. 91.08%; ∆ = 6.57%), shorter hospital stays (10.65 vs. 12.55 days; ∆ = 1.90 days), and QALYs gained per patient (4.190 vs. 4.063; ∆ = 0.126). The incremental cost-effectiveness ratio was €8039/QALY, which is well below the willingness-to-pay threshold of €30 000/QALY in Italy. The results showed that CAZ-AVI is expected to be a cost-effective treatment compared with imipenem for cUTI in Italy., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Atrial fibrillation (AF) is a chronic sustained heart rhythm disorder associated with an increased risk of stroke. Apixaban, a new oral anticoagulant, was approved by the European Medicines Agency for prevention of stroke in patients with AF. The efficacy of apixaban has been investigated in randomised controlled trials. Objectives: The objective of this study was to estimate the economic implications of using apixaban compared to other anti-coagulations to reduce the risk of stroke in patients with AF from the perspective of the Algerian payer. Methods: A previously published Markov model was adapted to the Algerian setting. The model included patients for whom vitamin K antagonist (VKA) treatment is suitable and could initiate on acenocoumarol, rivaroxaban or apixaban, and those unsuitable for VKA treatment who could initiate on aspirin or apixaban. Over a lifetime time horizon, costs were estimated in Algerian dinars (DZD) and outcomes included life-years (LYs), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results: In the VKA suitable population, apixaban was estimated to be a dominant treatment option over rivaroxaban, providing a higher number of QALYs at lower costs, while when compared with acenocoumarol, an ICER of 3 672 059 DZD per QALY gained was estimated. Amongst those unsuitable for VKA therapy, the ICER was 2 061 863 DZD per QALY gained. Conclusion: Apixaban was found to be a cost-effective choice for stroke prevention in patients with AF in Algeria compared to acenocoumarol and rivaroxaban in the VKA suitable population and compared to aspirin in the VKA unsuitable population.

Background: The clinical and economic benefits associated with apixaban treatment have been established in clinical trials and published economic evaluations. The benefits associated with apixaban could extend to improving hospital efficiencies, potentially influencing hospital resource use, and bed days. The objective of this study is to estimate the impact of 6-month treatment with apixaban vs low molecular weight heparin/vitamin k antagonist (LMWH/VKA) on hospital resource use among patients with venous thromboembolism (VTE)., Methods: A model was developed to assess the impact of apixaban vs LMWH/VKA for treatment of VTE and prevention of recurrences on hospital resource use and costs. Resource use items included total hospitalizations, length of stay (LOS), and emergency department (ED) visits, estimated for all incident VTE patients in the UK over a 5-year time horizon. Rates of hospitalizations, ED visits, and LOS associated with recurrent VTE, major, and clinically relevant non-major bleeding were obtained from the AMPLIFY trial; costs were obtained from UK published sources., Results: Over a 5-year time horizon, the model predicted that, compared to 6 months of LMWH/VKA, 6 months of apixaban led to 3,954 fewer hospitalizations (consisting of 2,341 fewer new admissions and 1,613 fewer re-admissions) and 32,214 fewer bed days, among 332,607 incident VTE patients. ED visits were reduced by 1,582. The reduction in hospital resource use led to a cost saving of ∼£4.5 million in a market of patients treated with apixaban as compared to a market treated with LMWH/VKA. Sensitivity analysis indicated these findings were robust over a wide range of inputs., Conclusions: 6-month treatment with apixaban for treatment of VTE and prevention of recurrences on hospital resource use led to a reduction in hospitalizations and LOS in comparison to LMWH/VKA. These findings can help the efforts in reducing the growing burden of preventable re-admissions to hospitals.

Purpose: The purpose of this analysis was to assess the cost-effectiveness of apixaban 5 mg BID versus high- and low-dose edoxaban (60 mg and 30 mg once daily) as intended starting dose strategies for stroke prevention in patients from a UK National Health Service perspective., Methods: A previously developed and validated Markov model was adapted to evaluate the lifetime clinical and economic impact of apixaban 5 mg BID versus edoxaban (high and low dose) in patients with nonvalvular atrial fibrillation. A pairwise indirect treatment comparison was conducted for clinical end points, and price parity was assumed between apixaban and edoxaban. Costs in 2012 British pounds, life-years, and quality-adjusted life-years (QALYs) gained, discounted at 3.5% per annum, were estimated., Findings: Apixaban was predicted to increase life expectancy and QALYs versus low- and high-dose edoxaban. These gains were achieved at cost-savings versus low-dose edoxaban, thus being dominant and nominal increases in costs versus high-dose edoxaban. The incremental cost-effectiveness ratio of apixaban versus high-dose edoxaban was £6763 per QALY gained., Implications: Apixaban was deemed to be dominant (less costly and more effective) versus low-dose edoxaban and a cost-effective alternative to high-dose edoxaban., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Although recommended by guidelines, the benefits of treating patients with atrial fibrillation with a low-stroke risk score, with aspirin or anticoagulants, have not been clearly established. With advent of safer non-vitamin K antagonist oral anticoagulant, we assessed the clinical and economic implications of 5 mg BID of apixaban versus aspirin among patients with a relative low risk of stroke as assessed using the CHADS2 (congestive heart failure, hypertension, age>75, diabetes mellitus, stroke/transient ischemic attack) and CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes mellitus, stroke/transient ischemic attack, vascular disease) stroke risk classification., Methods: A previously developed and validated Markov model was adapted. A secondary analysis of the Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) study was conducted to estimate event rates in different low-risk cohorts by treatment. Three cohorts (n=1000) with a CHADS2 score of 1, CHA2DS2-VASc score of 1, and CHA2DS2-VASc of score 2 to 4 were simulated to assess the number of clinical events avoided in terms of strokes and major bleeds, as well as life years gained, quality-adjusted life years gained, costs, and incremental costs per quality-adjusted life year gained., Results: Apixaban was associated with fewer strokes and systemic embolism versus aspirin across all subgroups; however, it caused more major bleeding events. The reduction in systemic embolism offset the increase in major bleeding events leading to increased life expectancy and quality-adjusted life year gains, achieved at an increased cost that was lower than the UK threshold of $44,400 (ie, £30,000) per quality-adjusted life year gained across the 3 cohorts examined., Conclusions: Anticoagulant treatment with apixaban versus aspirin in low-risk patients, as identified using CHADS2 or CHA2DS2-VASc, is projected to increase life expectancy and provide clinical benefits that are cost effective., (© 2015 American Heart Association, Inc.)

Background and Objective: Management of non-valvular atrial fibrillation (NVAF) focuses on the use of anticoagulation to mitigate the risk of stroke. Until recently, vitamin K antagonist (VKA) treatment was considered the standard of care, with the emergence of non-VKA oral anticoagulants (NOACs) shifting treatment practice. The objective of this study was therefore to assess the use of warfarin and the NOACs for stroke prevention in patients with NVAF from the perspective of a Belgian healthcare payer using a cost-effectiveness analysis and the efficiency frontier approach., Methods: A previously published Markov model was adapted to the Belgian healthcare setting. Clinical events modelled include ischaemic and haemorrhagic stroke, systemic embolism, intracranial haemorrhage, other major bleeding, clinically relevant non-major bleeding, myocardial infarction, cardiovascular hospitalisation and treatment discontinuations. Efficacy and bleeding data for warfarin and apixaban 5 mg twice daily were obtained from the ARISTOTLE trial, whilst those for other NOACs (rivaroxaban 20 mg once daily, dabigatran 110 mg twice daily, dabigatran 150 mg twice daily) were from published indirect comparisons. Acute medical costs were obtained from reimbursement payments made to Belgian hospitals, whilst long-term medical costs and utility data were derived from the literature. The efficiency frontier was calculated using total costs and quality-adjusted life-years (QALYs) as outcomes. Univariate and probabilistic sensitivity analyses were performed., Results: Warfarin and apixaban were the two optimal treatment choices, as the other three treatment alternatives including dabigatran 110 mg, dabigatran 150 mg switching to dabigatran 110 mg at the age of 80 years and rivaroxaban were extendedly or strictly dominated on the efficiency frontier. Apixaban was a cost-effective alternative vs warfarin at an incremental cost-effectiveness ratio of 7,212/QALY gained., Conclusions: Amongst NOACs, apixaban may be the most economically efficient alternative to warfarin in NVAF patients who are suitable for VKA treatment and eligible for stroke prevention in Belgium.

Background and Objective: Evidence indicates that vitamin K antagonists (VKAs) and oral anticoagulant therapy are under-utilised for stroke prevention in patients with non-valvular atrial fibrillation (AF), and patients who decline or cannot tolerate such treatment are often prescribed aspirin instead. Apixaban has been shown in the AVERROES trial to be superior to aspirin in preventing stroke and systemic embolism without significantly increasing the risk of major bleeding among patients with AF who are unsuitable for VKA therapy. This study estimates the economic implications and potential cost effectiveness of apixaban compared with aspirin in such individuals from the perspective of healthcare payers in Belgium., Methods: A Markov model was developed to evaluate the clinical and economic impact of apixaban compared with aspirin in patients unsuitable for VKA therapy. The clinical events modelled include ischaemic and haemorrhagic stroke, systemic embolism, intracranial haemorrhage, other major bleeding, clinically relevant non-major bleeding, myocardial infarction, cardiovascular hospitalisation and treatment discontinuations obtained from AVERROES. Outcomes included life-years and quality-adjusted life-years (QALYs) gained, costs and incremental cost-effectiveness ratios (ICERs) over a lifetime., Results: Apixaban was projected to increase life expectancy and QALYs compared with aspirin, with an associated increase in drug acquisition costs. The estimated ICER was 7,334 per QALY gained with apixaban compared with aspirin., Conclusions: Apixaban is a cost-effective alternative to aspirin for patients with AF in Belgium who decline or cannot tolerate VKA treatment.

Objective: The economic implications from the US Medicare perspective of adopting alternative treatment strategies for acute bacterial skin and skin structure infections (ABSSSIs) are substantial. The objective of this study is to describe a modeling framework that explores the impact of decisions related to both the location of care and switching to different antibiotics at discharge., Methods: A discrete event simulation (DES) was developed to model the treatment pathway of each patient through various locations (emergency department [ED], inpatient, and outpatient) and the treatments prescribed (empiric antibiotic, switching to a different antibiotic at discharge, or a second antibiotic). Costs are reported in 2012 USD., Results: The mean number of days on antibiotic in a cohort assigned to a full course of vancomycin was 11.2 days, with 64% of the treatment course being administered in the outpatient setting. Mean total costs per patient were $8671, with inpatient care accounting for 58% of the costs accrued. The majority of outpatient costs were associated with parenteral administration rather than drug acquisition or monitoring. Scenarios modifying the treatment pathway to increase the proportion of patients receiving the first dose in the ED, and then managing them in the outpatient setting or prescribing an oral antibiotic at discharge to avoid the cost associated with administering parenteral therapy, therefore have a major impact and lower the typical cost per patient by 11-20%. Since vancomycin is commonly used as empiric therapy in clinical practice, based on these analyses, a shift in treatment practice could result in substantial savings from the Medicare perspective., Conclusions: The choice of antibiotic and location of care influence the costs and resource use associated with the management of ABSSSIs. The DES framework presented here can provide insight into the potential economic implications of decisions that modify the treatment pathway.

Objectives: To conduct an economic evaluation of the currently prescribed treatments for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) including warfarin, aspirin, and novel oral anticoagulants (NOACs) from a French payer perspective., Methods: A previously published Markov model was adapted in accordance to the new French guidelines of the Commission for Economic Evaluation and Public Health (CEESP), to adopt the recommended efficiency frontier approach. A cohort of patients with NVAF eligible for stroke preventive treatment was simulated over lifetime. Clinical events modeled included strokes, systemic embolism, intracranial hemorrhage, other major bleeds, clinically relevant non-major bleeds, and myocardial infarction. Efficacy and bleeding data for warfarin, apixaban, and aspirin were obtained from ARISTOTLE and AVERROES trials, whilst efficacy data for other NOACs were from published indirect comparisons. Acute medical costs were obtained from a dedicated analysis of the French national hospitalization database (PMSI). Long-term medical costs and utility data were derived from the literature. Univariate and probabilistic sensitivity analyses were performed to assess the robustness of the model projections., Results: Warfarin and apixaban were the two optimal treatment choices, as the other five treatment strategies including aspirin, dabigatran 110 mg, dabigatran in sequential dosages, dabigatran 150 mg, and rivaroxaban were strictly dominated on the efficiency frontier. Further, apixaban was a cost-effective alternative vs warfarin with an incremental cost of €2314 and an incremental quality-adjusted life year (QALY) of 0.189, corresponding to an incremental cost-effectiveness ratio (ICER) of €12,227/QALY., Conclusions: Apixaban may be the most economically efficient alternative to warfarin in NVAF patients eligible for stroke prevention in France. All other strategies were dominated, yielding apixaban as a less costly yet more effective treatment alternative. As formally requested by the CEESP, these results need to be verified in a French clinical setting using stroke reduction and bleeding safety observed in real-life patient cohorts using these anticoagulants.

Introduction: Atrial fibrillation (AF), one of the major risk factors for stroke, imposing a substantial burden to the Swedish health care system. Apixaban has demonstrated superiority to warfarin and aspirin in stroke prevention amongst patients with AF in two large randomised clinical trials. The aim of this study was to assess the economic implications of apixaban against warfarin and aspirin in these patients from a Swedish societal perspective., Materials and Methods: A Markov cohort model was constructed to characterise the consequences of anticoagulant treatment with regards to thromboembolic and bleeding events, as well as the associated health care costs, life-years and quality-adjusted life years (QALYs) for patients with AF treated with apixaban, warfarin or aspirin. Incremental cost-effectiveness ratios (ICERs) per QALY gained of apixaban relative to warfarin (among patients suitable for warfarin treatment) and aspirin (among patients unsuitable for warfarin treatment) were calculated. Costs (in 2011 SEKs) and QALYs were discounted at 3% per annum., Results: The model estimated the ICER of apixaban versus warfarin amongst patients who are suitable for warfarin therapy to be SEK 33,458/QALY gained and that of apixaban versus aspirin amongst those unsuitable for warfarin therapy to be SEK 41,453/QALY gained. Probabilistic sensitivity analyses indicate that apixaban is an optimal treatment option compared with warfarin and aspirin, when the willingness-to-pay is above SEK 35,000 and SEK 45,000 per QALY, respectively., Conclusions: Apixaban was found to be a cost-effective alternative to warfarin and aspirin for stroke prevention in patients with AF in Sweden., (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Aims: Warfarin, a vitamin K antagonist (VKA), has been the standard of care for stroke prevention in patients with atrial fibrillation (AF). Aspirin is recommended for low-risk patients and those unsuitable for warfarin. Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies, respectively, and causes less bleeding than warfarin. We evaluated the potential cost-effectiveness of apixaban against warfarin and aspirin from the perspective of the UK payer perspective., Results and Methods: A lifetime Markov model was developed to evaluate the pharmacoeconomic impact of apixaban compared with warfarin and aspirin in VKA suitable and VKA unsuitable patients, respectively. Clinical events considered in the model include ischaemic stroke, haemorrhagic stroke, intracranial haemorrhage, other major bleed, clinically relevant non-major bleed, myocardial infarction, cardiovascular hospitalization and treatment discontinuations; data from the ARISTOTLE and AVERROES trials and published mortality rates and event-related utility rates were used in the model. Apixaban was projected to increase life expectancy and quality-adjusted life years (QALYs) compared with warfarin and aspirin. These gains were expected to be achieved at a drug acquisition-related cost increase over lifetime. The estimated incremental cost-effectiveness ratio was £11 909 and £7196 per QALY gained with apixaban compared with warfarin and aspirin, respectively. Sensitivity analyses indicated that results were robust to a wide range of inputs., Conclusions: Based on randomized trial data, apixaban is a cost-effective alternative to warfarin and aspirin, in VKA suitable and VKA unsuitable patients with AF, respectively., (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The objective of this analysis was to evaluate the cost-effectiveness of using bendamustine versus alemtuzumab or bendamustine versus chlorambucil as a first-line therapy in patients with Binet stage B or C chronic lymphocytic leukemia (CLL) in the US., Methods: A discrete event simulation of the disease course of CLL was developed to evaluate the economic implications of single-agent treatment with bendamustine, alemtuzumab, or chlorambucil, which are indicated for a treatment-naïve patient population with Binet stage B or C CLL. Data from clinical trials were used to create a simulated patient population, risk equations for progression-free survival and survival post disease progression, response rates, and rates of adverse events. Costs from a US health care payer perspective in 2012 US dollars, survival (life years), and quality-adjusted life years (QALYs) were estimated over a patient's lifetime; all were discounted at 3% per year., Results: Compared with alemtuzumab, bendamustine was considered to be a dominant treatment providing greater benefit (6.10 versus 5.37 life years and 4.02 versus 3.45 QALYs) at lower cost ($78,776 versus $121,441). Compared with chlorambucil, bendamustine was associated with higher costs ($78,776 versus $42,337) but with improved health outcomes (6.10 versus 5.21 life years and 4.02 versus 3.30 QALYs), resulting in incremental cost-effectiveness ratios of $40,971 per life year gained and $50,619 per QALY gained., Conclusion: Bendamustine is expected to provide cost savings and greater health benefit than alemtuzumab in treatment-naïve patients with CLL. Furthermore, it can be considered as a cost-effective treatment providing health benefits at an acceptable cost versus chlorambucil in the US.