Trial-based cost-effectiveness analysis of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) versus DSAEK.
ABSTRACT: PURPOSE:To evaluate the cost-effectiveness of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) versus standard DSAEK. METHODS:A cost-effectiveness analysis using data from a multicentre randomized clinical trial was performed. The time horizon was 12 months postoperatively. Sixty-four eyes of 64 patients with Fuchs' endothelial dystrophy were included and randomized to UT-DSAEK (n = 33) or DSAEK (n = 31). Relevant resources from healthcare and societal perspectives were included in the cost analysis. Quality-adjusted life years (QALYs) were determined using the Health Utilities Index Mark 3 questionnaire. The main outcome was the incremental cost-effectiveness ratio (ICER; incremental societal costs per QALY). RESULTS:Societal costs were €9431 (US$11 586) for UT-DSAEK and €9110 (US$11 192) for DSAEK. Quality-adjusted life years (QALYs) were 0.74 in both groups. The ICER indicated inferiority of UT-DSAEK. The cost-effectiveness probability ranged from 37% to 42%, assuming the maximum acceptable ICER ranged from €2500-€80 000 (US$3071-US$98 280) per QALY. Additional analyses were performed omitting one UT-DSAEK patient who required a regraft [ICER €9057 (US$11 127) per QALY, cost-effectiveness probability: 44-62%] and correcting QALYs for an imbalance in baseline utilities [ICER €23 827 (US$29 271) per QALY, cost-effectiveness probability: 36-59%]. Furthermore, the ICER was €2101 (US$2581) per patient with clinical improvement in best spectacle-corrected visual acuity (?0.2 logMAR) and €3274 (US$4022) per patient with clinical improvement in National Eye Institute Visual Functioning Questionnaire-25 composite score (?10 points). CONCLUSION:The base case analysis favoured DSAEK, since costs of UT-DSAEK were higher while QALYs were comparable. However, additional analyses revealed no preference for UT-DSAEK or DSAEK. Further cost-effectiveness studies are required to reduce uncertainty.
Project description:PURPOSE:To determine the cost-effectiveness of Descemet's membrane endothelial keratoplasty (DMEK) compared with Descemet's stripping automated endothelial keratoplasty (DSAEK) in the United States. DESIGN:Cost-effectiveness analysis in a surgical center in the United States. PARTICIPANTS:Binocular adult patient undergoing endothelial keratoplasty. METHODS:A base case of a 70-year-old man undergoing his first endothelial keratoplasty for bilateral Fuchs endothelial dystrophy. The cost-effectiveness of DMEK was compared with DSAEK over a 15-year time horizon. The incidences and costs of complications were derived from PubMed English literature searches, Medicare reimbursements, and average wholesale prices. All costs were discounted 3% per annum and adjusted for inflation to 2018 U.S. dollars. Uncertainty was evaluated using deterministic and probabilistic sensitivity analyses. MAIN OUTCOME MEASURES:Incremental cost-effectiveness ratios and incremental cost-utility ratios, measured in cost per quality-adjusted life-years (QALYs). RESULTS:Performing a DMEK instead of a DSAEK generated an extra 0.4 QALYs over a 15-year period. From a societal and third-party payer perspective, DMEK was cost-saving when compared with DSAEK in improving visual acuity in the base case. Probabilistic sensitivity analyses with variations in the costs and rebubble rates revealed that DMEK was cost-saving compared with DSAEK in 38% of iterations and was within a societal willingness-to-pay threshold of $50?000 in 98% of models. CONCLUSIONS:From the societal and third-party payer perspectives in the United States, DMEK generated greater utilities and was less costly than DSAEK. Therefore, DMEK was the dominant procedure and was cost-saving with respect to DSAEK. The economic model was robust based on sensitivity analyses.
Project description:<h4>Background</h4>The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion.<h4>Objective</h4>Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years.<h4>Methods</h4>Data were derived from a randomized trial of 330 patients. Data from the 12-Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated quality-adjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate.<h4>Results</h4>The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34?377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was -$165?103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50?000 per QALY in all scenarios (-$225?816 per QALY to $22?071 per QALY).<h4>Conclusion</h4>This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality.<h4>Abbreviations</h4>ACDF, anterior cervical discectomy and fusionAWP, average wholesale priceCE, cost-effectivenessCEA, cost-effectiveness analysisCPT, Current Procedural TerminologycTDR, cervical total disc replacementCUA, cost-utility analysisDDD, degenerative disc diseaseDRG, diagnosis-related groupFDA, US Food and Drug AdministrationICER, incremental cost-effectiveness ratioIDE, Investigational Device ExemptionNDI, neck disability indexQALY, quality-adjusted life yearsRCT, randomized controlled trialRTW, return-to-workSF-12, 12-Item Short Form Health SurveyVAS, visual analog scaleWTP, willingness-to-pay.
Project description:The purposes of this study are to investigate the cost-effectiveness of an implantable carotid body stimulator (Rheos; CVRx, Inc, Minneapolis, MN) for treating resistant hypertension and determine the range of starting systolic blood pressure (SBP) values where the device remains cost-effective. A Markov model compared a 20-mm Hg drop in SBP from an initial level of 180 mm Hg with Rheos to failed medical management in a hypothetical 50-year-old cohort. Direct costs (2007$), utilities, and event rates for future myocardial infarction, stroke, heart failure, and end-stage renal disease were modeled. Sensitivity analyses tested the assumptions in the model. The incremental cost-effectiveness ratio (ICER) for Rheos was $64,400 per quality-adjusted life-years (QALYs) using Framingham-derived event probabilities. The ICER was <$100,000 per QALYs for SBPs > or =142 mm Hg. A probability of device removal of <1% per year or SBP reductions of > or =24 mm Hg were variables that decreased the ICER below $50,000 per QALY. For cohort characteristics similar to Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure-Lowering Arm (ASCOT-BPLA) participants, the ICER became $26,700 per QALY. Two-way sensitivity analyses demonstrated that lowering SBP 12 mm Hg from 220 mm Hg or 21 mm Hg from 140 mm Hg were required. Rheos may be cost-effective, with an ICER between $50,000 and $100,000 per QALYs. Cohort characteristics and efficacy are key to the cost-effectiveness of new therapies for resistant hypertension .
Project description:<h4>Background</h4>The use of prasugrel or ticagrelor as part of dual antiplatelet therapy with acetylsalicylic acid after acute coronary syndrome (ACS) improves clinical outcomes relative to clopidogrel. The relative cost-effectiveness of these agents are unknown. We conducted an economic analysis evaluating 12 months of treatment with clopidogrel, prasugrel or ticagrelor after ACS.<h4>Methods</h4>We developed a fully probabilistic Markov cohort decision-analytic model using a lifetime horizon, from the perspective of the Ontario Ministry of Health and Long-Term Care. The model incorporated risks of death, recurrent ACS, heart failure, major bleeding and other adverse effects of treatment. Data on probabilities and utilities were obtained from the published literature where available. The primary outcome was quality-adjusted life-years (QALYs).<h4>Results</h4>Treatment with clopidogrel was associated with the lowest effectiveness (7.41 QALYs, 95% confidence interval [CI] 1.05-14.79) and the lowest cost ($39?601, 95% CI $8434-$111?186). Ticagrelor treatment had an effectiveness of 7.50 QALYs (95% CI 1.13-14.84) at a cost of $40?649 (95% CI $9327-$111?881). The incremental cost-effectiveness ratio (ICER) for ticagrelor relative to clopidogrel was $12?205 per QALY gained. Prasugrel had an ICER of $57?630 per QALY gained relative to clopidogrel. Ticagrelor was the preferred option in 90% of simulations at a willingness-to-pay threshold of $50?000 per QALY gained.<h4>Interpretation</h4>Ticagrelor was the most cost-effective agent when used as part of dual antiplatelet therapy after ACS. This conclusion was robust to wide variations in model parameters.
Project description:<h4>Objective</h4>The Intensive Diet and Exercise for Arthritis (IDEA) trial showed that an intensive diet and exercise (D+E) program led to a mean 10.6-kg weight reduction and 51% pain reduction in patients with knee osteoarthritis (OA). The aim of the current study was to investigate the cost-effectiveness of adding this D+E program to treatment in overweight and obese (body mass index >27 kg/m<sup>2</sup> ) patients with knee OA.<h4>Methods</h4>We used the Osteoarthritis Policy Model to estimate quality-adjusted life-years (QALYs) and lifetime costs for overweight and obese patients with knee OA, with and without the D+E program. We evaluated cost-effectiveness with the incremental cost-effectiveness ratio (ICER), a ratio of the differences in lifetime cost and QALYs between treatment strategies. We considered 3 cost-effectiveness thresholds: $50,000/QALY, $100,000/QALY, and $200,000/QALY. Analyses were conducted from health care sector and societal perspectives and used a lifetime horizon. Costs and QALYs were discounted at 3% per year. D+E characteristics were derived from the IDEA trial. Deterministic and probabilistic sensitivity analyses (PSAs) were used to evaluate parameter uncertainty and the effect of extending the duration of the D+E program.<h4>Results</h4>In the base case, D+E led to 0.054 QALYs gained per person and cost $1,845 from the health care sector perspective and $1,624 from the societal perspective. This resulted in ICERs of $34,100/QALY and $30,000/QALY. In the health care sector perspective PSA, D+E had 58% and 100% likelihoods of being cost-effective with thresholds of $50,000/QALY and $100,000/QALY, respectively.<h4>Conclusion</h4>Adding D+E to usual care for overweight and obese patients with knee OA is cost-effective and should be implemented in clinical practice.
Project description:OBJECTIVE:We evaluated the cost-effectiveness of Telephonic Health Coaching and Financial Incentives (THC + FI) to promote physical activity in total knee replacement recipients. DESIGN:We used the Osteoarthritis Policy Model, a computer simulation of knee osteoarthritis, to evaluate the cost-effectiveness of THC + FI compared to usual care. We derived transition probabilities, utilities, and costs from trial data. We conducted lifetime analyses from the healthcare perspective and discounted all cost-effectiveness outcomes by 3% annually. The primary outcome was the Incremental Cost-Effectiveness Ratio (ICER), defined as the ratio of the differences in costs and Quality-Adjusted Life Years (QALYs) between strategies. We considered ICERs <$100,000/QALY to be cost-effective. We conducted one-way sensitivity analyses that varied parameters across their 95% confidence intervals (CI) and limited the efficacy of THC + FI to 1 year or to 9 months. We also conducted a probabilistic sensitivity analysis (PSA), simultaneously varying cost, utilities, and transition probabilities. RESULTS:THC + FI had an ICER of $57,200/QALY in the base case and an ICER below $100,000/QALY in most deterministic sensitivity analyses. THC + FI cost-effectiveness depended on assumptions about long-term efficacy; when efficacy was limited to 1 year or to 9 months, the ICER was $93,300/QALY or $121,800/QALY, respectively. In the PSA, THC + FI had an ICER below $100,000/QALY in 70% of iterations. CONCLUSIONS:Based on currently available information, THC + FI might be a cost-effective alternative to usual care. However, the uncertainty surrounding this choice is considerable, and further research to reduce this uncertainty may be economically justified.
Project description:<b>Objectives:</b> Rapid socioeconomic and nutrition transitions in Chinese populations have contributed to the growth in childhood obesity. This study presents a cost-effectiveness analysis of a school- and family-based childhood obesity prevention programme in China. <b>Methods:</b> A trial-based economic evaluation assessed cost-effectiveness at 12 months. Forty schools with 1,641 children were randomised to either receive the multi-component (diet and physical activity) intervention or to continue with usual activities. Both public sector and societal perspectives were adopted. Costs and benefits in the form of quality-adjusted life years (QALYs) were compared and uncertainty was assessed using established UK and US thresholds. <b>Results:</b> The intervention cost was 35.53 Yuan (£7.04/US$10.01) per child from a public sector perspective and 536.95 Yuan (£106/US$151) from a societal perspective. The incremental cost-effectiveness ratio (ICER) was 272.7 Yuan (£54/US$77)/BMI z-score change. The ICER was 8,888 Yuan (£1,760/US$2,502) and 73,831 Yuan (£14,620/US$20,796) per QALY from a public sector and societal perspective, respectively and was cost-effective using UK (£20,000) and US (US$50,000) per QALY thresholds. <b>Conclusion:</b> A multi-component school-based prevention programme is a cost-effective means of preventing childhood obesity in China.
Project description:<h4>Objective</h4>The purpose of this analysis was to evaluate the cost effectiveness of the combination of pertuzumab, trastuzumab, and docetaxel (PTD) for the treatment of patients with human epidermal growth factor receptor-2 (HER2)-positive breast cancer in Japan.<h4>Methods</h4>A partitioned survival analysis model was developed to predict costs and quality-adjusted life-years (QALYs) in a PTD arm and a trastuzumab plus docetaxel (TD) arm. Direct medical costs were considered from the perspective of the Japanese healthcare system. The time horizon of the model was set to 20 years. Data on overall survival and progression-free survival were derived from the CLEOPATRA trial. Cost parameters were estimated using a real-world claims database. Utilities were derived from published sources outside Japan. The incremental cost-effectiveness ratio (ICER) of PTD therapy compared with TD therapy was estimated. Sensitivity analysis was conducted to assess the uncertainty in parameter settings.<h4>Results</h4>Compared with TD therapy, PTD therapy incurred an additional cost of $US174,479 and conferred an additional 0.949 QALYs. This resulted in an ICER of $US183,901 per QALY gained. Utility weights for progression-free survival and progressed disease had a relatively large impact on the base-case result, but the ICERs remained higher than $US75,000 per QALY over the full range of model parameters. Based on a probabilistic sensitivity analysis, the probability that PTD is cost effective was estimated to be 3.3%.<h4>Conclusions</h4>Applying a willingness-to-pay threshold of $US75,000 per QALY, PTD therapy as first-line therapy would not be cost effective. Further research is required on utilities and clinical benefits for Japanese patients with breast cancer.
Project description:<h4>Objective</h4>Continuous glucose monitoring (CGM) has been found to improve glucose control in type 1 diabetic patients. We estimated the cost-effectiveness of CGM versus standard glucose monitoring in type 1 diabetes. RESEARCH DESIGN AND METHODS This societal cost-effectiveness analysis (CEA) was conducted in trial populations in which CGM has produced a significant glycemic benefit (A1C >or=7.0% in a cohort of adults aged >or=25 years and A1C <7.0% in a cohort of all ages). Trial data were integrated into a simulation model of type 1 diabetes complications. The main outcome was the cost per quality-adjusted life-year (QALY) gained.<h4>Results</h4>During the trials, CGM patients experienced an immediate quality-of-life benefit (A1C >or=7.0% cohort: 0.70 quality-adjusted life-weeks [QALWs], P = 0.49; A1C <7.0% cohort: 1.39 QALWs, P = 0.04) and improved glucose control. In the long-term, CEA for the A1C >or=7.0% cohort, CGM was projected to reduce the lifetime probability of microvascular complications; the average gain in QALYs was 0.60. The incremental cost-effectiveness ratio (ICER) was $98,679/QALY (95% CI -60,000 [fourth quadrant] to -87,000 [second quadrant]). For the A1C <7.0% cohort, the average gain in QALYs was 1.11. The ICER was $78,943/QALY (15,000 [first quadrant] to -291,000 [second quadrant]). If the benefit of CGM had been limited to the long-term effects of improved glucose control, the ICER would exceed $700,000/QALY. If test strip use had been two per day with CGM long term the ICER for CGM would improve significantly.<h4>Conclusions</h4>Long-term projections indicate that CGM is cost-effective among type 1 diabetic patients at the $100,000/QALY threshold, although considerable uncertainty surrounds these estimates.
Project description:BACKGROUND:Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. METHODS:We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. RESULTS:For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. CONCLUSIONS:All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.