scholarly journals Cost-Effectiveness of the FDA Menu Labeling to Reduce Obesity-Associated Cancer Burden in the United States

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1712-1712
Author(s):  
Mengxi Du ◽  
Christina Griecci ◽  
Frederick Cudhea ◽  
Heesun Eom ◽  
John Wong ◽  
...  

Abstract Objectives The FDA menu labeling policy requires chain restaurants with ≥20 outlets to list total calories on menus or menu boards. While obesity is a known risk factor for 13 cancers, the potential impact of this policy on cancer burdens and healthcare costs in the US is unknown. Methods Using a probabilistic cohort state-transition model, we estimated the health impacts, costs, and cost-effectiveness of the FDA menu labeling policy on reducing calorie intake, subsequent weight change, and obesity-related cancer cases among US adults over a lifetime. Baseline demographics and calorie intake from restaurants were estimated using NHANES 2013–2016. Based on published meta-analyses, we assumed that labeling would reduce calorie intake per meal by 7.3%, evaluated with and without an additional 5% reduction through industry reformulations; and assumed only half of these calorie reductions would be sustained by individuals throughout their day (i.e., to account for potential calorie compensation outside restaurants). Changes in BMI were derived from published energy models (0.45 kg lower long-term weight per 55 kcal/d calorie reduction). National cancer rates and healthcare costs were obtained from published sources. Uncertainties of inputs were incorporated in probabilistic sensitivity analyses using 1000 simulations. Results The FDA menu labeling policy was estimated to prevent 31,300 (95% UI: 27,600–35,500) new cancer cases and 18,700 (16,400–21,300) cancer deaths, gaining 134,000 (117,000–153,000) quality-adjusted life years (QALYs) among US adults over a lifetime. Top three cancers prevented were endometrial, post-menopausal breast, and kidney. Accounting for policy implementation and healthcare costs, the policy was net cost saving at $1.74B ($1.55–$1.95B) and $1.76B ($1.46–$2.09B) from healthcare and societal perspectives, respectively. A modest industry response (5% calorie reduction) would prevent a total of 51,800 new cancer cases (47,900–56,400) and 30,900 cancer deaths (28,600–34,000) and increase net savings to $2.87B ($2.68–$3.12B) and $3.19B ($2.86–$3.54B), respectively. Conclusions Our model suggests implementation of the FDA menu calorie labeling policy would substantially reduce incident cancers and deaths and be cost-saving, with even larger effects if accompanied by modest industry reformulation. Funding Sources NIH/NIMHD.

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038433
Author(s):  
Li Yang ◽  
Jingjing Wu

ObjectiveLimited economic evaluation data for rivaroxaban compared with standard of care (SoC) exists in China. The objective of this analysis was to evaluate the cost-effectiveness of rivaroxaban compared with current SoC (enoxaparin overlapped with warfarin) for the treatment of acute deep vein thrombosis (DVT) in China.MethodsA Markov model was adapted from a payer’s perspective to evaluate the costs and quality-adjusted life years (QALYs) of patients with DVT treated with rivaroxaban or enoxaparin/warfarin. Clinical data from the EINSTEIN-DVT trial were obtained to estimate the transition probabilities. Data on Chinese health resource use, unit costs and utility parameters were collected from previously published literature and used to estimate the total costs and QALYs. The time horizon was set at 5 years and a 3-month cycle length was used in the model. A 5% discount rate was applied to the projected costs. One-way sensitivity analyses and probabilistic sensitivity analyses were undertaken to assess the impact of uncertainty on results.ResultsRivaroxaban therapy resulted in an increase of 0.008 QALYs and was associated with lower total costs compared with enoxaparin/warfarin (US$4744.4 vs US$5572.4, respectively), demonstrating it to be a cost-saving treatment strategy. The results were mainly sensitive to length of hospitalisation due to DVT on enoxaparin/warfarin, cost per day of hospitalisation and the difference in length of stay of rivaroxaban-treated and enoxaparin/warfarin-treated patients.ConclusionRivaroxaban therapy resulted in a cost saving compared with enoxaparin/warfarin for the anticoagulation treatment of patients with hospitalised acute DVT in China.Trial registration numberNCT00440193; Post-results.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18356-e18356
Author(s):  
Shaji Kumar ◽  
Istvan Majer ◽  
Sumeet Panjabi ◽  
Jean Malacan ◽  
Rohan Medhekar ◽  
...  

e18356 Background: Carfilzomib plus dexamethasone (Kd) dosed once weekly at 70 mg/m2 (QW Kd70) was recently approved in the US for treating patients with relapsed and refractory multiple myeloma (RRMM). To assess the cost-effectiveness (CE) of QW Kd70 vs twice weekly Kd dosed at 27 mg/m2 (BIW Kd27), data from the phase 3 ARROW trial, which directly compared these regimens in patients with 2-3 prior lines of therapy were used. Methods: A partitioned survival model was developed for the CE analysis. Time to treatment discontinuation, progression-free survival, and overall survival (OS) were estimated from the ARROW trial. Long-term OS was extrapolated using Surveillance Epidemiology and End Results registry data after matching characteristics of patients in the registry and ARROW trial. Direct costs were estimated from a US health care payer perspective. Utilities collected in the ARROW trial using the five-level version of the EuroQol questionnaire (EQ-5D-5L) were applied to estimate the quality-adjusted life years (QALYs). Uncertainty was explored using sensitivity analyses. Two subgroups of patients refractory to lenalidomide or bortezomib were assessed. Main outcomes were mean life-years (LYs), QALYs, lifetime costs, and incremental cost-effectiveness ratios (ICERs). Results: For QW Kd70 and BIW Kd27, the model predicted mean LYs of 4.17 and 3.07 years, QALYs of 2.98 and 2.03 years, and mean total lifetime costs of $444,563 and $373,364, respectively. The incremental LYs gain, QALY gain, and incremental costs of QW Kd70 vs BIW Kd27 were estimated to be 1.10 years, 0.95 year, and $71,199, respectively, resulting in an ICER of $64,595 per LY gained and $75,204 per QALY gained. For patients refractory to lenalidomide and bortezomib, similar results were found with ICERs of $79,988 and $76,793, respectively. Conclusions: In line with ARROW trial results, this CE analysis showed that QW Kd70 is expected to provide considerable additional benefit in terms of LYs and QALYs gained compared with BIW Kd27. In the RRMM setting, QW Kd70 is cost-effective with ICERs below accepted willingness to pay thresholds in US and represents an efficient utilization of the health care budget.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1720-1720
Author(s):  
Matti Marklund ◽  
Miaobing Zheng ◽  
J Lennert Veerman ◽  
Jason H Y Wu

Abstract Objectives To assess the potential cost-effectiveness, health gains, and effects on health equality of eliminating industrial trans-fatty acids (TFAs) from the Australian food supply. Methods Markov cohort models were used to estimate the cost-effectiveness and policy impact on (ischemic heart disease) IHD burden and health equity of a national ban of industrial TFAs in Australia. Intake of TFA was assessed using the 2011–2012 Australian National Nutrition and Physical Activity Survey. The IHD burden attributable to TFA was calculated by comparing the current level of TFA intake to a counterfactual setting (0.5% energy per day from TFA; corresponding to TFA intake only from non-industrial sources, e.g., dairy foods). Policy costs, avoided IHD events and deaths, health-adjusted life years (HALYs) gained, and IHD-related healthcare costs saved were estimated over 10 years and lifetime of the adult Australian population. Cost-effectiveness was assessed by calculation of incremental cost-effectiveness ratios (ICER) using net policy cost and HALYs gained. Health benefits and health care cost changes were also assessed in subgroups based on socioeconomic status and remoteness. Results Elimination of industrial TFA was estimated to prevent 2,294 (95% uncertainty interval [UI]: 1,765; 2,851) IHD deaths and 9,931 (95% UI: 8,429; 11,532) IHD events over the first 10 years. The greatest health benefits were accrued to the most socioeconomically disadvantaged quintiles and among Australians living outside of major cities. The intervention was estimated to be cost-saving or cost-effective (i.e., ICER < 169,361 AUD/HALY) regardless of the time horizon, with ICERs of 1,073 (95% UI: dominant; 3,503) and 1,956 (95% UI: 1,010; 2,750) AUD/HALY over 10 years and life time, respectively. The TFA ban was estimated to be cost-saving or highly cost-effective in sensitivity analyses altering assumptions of post-intervention TFA intake, abundance of TFA-containing products, or discount rate. Conclusions A ban of industrial TFAs could avert substantial numbers of IHD events and deaths in Australia and will likely be a highly cost-effective strategy to reduce social-economic and urban-rural inequalities in health. Funding Sources National Health and Medical Research Council; and UNSW.


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Mengxi Du ◽  
Christina Griecci ◽  
Frederick Cudhea ◽  
David Kim ◽  
Heesun Eom ◽  
...  

Abstract Objectives Meta-analyses have identified obesity as an independent risk factor for 13 cancers and added sugars as a contributor to obesity. In 2016, the new Nutrition Facts label on US packaged foods mandated the inclusion of added sugar content. We assessed the health outcomes, costs, and cost-effectiveness of this policy on obesity-related cancer burdens among 250 million US adults over their lifetime. Methods We populated the Diet Cancer Outcome Model (DiCOM), a probabilistic cohort-state transitional model, to evaluate two effects of the policy on (a) consumer behavior alone; and (b) consumer behavior plus industry reformulation. Policy effect on consumer behavior was derived from a meta-analysis of calorie labeling; and on industry reformulation, from the FDA's regulatory impact analysis and the UK sugar reformulation strategy. Effects of added sugar on obesity and obesity on cancer incidence were derived from meta-analyses and published literature. Cost-effectiveness was evaluated as net costs with 3% annual discounting, under both government affordability and societal perspectives. Results We estimated that, based on consumer responses alone, the added sugar labeling would prevent 35,500 new cancer cases (95% uncertainty interval [UI]: 12,300 to 65,800) and 16,700 cancer deaths (95% UI: 5720 to 31,400) and gain 113,000 quality-adjusted life years (QALYs) (95% UI: 38,800 to 210,000) over a lifetime. Adding potential additional effects on industry reformulation, corresponding values were 79,700 new cancer cases (95% UI: 28,100 to 140,000), 37,500 cancer deaths (95% UI: 13,200 to 66,000), and 253,000 QALYs (95% UI: 89,600 to 444,000). Policy would result in estimated net cost savings of $8600 M (95% UI: $6900 M to $11,000 M) from governmental affordability and $7500 M ($5400 M to $9900 M) from societal perspectives based on consumer responses alone. With industry reformulation, net savings were $19,000 (95% UI: $15,000 M to $23,000 M) and $16,000 M (95% UI: $12,000 M to $20,000 M), respectively. Conclusions Our modeling estimates that implementation of the FDA added sugar labeling will lead to significant numbers of averted cancer cases and deaths, with net cost-savings; and that potential industry responses may contribute to similar or larger benefits than consumer responses alone. Funding Sources NIH/NIMHD. Supporting Tables, Images and/or Graphs


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ronuk Modi ◽  
Peter Zimetbaum ◽  
Nicolas Isaza ◽  
Paola Calvachi ◽  
Inbar Raber ◽  
...  

Introduction: Infections of cardiac implantable electronic devices result in substantial morbidity and healthcare costs. Using an antibiotic-eluting envelope (AEE) during implantation may reduce the incidence of device-related infection. We examined the cost-effectiveness of an AEE in patients receiving CRT-D devices. Methods: This analysis was conducted independent of the trial sponsor. We developed a state-transition Markov model to compare the use of an AEE with usual care during CRT-D initial implantation or reimplantation. Effectiveness of the AEE (unit cost $1000) was estimated from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial. Other inputs were derived from prior trials, registries, vital statistics, and nationally representative datasets. Long-term survival was projected using a non-parametric approach. The model reported incidence of infections, mortality, quality-adjusted life years (QALYs), and direct healthcare costs. Future costs and QALYs were discounted by 3% annually. The primary outcome was the incremental cost-effectiveness ratio (ICER) of AEE use from the US healthcare sector perspective over a lifetime analytic horizon. We assumed a cost-effectiveness threshold of $100,000 per QALY gained. Results: Use of an AEE at initial CRT-D implantation added 0.008 QALYs per patient at an incremental cost of $918 (ICER $118,000/QALY). Due to higher infection rates, the use of AEE in reimplantation procedures was more economically attractive (ICER $55,900/QALY). One-way sensitivity analyses showed an inverse relationship between ICER and rate of infection. The ICER was less than $100,000/QALY with infection rate greater than 2.42% in the first year after new CRT-D (Figure 1). Conclusions: At current prices, use of AEE is cost-effective for CRT-D reimplantation procedures but not for initial CRT-D implants. Cost-effectiveness of AEEs may be improved by restricting use to patients at increased risk of infection.


2019 ◽  
Vol 111 (1) ◽  
pp. 141-148 ◽  
Author(s):  
Vikram K Raghu ◽  
David G Binion ◽  
Kenneth J Smith

ABSTRACT Background Adults with short bowel syndrome have a high mortality and significant morbidity due to unsuccessful attempts at rehabilitation that necessitate chronic use of parenteral nutrition (PN). Teduglutide is a novel therapy that promotes intestinal adaptation to improve rehabilitation but with a price >$400,000/y. Objective The current study evaluated the cost-effectiveness of using teduglutide in US adult patients with short bowel syndrome. Methods A Markov model evaluated the costs (in US dollars) and effectiveness (in quality-adjusted life years, or QALYs) of treatment compared with no teduglutide use, with a presumed starting age of 40 y. Parameters were obtained from published data or estimation. The primary effect modeled was the increased likelihood of reduced PN days per week when using teduglutide, leading to greater quality of life and lower PN costs. Sensitivity analyses were performed on all model parameters. Results In the base scenario, teduglutide cost $949,910/QALY gained. In 1-way sensitivity analyses, only reducing teduglutide cost decreased the cost/QALY gained to below the typical threshold of $100,000/QALY gained. Specifically, teduglutide cost would need to be reduced by >65% for it to reach the threshold value. Probabilistic sensitivity analysis favored no teduglutide use in 80% of iterations at a $100,000/QALY threshold. However, teduglutide therapy was cost-saving in 13% of model iterations. Conclusions Teduglutide does not meet a traditional cost-effectiveness threshold as treatment for PN reduction in adult patients with short bowel syndrome compared with standard intestinal rehabilitation. Subpopulations that demonstrate maximum benefit could be cost-saving, and complete nonuse could lead to financial loss. Teduglutide becomes economically reasonable only if its cost is substantially reduced.


10.36469/9895 ◽  
2015 ◽  
Vol 2 (2) ◽  
pp. 131-146
Author(s):  
William V. Padula ◽  
Miguel Cordero-Coma ◽  
Taygan Yilmaz ◽  
William V. Padula ◽  
Michéal J. Gallagher ◽  
...  

Background: Approximately 3.75% of cases of blindness in the United States are caused by uveitis. Incurred clinical costs and lost productivity related to vision loss in these cases totals $3.58 billion annually. Objective: To evaluate whether infliximab, a modern off-label biologic, is cost-effective for treating posterior uveitis and panuveitis compared to current standards of care, methotrexate and prednisone. Methods: A cost-effectiveness analysis using a Markov model to simulate a patient cohort with posterior uveitis or panuveitis. The model followed patients’ therapy from the onset of posterior uveitis or panuveitis using the U.S. societal perspective. The lifetime model simulated health states that could lead to successful reversal of uveitis with standard or intensified treatment with prednisone, methotrexate, or infliximab. Probabilities, health utilities, and costs were included in the model based on findings from the literature. We conducted univariate sensitivity analyses and a Bayesian multivariate probablistic sensitivity analysis to estimate uncertainty in results. Outcomes were measured in terms of costs ($US, 2010) and effects (qualityadjusted life years; QALYs) discounted at 3% per year were estimated for each simulated treatment. An incremental cost-effectiveness ratio (ICER) for pairwise results was interpretted assuming a predetermined willingness-to-pay threshold of $100,000/QALY. Results: Average lifetime costs and QALYs for each drug were ($306.95; 15.80 QALYs) for prednisone, methotrexate ($36,232.24; 16.21 QALYs), and inflixmab ($74,762.63; 15.04 QALYs). Methotrexate was on average compared to prednisone, with an ICER of $86,901.16/QALY. Prednisone and methotrexate dominated infliximab. Sensitivity analyses suggested that the model was most sensitive to the utility for successful recovery from uveitis. The probabilistic sensitivity analysis returned results similar to the base case. Conclusion: This cost-effectiveness analysis suggests that despite advances in the use of biologics for treating sight-threatening posterior uveitis and panuveitis, infliximab had lower effectiveness and higher costs compared to both prednisone and methotrexate. As compared to prednisone, methotrexate was associated with increased costs and QALYs and was found to be a good value. Clinical trials of infliximab in the uveitis population are needed to reduce the uncertain estimates of inflixmab treatment success and the drug’s cost-effectiveness.


2018 ◽  
Vol 7 (8) ◽  
pp. 785-795
Author(s):  
Wen Chen ◽  
Thomas Ward ◽  
Mai Ping Tan ◽  
Jing Yan ◽  
Peter Feng Wang ◽  
...  

Aim: To evaluate the cost–effectiveness of the novel all-oral direct-acting antiviral regimen daclatasvir + asunaprevir (DUAL), versus interferon-based regimens for the treatment of chronic hepatitis C virus genotype 1b infection. Methods: Inputs for a lifetime Markov model were sourced from clinical trials and published literature. Outputs include disease management costs, life expectancy, quality-adjusted life-years and cost–effectiveness. Sensitivity analyses assessed the drivers of cost–effectiveness and sustained virologic response thresholds at which DUAL is cost-saving. Results: DUAL was associated with discounted incremental quality-adjusted life-years of 1.29–3.85 and incremental life-years of 0.85–2.59 per patient, with discounted lifetime cost savings of USD$1415–8525. Associated sustained virologic response rates could fall to 45.1–84.8%, while remaining dominant. Conclusion: Treatment with DUAL provides significant clinical benefit, while accruing lower lifetime costs.


10.36469/9829 ◽  
2016 ◽  
Vol 4 (1) ◽  
pp. 90-102
Author(s):  
Louise Perrault ◽  
Dilip Makhija ◽  
Idal Beer ◽  
Suzanne Laplante ◽  
Sergio Iannazzo ◽  
...  

Background: Patients developing acute kidney injury (AKI) during critical illness or major surgery are at risk for renal sequelae such as costly and invasive acute renal replacement therapy (RRT) and chronic dialysis (CD). Rates of renal injury may be reduced with use of chloride-restrictive intravenous (IV) resuscitation fluids instead of chloride-liberal fluids. Objectives: To compare the cost-effectiveness of chloride-restrictive versus chloride-liberal crystalloid fluids used during fluid resuscitation or for the maintenance of hydration among patients hospitalized in the US for critical illnesses or major surgery. Methods: Clinical outcomes and costs for a simulated patient cohort (starting age 60 years) receiving either chloride-restrictive or chloride-liberal crystalloids were estimated using a decision tree for the first 90-day period after IV fluid initiation followed by a Markov model over the remainder of the cohort lifespan. Outcomes modeled in the decision tree were AKI development, recovery from AKI, progression to acute RRT, progression to CD, and death. Health states included in the Markov model were dialysis free without prior AKI, dialysis-free following AKI, CD, and death. Estimates of clinical parameters were taken from a recent meta-analysis, other published studies, and the US Renal Data System. Direct healthcare costs (in 2015 USD) were included for IV fluids, RRT, and CD. US-normalized health-state utilities were used to calculate quality-adjusted life years (QALYs). Results: In the cohort of 100 patients, AKI was predicted to develop in the first 90 days in 36 patients receiving chloride-liberal crystalloids versus 22 receiving chloride-restrictive crystalloids. Higher costs of chloride-restrictive crystalloids were offset by savings from avoided renal adverse events. Chloride-liberal crystalloids were dominant over chloride-restrictive crystalloids, gaining 93.5 life-years and 81.4 QALYs while saving $298 576 over the cohort lifespan. One-way sensitivity analyses indicated results were most sensitive to the relative risk for AKI development and relatively insensitive to fluid cost. In probabilistic sensitivity analyses with 1000 iterations, chloride-restrictive crystalloids were dominant in 94.7% of iterations, with incremental cost-effectiveness ratios below $50 000/QALY in 99.6%. Conclusions: This analysis predicts improved patient survival and fewer renal complications with chloriderestrictive IV fluids, yielding net savings versus chloride-liberal fluids. Results require confirmation in adequately powered head-to-head randomized trials.


Author(s):  
Siyi Shangguan ◽  
Dariush Mozaffarian ◽  
Stephen Sy ◽  
Yujin Lee ◽  
Junxiu Liu ◽  
...  

Background: High intake of added sugar is linked to weight gain and cardiometabolic risk. In 2018, the US National Salt and Sugar Reduction Initiative (NSSRI) proposed government supported voluntary national sugar reduction targets. This intervention's potential health and equity impacts, and cost-effectiveness are unclear. Methods: A validated microsimulation model, CVD-PREDICT, coded in C++, was used to estimate incremental changes in type 2 diabetes, cardiovascular disease (CVD), quality-adjusted life-years (QALYs), costs and cost-effectiveness of the NSSRI policy. The model was run at the individual-level, incorporating the annual probability of each person's transition between health status based on their risk factors. The model incorporated national demographic and dietary data from the National Health and Nutrition Examination Survey across 3 cycles (2011-2016), added sugar-related diseases from meta-analyses, and policy costs and health-related costs from established sources. A simulated nationally representative US population was created and followed until age 100 years or death, with 2019 as the year of intervention start. Findings were evaluated over 10 years and a lifetime from healthcare and societal perspectives. Uncertainty was evaluated in a one-way analysis by assuming 50% industry compliance, and probabilistic sensitivity analyses via a second-order Monte Carlo approach. Model outputs included averted diabetes cases, CVD events and CVD deaths, QALYs gained, and formal healthcare cost savings, stratified by age, race, income and education. Results: Achieving the NSSRI sugar reduction targets could prevent 2.48 million CVD events, 0.49 million CVD deaths, and 0.75 million diabetes cases; gain 6.67 million QALYs; and save $160.88 billion net costs from a societal perspective over a lifetime. The policy became cost-effective (<150K/QALYs) at 6 years, highly cost-effective (< 50K/QALYs) at 7 years, and cost-saving at 9 years. Results were robust from a healthcare perspective, with lower (50%) industry compliance, and in probabilistic sensitivity analyses. The policy could also reduce disparities, with greatest estimated health gains per million adults among Black and Hispanic, lower income, and less educated Americans. Conclusions: Implementing and achieving the NSSRI sugar reformation targets could generate substantial health gains, equity gains and cost-savings.


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