Dataset Information

FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis.

ABSTRACT: Policy Points The World Health Organization has recommended sodium reduction as a "best buy" to prevent cardiovascular disease (CVD). Despite this, Congress has temporarily blocked the US Food and Drug Administration (FDA) from implementing voluntary industry targets for sodium reduction in processed foods, the implementation of which could cost the industry around $16 billion over 10 years. We modeled the health and economic impact of meeting the two-year and ten-year FDA targets, from the perspective of people working in the food system itself, over 20 years, from 2017 to 2036. Benefits of implementing the FDA voluntary sodium targets extend to food companies and food system workers, and the value of CVD-related health gains and cost savings are together greater than the government and industry costs of reformulation. CONTEXT:The US Food and Drug Administration (FDA) set draft voluntary targets to reduce sodium levels in processed foods. We aimed to determine cost effectiveness of meeting these draft sodium targets, from the perspective of US food system workers. METHODS:We employed a microsimulation cost-effectiveness analysis using the US IMPACT Food Policy model with two scenarios: (1) short term, achieving two-year FDA reformulation targets only, and (2) long term, achieving 10-year FDA reformulation targets. We modeled four close-to-reality populations: food system "ever" workers; food system "current" workers in 2017; and subsets of processed food "ever" and "current" workers. Outcomes included cardiovascular disease cases prevented and postponed as well as incremental cost-effectiveness ratio per quality-adjusted life year (QALY) gained from 2017 to 2036. FINDINGS:Among food system ever workers, achieving long-term sodium reduction targets could produce 20-year health gains of approximately 180,000 QALYs (95% uncertainty interval [UI]: 150,000 to 209,000) and health cost savings of approximately $5.2 billion (95% UI: $3.5 billion to $8.3 billion), with an incremental cost-effectiveness ratio (ICER) of $62,000 (95% UI: $1,000 to $171,000) per QALY gained. For the subset of processed food industry workers, health gains would be approximately 32,000 QALYs (95% UI: 27,000 to 37,000); cost savings, $1.0 billion (95% UI: $0.7bn to $1.6bn); and ICER, $486,000 (95% UI: $148,000 to $1,094,000) per QALY gained. Because many health benefits may occur in individuals older than 65 or the uninsured, these health savings would be shared among individuals, industry, and government. CONCLUSIONS:The benefits of implementing the FDA voluntary sodium targets extend to food companies and food system workers, with the value of health gains and health care cost savings outweighing the costs of reformulation, although not for the processed food industry.

SUBMITTER: Collins B

PROVIDER: S-EPMC6739614 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis.

Collins Brendan B Kypridemos Chris C Pearson-Stuttard Jonathan J Huang Yue Y Bandosz Piotr P Wilde Parke P Kersh Rogan R Capewell Simon S Mozaffarian Dariush D Whitsel Laurie P LP Micha Renata R O'Flaherty Martin M

The Milbank quarterly 20190722 3

Policy Points The World Health Organization has recommended sodium reduction as a "best buy" to prevent cardiovascular disease (CVD). Despite this, Congress has temporarily blocked the US Food and Drug Administration (FDA) from implementing voluntary industry targets for sodium reduction in processed foods, the implementation of which could cost the industry around $16 billion over 10 years. We modeled the health and economic impact of meeting the two-year and ten-year FDA targets, from the pers ...[more]

PMID: 31332837

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Project description:BackgroundThe Supplemental Nutrition Assistance Program (SNAP) provides approximately US$70 billion annually to support food purchases by low-income households, supporting approximately 1 in 7 Americans. In the 2018 Farm Bill, potential SNAP revisions to improve diets and health could include financial incentives, disincentives, or restrictions for certain foods. However, the overall and comparative impacts on health outcomes and costs are not established. We aimed to estimate the health impact, program and healthcare costs, and cost-effectiveness of food incentives, disincentives, or restrictions in SNAP.Methods and findingsWe used a validated microsimulation model (CVD-PREDICT), populated with national data on adult SNAP participants from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects from SNAP pilots and food pricing meta-analyses, diet-disease effects from meta-analyses, and policy, food, and healthcare costs from published literature to estimate the overall and comparative impacts of 3 dietary policy interventions: (1) a 30% incentive for fruits and vegetables (F&V), (2) a 30% F&V incentive with a restriction of sugar-sweetened beverages (SSBs), and (3) a broader incentive/disincentive program for multiple foods that also preserves choice (SNAP-plus), combining 30% incentives for F&V, nuts, whole grains, fish, and plant-based oils and 30% disincentives for SSBs, junk food, and processed meats. Among approximately 14.5 million adults on SNAP at baseline with mean age 52 years, our simulation estimates that the F&V incentive over 5 years would prevent 38,782 cardiovascular disease (CVD) events, gain 18,928 quality-adjusted life years (QALYs), and save $1.21 billion in healthcare costs. Adding SSB restriction increased gains to 93,933 CVD events prevented, 45,864 QALYs gained, and $4.33 billion saved. For SNAP-plus, corresponding gains were 116,875 CVD events prevented, 56,056 QALYs gained, and $5.28 billion saved. Over a lifetime, the F&V incentive would prevent approximately 303,900 CVD events, gain 649,000 QALYs, and save $6.77 billion in healthcare costs. Adding SSB restriction increased gains to approximately 797,900 CVD events prevented, 2.11 million QALYs gained, and $39.16 billion in healthcare costs saved. For SNAP-plus, corresponding gains were approximately 940,000 CVD events prevented, 2.47 million QALYs gained, and $41.93 billion saved. From a societal perspective (including programmatic costs but excluding food subsidy costs as an intra-societal transfer), all 3 scenarios were cost-saving. From a government affordability perspective (i.e., incorporating food subsidy costs, including for children and young adults for whom no health gains were modeled), the F&V incentive was of low cost-effectiveness at 5 years (incremental cost-effectiveness ratio: $548,053/QALY) but achieved cost-effectiveness ($66,525/QALY) over a lifetime. Adding SSB restriction, the intervention was cost-effective at 10 years ($68,857/QALY) and very cost-effective at 20 years ($26,435/QALY) and over a lifetime ($5,216/QALY). The combined incentive/disincentive program produced the largest health gains and reduced both healthcare and food costs, with net cost-savings of $10.16 billion at 5 years and $63.33 billion over a lifetime. Results were consistent in probabilistic sensitivity analyses: for example, from a societal perspective, 1,000 of 1,000 iterations (100%) were cost-saving for all 3 interventions. Due to the nature of simulation studies, the findings cannot prove the health and cost impacts of national SNAP interventions.ConclusionsLeveraging healthier eating through SNAP could generate substantial health benefits and be cost-effective or cost-saving. A combined food incentive/disincentive program appears most effective and may be most attractive to policy-makers.

Project description:Background: Sodium consumption is a modifiable risk factor for higher blood pressure (BP) and cardiovascular disease (CVD). The US Food and Drug Administration (FDA) has proposed voluntary sodium reduction goals targeting processed and commercially prepared foods. We aimed to quantify the potential health and economic impact of this policy.Methods and findings: We used a microsimulation approach of a close-to-reality synthetic population (US IMPACT Food Policy Model) to estimate CVD deaths and cases prevented or postponed, quality-adjusted life years (QALYs), and cost-effectiveness from 2017 to 2036 of 3 scenarios: (1) optimal, 100% compliance with 10-year reformulation targets; (2) modest, 50% compliance with 10-year reformulation targets; and (3) pessimistic, 100% compliance with 2-year reformulation targets, but with no further progress. We used the National Health and Nutrition Examination Survey and high-quality meta-analyses to inform model inputs. Costs included government costs to administer and monitor the policy, industry reformulation costs, and CVD-related healthcare, productivity, and informal care costs. Between 2017 and 2036, the optimal reformulation scenario achieving the FDA sodium reduction targets could prevent approximately 450,000 CVD cases (95% uncertainty interval: 240,000 to 740,000), gain approximately 2.1 million discounted QALYs (1.7 million to 2.4 million), and produce discounted cost savings (health savings minus policy costs) of approximately $41 billion ($14 billion to $81 billion). In the modest and pessimistic scenarios, health gains would be 1.1 million and 0.7 million QALYS, with savings of $19 billion and $12 billion, respectively. All the scenarios were estimated with more than 80% probability to be cost-effective (incremental cost/QALY < $100,000) by 2021 and to become cost-saving by 2031. Limitations include evaluating only diseases mediated through BP, while decreasing sodium consumption could have beneficial effects upon other health burdens such as gastric cancer. Further, the effect estimates in the model are based on interventional and prospective observational studies. They are therefore subject to biases and confounding that may have influenced also our model estimates.Conclusions: Implementing and achieving the FDA sodium reformulation targets could generate substantial health gains and net cost savings.

Project description:BackgroundEconomic incentives through health insurance may promote healthier behaviors. Little is known about health and economic impacts of incentivizing diet, a leading risk factor for diabetes and cardiovascular disease (CVD), through Medicare and Medicaid.Methods and findingsA validated microsimulation model (CVD-PREDICT) estimated CVD and diabetes cases prevented, quality-adjusted life years (QALYs), health-related costs (formal healthcare, informal healthcare, and lost-productivity costs), and incremental cost-effectiveness ratios (ICERs) of two policy scenarios for adults within Medicare and Medicaid, compared to a base case of no new intervention: (1) 30% subsidy on fruits and vegetables ("F&V incentive") and (2) 30% subsidy on broader healthful foods including F&V, whole grains, nuts/seeds, seafood, and plant oils ("healthy food incentive"). Inputs included national demographic and dietary data from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects and diet-disease effects from meta-analyses, and policy and health-related costs from established sources. Overall, 82 million adults (35-80 years old) were on Medicare and/or Medicaid. The mean (SD) age was 68.1 (11.4) years, 56.2% were female, and 25.5% were non-whites. Health and cost impacts were simulated over the lifetime of current Medicare and Medicaid participants (average simulated years = 18.3 years). The F&V incentive was estimated to prevent 1.93 million CVD events, gain 4.64 million QALYs, and save $39.7 billion in formal healthcare costs. For the healthy food incentive, corresponding gains were 3.28 million CVD and 0.12 million diabetes cases prevented, 8.40 million QALYs gained, and $100.2 billion in formal healthcare costs saved, respectively. From a healthcare perspective, both scenarios were cost-effective at 5 years and beyond, with lifetime ICERs of $18,184/QALY (F&V incentive) and $13,194/QALY (healthy food incentive). From a societal perspective including informal healthcare costs and lost productivity, respective ICERs were $14,576/QALY and $9,497/QALY. Results were robust in probabilistic sensitivity analyses and a range of one-way sensitivity and subgroup analyses, including by different durations of the intervention (5, 10, and 20 years and lifetime), food subsidy levels (20%, 50%), insurance groups (Medicare, Medicaid, and dual-eligible), and beneficiary characteristics within each insurance group (age, race/ethnicity, education, income, and Supplemental Nutrition Assistant Program [SNAP] status). Simulation studies such as this one provide quantitative estimates of benefits and uncertainty but cannot directly prove health and economic impacts.ConclusionsEconomic incentives for healthier foods through Medicare and Medicaid could generate substantial health gains and be highly cost-effective.

Project description:BackgroundHigh intake of added sugar is linked to weight gain and cardiometabolic risk. In 2018, the US National Salt and Sugar Reduction Initiative proposed government-supported voluntary national sugar reduction targets. This intervention's potential effects and cost-effectiveness are unclear.MethodsA validated microsimulation model, CVD-PREDICT (Cardiovascular Disease Policy Model for Risk, Events, Detection, Interventions, Costs, and Trends), 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 US National Salt and Sugar Reduction Initiative policy. The model was run at the individual level, incorporating the annual probability of each person's transition between health statuses on the basis of risk factors. The model incorporated national demographic and dietary data from the National Health and Nutrition Examination Survey across 3 cycles (2011 through 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 health care and societal perspectives. Uncertainty was evaluated in a 1-way analysis by assuming 50% industry compliance and probabilistic sensitivity analyses through a second-order Monte Carlo approach. Model outputs included averted diabetes cases, CVD events and CVD deaths, QALYs gained, and formal health care cost savings, stratified by age, race, income, and education.ResultsAchieving the US National Salt and Sugar Reduction Initiative 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 (<150 000/QALYs) at 6 years, highly cost-effective (<50 000/QALYs) at 7 years, and cost-saving at 9 years. Results were robust from a health care 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 or Hispanic individuals, lower income, and less educated Americans.ConclusionsImplementing and achieving the US National Salt and Sugar Reduction Initiative sugar reformation targets could generate substantial health gains, equity gains, and cost savings.

Project description:BackgroundExcessive sodium consumption is one of the leading dietary risk factors for non-communicable diseases, including cardiovascular disease (CVD), mediated by high blood pressure. Brazil has implemented voluntary sodium reduction targets with food industries since 2011. This study aimed to analyse the potential health and economic impact of these sodium reduction targets in Brazil from 2013 to 2032.MethodsWe developed a microsimulation of a close-to-reality synthetic population (IMPACTNCD-BR) to evaluate the potential health benefits of setting voluntary upper limits for sodium content as part of the Brazilian government strategy. The model estimates CVD deaths and cases prevented or postponed, and disease treatment costs. Model inputs were informed by the 2013 National Health Survey, the 2008-2009 Household Budget Survey, and high-quality meta-analyses, assuming that all individuals were exposed to the policy proportionally to their sodium intake from processed food. Costs included costs of the National Health System on CVD treatment and informal care costs. The primary outcome measures of the model are cardiovascular disease cases and deaths prevented or postponed over 20 years (2013-2032), stratified by age and sex.ResultsThe study found that the application of the Brazilian voluntary sodium targets for packaged foods between 2013 and 2032 could prevent or postpone approximately 110,000 CVD cases (95% uncertainty intervals (UI): 28,000 to 260,000) among men and 70,000 cases among women (95% UI: 16,000 to 170,000), and also prevent or postpone approximately 2600 CVD deaths (95% UI: - 1000 to 11,000), 55% in men. The policy could also produce a net cost saving of approximately US$ 220 million (95% UI: US$ 54 to 520 million) in medical costs to the Brazilian National Health System for the treatment of CHD and stroke and save approximately US$ 71 million (95% UI: US$ 17 to170 million) in informal costs.ConclusionBrazilian voluntary sodium targets could generate substantial health and economic impacts. The reduction in sodium intake that was likely achieved from the voluntary targets indicates that sodium reduction in Brazil must go further and faster to achieve the national and World Health Organization goals for sodium intake.

Dataset Information

FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis.

Publications

FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis.

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