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Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

ABSTRACT: 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.

SUBMITTER: Pearson-Stuttard J

PROVIDER: S-EPMC5892867 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

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

PLoS medicine 20180410 4

<h4>Background</h4>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.<h4>Methods and findings</h4>We used a microsimulation approach of a close-to-reality synthetic population (US IMPACT Food Policy Model) to estimate CV ...[more]

PMID: 29634725

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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.

Project description: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.

Project description:Non-communicable diseases (NCDs) are the leading cause of mortality and morbidity worldwide. Unhealthy diets are one of four main behavioral risk factors contributing to the majority of NCDs. To promote healthy eating and reduce dietary risks, the Australian Commonwealth Government established the Healthy Food Partnership (HFP). In 2018, the HFP consulted on proposed nutrient reformulation targets for 36 food categories to improve the overall quality of the food supply. This study assessed whether the proposed targets were feasible and appropriate. The HFP used a five-step approach to inform the proposed targets. We replicated and extended this approach using a different nutrient composition database (FoodSwitch). Products in FoodSwitch were mapped to the proposed HFP targets. The proportion of products meeting each target was calculated and the FoodSwitch data were compared with HFP data to determine whether the proposed target nutrient levels were appropriate or whether a more stringent target was feasible. Products from the FoodSwitch database (10,599) were mapped against the proposed HFP categories: 8434 products across 30 categories for sodium, 2875 products across seven categories for sugar, and 612 products across five categories for saturated fat. The analyses revealed that 14 of 30 proposed HFP targets for sodium, one of seven targets for sugar, and one of five targets for saturated fat were feasible and appropriate. For the remaining 26 reformulation targets, the results indicate that these target levels could be more stringent and alternative targets are proposed. The draft HFP targets are feasible but the majority are too conservative. If Australia is to meet its commitment to a 30 per cent reduction in the average population salt intake by 2025, these targets could be implemented as interim targets to be reached within two years. However, the opportunity exists to improve the food supply and strengthen the HFP's population health impact by adopting more ambitious and incremental targets. Reformulation programs should be prioritized and closely monitored as part of a coordinated, multi-faceted national food and nutrition strategy.

Project description:BackgroundThe Australian Government recently established sodium targets for packaged foods to encourage voluntary reformulation to reduce population sodium consumption and related diseases. We modeled the health impact of Australia's sodium reformulation targets and additional likely health gains if more ambitious, yet feasible sodium targets had been adopted instead.Methods and findingsUsing comparative risk assessment models, we estimated the averted deaths, incidence, and disability-adjusted life years (DALYs) from cardiovascular disease (CVD), chronic kidney disease (CKD) and stomach cancer after implementation of (a) Australia's sodium targets (overall and by individual companies); (b) United Kingdom's targets (that covers more product categories); and (c) an optimistic scenario (sales-weighted 25th percentile sodium content for each food category included in the UK program). We used nationally representative data to estimate pre- and post-intervention sodium intake, and other key data sources from the Global Burden of Disease study. Full compliance with the Australian government's sodium targets could prevent approximately 510 deaths/year (95% UI, 335 to 757), corresponding to about 1% of CVD, CKD, and stomach cancer deaths, and prevent some 1,920 (1,274 to 2,600) new cases and 7,240 (5,138 to 10,008) DALYs/year attributable to these diseases. Over half (59%) of deaths prevented is attributed to reformulation by 5 market-dominant companies. Compliance with the UK and optimistic scenario could avert approximately an additional 660 (207 to 1,227) and 1,070 (511 to 1,856) deaths/year, respectively, compared to Australia's targets. The main limitation of this study (like other modeling studies) is that it does not prove that sodium reformulation programs will prevent deaths and disease events; rather, it provides the best quantitative estimates and the corresponding uncertainty of the potential effect of the different programs to guide the design of policies.ConclusionsThere is significant potential to strengthen Australia's sodium reformulation targets to improve its health impact. Promoting compliance by market-dominant food companies will be critical to achieving the potential health gains.

Project description:BackgroundThere is a pressing need to include cost data in the Lives Saved Tool (LiST). This paper proposes a method that combines data from both the WHO CHOosing Interventions that are Cost-Effective (CHOICE) database and the OneHealth Tool (OHT) to develop unit costs for delivering child and maternal health services, both alone and bundled.MethodsFirst, a translog cost function is estimated to calculate factor shares of personnel, consumables, other direct (variable or recurrent costs excluding personnel and consumables) and indirect (capital or investment) costs. Primary source facility level data from Kenya, Namibia, South Africa, Uganda, Zambia and Zimbabwe are utilized, with separate analyses for hospitals and health centres. Second, the resulting other-direct and indirect factor shares are applied to country unit costs from the WHO CHOICE unit cost database to calculate those portions of unit cost. Third, the remainder of the costs is calculated using default data from the OHT. Fourth, we calculate the effect of bundling services by assuming that a LiST intervention visit takes an average of 20 minutes when delivered alone but only incremental time in addition to the basic visit when delivered in a bundle.ResultsPersonnel costs account for the greatest share of costs for both hospitals and health centres at 50% and 38%, respectively. The percentages differ between hospitals and health centres for consumables (21% versus 17%), other direct (7.5% versus 6.75%), and indirect (22% versus 23%) costs. Combining the other-direct and indirect factor shares with the WHO CHOICE database and the other costs from OHT provides a comprehensive cost estimate of LiST interventions. Finally, the cost of six recommended antenatal care (ANC) interventions is $69.76 when delivered alone, but $61.18 when delivered as a bundle, a savings of $8.58 (12.2%).ConclusionsThis paper proposes a method for estimating a comprehensive cost of providing child and maternal health interventions by combining labor, consumables and drug costs from OHT with indirect and other-direct proportional costs from WHO CHOICE. In addition, we demonstrate the potential cost savings that can be achieved from bundling the delivery of essential antenatal care interventions rather than delivering the same interventions alone.

Project description:BackgroundFront-of-pack nutrition labelling (FoPL) of packaged foods can promote healthier diets. Australia and New Zealand (NZ) adopted the voluntary Health Star Rating (HSR) scheme in 2014. We studied the impact of voluntary adoption of HSR on food reformulation relative to unlabelled foods and examined differential impacts for more-versus-less healthy foods.Methods and findingsAnnual nutrition information panel data were collected for nonseasonal packaged foods sold in major supermarkets in Auckland from 2013 to 2019 and in Sydney from 2014 to 2018. The analysis sample covered 58,905 unique products over 14 major food groups. We used a difference-in-differences design to estimate reformulation associated with HSR adoption. Healthier products adopted HSR more than unhealthy products: >35% of products that achieved 4 or more stars displayed the label compared to <15% of products that achieved 2 stars or less. Products that adopted HSR were 6.5% and 10.7% more likely to increase their rating by ≥0.5 stars in Australia and NZ, respectively. Labelled products showed a -4.0% [95% confidence interval (CI): -6.4% to -1.7%, p = 0.001] relative decline in sodium content in NZ, and there was a -1.4% [95% CI: -2.7% to -0.0%, p = 0.045] sodium change in Australia. HSR adoption was associated with a -2.3% [-3.7% to -0.9%, p = 0.001] change in sugar content in NZ and a statistically insignificant -1.1% [-2.3% to 0.1%, p = 0.061] difference in Australia. Initially unhealthy products showed larger reformulation effects when adopting HSR than healthier products. No evidence of a change in protein or saturated fat content was observed. A limitation of our study is that results are not sales weighted. Thus, it is not able to assess changes in overall nutrient consumption that occur because of HSR-caused reformulation. Also, participation into labelling and reformulation is jointly determined by producers in this observational study, impacting its generalisability to settings with mandatory labelling.ConclusionsIn this study, we observed that reformulation changes following voluntary HSR labelling are small, but greater for initially unhealthy products. Initially unhealthy foods were, however, less likely to adopt HSR. Our results, therefore, suggest that mandatory labelling has the greatest potential for improving the healthiness of packaged foods.

Dataset Information

Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

Publications

Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

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