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

Abstract

BackgroundSodium 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 findingsWe 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.ConclusionsImplementing and achieving the FDA sodium reformulation targets could generate substantial health gains and net cost savings.

Cost-Effectiveness of the US Food and Drug Administration Added Sugar Labeling Policy for Improving Diet and Health

“…The extended U.S. IMPACT Food Policy model is a stochastic dynamic microsimulation model that simulates the life course of synthetic individuals under different policy scenarios. 23 Compared to previous versions of the model, 15 it allows for more detailed and flexible simulation of food policies in a competing risk framework, taking into account individual heterogeneity and lag times between exposures and outcomes. The model first simulated the life courses of synthetic individuals aged 30-84 under the base-case scenario and estimated their added sugar intake, BMI, incidence of type 2 diabetes, first episode of CHD and/or stroke, quality-adjusted life-years (QALYs), costs, and death from these diseases or any other cause on an annual basis.…”

“…Then, it calculated the life courses of the same synthetic individuals under both labeling scenarios and generated annual estimated changes in each health outcome at the individual level ( Figure 2). CVD and type 2 diabetes outcomes were modeled as previously reported 23 and are fully described in Text S1. Briefly, using a population attributable risk approach, the model estimated the annual risks of the synthetic individuals aged 30-84 years to develop CHD and stroke based on their BMI, type 2 diabetes status, incidence rate forecasts and etiologic effects of added sugar intake ( Figure 2).…”

Determinants of Food Safety Knowledge among University Students in Pakistan: A Cross-Sectional Study

“…According to United States FDA statistics 2017, nearly 23% of the processed foods in United States had been recalled due to potential risk linked to public health epidemic and food safety concerns. However, for developing countries there is no such reliable data exists even that can portray a glooming snapshot of food safety (6).…”

Determinants of Food Safety Knowledge among University Students in Pakistan: A Cross-Sectional Study

“…According to United States FDA statistics 2017, nearly 23% of the processed foods in United States had been recalled due to potential risk linked to public health epidemic and food safety concerns. However, for developing countries there is no such reliable data exists even that can portray a glooming snapshot of food safety (Pearson-Stuttard et al 2018).…”