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.

Fig 1. Simplified model structure.

CHD, coronary heart disease; NHANES, National Health and Nutrition Examination Survey; QALY, quality-adjusted life year.

Fig 2. Median US sodium consumption among adults aged 30–84 years under the baseline projection and 3 modeled scenarios.

The dashed horizontal line depicts the 2015–2020 Dietary Guidelines for Americans recommended upper bound of 2,300 mg/day [5].

Fig 3. Estimated disaggregated discounted cumulative costs for the simulated period 2017 to 2036.

Negative costs represent savings. The shaded areas depict 95% uncertainty intervals. USD, US dollars.

Fig 4. Cost-effectiveness plane by the end of simulation (year 2036).

Each colored dot is the result of a stochastic Monte Carlo iteration. The black dots are the median combinations of cumulative discounted net costs (2017 US dollars) and discounted net QALYs for each simulated scenario, and the ellipses depict the 95% uncertainty interval. Negative costs represent savings. QALY, quality-adjusted life year; USD, US dollars.

Fig 5. Estimated probability of cost-effective and cost-saving policy over the 20-year simulated period.

Cost-effectiveness at the willingness to pay value of $100,000 per quality-adjusted life year.