Health benefits and costs of functional foods with phytosterols/-stanols in addition to statins in the prevention of cardiovascular disease

The Dutch guidelines for cardiovascular risk management recommend that all persons with a 10-year SCORE risk ≥5% should be given lifestyle recommendations, including encouragement of the use of phytosterols/-stanols as part of a healthy diet. Treatment with a statin is recommended for all persons with a 10-year SCORE risk of fatal cardiovascular disease (CVD) ≥10%. In the Netherlands the detection of high cholesterol values and other CVD risk factors occurs primarily through clinical case finding. The current study aimed to assess whether functional foods enriched with phytosterols/-stanols add to the benefits of statins in terms of effects and costs. Cost-effectiveness of bread spread with phytosterols/-stanols (PS) was evaluated both in a 'case-findingsituation' and in a hypothetical 'universal screening-situation' (assuming free population-based screening resulting in known SCORE risks). We compared two scenarios per situation: One with and one without additional PS use in all subjects that were known to qualify according to the guidelines. Since many people discontinue the use of PS and statins in the first two year we included discontinuation rates for new users based on empirical data. Long term health benefits were estimated using the RIVM Chronic Disease Model and measured in terms of Quality Adjusted Life Years (QALYs) gained. This simulation model also gave estimates for long term differences in health care costs between the scenarios. Intervention costs were estimated bottom-up from resource use and Dutch unit costs. Finally, health care and intervention costs per QALY were calculated and compared with standards for cost effectiveness. Uncertainty of these outcomes will be assessed using probabilistic sensitivity analysis. Preliminary results showed that addition of phytosterols/-stanols was not cost-effective, meaning that the costs of the addition were relatively high compared to the health gains.