A systematic review on the application of cardiovascular risk prediction models in pharmacoeconomics, with a focus on primary prevention

OBJECTIVES: In the absence of long-term randomized clinical trials (RCTs) on the effectiveness of pharmacological treatment for primary cardiovascular disease (CVD) prevention, risk prediction models are used to project changes in CVD incidence due to changes on risk factor levels observed in short-term RCTs. This study aims to summarize the literature on the application of these CVD risk models in pharmacoeconomic studies for primary CVD prevention interventions in high in- come countries. METHODS: We systematically reviewed the literature on the application of CVD risk models in pharmacoeconomic studies. We assessed the quality of incorporation of risk models in these studies by evaluating the agreement of the population characteristics and the time horizon applied between the risk model and the pharmacoeconomic study, the appropriateness of the risk model for the population studied, and the incorporation of the uncertainty of the risk model in the sensitivity analysis. RESULTS: We identified 12 studies using published CVD risk models. The studies demonstrated the usefulness of projecting intermediate effectiveness endpoints to long term, health and cost related, benefits. However, our quality assessment highlighted the distance between the populations of the risk model and the studies reviewed, the disagreement between risk model and study time horizons, and the lack of consideration of all uncertainty surrounding risk predictions. CONCLUSIONS: Given that utilizing a risk model to project the effect of a pharmacological intervention to CVD events provides an estimate of the intervention's clinical and economic impact, consideration should be paid on the agreement between the study and risk model populations as well as the level of uncertainty that these predictions add to the decision-analytic model. In the absence of hard endpoint trials, the value of risk models to model pharmacological efficacy in primary CVD prevention remains high, although their limitation should be acknowledged