Abstract
BACKGROUND: The SECURE trial (NCT02596126) demonstrated the efficacy of the cardiovascular polypill ("CV-Polypill"-acetyl salicylic acid, atorvastatin and ramipril) in reducing the risk of recurrent major cardiovascular events compared with standard care when initiated within six months of a myocardial infarction. This analysis aimed to estimate the cost-effectiveness of the CV-Polypill from the Spanish healthcare perspective using SECURE trial data. METHODS: A decision analytic Markov modelling approach was conducted to compare the CV-Polypill with standard care over a lifetime time horizon. Six parametric distributions were fitted to SECURE trial data on time to reinfarction, stroke or death (cardiovascular or non-cardiovascular). Cost and utility data were sourced from literature. Respective model outputs were discounted at 3%. The model captured direct medical costs associated with treatment acquisition and acute/ongoing cardiovascular events. Probabilistic sensitivity analyses (PSA) and scenario analyses were conducted. FINDINGS: The CV-Polypill is dominant (improves health outcomes and reduces costs) in 84·8% of PSA iterations (848/1000 iterations), and cost effective in 89·3% of PSA iterations (893/1000 iterations) at a €30,000 threshold. Secondary prevention with the CV-Polypill reduces the recurrence of cardiovascular events and costs over the time horizon, from the Spanish healthcare perspective. A range of scenario analyses were conducted, demonstrating the robustness of the results when different inputs and assumptions were varied. INTERPRETATION: The CV-Polypill is a dominant strategy in secondary cardiovascular prevention, compared with standard care, from the Spanish healthcare perspective. The CV-Polypill should be considered as a secondary prevention for Spanish patients, like those enrolled in SECURE, at hospital discharge. FUNDING: By Ferrer International.