OBJECTIVES : Dyslipidemia, in particular elevated total and low-density lipoprotein cholesterol (LDL-C), results in atherosclerosis and increases the risk of cardiovascular (CV) events. Despite treatment with statins, many patients fail to reduce their LDL-C enough to optimally minimize their risk. Aim of this study was to evaluate the cost-effectiveness of alirocumab on top of statins at maximum dose tolerated plus ezetimibe (MDTS+E).

METHODS : A 1-year cycles Markov model with lifetime model horizon, was developed. Target population consisted of patients with high baseline risk of CV events; specifically, patients with acute coronary syndrome, myocardial infarction or unstable angina. Baseline characteristics were obtained from a national primary care database analysis. Patients entered the model in stable disease and could experience a non- fatal CV event (acute coronary syndrome, elective revascularization or ischemic stroke) or die. Results from the ODYSSEY trial (for the LDL-C>100 mg/dl subgroup) were used to evaluate CV risk reduction due to alirocumab add-on. Only pharmaceutical, CV events, and LDL-C levels’ detection costs are considered in the analysis from the perspective of Italian National Health Service.

RESULTS : According to national database analysis, simulated cohort was 75 years old on average, 66% male, 42% diabetes mellitus and baseline LDL-C level equal to 121 mg/dl. Alirocumab used as an add-on to MDTS+E was more costly (€45,294 vs €13,123 for MDTS+E) but more effective (8.01 LY vs 6.33 LY for MDTS+E) leading to an ICER of €19,171 per LY (95%CI €11,617─31,496). At a willingness to pay threshold of €30,000 per LY, alirocumab had 96% probability to be cost effective vs. MDTS+E alone. Results were relatively more favorable in the patient subset with recent CV event (<12 months from index).

CONCLUSIONS : The results indicate that alirocumab in addition to MDTS+E is cost-effective versus MDTS+E alone in a representative cohort of high CV risk patients in Italy.