OBJECTIVES: This real-world analysis evaluated clinical characteristics and economic impact for the Italian National Health System in patients receiving rosuvastatin/ezetimibe (ROS/EZE) as free (FC) vs single-pill combination (SPC).

METHODS: A retrospective analysis was conducted on Italian administrative databases, covering approximately 7 million residents. From January 2018-June 2020 adults prescribed with ROS/EZE were included, then divided into FC and SPC cohorts. The time of first simultaneous prescription of the two lipid-lowering agents (within one-month interval) or first prescription of SPC was defined as index-date. Patients were characterized during all available period before index-date and followed-up until end of data availability [1.6±0.6 years (SPC); 2.5±0.8 years (FC)]. Groups were balanced for demographic and clinical characteristics, including cardiovascular (CV) risk, using propensity score matching (PSM).

RESULTS: Before PSM, the FC and SPC groups consisted of 7,309 and 25,886 patients. Patients in FC group were significantly older and more often had very high CV risk. After PSM-balance with a 1:3 algorithm, the analysis focused on 7,309 FC and 21,927 SPC-treated patients with comparable mean age, gender distribution (65.7±11 years, 58.6% males), proportion of concomitant diseases/medications and CV risk. A higher percentage of patients were adherent to SPC vs FC (56.8% vs 44.5%, p<0.001). Total annual healthcare costs patient/year were significantly higher in FC than SPC cohort (2,337€ vs 1,890€, p<0.001), mostly due to medication expenses (1,370€ vs 1,119€, p<0.001), CV drug costs (862€ vs 608€, p<0.001), CV-related hospitalizations (270€ vs 217€, p<0.01) and all outpatient-service costs (329€ vs 253€, p <0.001). Among baseline variables, age, male gender, chronic obstructive pulmonary disease diagnosis, treatment adherence and FC combination use were significant predictors of increased annual costs.

CONCLUSIONS: This real-world analysis in Italian patients with hypercholesterolemia showed that treatment with ROS/EZE as SPC versus FC is associated with cost savings for the national health system.