Cost-utility analysis of a flash continuous glucose monitoring system in the management of people with type 2 diabetes mellitus on basal insulin therapy-An Italian healthcare system perspective

Aims: To assess the cost-utility of the FreeStyle Libre flash continuous glucose monitoring (CGM) system from an Italian healthcare system perspective, when compared with self-monitoring of blood glucose (SMBG) in people living with type 2 diabetes mellitus (T2DM) receiving basal insulin. Materials and Methods: A patient-level microsimulation model was run using Microsoft Excel for 10 000 patients over a lifetime horizon, with 3.0% discounting for costs and utilities. Inputs were based on clinical trials and real-world evidence, with patient characteristics reflecting Italian population data. The effect of flash CGM was modelled as a persistent 0.8% reduction in glycated haemoglobin versus SMBG. Costs ( 2023) and disutilities were applied to glucose monitoring, diabetes complications, severe hypoglycaemia, and diabetic ketoacidosis. The health outcome was measured as quality-adjusted life-years (QALYs). Results: Direct costs were 5338 higher with flash CGM than with SMBG. Flash CGM was associated with 0.51 more QALYs than SMBG, giving an incremental cost-effectiveness ratio (ICER) of 10 556/QALY. Scenario analysis ICERs ranged from 3825/QALY to 26 737/QALY. In probabilistic analysis, flash CGM was 100% likely to be cost effective at willingness-to-pay thresholds > 20 000/QALY. Conclusions: From an Italian healthcare system perspective, flash CGM is cost effective compared with SMBG for people living with T2DM on basal insulin.