Budget Impact Analysis (BIA) of Adopting Real-Time Continuous Glucose Monitoring (rt-CGM) vs Intermittent-Scanning Continuous Glucose Monitoring (is-CGM) in Patients With Type 1 Diabetes on Insulin Therapy (PWT1D) in Italy

OBJECTIVES: rt-CGM systems have demonstrated clinical benefits over is-CGM systems, including better glycemic control, and reduced severe hypoglycemia (SHE) and diabetic ketoacidosis (DKA) events. However, access to rt-CGM is limited in Italy due to restrictive criteria, leading to regional inequity.

METHODS: Our BIA compares the costs associated with the adoption of rt-CGM vs is-CGM for the Italian healthcare system from a payer perspective. Four categories of costs were included: CGM acquisition costs, costs of SHE and DKA hospitalizations, and the impact of HbA1c reduction on healthcare resources utilization (HCRU) costs. Each 1% reduction in HbA1c is estimated to reduce annual HCRU costs by €851 (Bansal et al. 2018). Clinical effectiveness inputs were derived from the ALERTT-1 trial, which showed -0.36 HbA1c reduction vs is-CGM, and a SHE rate of 1.6% vs 4.9% in rt-CGM vs is-CGM. DKA rates were based on RESCUE and FUTURE studies and epidemiological data with rates of 0.4% and 1.3% for rt-CGM and is-CGM, respectively. Acquisition costs of CGM systems were based on the cost of Dexcom ONE rt-CGM and FreeStyle Libre 2 is-CGM. Costs of SHE and DKA were sourced from literature and inflated to 2022 Euros.

RESULTS: With an estimated 209,952 adult PwT1D in Italy, adopting rt-CGM will result in annual cost savings of €157.6 per patient with T1D with total overall savings of €33,081,387. The incremental acquisition costs of rt-CGM, €400 per patient, are offset by per-patient savings of €306, €197, and €53.8 from the reduction in HCRU, SHE, and DKA events respectively.

CONCLUSIONS: Our study suggests that the adoption of rt-CGM can be cost-saving to the Italian healthcare system relative to is-CGM. The results can inform regional access policies for CGM systems in Italy.