Cost-Utility Analysis of FreeStyle Libre Systems in People with Type 2 Diabetes Mellitus on Treatment with Basal Insulin and Poor Glycemic Control in Spain

Abstract

INTRODUCTION: FreeStyle Libre (FSL) systems are effective and user-friendly glucose monitoring devices. This cost-effectiveness analysis compared FSL vs. self-blood glucose monitoring (SBGM) in patients with poorly controlled [hemoglobin A1c (HbA1c) > 8%] type 2 diabetes (T2DM) on basal insulin, from the Spanish National Health System perspective. METHODS: The DEDUCE model, which simulated 10,000 patients with T2DM over a 50 years' time horizon (annual discount rate = 3.00%), was adapted to the Spanish setting. The population characteristics, frequency of acute and chronic diabetic complications, costs (?, 2025) and utilities/disutilities proceeded from scientific literature and were validated by national multidisciplinary experts. The annual probabilities of acute events associated with SBGM were 17.02% for non-severe hypoglycemia (SHE) (?3.92; disutility = - 0.0016), 2.50% for SHE (?1031.69; disutility = - 0.0470) and 0.25% for ketoacidosis (DKA) (?2523.93; disutility = - 0.0470). The RECODe risk engine was used to model chronic diabetic complications (myocardial infarction [?1248.44-?31,013.22; disutility = - 0.0550]; heart failure [?1523.14-6505.08; disutility = - 0.1080]; stroke [?3187.92-7849.48; disutility = - 0.1640]; blindness [?2943.37; disutility = - 0.0740]; renal failure [?4057.05-42,757.39; disutility = - 0.2040]). According to the Spanish recommendations, a patient with SBGM required 2.5 reactive strips/day and 2.5 lancets/day (?0.57/strip; ?0.14/lancet; VAT included). FSL (26 sensors/year; ?3.00/day; VAT included) was associated with reductions of 58% in hypoglycemia, 68% in DKA, 83% in the use of strips/lancets, and an absolute decrease of 1.1% in HbA1c. Deterministic and probabilistic sensitivity analyses (SAs) were conducted. RESULTS: While SBGM yielded 9.18 quality-adjusted life years (QALYs) and total costs of ?77,092 (glucose monitoring = ?17,080; diabetic complications = ?68,272), FSL yielded 9.98 QALYs and total costs of ?61,447 (glucose monitoring = ?8820; diabetic complications = ?44,367). Compared with SBGM, FSL produced total cost savings of ?15,645 and 0.80 additional QALYs per patient, being a dominant alternative compared to SBGM. FSL was found to be dominant in all SAs. CONCLUSIONS: This analysis suggests that FSL, which provides better clinical outcomes at a lower overall cost, is a preferable alternative to SBGM among people with poorly controlled T2DM on basal insulin.