Abstract

Regular glucose monitoring is important for insulin-treated T1DM patients. A novel, minimally-invasive flash glucose monitor (the FreeStyle Libre™ system, “FM”) has been developed to continuously measure glucose levels from interstitial fluid. Data transfers to a handheld reader from a wearable arm sensor without requiring routine lancing and blood samples for self-monitoring of blood glucose (SMBG). The IMPACT trial showed reduced time spent in hypoglycaemia in T1DM when using FM compared to standard SMBG, while decreasing the number of blood glucose tests. A recent study also showed utility improvement with FM. Therefore, this analysis evaluates the cost-effectiveness of FM vs SMBG in eight countries. The IMS Core Diabetes Model was run over a 50-year lifetime horizon, modelling a population reflecting the IMPACT trial. Intervention effects included trial-based reductions in hypoglycaemic events (“hypo”, glucose <70mg/dL; 25.5% fewer daytime events, 33.2% fewer nocturnal events), and FM utility benefit (0.03; Matza 2015). Cost data from published literature and government sources were inflated to 2015 currency, with the €59/sensor cash price. Incremental cost-effectiveness ratios (ICERs) were reported, with sensitivity analyses conducted for key inputs. Base case ICERs (cost/quality-adjusted life year (QALY)) were SEK240,909 (Sweden), $24,621 (Australia), €22,099 (Germany), €22,503 (Spain), €16,008 (Italy), €31,887 (France), €19,445 (Portugal), and €14,209 (Netherlands). Costs/hypo-averted were SEK281, AUS$22, and €17-33 across other European countries. Among scenario analyses, a 20% reduction in utility benefit had the largest impact on ICERs/QALY, raising them to SEK296,290, AUS$30,289, and €17,329-€39,233 for other European countries. Improved hypoglycaemia outcomes and health utility benefit translate to base case ICERs/QALY under published thresholds. Results were robust in scenario analysis as well. FM may be considered cost effective for use in T1DM in the countries considered.

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