OBJECTIVES: To estimate the cost-effectiveness of continuous subcutaneous insulin (CSI) external pump therapy after multiple daily insulin (MDI) injections in one center in France in adult patients with T1DM from the real life medical/costs information generated by an observational prospective study- the EMIPE study.

METHODS: We enrolled 56 patients treated with MDI injections and eligible for CSI external pump therapy. Of these patients, we studied a sub-group of 34 patients for which the medical resources use and costs associated with T1DM were available from the local sickness fund (CPAM). According to the EMIPE study design, the incremental cost-effectiveness ratio (ICER) calculation considered sequentially the direct medical cost and the the efficacy endpoint (HbA1C level) for the period of treatment by MDI and for the period of treatment by CSI. For each period, the cost calculation were extrapolated / measured over 1 year; HbA1C levels were the last value known under treatment by MDI and the value at 12 months after treatment by CSI. Gain in utility score due to HbA1C level improvement were applied using the international literature. Base case results were calculated using 2010 year costs and scenario analysis has considered an update with 2017 year costs.

RESULTS: For the 34 patients, the mean difference in costs between the two annual periods was estimated to be 8982 Euros. By switching from MDI to CSI we observed an improvement (decrease) of HbA1C level of 0,46 % which was converted in 0.28 QALYs gain. The base case and the scenario ICERs were estimated at 32078 EUROS/QALY and 18248 EUROS/QALY, respectively.

CONCLUSIONS: Our approach met the needs of real life information on medical devices requested by health payers and was useful to evaluate and confirm the value for money of a well-established therapeutic strategy for T1DM like SCI external pump therapy.