Abstract
This study assesses the cost-effectiveness of Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) wound dressings versus neutral dressings in the management of diabetic foot ulcers (DFUs) from a French collective perspective. We used a Markov microsimulation cohort model to simulate the DFU monthly progression over the lifetime horizon. Our study employed a mixed method design with model inputs including data from interventional and observational studies, French databases and expert opinion. The demographic characteristics of the simulated population and clinical efficacy were based on the EXPLORER double-blind randomized controlled trial. Health-related quality of life, costs, and resource use inputs were taken from the literature relevant to the French context. The main outcomes included life-years without DFU (LYsw/DFU), quality-adjusted life-years (QALYs), amputations, and lifetime costs. To assess the robustness of the results, sensitivity and subgroup analyses based on the wound duration at treatment initiation were performed. Treatment with the TLC-NOSF dressing led to total cost savings per patient of EUR 35,489, associated with gains of 0.50 LYw/DFU and 0.16 QALY. TLC-NOSF dressings were established as the dominant strategy in the base case and all sensitivity analyses. Furthermore, the model revealed that, for every 100 patients treated with TLC-NOSF dressings, two amputations could be avoided. According to the subgroup analysis results, the sooner the TLC-NOSF treatment was initiated, the better were the outcomes, with the highest benefits for ulcers with a duration of two months or less (+0.65 LYw/DFU, +0.23 QALY, and cost savings of EUR 55,710). The results from the French perspective are consistent with the ones from the German and British perspectives. TLC-NOSF dressings are cost-saving compared to neutral dressings, leading to an increase in patients’ health benefits and a decrease in the associated treatment costs. These results can thus be used to guide healthcare decisionmakers. The potential savings could represent EUR 3,345 per treated patient per year and even reach EUR 4,771 when TLC-NOSF dressings are used as first line treatment. The EXPLORER trial is registered with ClinicalTrials.gov, number NCT01717183.
Highlights
Diabetes is a serious progressive disease estimated to affect 422 million adults worldwide
The one-year time-horizon results obtained using our model indicated that the TLC-NOSF dressing is associated with a gain of 0.06 LYs w/diabetic foot ulcers (DFUs) DFU (0.24 versus 0.18 for the TLC-NOSF and control dressings, respectively), a gain of 0.01 Quality-adjusted life years (QALYs) (0.60 versus 0.59), a reduction of 0.005 in amputations (0.006 versus 0.011), and a total cost reduction of EUR 3,699 (EUR 40,182 versus EUR 43,881)
The cost effectiveness and cost utility of TLC-NOSF dressings were established from a French collective perspective compared to those of neutral dressings
Summary
Diabetes is a serious progressive disease estimated to affect 422 million adults worldwide. Diabetes damages various organs and can result in reduced distal blood flow, which, combined with nerve damage in the feet, increases the occurrence of foot ulcers and infection, eventually requiring limb amputation. It is estimated that 19% to 34% of patients with diabetes mellitus will develop a diabetic foot ulcer (DFU) during their lifetime [3]. These chronic wounds require several months to heal, and their recurrence rate is around 40% within one year after the initial wound closure [3].
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