Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France

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.

Conflict of interest statement

This cost-effectiveness study was funded by Urgo Medical Company FM, https://www.urgo-group.fr/. The assessed dressings are devices marketed by Urgo Medical. The funder provided support in the form of salaries for authors AO, SF, LT, and SB. FM is the CEO of Statesia. A service agreement (commercial contract) was arranged between Urgo Medical and Statesia. Statesia had no other competing interests in the area of this publication relating to employment, consultancy, patents, products in development, or marketed products. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Wound closure rates by week 20 from the EXPLORER study for all patients.

Fig 2. Wound closure rates by week 20 from the EXPLORER study, according to wound duration at treatment initiation.

Fig 3. Markov diagram for patients with diabetic foot ulcers.

Fig 4. Tornado diagram of key parameters driving the model outcomes.

UC_: Unit cost for, UP_: Unit price for, Daily_UC_Hosp: Unit cost per hospitalization day.

Fig 5. Probabilistic sensitivity analysis: Cost-utility plane for the base case analysis.

Fig 6. Cost-utility acceptability curves.

Fig 7. Health benefits: Gain in life years without diabetic foot ulcer for all wounds.

Fig 8. Health benefits: Gain in life years without diabetic foot ulcer for recent wounds (≤ 2 months).

Fig 9. Health benefits: Gain in quality-adjusted life years for all wounds.

Fig 10. Health benefits: Gain in quality-adjusted life years for recent wounds (≤ 2 months).