External fixation versus amputation in the treatment of ulcerated diabetic foot: a cost-utility analysis using real-world data and a discrete-event simulation model

BACKGROUND: Diabetic foot is a severe complication of diabetes mellitus, with a significant impact on patients’ quality of life. The traditional treatment has been amputation, but its high mortality rate has prompted a search for alternatives, such as the resection of non-viable tissue and limb stabilization using external fixation. This study evaluates the cost-effectiveness relationship between these two strategies. METHODS: An assessment was made of the incremental cost-effectiveness ratio (ICER), calculated over a ten-year time horizon, of both amputation and external fixation. The analysis was based on clinical and cost data obtained from a previous study and used a discrete event simulation model. RESULTS: The mean ten-year quality-adjusted life expectancy for amputated patients was 2.641 ± 1.64 quality-adjusted life years (QALYs) as compared with 6.627 ± 1.46 QALYs for patients treated with external fixation (p < 0.001). The average cost-effectiveness ratio (CER) was estimated at €29,717/QALY for amputation and €15,360/QALY for external fixation. A comparison between both options resulted in an ICER of €5,847/QALY. Sensitivity analyses found ICER values ranging between €5,847/QALY and €12,296/QALY. A budget impact analysis revealed that the incorporation of the new treatment alternative into the Spanish National Health System would lead to a budget increase of €528.2 million over a ten-year horizon. CONCLUSIONS: The use of external fixation in the treatment of ulcerated diabetic foot was shown to be a cost-effective option compared to major amputations.