Health Economics
A recent randomized-controlled trial (RCT) demonstrated a 44% reduction in time for achieving diabetic foot ulcer (DFU) healing when using a novel polylactic acid (PLA) matrix compared to standard of care (collagen dressings). Here, we present a cost-utility analysis of the RCT data to highlight the immediate economic advantages and the health outcomes of using PLA matrices in managing DFUs.
Methods:
Effectiveness data, including weekly wound size, were derived from the primary RCT outputs. Cost components, including debridement and wound care, corresponding to Ohio State's cost listings for 2022, were sourced from the United States Centers for Medicare & Medicaid Services. Other costs were extracted from price lists of wound care product manufacturers. The total and mean costs associated with the wound healing process were calculated for the cost analysis. Health utilities for a non-healed and healed DFU were obtained based on the literature. For the cost-utility analysis, the time frame assessed corresponded to one full episode of a DFU lasting 29 weeks. Health outcomes were calculated using quality-adjusted life years (QALYs).
Results:
The PLA intervention cost decreased gradually, so patients did not incur any costs from the 13th week onwards because they were completely healed. In contrast, patients in the collagen group were treated until the 31st week, which resulted in a longer payment period with a lower QALY. Therefore, cumulative cost analysis showed a higher cost for the collagen group after the 8th week. By the end of the trial, the total mean costs per patient to achieve closure of a DFU were almost twice as high in the collagen group than those in the PLA group. Noteworthy, PLA matrix costs accounted for only 22% of this group's total mean cost per patient. Most costs were associated with debridement and wound care. PLA matrices also provided higher QALYs than collagen dressings. This translated into a difference of approximately 2 weeks more with complete health over the full DFU episode when using PLA.
Discussion: Our analysis demonstrates that PLA matrices provide a lower cost and higher QALY for achieving healing of DFUs than the standard of care, making PLA a cost-effective treatment option. In addition to reducing the duration of the treatment period considerably, which improved patients' quality of life, it also reduced the burden of costs. For both groups, debridement and wound care accounted for most costs, not the product.