1980-P: Cost Burden of Diabetic Foot Ulcer and Amputation under Modeled Treatment Discontinuation in Painful Diabetic Peripheral Neuropathy

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Introduction and Objective: Treatment discontinuation in painful diabetic peripheral neuropathy (PDPN) is common and may result in periods without active therapy. We used a decision tree model to evaluate how discontinuation patterns influence risk of diabetic foot ulcer (DFU), amputation, and costs.Methods: A decision tree simulated 1,000 adults initiating PDPN therapies modeling periods without treatment. Discontinuation probabilities were from a targeted review of 78 PDPN trials of capsaicin 8% (HCCTS) or oral therapies (duloxetine, pregabalin, gabapentin, amitriptyline, venlafaxine, topiramate). After discontinuation, 25% of these patients (scenarios: 10-50%) were assumed to accrue untreated person time, during which DFU and amputation risks were applied and held constant across treatments. Using US studies, annual DFU risk during the untreated time was 6%. Among DFU cases, major and minor amputation probabilities were 3.8% and 3.8-19%, respectively. Episode costs were DFU $17,500, minor amputation $22,703, and major amputation $59,846 (2025 USD).Results: Across 15,092 trial participants (mean age 59 years; 52% male) annual discontinuation probabilities were 2.6% for HCCTS and 35-90% for oral therapies. Per 1,000 patients initiating therapy, projected amputations during untreated time after discontinuation were 0.4 per year with HCCTS and 5.3 to 14 per year with oral therapy. Corresponding costs were ~$11,000 per 1,000 patients initiating HCCTS and $199,000-$238,000 initiating oral therapies. Cost results were directionally consistent across scenarios.Conclusion: Higher discontinuation led to longer untreated person time and higher projected DFU events, amputations, and costs under fixed risk assumptions. Lower discontinuation with HCCTS was associated with lower projected downstream cost. Prospective studies linking treatment persistence, untreated time, and foot complications are needed to causally assess treatment effects on DFU and amputation risk.

Disclosure

J. Fishman: Employee; Current; Averitas Pharma, Inc. L.P. Marcondes: Employee; Current; Averitas Pharma, Inc. H. Kalia: Consultant; Current; Abbott. N.M. Schuster: Consultant; Current; Averitas, Vertex Pharmaceuticals Incorporated, Eli Lilly and Company, Rapport, Lohocla, Syqe, Schedule 1. Research Support; Current; ShiraTronics.



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