title: Cost-effectiveness of becaplermin for nonhealing neuropathic diabetic foot ulcers.
abstract: Foot ulcers secondary to peripheral neuropathy and vascular disease are a commonly occurring complication for people with diabetes. Becaplermin, a genetically-engineered growth factor in a hydrogel vehicle, has been shown to be more effective than vehicle-only control in healing chronic foot ulcers of patients with adequate vasculature receiving best clinical care. To evaluate the cost-effectiveness of adding up to 20 weeks of becaplermin to a regimen of best clinical care, a 1-year decision-analytic model was developed and tested using data from a previously published controlled clinical study involving 251 people with diabetes (124 becaplermin/127 control) and adequate vasculature presenting with an infection-free ulcer that had failed to heal despite appropriate therapy. A 20-week healing rate was estimated based on the clinical trial data assuming becaplermin treatment was terminated at 10 weeks in non-responding ulcers, and follow-up data were extended to 1 year. Resource utilization was estimated by an expert panel using a modified Delphi approach. Using the model, it was found that incorporating becaplermin with best clinical care resulted in 26 fewer ulcer-days per patient per year compared to best clinical care alone with an incremental cost-effectiveness ratio of $6 per ulcer-day averted. Results were sensitive to becaplermin cost, efficacy, and effect on infection and recurrence rates. The clinical benefits of becaplermin deserve further investigation to enhance cost-effectiveness information for informed treatment decisions.
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada. gary.sibbald@utoronto.ca
authors.forename: R Gary
authors.initials: RG
authors.lastname: Sibbald
authors.forename: George
authors.initials: G
authors.lastname: Torrance
authors.forename: Margaret
authors.initials: M
authors.lastname: Hux
authors.forename: Cheryl
authors.initials: C
authors.lastname: Attard
authors.forename: Natalie
authors.initials: N
authors.lastname: Milkovich
mesh_terms: D000925:Anticoagulants / Q000191:economics* / Q000627:therapeutic use*; D000077214:Becaplermin; D019985:Benchmarking; D017326:Clinical Trials, Phase III as Topic; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D003697:Delphi Technique; D017719:Diabetic Foot / Q000188:drug therapy* / Q000191:economics; D016527:Drug Costs / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D017059:Models, Econometric; D010982:Platelet-Derived Growth Factor / Q000191:economics* / Q000627:therapeutic use*; D020574:Proto-Oncogene Proteins c-sis; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012680:Sensitivity and Specificity; D017592:Skin Care / Q000191:economics / Q000379:methods; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000925:Anticoagulants; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D000077214:Becaplermin