The objective of this study was to develop a model capable of assessing the cost-effectiveness in Sweden of treating diabetic neuropathic lower extremity ulcers with becaplermin gel (Regranex) plus good wound care (GWC) relative to treating them with GWC alone.
A Markov simulation model was developed that includes six health states: Uninfected Ulcer, Infected Ulcer, Gangrene, Healed Ulcer, Healed Ulcer-History of Amputation, and Deceased. To predict clinical outcomes, information was taken from a specially designed prospective 9-month follow-up study of 183 neuropathic patients in the US treated with GWC. Cost of treatment data were taken primarily from a study of a cohort of 314 patients in Sweden. The efficacy of becaplermin was assumed equal to that achieved in a pooled analysis of four randomized clinical trials. A model application provides expected clinical outcomes for a cohort of patients. Annual treatment costs per patient were estimated using treatment practice and unit prices from Sweden.
Due to a higher rate of healing and a shorter average healing time, treatment with becaplermin gel was predicted to increase the average number of months spent in the healed state over the first year following development of an ulcer by 24% relative to GWC alone. In addition, the corresponding number of amputations was 9% lower for the becaplermin-treated cohort. The average expected cost of $12,078 US for an individual treated with GWC alone declines to $11,708 US for one treated with becaplermin, in spite of $1262 becaplermin costs. Expenses related to topical treatment and inpatient care account for 83% of the resources conserved.
Our results suggest that in Sweden treatment with becaplermin in conjunction with GWC consumes fewer resources and generates better outcomes than treatment with GWC alone for diabetic neuropathic ulcers. In light of the high and increasing incidence of such ulcers, the potential savings in costs and suffering may be important. Results are difficult to extrapolate internationally because they are strongly related to country-specific treatment practices and price levels.