In patients with overactive bladder (OAB), onabotulinumtoxinA 100U has been demonstrated to reduce urinary incontinence (UI) and significantly improve quality of life. However, little information is available regarding cost savings seen after onabotulinumtoxinA treatment as a result of a reduced reliance on incontinence products. The aim of this analysis of the phase 4 GRACE study was to estimate those potential cost savings in a real-world clinical setting.

This 12-month prospective, observational, non-randomized multinational phase 4 study (ClinicalTrials.gov: NCT02161159) was performed in 4 European countries (Germany, Sweden, Spain, and the United Kingdom). Efficacy outcomes reported here include percent reduction from baseline in UI episodes/day, proportion of patients achieving ≥50% and 100% reduction in UI episodes/day, treatment benefit score (TBS), and the number of incontinence products (liner/pads/diapers) used in the previous month. Costs of incontinence products (pads/liners and diaper pants) were estimated using available pricing data from reliable sources (Medical Supply Depot and Healthy Kin.com) filtered by medium female waist size for diaper pants and largest package size for best value. The mean overall costs of incontinence product use were determined at each time point (12, 20, 28, 36, and 52 weeks). Patients could request retreatment ≥12 weeks after the first treatment. This study was performed in compliance with Good Clinical Practice regulations and was approved by the independent ethics committee at each site prior to study initiation as required by each country. All patients provided written informed consent prior to initiation of any study treatment.

Overall, 504 patients received onabotulinumtoxinA treatment in this study. The mean number of pads/liners and diaper pants used in the previous month dropped from baseline (67.7 and 13.9) to week 12 (29.9 and 4.4) and was sustained until week 52 (23.6 and 4.3). The mean cost for pads/liners was determined to be $0.51/unit (range of cost $0.08/unit to $2.06/unit) and for diaper pants was $0.82/unit (range of cost $0.25/unit to $3.33/unit). Overall monthly costs of pads/liners and diaper pants decreased substantially from baseline ($34.43 and $11.37, respectively) to week 12 ($15.21 and $3.60, Figure 1). The reduction in cost was sustained through to week 52 ($12.00 and $3.52). Daily episodes of urinary incontinence were (mean ± standard deviation [SD]) 4.9 ± 4.2 episodes/day at baseline. UI episodes were significantly reduced by 46.9% ± 64.8% (P < .001) at week 1 and 61.3% ± 58.6% at week 12 (P < .001, Figure 2). The proportion of patients achieving a ≥50% and 100% reduction in UI episodes/day was 60.7% and 25.5% at week 1 and 73.9% and 41.8% at week 12. TBS data were available for 347 patients at week 12 and a positive treatment response was seen in 87.6% of these patients.

This preliminary analysis is the first of its kind based on a prospective, real-world clinical study detailing potential cost savings in patients with OAB treated with onabotulinumtoxinA that resulted in a reduced need for incontinence products. After treatment with onabotulinumtoxinA there was a greater than 50% reduction in monthly costs of pads/liners and a nearly 70% reduction in diaper pant costs. The reductions in monthly cost of incontinence products were in line with the proportion of patients becoming completely continent over the same time period. The cost savings were sustained out to 52 weeks.

Following treatment with onabotulinumtoxinA, patients saw considerable reductions in monthly costs associated with incontinence product use. This information could assist physicians in counseling patients refractory to second-line treatments for OAB.