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Cost effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for refractory urgency urinary incontinence
Results of the ROSETTA randomized trial
Harvie, H. S., Amundsen, C. L., Neuwahl, S. J., Honeycutt, A. A., Lukacz, E. S., Sung, V. W., Rogers, R. G., Ellington, D., Ferrando, C. A., Chermansky, C. J., Mazloomdoost, D., Thomas, S., & NICHD Pelvic Floor Disorders Network (2020). Cost effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for refractory urgency urinary incontinence: Results of the ROSETTA randomized trial. Journal of Urology, (5), 101097JU0000000000000656. https://doi.org/10.1097/JU.0000000000000656
PURPOSE: Sacral neuromodulation and intradetrusor injection of onabotulinumtoxinA are therapies for refractory urgency-urinary incontinence. Sacral neuromodulation involves surgical implant of a device that can last 4-6 years, while onabotulinumtoxinA involves serial office injections. Objective was to assess cost-effectiveness of 2-stage implantation sacral neuromodulation versus 200 units onabotulinumtoxinA for the treatment of urgency-urinary incontinence.
MATERIAL AND METHODS: Prospective economic evaluation concurrent with Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) randomized trial of 386 women with ≥ 6 urgency-urinary-incontinence episodes in 3-day diary. Analysis from healthcare system perspective, with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs in 2018 U.S. dollars. Effectiveness measured in quality-adjusted life-years (QALYs) and reductions in urgency-urinary-incontinence episodes/day. Generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.
RESULTS: Two-year costs were higher for sacral neuromodulation versus onabotulinumtoxinA ($35,680 [95%CI $33,920-$37,440] versus $7,460 [95%CI $5,780-$9,150], p<0.01), persisting through 5 years ($36,550 [95%CI $34,787-$38,309] versus $12,020 [95%CI $10,330-$13,700], p<0.01). At 2 years, there were no differences in mean reduction in urgency-urinary-incontinence episodes/day (-3.00 [95%CI -3.38 - -2.62] versus -3.12 [95%CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95%CI 1.34-1.44] versus 1.41 [95%CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost effective relative to onabotulinumtoxinA is less than 0.025 for all willingness-to-pay values below $580,000/QALY at 2 years and $204,000/QALY at 5 years.
CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency-urinary incontinence compared with 200 units onabotulinumtoxinA.