The Journal of urology | 2019
Cost Effectiveness of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.
Abstract
PURPOSE\nSacral 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.\n\n\nMATERIAL AND METHODS\nProspective 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.\n\n\nRESULTS\nTwo-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.\n\n\nCONCLUSIONS\nAlthough both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency-urinary incontinence compared with 200 units onabotulinumtoxinA.