Cost Effectiveness of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

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.

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.

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.

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.

The Journal of urology. 2019 Nov 18 [Epub ahead of print]

Heidi S Harvie, Cindy L Amundsen, Simon J Neuwahl, Amanda A Honeycutt, Emily S Lukacz, Vivian W Sung, Rebecca G Rogers, David Ellington, Cecile A Ferrando, Christopher J Chermansky, Donna Mazloomdoost, Sonia Thomas, NICHD Pelvic Floor Disorders Network

Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania., Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina., Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, North Carolina., Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Diego, California., Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island., Department of Obstetrics and Gynecology, University of New Mexico and Department of Women's Health, Dell Medical School, University of Texas, Austin, Texas., Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama., Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio., Department of Urology, University of Pittsburgh, Pennsylvania., Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.