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

Abstract

Purpose: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence.

Materials and methods: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.

Results: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $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 per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 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 per QALY at 2 years and $204,000 per 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 to 200 units onabotulinumtoxinA.

Keywords: botulinum toxins; cost-benefit analysis; transcutaneous electric nerve stimulation; type A; urge; urinary incontinence.

Figure 1.

Flow diagram of randomized participants and effectiveness questionnaire respondents. a, includes intent to treat primary analysis population used for 6-month ROSETTA results. Population was limited to subjects who completed treatment and had baseline and at least 1 followup UUIE diary. b, limited to subjects with at least 1 baseline and 1 followup HUI-3 measurement, minimum data required to implement repeated measures mixed linear model to estimate QALYs.

Figure 2.

ICER scatterplot (A) and cost-effectiveness acceptability curve (B) for SNM vs BTX for 2 and 5-year estimates. A, scatterplot of points representing pairs of mean differences in cost and mean differences in QALYs for SNM vs BTX using 2 and 5-year analysis horizons. All points from 5,000 replications for both time horizons lie above horizontal axis, indicating that SNM is expected to always be more costly than BTX. Points to right of vertical axis represent replications in which SNM was more effective than BTX, while points on left indicate replications in which BTX was more effective than SNM. X points indicate ICER point estimates. B, cost-effectiveness acceptability curves for SNM vs BTX for 2 and 5-year analysis horizons. For willingness to pay of $580,000 per QALY gained over 2 years, SNM had 2.5% probability of being cost-effective vs BTX. For willingness to pay of $204,000 per QALY gained over 5 years, SNM had 2.5% probability of being cost-effective vs BTX.