Cost-effectiveness results favored botulinum toxin at 2 years as well as in an analysis at 5 years accounting for increased cost of the botulinum approach due to repeat injections, according to investigator Heidi S. Harvie, MD, MSCE.
In patients with refractory urgency urinary incontinence, 200 units of onabotulinumtoxinA (Botox) is less costly than sacral neuromodulation, according to follow-up results of a multicenter, open-label randomized clinical trial.
Cost-effectiveness results favored botulinum toxin at 2 years as well as in an analysis at 5 years accounting for increased cost of the botulinum approach due to repeat injections, said investigator Heidi S. Harvie, MD, MSCE, of the University of Pennsylvania, Philadelphia on behalf of researchers in the Pelvic Floor Disorders Network.
The report is based on the ROSETTA trial, which demonstrated that sacral neuromodulation (SNM) (InterStim) and 200 units of botulinum toxin have similar efficacy at 2 years, according to results previously published in JAMA (2016; 316:1366-74).
However, follow-up analysis shows that costs were significantly higher for sacral neuromodulation versus 200 units of botulinum toxin, Dr. Harvie reported at theInternational Continence Society annual meeting in Philadelphia.
“Cost-effectiveness analysis using both quality-adjusted life year and condition-specific measures favor Botox over SNM,” Dr. Harvie told attendees in her podium presentation of the results. “Thus, SNM in its current form is not good value compared to 200 units of Botox.”
The ROSETTA trial included 386 women (mean age, approximately 63 years) with refractory urgency urinary incontinence. They were randomized to SNM versus 200 units of botulinum toxin and followed for 2 years.
At 2 years, there were no differences between botulinum toxin and SNM in reduction of urge urinary incontinence episodes per day or quality-adjusted life years. However, the mean estimated cost per person was $35,674 for SNM and $7,463 for botulinum toxin, a difference of $28,211 (p<.01), Dr. Harvie reported.
Next:SNM cost still higher over 5-year periodThe cost difference between SNM and botulinum toxin narrowed to $24,522 in projections of per-person cost over 5 years that accounted for additional botulinum toxin injections, but the cost of SNM continued to be significantly higher, she said. In that 5-year analysis, the cost of SNM remained unchanged, and the cost of botulinum toxin increased from $7,463 to $12,019.
The main cost-effectiveness outcome Dr. Harvie and colleagues sought to evaluate was the incremental cost-effectiveness ratio, or the difference in cost between two interventions compared to the difference in quality-adjusted life years.
“Relative cost per effectiveness and improvement in patient quality of life can often form decisions,” Dr. Harvie said.
In the ROSETTA data, the incremental cost effectiveness ratio for SNM versus botulinum toxin was approximately $1.8 million per quality-adjusted life year at 2 years, and about $4.2 million at 5 years, Dr. Harvie reported.
Reducing the cost of the SNM device and procedure by at least 68% would result in cost-effectiveness at $50,000 per quality-adjusted life year, according to results of a threshold analysis, the investigators conducted.
“In the UK, thresholds over which treatments would be less likely to be recommended are typically between £20,000 to £30,000 per quality-adjusted life year,” Dr. Harvie said. “In the U.S., while there are no specific guidelines, thresholds of $50,000 to $150,000 per quality-adjusted life year are commonly used.”
Dr. Harvie reported funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health.