Kate Johnson

October 23, 2013

LAS VEGAS — For patients with urge urinary incontinence, the cost and effectiveness of a single intravesical injection with onabotulinumtoxin A (Botox) are similar to that of daily anticholinergic medication at 6 months, according to a new analysis from the Anticholinergic vs Botox Comparison Study (ABC).

"Onabotulinumtoxin A is significantly more expensive upfront — you pay for the product, you pay for the procedure. In comparison, the anticholinergics are relatively cheap," said Anthony Visco, MD, from Duke University in Durham, North Carolina, who was one of the researchers.

This finding is good news because patients are frequently noncompliant with anticholinergics, with poor results, said another researcher, Rebecca Rogers, MD, an obstetrician and gynecologist from the University of New Mexico Health Sciences Center in Albuquerque, New Mexico.

"Our paradigm has always been that people should do conservative therapies before moving to the more invasive ones, but this is giving us a glimpse that sometimes the more complex therapies have a first-line role," she told Medscape Medical News.

Dr. Rogers presented the results here at the American Urogynecologic Society (AUGS) 34th Annual Scientific Meeting.

Results from ABC, published last year, showed similar significant improvement in women with idiopathic urgency urinary incontinence randomized to 1 of 2 treatments (N Engl J Med. 2012;367:1803-1813). One group was treated with a daily oral anticholinergic — initially solifenacin 5 - 10 mg, with the possibility of switching to extended-release trospium 60 mg — for 6 months. The other group was treated with a single intradetrusor injection of onabotulinumtoxin A 100 U.

To maintain blinding, the anticholinergic group received 1 intradetrusor injection of saline, and the onabotulinumtoxin A group received a daily oral placebo for the duration of the study.

At 6 months, complete resolution of urgency urinary incontinence was more common in the onabotulinumtoxin A group than in the anticholinergic group (27% vs 13%; P = .003), and the average number of daily urinary incontinence episodes had decreased from 5.0 in both groups to 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxin A group (P = .81).

In terms of adverse effects, there were more urinary tract infections in the onabotulinumtoxin A group (33% vs 13%; < .001), and there was more catheter use (5% vs 0%; P = .01). Dry mouth was more common in the anticholinergic group (46% vs 31%; P = .02).

The new analysis used the ABC data to look at direct and indirect costs of treatment.

Price of Treatment

"For direct costs, we used things like doctor visits, the procedures, and medication costs. We also included not just the cost for treatment, but also for complications — things like urinary tract infections and retention," said Dr. Visco, who is outgoing president of the AUGS.

Indirect costs included management of the condition (pad use, laundry) and time off work, he said.

The analysis showed that the cost of both treatments was "essentially the same" at 6 months, he reported.

Direct costs were $1339 in the anticholinergic group and $1266 in the onabotulinumtoxin A group (P = .07). Indirect costs were $150 and $106, respectively (P = 0.62).

There was a reduction of 3.3 daily urinary incontinence episodes in both groups, and similar gains in quality-of-life years in the 2 groups.

Daily anticholinergic therapy stopped at 6 months, with an adequate efficacy rate of 73%, so extending the analysis beyond that time involved estimating maintained efficacy for the anticholinergic group, Dr. Visco explained.

As anticipated, there was a "slow degradation of effect" with onabotulinumtoxin A. The rate of adequate symptom control dropped from 74% at 6 months to 55% at 9 months.

At 9 months, direct and indirect costs in the onabotulinumtoxin A group fell below those in the anticholinergic group ($1266 vs $1942), making the monthly cost of adequate symptom control significantly lower with onabotulinumtoxin A ($207 vs $305; P < .001).

"People have always thought of onabotulinumtoxin A as being very expensive. If they're equivalent at 6 months, I think it makes it more of a competitive therapy for overactive bladder," Dr. Rogers told Medscape Medical News.

"In real life, people don't continue their anticholinergics. A very significant portion of people don't even fill their prescriptions because of side effects, like dry mouth and constipation, and the idea of starting a treatment that will be lifelong," she said.

Dr. Visco and Dr. Rogers have disclosed no relevant financial relationships.

American Urogynecologic Society (AUGS) 34th Annual Scientific Meeting: Paper 2. Presented October 17, 2013.

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