Purpose of Technology

Botulinum toxin (BTX), a neurotoxin produced by the bacterium Clostridium
(C.)
botulinum, is being evaluated as a treatment for urinary incontinence (UI) due to detrusor overactivity (also known as detrusor instability or detrusor hyperreflexia), involuntary contractions of the detrusor muscle, which causes contraction of the bladder. BTX inhibits muscular contraction so it is being investigated as a means to relieve excessive or uncontrolled contractions of the detrusor and improve urinary control.

Questions addressed in this report include:

• OnabotulinumtoxinA (BTX-A, marketed as Botox®/Botox Cosmetic®; Allergan Inc.)
• AbobotulinumtoxinA (BTX-A, marketed as Dysport®; Ipsen Ltd.)
• RimabotulinumtoxinB (BTX-B, marketed as Myobloc®; Solstice Neurosciences Inc.)
• Does BTX reduce the symptoms associated with detrusor overactivity?
• Is BTX safe for the treatment of detrusor overactivity?
• How does BTX compare with other invasive treatments for detrusor overactivity?
• Have definitive patient selection criteria been established for BTX for the treatment of detrusor instability?

These questions provide a framework for review and synthesis of the best available evidence, which is presented in this report, along with the Hayes Ratings for the technology. This report also provides background information about the condition being treated, a description of the technology, and the context for development of the technology. Other key elements addressed in the report include the regulatory status; applicable Medicare and commercial payer coverage policies; relevant ICD-9 and ICD-10 diagnosis codes; cost and cost effectiveness; credentialing; hospital length of stay; need for large case management; and ongoing and future clinical trials of the technology.

Posted in Directory Reports
This entry was posted on Friday, December 30th, 2011 at 8:00 am.