Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance

Abstract

The Axonics sacral neuromodulation (SNM) system can be used by people with refractory overactive bladder (OAB) to reduce symptoms of urge urinary incontinence and urinary frequency, where conservative treatments have failed or are not suitable. It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications. We describe the evidence considered by the UK National Institute of Health and Care Excellence (NICE) in their evaluation of this evidence, supported by Cedar Healthcare Technology Research Centre. Two observational studies provided descriptive data that suggested improvement in control of symptoms after implantation of the Axonics SNM system; however, there was no peer-reviewed evidence that directly compared rechargeable and non-rechargeable SNM systems. In the absence of long-term data, economic modelling relies on the accuracy of battery life estimates. The evidence supports the case for adopting the Axonics SNM system for treating refractory OAB, when conservative treatment or treatment with medicines has not worked. This conclusion is consistent with other relevant NICE guidelines. Use of Axonics SNM technology in the UK National Health Service (NHS) is associated with a potential cost saving of £6025 per person over a 15-year period when compared with an equivalent non-rechargeable SNM system, assuming the claimed battery life estimate (a minimum of 15 years) is accurate. The cost savings are estimated to start around 6 years after implantation. Key Points for Decision MakersPublished evidence from two non-comparative observational studies suggests that use of the Axonics Sacral Neuromodulation (SNM) system can help people with overactive bladder (OAB) to manage symptoms of urinary frequency and urinary incontinence.National Institute of Health and Care Excellence (NICE) concluded that the Axonics SNM system should be considered as an option for people with refractory OAB when conservative treatment or treatment with medicine has not worked.

Sacral neuromodulation in the management of chronic pelvic pain: A systematic review and meta‐analysis

“…6 SNM for CPP remains off-licence although it is included in EAU and AUA guidelines as an option for patients who have failed initial treatments. 7 Current literature reporting the use of SNM for CPP predominantly comprises pilot studies and other IDEAL 1-2a stage studies with short-term follow-up. Demonstrating the reliability of results in the medium to long term is particularly important for implant surgery like SNM.…”