Axonics Neuromodulation device approved by NICE

The Axonics neuromodulation device has just received NICE approval. Click here for the NICE guidelines

1 Recommendations

1.1Evidence supports the case for adopting Axonics sacral neuromodulation (SNM) system for treating refractory overactive bladder in the NHS. Axonics SNM system improves symptoms and quality of life. It also has a longer battery life than the non-rechargeable system used in NHS clinical practice.

1.2Axonics SNM system should be considered as an option for people with refractory overactive bladder, that is, when conservative treatment or treatment with medicine has not worked, in line with NICE's guidelines on urinary incontinence and pelvic organ prolapse and lower urinary tract symptoms. Axonics SNM system is small and does not need to be removed for most types of MRI scans, so it may be useful for people with a low body mass index (BMI) or when an MRI is likely.

1.3Cost modelling estimates that, over 15 years, Axonics SNM system is cost saving compared with the non-rechargeable system by about £6,025 per person. Cost savings are estimated to begin 6 years after implant. This is because the device needs to be replaced less frequently than the non-rechargeable system, assuming Axonics has a life span of at least 15 years. For more details, see the NICE resource impact statement.

Why the committee made these recommendations

Axonics SNM system uses electrical impulses to stimulate the sacral nerves in the pelvic floor or groin area, to help bladder control. The system is implanted surgically and has a small stimulator that uses a rechargeable battery. Axonics SNM system should be considered when other medicines and treatments do not work.

Axonics SNM system has a longer battery life than the non-rechargeable system used in NHS practice. This means that it needs replacing less frequently, so people need surgery less often. Also, the small size and shape of the stimulator makes it more suitable for people with a lower BMI than the larger, non-rechargeable system. If people need an MRI, the system does not need to be removed, which means surgery to replace it would not be needed.

Evidence from clinical trials shows that Axonics SNM system improves symptoms of overactive bladder and quality of life.

The cost analysis suggests that using Axonics SNM system may lead to cost savings, but this depends on the length of time the battery lasts. The battery is expected to last at least 6 years, at which point it is estimated that Axonics SNM system becomes cost saving to the NHS