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Axonics sacral neuromodulation system for treating refractory overactive bladder

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4 Committee discussion

Clinical-effectiveness overview

Axonics SNM system is clinically effective

4.1 The committee noted the non-comparative evidence from 2 studies (ARTISAN‑SNM and RELAX‑OAB) and testimony from a patient survey. Some patients described the technology as 'completely life changing', others felt in control of their condition. The clinical experts said that, in their opinion, Axonics SNM system improves symptoms and quality of life compared with the standard non-rechargeable system. The clinical experts noted that the test phase programming for both devices was different. Axonics SNM system has 1 program that can be optimised while the standard non-rechargeable SNM system has 4 default programs that a patient can switch across remotely. The permanent implantation procedure is similar for both devices. The committee concluded that Axonics improves symptoms of overactive bladder and quality of life.

The 15‑year battery life of the Axonics SNM system is plausible

4.2 The committee noted that there was a lack of long-term follow-up data from the existing studies that validated the company's claim of extended battery life in real-world use. The technical expert explained that battery longevity depends on the recharge interval, charging regime and discharge profile. The EAC carried out an assessment of accelerated battery bench testing data submitted by the company. Based on this and expert advice, the committee concluded that it is plausible that the Axonics SNM battery will last 15 years for a person who needs typical stimulus (2.1 mA) to manage their symptoms. No data on battery failure were submitted and the committee was also advised that the recharge interval depended on stimulation parameters. Also, some devices may fail within the 15‑year life span if stimulus current of up to 4 mA is needed to manage symptoms. Mild cases of lead migration were noted as a possible cause of changes in stimulus current. The committee further considered that although evidence from RELAX‑OAB showed that stimulation amplitude increased up to 3 months after the device was implanted, in the longer term, once the lead settles in the body, amplitude may stabilise or decrease. The committee concluded that even though evidence on battery life was limited, it was plausible that the battery would last at least 6 years and possibly beyond 15 years.

Dropout rates and desensitisation occurring with Axonics SNM system are unpredictable

4.3 The clinical experts explained that it was difficult to predict what proportion of people had symptoms that would stop responding over the 15‑year life span of the Axonics SNM system. The experts stated that all treatments for overactive bladder are associated with some level of decline in response. This could be as a result of the person's lifestyle, loss of efficacy, break in circuit and anticipated changes in stimulation delivered. Clinical experts advised that a therapy break may be recommended to assess if people should continue to use SNM therapy (rechargeable or non-rechargeable). The committee noted that long-term therapy breaks (for desensitisation or pregnancy) may reduce the rechargeable battery life although evidence of this was not available. The committee concluded that although desensitisation may occur, this was unlikely to be different with Axonics SNM system than with the non-rechargeable system.

Axonics SNM may benefit people with protected characteristics under the Equality Act 2010

4.4 Overactive bladder is common in women who have been pregnant or who are postmenopausal. It is more common in older people, people with obesity and may be common in disabled people. Axonics SNM system should not be used by people who may be unable to use the device, for example, some disabled people or people with a learning disability. The clinical experts explained that the device can be recharged by a carer. The committee noted that when a carer was not available to help with recharging Axonics SNM system, the option of a non-rechargeable SNM system would still be available.

Axonics SNM system has advantages for people with low body mass index or who are likely to need an MRI scan

4.5 The clinical experts said that the smaller size of the Axonics SNM system compared with the non-rechargeable device makes it more suitable for people with low body mass index. The full body MRI compatibility of the device means that people with overactive bladder who may need future MRI scanning do not need to have their device removed, avoiding replacement surgery. This consideration was also relevant to people with chronic conditions such as multiple sclerosis, who are likely to need regular MRI scans.

Side effects and adverse events

Axonics SNM system has no serious adverse effects

4.6 No serious adverse events have been reported with Axonics SNM system. There was no evidence on adverse events beyond 2 years. The most common minor device-related adverse events related to discomfort associated with stimulation. Clinical experts agreed that discomfort with stimulation can usually be corrected with reprogramming.

NHS considerations overview

Axonics SNM system should be used on its own

4.7 The clinical experts explained that Axonics SNM system is usually used in their practice as a third-line therapy after conservative treatment and drug therapy have failed, which is in line with NICE's guidelines on urinary incontinence and pelvic organ prolapse and lower urinary tract symptoms. They explained that sacral neuromodulation is normally expected to be the only therapy needed to improve symptoms of overactive bladder, but that occasionally drugs might also be used. This may mean that SNM stimulation is becoming less effective. The committee concluded that Axonics SNM system should be the only treatment for overactive bladder until symptoms are no longer adequately controlled.

Patient choice is key to deciding whether to use a rechargeable SNM system

4.8 The clinical experts explained that people are told about the advantages and disadvantages of the rechargeable and non-rechargeable systems before a device is implanted. These include uncertainty about device longevity and possible causes for device failure. The longer battery life of Axonics SNM system may appeal to a person using the device. The committee concluded that this is ultimately the person's decision.

Axonics SNM system is easy to use

4.9 Clinical experts stated that Axonics SNM system is easy to use, for the person and the healthcare professional, and needs little in the way of additional training. They also explained that the implant procedure for the Axonics SNM system is minimally invasive and no more complex than for the non-rechargeable device. A clinical expert explained that people with memory problems may prefer the non-rechargeable device but that people with mild cognitive impairment may be able to have a Axonics SNM system if support is available. The committee concluded that Axonics SNM system could be used by most people, particularly if a carer can help.

Cost modelling overview

The EAC's revised cost model is more plausible

4.10 The committee accepted the EAC's preferred cost model, which showed that Axonics SNM system becomes cost saving at 6 years after implant. The committee acknowledged the uncertainties in extrapolating data collected over 2 years to a 15‑year time horizon but considered this approach to be suitable for decision making. The committee acknowledged that failure to include the cost of battery disposal in the cost modelling was a limitation.

The risk of device failure after 1 year should be shared with the company

4.11 The company explained that the device warranty lasts for 12 months. The clinical experts explained that people are advised to include their device in insurance policies to cover loss of, or damage to, the remote or charger. The committee considered that, based on the company's confidence in the longevity of the device and the results of the cost modelling, the warranty should be extended by the company to at least 6 years.

Main cost drivers

Time to device replacement is key

4.12 The EAC's sensitivity analyses identified time to device replacement as a key driver of cost savings. The committee concluded that Axonics is cost saving only if it lasts longer than the non-rechargeable device.

Cost savings

Axonics SNM system is cost saving compared with standard care

4.13 The EAC's revised cost modelling showed that over 15 years, using Axonics SNM system for managing refractory overactive bladder is associated with an estimated cost saving of £6,273 per person in the base case. Also, the amount of cost savings increases progressively from 6 years after implant.

Further research

Further research would help address uncertainties

4.14 Further evidence on the long-term clinical benefits and device longevity of Axonics SNM in people with refractory overactive bladder would be welcomed.