The technology

Advice

Innovations
Current NHS pathway or current care pathway
Population, setting and intended user
Costs
Resource consequences

The technology

Aptiva (Fremslife) is a non-invasive frequency rhythmic electrical modulated system (FREMS) for treating diabetic neuropathy.

The device consists of the FREMS unit including a liquid crystal display with touchscreen, 1 power supply unit and power cable, 1 remote control, electrode connection cables for neuromodulation, electrodes, 1 user treatment card and 1 connection protection cover.

During a treatment session, a series of monophase-compensated negative potential electrical pulses are delivered through disposable electrode pads applied to the skin along the pathway of the nerve involved in the neuropathy. The pulses are characterised by:

a sharp spike and an asymmetrical shape with a peak amplitude variable from 0 V to 255 V
pulse frequency variable within a range of 0 Hz to 50 Hz
pulse duration variable within the range of 10 μs to 40 μs.

For diabetic neuropathy, 8 electrode pads (2 per connection cable) are applied to the calf, shinbone, ankle and midfoot of each leg. At the beginning of each treatment session, the electrical dose is set by the clinician, based on the sensation felt by the patient: the electrical stimulation should be felt but should not be painful. The duration of a treatment session is 35 minutes with a treatment cycle comprising 10 daily sessions. The company's suggested treatment frequency is 3 cycles per year, depending on the response to treatment.

The device was formerly known as PhysioFlog ETS 501.

Innovations

Aptiva is designed to provide a non-drug approach for treating painful diabetic neuropathy. It uses modulated electrical pulses, which differ from those used in percutaneous electrical nerve stimulation (PENS), and it is intended to improve the supply of oxygen to nerve cells with the aim of reducing pain.

Current NHS pathway or current care pathway

An estimated 9% of adults in the UK have a diagnosis of type 1 or type 2 diabetes (Diabetes UK) with about 21–25% of these diagnosed with painful diabetic neuropathy (Abbot et al. 2011; Tesfaye et al. 2010). The NICE guideline on neuropathic pain in adults: pharmacological management in non-specialist settings recommends a stepped approach to managing neuropathy. A choice of amitriptyline, duloxetine, gabapentin or pregabalin should be offered as an initial treatment for neuropathic pain (including diabetic neuropathy). If the first choice of drug is not effective, the remaining drugs should be tried in turn depending on response and tolerance. Tramadol should be considered if acute rescue therapy is needed and capsaicin cream should be considered for people with localised neuropathic pain who do not want, or who cannot tolerate, oral treatments.

NICE guidance on percutaneous electrical nerve stimulation (PENS) for refractory neuropathic pain states that PENS can be used with normal arrangements for clinical governance, consent and audit for patients selected by teams specialising in pain management. With PENS, one or more individual nerves are stimulated using needle probes with low voltage electrical currents. Each session lasts between 15 and 60 minutes with the duration of treatment varying between patients.

Aptiva would be used in addition to, or as a replacement for, pharmacological treatments if they fail to adequately manage pain or are poorly tolerated.

Population, setting and intended user

The Aptiva device would be offered to adults with painful neuropathy caused by type 1 or type 2 diabetes. It may be used by diabetes specialist nurses but also by any member of a diabetes or podiatry multidisciplinary team. In some hospitals it may also be administered by healthcare assistants. Treatment would be administered either in secondary care or in a community setting. Minimal training is needed and this is provided by the manufacturer at no additional cost.

Costs

Technology costs

Table 1 Costs of Aptiva device (excluding VAT)

Description	Cost	Additional information
Device cost	£28,750	Multiple use
Electrodes and treatment cards (consumables)	£3,500	This includes 10,240 single-use electrodes, equivalent to 640 treatment sessions

Table 1 shows the device and consumable costs for Aptiva. Each treatment uses 16 electrodes costing £5.46. Ten treatments are needed per cycle, and there are up to 3 cycles of treatment each year. In the case that the full 3 cycles are completed, it would cost £163.80 per year in consumables.

Costs of standard care

Table 2 shows the costs of standard pharmacological treatments recommended for the treatment of diabetic neuropathy.

Table 2 Cost of pharmacological treatments ( NHS Electronic Drug Tariff 2017 )

Description	Cost per 28 days	Cost per 1 year	Additional information
Duloxetine	£2.17 to £4.34	£28.21 to £56.42	Based on dosage of 60 mg to 120 mg per day
Amitriptyline	£0.83 to £3.57	£10.79 to £46.41	Based on dosage of 10 mg to 75 mg per day
Gabapentin	£2.65 to £10.60	£34.45 to £137.80	Based on dosage of 900 mg to 3.6 g per day
Pregabalin	£32.20 to £64.40	£418.60 to £837.20	Based on dosage of 150 mg to 600 mg per day
Tramadol	£3.13 to £6.26	£40.69 to £81.38	Based on dosage of 200 mg to 400 mg per day

The cost of a multi-use Biowave PENS machine is £2,000 (excluding VAT) and the cost of the single-use PENS electrodes is £100 per treatment.

Resource consequences

Aptiva would generate additional costs to the NHS compared with standard care: for the cost of the device itself, consumables and additional staff time. For example, if it were administered by a band 3 healthcare assistant it would cost an extra £437.50 per patient per year. That figure rises to £770 if administered by a band 6 diabetes specialist nurse (PSSRU 2016).

The overall resource consequences are uncertain and depend on whether Aptiva were used in addition to, or in place of, current drug treatments. Among people using Aptiva in a randomised controlled trial (Bosi et al. 2013), none of those already on medication stopped it in the course of the study; no information was given on whether using Aptiva reduced dosage. Aptiva could be cost effective if it were shown to significantly improve quality of life compared with current drug therapies, but there is no evidence available to determine this.

Aptiva could lead to significant changes in the current care pathway, mainly from the time needed for treatment. Each cycle involves 10 35‑minute sessions and up to 3 cycles are recommended per year. Additional clinic space is needed for each treatment.

Aptiva is currently used in 1 NHS Trust.