Advice

The technology

The technology

Differential target multiplexed spinal cord stimulation (DTM SCS; Medtronic) is a novel spinal cord stimulation therapy for people with chronic, intractable, lower back pain and leg pain. It is based on a proprietary algorithm that is programmed into the Intellis neurostimulator.

The algorithm delivers 3 therapy options with each option consisting of 4 stimulation signals (1 base signal and 3 prime signals). The base and prime signals differ from each other in frequency, pulse width, charge balancing and amplitude, and differentially target 2 anatomical locations in a person's spinal cord. This means that in total the multiplexed signals of the DTM SCS algorithm target 6 anatomical locations. The amplitudes for the base and prime signals at each of the 6 anatomical targets can be adjusted to suit the person's pain needs.

The DTM SCS therapy system consists of:

  • an implantable neurostimulator (Intellis)

  • percutaneous or surgical leads (Vectris)

  • an external wireless stimulator used for testing during trial and implantation

  • a clinician programmer

  • a patient programmer and recharger.

Innovations

DTM SCS represents a novel spinal cord stimulation waveform that targets multiple anatomical locations using multiple electrical signals. Pre-clinical studies suggest that DTM SCS better modulates glial and neuronal gene expression back towards a non-pain state when compared with low- or high‑frequency spinal cord stimulation (Vallejo et al. 2020).

The system components also have several innovative features. This includes the extended battery life of the Intellis neurostimulator which is powered by overdrive battery technology (provides up to 95% battery capacity at 9 years). The system also provides wireless programming and Snapshot reporting that allows objective monitoring of the person's progress. It also includes other features such as AdaptiveStim technology which automatically adjusts therapy as a person moves and SureScan MRI technology to allow full body MRI scanning under specific conditions.

Current care pathway

People presenting with chronic pain are usually assessed by a multidisciplinary team experienced in managing chronic pain. Treatment offered is based on the presentation and severity of pain and includes pharmacological and non-pharmacological options. Pharmacological treatment options include non-steroidal anti-inflammatory medicines, tricyclic antidepressants, antiseizure medicines, analgesics and opioids. Non‑pharmacological treatment options include physiotherapy, psychological therapy and spinal cord stimulation. Spinal cord stimulation is recommended by NICE for adults who have chronic neuropathic pain (for at least 6 months) and have had a successful spinal cord stimulation trial.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

DTM SCS therapy is intended to be used for adults experiencing chronic lower back and leg pain, including unilateral pain.

Treatment would be managed by a multidisciplinary team with experience in neuromodulation. The Intellis neurostimulator and percutaneous or surgical leads would be implanted by specialist pain consultants or surgeons in an operating theatre. Stimulation settings can be adjusted by clinicians or the person using the therapy to suit individual pain needs using an external programmer.

Costs

Technology costs

The cost of DTM SCS therapy is £18,246 (excluding VAT) and includes the cost of:

  • the implantable neurostimulator (Intellis): £15,046 (excluding VAT), including a 9‑year limited device warranty

  • 2 percutaneous leads (Vectris): £3,200 (excluding VAT).

There are additional costs for the trial phase and the surgical procedure. The trial phase costs £2,170, which includes the cost of a trial lead (£1,200) and the cost of an external trial battery (£970). The cost of the surgical procedure is £6,564 (average NHS reference costs 2019 to 2020 for Healthcare Resource Group [HRG] codes AB12Z for insertion of neurostimulator and AB14Z for insertion of neurostimulator electrodes). Spinal cord stimulation devices are NHS England, high-cost tariff-excluded devices (HCTED).

Costs of standard care

NICE's technology appraisal guidance on spinal cord stimulation for chronic pain of neuropathic or ischaemic origin describes spinal cord stimulation devices (including stimulator, controller and charger, but excluding leads) as ranging from £6,858 to £13,289. The cost of leads ranges from £928 to £1,804 for surgical implantation and £1,065 to £1,158 for percutaneous implantation. However, these costs were last reviewed in 2013. NICE's medical technologies guidance on Senza spinal cord stimulation system for delivering HF10 therapy to treat chronic neuropathic pain reports more recent costs:

  • Senza costs £16,648 (including electrodes, leads, implantable pulse generator, remote control and battery charger).

  • Non-rechargeable spinal cord stimulation system costs £11,281 (95% CI £8,888 to £14,516), with a lifespan of 4 years.

  • Rechargeable spinal cord stimulation system costs £17,422 (95% CI £13,726 to £22,418).

An updated version of the Senza spinal cord stimulation system is now available, called Senza Omnia (2500). Costs may be higher than those listed above. Experts noted that the device costs listed here may have changed since the time of the NICE publication.

Resource consequences

DTM SCS therapy on Intellis has been launched in the UK and is currently being used in 9 NHS hospitals. DTM SCS would be used as an alternative to conventional spinal cord stimulation devices and the care pathway would remain unchanged. The costs for DTM SCS therapy are within the range of conventional spinal cord stimulation systems currently available in the NHS. Training of healthcare professionals on the Intellis system and DTM SCS is provided by the company.