A Department of Health, Disability and Ageing-led review of the controversial back pain treatment was spurred by concerns about its safety profile.
Spinal cord stimulators are the subject of yet another health department review, with the latest recommendation being to reduce private health benefits for neurostimulator implantable pulse generators (IPGs) by 43%.
The medical devices were added to the Prescribed List – the document which specifies the minimum benefit that a health insurer must pay for a certain device or product – without being assessed by the Medical Services Advisory Committee or the Medical Devices and Human Tissue Advisory Committee.
In the years since spinal cord stimulators were added to the Prescribed List, multiple systematic reviews have raised doubt over the intervention’s efficacy.
A 2022 Cochrane review led by University of Sydney researchers found that the evidence did not support the use of spinal cord stimulators to manage low back pain outside of a clinical trial. It also found that spinal cord stimulation probably did not have the sustained clinical benefits that would outweigh the costs and risks associated with it.
Given these findings, it is perhaps unsurprising that spinal cord stimulators were singled out as one of four topics suitable for a post-listing review pilot.
This is separate to the TGA post-market review published in 2024, which only focussed on safety and performance of spinal cord stimulator devices.
Instead, the post-listing review specifically looks at whether the Prescribed List benefits for spinal cord stimulator devices reflect clinical effectiveness and cost effectiveness.
According to the draft review report, which was published on Monday, multiple experts had noted that spinal cord stimulation devices attracted a substantially higher benefit than other neurostimulation devices on the Prescribed List, with no clear reason for the discrepancy.
It recommended reducing the Prescribed List benefits for non-rechargeable and rechargeable IPGs by 37% and 26% respectively.
Where insurers had to pay a minimum benefit of $21,660 for non-rechargeable spinal IPGs beforehand, they would now have to pay $13,592.
For rechargeable devices, it would change from $23,465 to $17,283.
This brings spinal cord stimulators in line with vagal, sacral and deep brain neurostimulation devices on the Prescribed List.
There were also proposed changes to the benefits for the leads which are used in the devices.
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Insurers would go from paying between $3041 and $8123 in benefits for percutaneous leads, depending on the number of electrodes, to a flat fee of $3041.
For epidural paddle leads, the minimum benefits would go from between $6895 and $11,011 to just $4561.
Private Healthcare Australia, which represents insurers, told The Medical Republic that taxpayers and private health insurers currently fund around 90% of spinal cord stimulation procedures in the private sector.
“The cost of any medical device funded by health insurers and government must be justified by clear, proven clinical value,” CEO Dr Rachel David said.
“If spinal cord stimulators are to remain on the market, their pricing must reflect the evidence.
“In addition, robust oversight and transparent reporting of patient outcomes are essential to safeguard both patients and the sustainability of our health system.”
