What the review is about
Spinal cord stimulators (SCS) are implanted under the skin and treat certain types of complex chronic pain by sending electrical impulses to the spinal cord. They may be offered to people when standard pain treatments haven’t worked.
We commenced the post-listing review because of concerns about the comparative clinical effectiveness and cost-effectiveness of SCS.
The Therapeutic Goods Administration (TGA) is reviewing the safety and performance of these devices.
The review process
We are conducting a post-listing review of spinal cord stimulators on the Prescribed List. We are considering comparative clinical effectiveness and cost-effectiveness.
We are conducting this review as a focused health technology assessment through an external consultant, following an internal utilisation review.
The Prescribed List includes spinal cord stimulator devices in Group 04.05.01 Pulse Generators under the Neurostimulation Therapies for Pain subcategory. This subcategory includes:
- spinal cord stimulators
- dorsal root ganglion stimulators
- two peripheral nerve stimulators (PNS).
The PNS devices are out of scope for this review.
Timeline
We are currently considering the findings of the final report from the external consultant. This report was also provided to the Spinal and Neurosurgical Expert Clinical Advisory Group and the Medical Devices and Human Tissue Advisory Committee for their consideration.
The external consultant report found that:
- the evidence for comparative clinical effectiveness of SCS compared to standard care is uncertain
- despite a large body of evidence there remains doubt as to the magnitude of the clinical effect of SCS and the long term risk of adverse effects
- there was insufficient evidence to inform alternative PL listing settings.
We will undertake further analysis to assess the PL benefits for SCS.
Date | Activity |
---|---|
December 2023 | Report findings were considered by the Medical Devices and Human Tissue Advisory Committee |
November 2023 | Report findings were considered by the Spinal and Neurosurgical Expert Clinical Advisory Group |
September 2023 | Final report received from external provider |
30 June to 17 July 2023 | Targeted consultation on draft report |
16 May 2023 | Draft report received from external provider |
16 December 2022 to 10 March 2023 | Targeted consultation on the scope of the review |
Result of the review
This review is currently ongoing. We will release the outcome of the review once the review is complete.