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) completed a review on the safety and performance of SAS in 2024.
The Prescribed List includes SCS devices in Group 04.05.01 Pulse Generators under the Neurostimulation Therapies for Pain Management 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.
The review process
We are conducting the post-listing review of SCS in several stages.
Stage 1
We engaged an external consultant to assess the comparative clinical effectiveness and cost effectiveness of spinal cord stimulators.
The external consultant report found:
- 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.
The external consultant report was provided to the Spinal and Neurosurgical Expert Clinical Advisory Group and the Medical Devices and Human Tissue Advisory Committee (MDHTAC) for their consideration. MDHTAC recommended we review the benefits for SCS.
Stage 2
In Stage 2, we reviewed the benefits for SCS as recommended by the MDHTAC.
Stage 2 focused on 2 components of a SCS system, the implantable pulse generators (IPGs) and leads. These devices make up most of the SCS benefit.
We engaged an external consultant to analyse the benefits for IPGs and leads. The MDHTAC reviewed the external consultant benefit analysis and advised us to undertake further assessment of the benefits.
Stakeholder input into Stage 1 identified increasing use of permanent leads (subgroup 04.04.03.01 - Permanent Leads) in SCS trial procedures. In stage 2, we consulted with clinical stakeholders and sponsors to understand more about leads used during a SCS trial procedure. Amongst other factors, we learnt that specifically designed trial leads are not currently used in Australia.
Stage 3
We are building on the findings from stages 1 and 2 to review the benefit settings for IPGs and leads separately.
IPG
We have engaged an external consultant to provide a commentary on benefit setting options for IPGs.
Leads
We have engaged an external consultant to review the use of leads in a SCS trial procedure and provide us with benefit setting options.
We are also reviewing internal data on the use of leads from the product subgroup 04.04.03.01 – Permanent Leads in a SCS trial procedure.
Timeline
May 2025 – Present options to MDHTAC
June - November 2025 – Stakeholder consultation
| Date | Activity |
|---|---|
| Stage3 | |
| January – March 2025 | Received commentary from external consultant |
| November – December 2024 | Consultation with clinical stakeholders and sponsors |
| Stage 2 | |
| September 2024 | Report findings considered by the MDHTAC |
| June 2024 | Report on benefit setting received from external consultant |
| Stage 1 | |
| 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 when the review is complete.
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