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 SCS in 2024.
The PL 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 (SNECAG) and the Medical Devices and Human Tissue Advisory Committee
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 built on the findings from stages 1 and 2 and reviewed the benefit settings for IPGs and leads separately.
IPG
We engaged an external consultant to provide expert advice on benefit setting options for IPGs.
Leads
We have engaged an external consultant to provide expert advice on review the use of leads claimed in a SCS trial procedure and provide us with benefit setting options.
We reviewed internal data on claims for the use of leads from the product subgroup 04.04.03.01 – Permanent Leads in a SCS trial procedure.
The MDHTAC considered the expert advice and benefit setting options for IPG and leads at the May 2025 meeting. The MDHTAC recommended the department consider:
- removing subgroup 04.05.03.02 – Trial Lead from the PL due to redundancy
- adjusting the benefits for IPG and
- adjusting the benefits for leads.
We have published a draft summary report which outlines the review process, findings and proposed outcomes.
Impact Assessment
We are completing an impact assessment on the proposed outcomes of the review. We are working with key stakeholders (including patient support groups, private health insurers, clinical associations and sponsors) to understand the potential impacts of the proposed changes. Other stakeholders can provide feedback via the consultation hub. The consultation hub will close at 4pm on 23 March 2026.
We will collate feedback on the draft report and impact assessment before presenting options to the delegate for decision.
Timeline
| Date | Activity |
|---|---|
| June 2026 | Finalise department report |
| May 2026 | MDHTAC advice on impact assessment |
| February – April 2026 | Impact assessment on proposed outcomes |
| Stage 3 | |
| May 2025 | Present options to the MDHTAC |
| 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
We have published a draft departmental report. The report summarises the process, findings and proposed outcomes from the review. We have invited stakeholders to provide feedback on the draft summary report.
We will publish the final report on our webpage.
Contact
