Spinal cord stimulation: The debate amidst promising data and health insurance caution

MedTech & Diagnostics News: Two new clinical trials have underscored the efficacy of spinal cord stimulation (SCS) technologies. However, despite the promising findings, private health insurers maintain a cautious stance on the benefits neuromodulation.

A recent consumer report by Painaustralia has shed light on the transformative impact of spinal cord stimulators (SCS) on patients’ lives. The report indicates that SCS procedures have not only enhanced the quality of life for patients but have also led to a notable reduction in medication usage and an improvement in their ability to undertake everyday activities.

Adding to the patient lived experiences, Medtronic recently presented trial data highlighting the benefits of SCS in patients suffering from chronic low back pain and leg pain. The study, conducted over three months in Australia, focused on Medtronic’s next-generation rechargeable SCS system, currently holding approvals in Europe and Japan, but still investigational in the U.S. and Australia.

Presented at the North American Neuromodulation Society (NANS) annual meeting, the primary objective of the study was met with 89% of patients reporting a significant reduction in overstimulation compared to open-loop systems. Furthermore, 86% expressed a preference for closed-loop therapy during blinded testing at one month, with clinically meaningful improvements observed in pain, physical function, and overall quality of life at three months.

Medtronic also reported success in its secondary objective, with 86% of subjects experiencing a 50% or more reduction in overall back and leg pain at three months, culminating in satisfaction with closed-loop SCS therapy.

Additionally, Medtronic shared 24-month outcomes for its Differential Target Multiplexed (DTM) SCS compared to conventional medical management. Notably, the study demonstrated a 77% reduction in chronic low back pain at 24 months for patients utilising DTM SCS, along with an impressive 93% leg pain responder rate for those achieving more than 50% leg pain relief.

However, amid the positive strides in neuromodulation, CEO of Private Healthcare Australia, Dr Rachel David, urged caution regarding the Painaustralia survey. She emphasised the need for scrutiny, stating, “This is a billion-dollar industry that some doctors and medical technology companies profit from, so any consumer research funded by that industry must be heavily scrutinised.”

According to a recent Cochrane review “No studies have tested whether spinal cord stimulation surgery is better than placebo (sham or ‘dummy’ treatment) in people followed up for longer than 6 months. This means that the benefits of the treatment in the long term are unknown.”

Australian health insurance data paints a complex picture. Over the past year, 1351 spinal cord stimulator procedures were conducted in Australia, with 27% of patients requiring revision surgery due to complications. The average cost of the procedure stands at $58,377.

In response, Painaustralia CEO Giulia Jones defended the consumer perspective, stating, “We know that 1 in 2 consumers living with chronic pain have considered suicide, and various treatments have been restricted and made almost impossible to get in recent years. So, we see a need to let the consumers speak for themselves about their experience of SCS.”

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