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CHANGE is apace in the Australian neuromodulation world.
Neuromodulation is defined by the International Neuromodulation Society (INS) as the field of medicine and science that encompasses implantable and non-implantable technologies, delivering electrical signals or micro-doses of chemicals directly where they are needed (at neural interfaces) with the aim of improving quality of life for humanity.
Neuromodulation turned 52 years old in 2019, and is now practised by medical specialists, such as pain physicians, spine surgeons, neurosurgeons, and urogynaecological and colorectal surgeons.
Implantable technologies used include spinal cord stimulation (SCS), sacral nerve stimulation, intrathecal pump therapy, and even brain stimulation.
Since the first SCS implant in 1967 by Norman Shealy, neuromodulation has made some remarkable advancements. However, many doctors and health professionals still do not understand what neuromodulation is, or how it works. Nor do they comprehend its place in modern medical practice as a therapy that can dramatically and quickly treat diseases such as chronic pain and significantly improve patients’ quality of life. Unfortunately, many patients wait years to access this therapy and are usually a fortunate few are treated.
There is a growing level of high-quality evidence to support its use, particularly in chronic pain, with carefully selected and prepared patients likely to obtain substantial pain reduction. In a trial of patients with chronic back and leg pain (Kapural et al, 2016), 84.5% of back pain subjects and 83.1% of leg pain subjects demonstrated over 50% pain reduction at 2 years’ follow-up, with 65% of subjects considered in pain remission with pain scores below 2.5/10. On the whole, no other pain therapy has been able to demonstrate this magnitude of reduction in pain scores.
The list of indications for the use of neuromodulation for chronic pain is expanding. Traditionally, it was reserved for severe treatment-refractory cases of complex regional pain syndrome (CRPS) (here, here, and here) and chronic pain after spinal surgery (also known as failed back surgery syndrome or FBSS) (here, and here). Today, indications also include neuropathic low back pain, neuropathic pain after injury/surgery, postherpetic neuralgia, painful diabetic and post-chemotherapy neuropathy, bladder instability, and rectal voiding issues. Not surprisingly, these new indications challenge existing dogma and are sparser in their levels of evidence compared with the traditional indications, but are offering patients much needed alternatives to failed medications and the symptom burden of those chronic diseases.
SCS may help mitigate the growing opioid crisis. Following promising early studies, neuromodulation is now the focus of randomised controlled trials, such as the REDUCE trial, which aims to better understand how SCS can be used to support opioid dose reduction.
Despite a growing body of evidence to support the use of neuromodulation more widely in medicine, there are a number of factors that need consideration.
This therapy is reversible, and the risks are generally considered to be low, but, like any advanced medical treatment, neuromodulation requires a level of expertise to safely and effectively manage, and to keep more significant risks to a minimum. There is a need for a structured training program in this field across pain and surgical disciplines. While individual centres of excellence train physicians internally, and societies like the Neuromodulation Society of Australia and New Zealand (NSANZ) run regular teaching and cadaver courses, a more structured and explicit training program is likely to yield more consistent levels of competency and experience. The Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists’ recent pivot to incorporating procedural training is a welcome step forward in this area.
To further mitigate risk, there is recognition by both clinicians and external parties that a registry of implant procedures and relevant outcomes is needed to improve clinical practice, document long-term outcomes, and identify potentially sub-optimal implant designs and complication rates. This would be similar to the Australian Orthopaedic Association National Joint Replacement Registry. Despite continuous attempts by both NSANZ and the Faculty of Pain Medicine, a registry has not yet been set up. This situation cannot continue, and NSANZ is dedicated to seeing such a registry come to fruition.
This therapy is expensive at the front end, with costs recouped over time, and has traditionally been supported by the private health insurance companies. However, with the changes in private health insurance coverage and the introduction of the new Gold, Silver, and Bronze tiered system, neuromodulation devices have been placed in the Gold tier, thereby restricting access to this therapy for an estimated 50% of the privately insured population.
If patients are not provided access to this therapy, the alternatives include long-term opioid therapy, or undergoing repeated hospital admissions, and even further and often unnecessary operations. This realisation has recently caused some of the private health insurers to recognise the serious and detrimental effect of withholding this therapy, and some have now elected to move neuromodulation back into Silver tiers of cover. It is likely that more insurance companies will follow suit when the true opportunity cost of denied treatment is both calculated and further understood.
Anecdotally, there is some recognition that these device costs have not become cheaper over time. In inflation-adjusted terms, the devices have been constant in cost, while delivering more technical capability. In a cost-constrained health care system where their applicability may expand significantly over time, one would expect market or regulatory forces to produce downward pressure on pricing. This has been clearly realised in the cardiac pacemaker field, and we expect to see this price reduction to occur in the neuromodulation field over the next 5-7 years.
There are increasing numbers of neuromodulation companies entering the field and offering medical devices, each with unique features, such as specific electrical waveforms and even smaller implantable batteries, also called pulse generators. Currently, five companies operate in the Australian market, but over the next 18 months another four or five companies are expected to be registered and gain Therapeutic Goods Administration approval. This will provide real challenges to the companies’ financial models, competing in a relatively small market (only some 2000 implants are estimated to occur per year in Australia). We hope this will drive further efficacy improvements and cost reductions, which will likely provide significant benefits to our patients and the broader community.
NSANZ is facing multiple tasks in a very rapidly changing landscape. It is charged with advocacy over knowledge and access to the therapy and educating others about this emerging standard therapy for proven indications. NSANZ will partner with stakeholders in guiding a formal training program as a sub-specialty area, and advocate for a registry of device implants. We will publish documents focusing on best practices using this therapy.
Cost reduction must go hand-in-hand with technological advancement and safety if this therapy is to take its place in relieving pain and improving function in chronically impaired individuals.
Finally, there is increasing demand for evidence of efficacy and cost-effectiveness from government, private health industry and WorkCover insurance companies. While 500 cases of pain device implants per year may fly under the radar, 2000 cases per year increasing at a rate of 5-7% per annum, rightly focus the spotlight on ensuring implants are producing the outcomes for which they were intended, and that the therapies have acceptable cost-effectiveness prima facie in comparison with alternative therapies. NSANZ is focused on engaging with key stakeholders to ensure all work towards cost-effective models of care and has recently commissioned a Deloitte Access Economics report focused on the issue of cost.
In many ways, it will be case of watch this space.
Dr Nick Christelis is a specialist pain medicine physician, specialising in the use of neuromodulation for complex neuropathic pain conditions. He is director of Pain Specialists Australia in Melbourne, Victoria and President of the Neuromodulation Society of Australia and New Zealand. You can find him on Twitter @PainSpecialistN
Dr Marc Russo is a specialist pain medicine physician and Founding President of NSANZ. He is Director of Hunter Pain Clinic, Hamilton Day surgery Centre, Genesis Research Services and Co-Director of Innervate Pain Management Program in Newcastle, NSW. He is a Founding Member and Director at Large of the Australian Chapter of the International Neuromodulation Society, and he is President-Elect of the INS.
The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.