By Simon Thomson
In 2009 I became president of the International Neuromodulation Society (INS). I realised then that the INS had to brand the term neuromodulation in order to support the broad acceptance of a diverse range of neurostimulation therapies within the dogma of medical practice and wider health economy. The three biennial congresses that followed in London 2011, Berlin 2013 and Montreal 2015 each had a strap line that were written in the present tense and linked innovative technological medicine with chronic disease management and care that put patients at the centre of their care: “Technology that Improves Patient Care”, “Technology Transforming Chronic Illness Management”, and “Medicine evolving through Technology”. These phrases also capture the sense that medical practice and our understanding of disease management is changing and will change more.
The three most accepted neurostimulation therapies are spinal cord stimulation (SCS) for neuropathic pain, subthalamic deep brain stimulation (DBS) for Parkinson’s disease, and sacral nerve stimulation (SNS) for overactive bladder, non-obstructive urinary retention and faecal incontinence. Despite the proven clinical and cost effectiveness of these therapies only a small percentage of those patients in developed health economies that should have access actually have it. In Europe, perhaps only 5% of patients with chronic neuropathic back and leg pain have SCS (perhaps 15% in USA) or 23% of severe appropriate Parkinson’s disease sufferers in USA (9% in Europe) or 1% of patients with overactive bladder in Europe (6% in USA). Exploring the reasons for these low levels of access deserves some effort. Until these hurdles are addressed and overcome even these neuromodulation therapies will struggle to become the standard in disease treatment.
Neuromodulation has evolved as an expensive treatment for expensive conditions. Device manufacturers have innovated and tried to find markets to give a return on their investment. An industry selling high-priced devices with a high level of service but at low volumes has evolved. At some stage there will be a shift towards lower-cost devices and service, but at higher volumes.
Now, there are five SCS companies but the prices keep increasing as they are still competing to provide better outcomes through technological change whilst the professional societies (like the INS) are trying to increase quality of provision.
A further drive towards acceptance by the wider profession, patients and payers will come from the development of less or non-invasive devices to manage more common or less severe complaints that are normally provided for pharmacologically. This area is where the mass market for neuromodulation resides. With increasing acceptance of such less or non-invasive targeted therapies, a lower threshold to the more effective and manageable implanted therapies will become more normal.
A current imperative for the neuromodulation field is to produce the research data to demonstrate the clinical and cost effectiveness of the added value of these technologies when added to best medical practice. This has become the normal in some countries like the UK. Even in the USA with a previously open health budget this is beginning to change amongst many health payers.
The UK, through its National Health Service is able to boast that it has one of the most equitable of access to healthcare services in the developed world. It may have many other shortcomings but this is not supposed to be one of them. Despite that, there is a 20-fold variation of uptake of SCS from one region of the UK to another. This is despite NICE’s Technology Appraisal 159, that clearly recommends SCS for refractory neuropathic pain. So, if Policy is NOT the barrier to equitable access for SCS, then what is? I will discuss this later, but first let us consider the other two neuromodulation therapies mentioned, albeit within the UK context.
DBS for Parkinson’s and SNS for overactive bladder/retention and faecal incontinence are funded via a separate budget within the NHS for “Specialised services”, namely NHS England. This is in contrast to SCS, which is funded by local/regional core commissioning groups. Core commissioning groups are responsible for the effective purchasing and provision of all healthcare within a locality apart from those specialised services provided more centrally by NHS England. There is ONE NHS England but 100+ core commissioning groups.
NHS England has created policies to provide DBS for Parkinson’s disease and SNS for overactive bladder/retention and faecal incontinence based upon NICE Interventional Procedural guidance and clinical guidelines. The cost effectiveness for these therapies in carefully selected populations is favourable within a UK NHS setting. It is a relatively straightforward step to implement this through NHS England Specialised service networks. Both these therapies have a single point of access via specialist movement disorder neurology or incontinence services respectively. A clinical pathway with agreed treatment escalation points is relatively straightforward.
Contrast this with the management of chronic neuropathic back and leg pain (often referred to as failed back surgery syndrome, FBSS, a term that really should be abandoned) or complex regional pain syndrome where there is a whole variety of disconnected teams trying to manage the same condition but often with widely different understandings of the central disease concept and the sorts of outcomes that can be achieved with their particular management strategy.
However, there is some good news. Several countries have produced multidisciplinary guidelines for complex regional pain syndrome and back and radicular pain. The NHS England Pathfinder projects published its National Pathway of Care for Low Back and Radicular Pain in February 2015. It draws together all the stakeholders and through a consensual process has positioned various services on a pathway dependent upon the dominant features of non-specific back pain and radicular pain. It is now implicit that SCS is established as a standard treatment for neuropathic back and leg pain not only in the minds of implanting SCS physicians or surgeons but with other pain colleagues, orthopaedic and neurosurgical spine, physiotherapists and commissioners. However, we still await implementation of this guidance! Meanwhile we continue with our local commissioning guidelines that are mainly centred on particular centres of SCS provision further exacerbating the inequity of access nationally.
The average time a patient waits with known refractory neuropathic pain before they receive SCS is between five and seven years. The professional groups that prevent these patients with refractory pain from access to SCS are pain specialists, orthopaedic and neurosurgical spinal surgeons in descending order.
A recent market research online survey asked 150 respondents (72 pain anaesthetists and 78 orthopaedic or neurosurgical spinal surgeons) about their perception of SCS as a treatment option for non-operable chronic neuropathic back and leg pain. Only half of pain anaesthetists and 14% of spinal surgeons would regularly treat or refer for SCS. Two thirds of pain anaesthetists and one third of spinal surgeons would use long-term drug therapy for chronic back and leg pain, with 75% pain anaesthetists also employing repeat nerve and steroid injections and a third referring for physiotherapy. Meanwhile, half of spinal surgeons refer such cases to pain anaesthetists.
When asked what additional information would be required to enable SCS treatment, 89% of spinal surgeons and 52% of pain anaesthetists wanted NICE guidance. This is rather bizarre since it is freely available since 2008 on the NICE website. Other factors that limited referral were concerns over funding if referred, lack of clear referral destination and for the spine surgeons, a lack of precise referral criteria.
So for SCS and chronic neuropathic back and leg pain it is clear where the true barriers are to SCS becoming a standard of disease treatment. Parts of this will be true for other neuromodulation therapies as well. We are not getting the message across to our professional colleagues where they are acting as gatekeepers to patient access. Cross specialty education in an age of super specialisation is more important than ever.
Simon Thomson is a consultant in Pain Medicine and Neuromodulation at Basildon & Thurrock University Hospitals NHS Foundation Trust, Essex, UK and the Immediate Past President of the International Neuromodulation Society