The year is 2000, and Tim Herbert, a product development engineer at Medtronic, is working on the final stages of an exciting project years in the making. Since the early 1990’s, Tim and his R&D colleagues had been working on a device with the potential to revolutionise the treatment of a common sleep disorder affecting 1 billion people. By 2007, Tim had spun the technology and intellectual property of the device, called Inspire, out of Medtronic and into its own company.
Tim and his team were onto a winner. They had managed to successfully adapt neurostimulation technology, used in chronic pain and movement disorders, to stimulate the hypoglossal nerve in people with Obstructive Sleep Apnoea (OSA), a disease impacting 1 billion people with limited treatment options. The distal branches of the hypoglossal nerve control two important airway dilator muscles, the genioglossus and the transverse vertical muscle, and with targeted stimulation these muscles gently push the tongue forward to open a collapsed airway, the defining feature of OSA.
OSA suffers from a bad reputation that prevents patients from seeking treatment, and medical device companies from developing a solution. Thought by many to be nothing more than harmless snoring, innovation in the form of an implantable device has lagged behind many other chronic diseases. This is despite OSA’s high prevalence and associated health risks, such as stroke and cardiovascular disease, when left untreated.
A pug, vacuum and a hosepipe
Since its early development by Elliot Philipson and Collin Sullivan in the 1970s, the mainstay of treatment for OSA has been Continuous Positive Airway Pressure, or CPAP. Using a vacuum motor and a mask attached to a hosepipe, Dr Sullivan tested the first ever CPAP machine on brachycephalic animals, like pugs and bulldogs, who struggled to breathe because of their poor facial architecture.
Today’s CPAP machine shoots a continuous flow of pressurized air through the nose to prevent airways from collapsing, and when used correctly and consistently, has a high efficacy rate. But even though the technology has advanced significantly, CPAP patients are still wearing uncomfortable, bulky masks and tubes to bed.
Ironically, people with OSA can sleep worse with CPAP than without it because of its discomfort, leading to non-compliance rates of 50%, according to clinical data. This makes the prospect of a tiny device doing the same job as CPAP from inside the body, very appealing for patients.
In 2014, the United States Food and Drug Administration announced the approval of Inspire, the neurostimulator developed by Tim and his team, for people who were unable to tolerate CPAP. With no competition, a significant market opportunity in the 1 billion people worldwide who live with OSA, and experts believing 75% of people who snore are undiagnosed, Inspire Medical Systems has begun an expansion into Asia, beginning with Singapore and Japan.
Dr Han is one of three ENT surgeons in Singapore trained to fit Inspire. One of his first patients of 2023 is Rob, a man in his early 30’s who is prone to falling asleep in taxis, on sofas and as soon as his head hits the pillow at night. This is because of the significant ‘sleep debt’ Rob has racked up in his many years of living with the disorder. Sleep debt is the difference between the amount of sleep someone needs, versus what they actually get. Rob is permanently tired because his breathing is interrupted 21 times an hour during sleep, due to his collapsing airways.
From left to right: Consultant Otorhinolaryngologist Dr Shaun Loh from Singapore General Hospital, Rob, Dr Han, and May Fang, Inspire’s Patient Outcomes Manager for Asia Pacific, before Rob’s outpatient surgery
“People don’t seek treatment for sleep apnoea largely due to a lack of awareness of the condition. Most people who snore do not realise that they do it, and it takes a family member to alert them. It’s always been accepted that snoring is natural and harmless.” Said Dr Han.
How Inspire works
In a simple outpatient surgery, two incisions are made. One along the right side of the neck, and the other in the chest wall during a procedure that takes around 2 hours. Usually, patients don’t experience much discomfort post-op, according to Dr Han. After the device settles, roughly three weeks from the date of surgery, Dr Han will switch on the device and over time, Rob will gradually increase the level of stimulation to his hypoglossal nerve.
A regulatory approval isn’t enough for a device like Inspire to get the traction it needs
Inspire was approved in Singapore and Japan in 2018, but an approval alone doesn’t guarantee an easy sell. Educating conservative physicians who prefer to prescribe CPAP is an obstacle preventing eligible patients from receiving treatment, and this was almost the case for Rob. “It was actually my wife who told me about Inspire. The first doctor I saw didn’t mention it at all.” For Inspire to reach those who need it the most, physician education at all levels is critical, says Dr Han.
“Physicians should begin the conversation about Inspire at the start, so that patients are aware of their options when CPAP fails. Education of Inspire is lacking at both the primary and specialist level, but we’re aiming to change that. Doctors of all levels should be included in the care process for OSA, because of how common a problem it is.” Said Dr Han.
Despite over 36,000 procedures to date, only 20 patients come from Asia, in part due to recent entry to the regional market but also due to education and awareness challenges facing the company.
“The current challenges in Asia are very similar to those we experienced in the US and Europe when the therapy was new. Not all clinicians are aware of the therapy and those who are may be hesitant to recommend it to their patients because of their lack of experience with it.” Commented May Fang, Inspire’s Patient Outcomes Manager for APAC.
Who pays for Inspire and how does the device fit into a future of preventive healthcare that Asian economies are striving for?
It’s no secret that Asia is ageing faster than any other region in the world. People here are living longer, but not healthier, adding huge pressure to reactive healthcare systems. Governments are calling for earlier intervention by care providers and hammering home the message that prevention is better than the cure.
Untreated sleep apnoea (as much as 80% of all cases) increases the risk of heart failure by 140%, the risk of stroke by 60%, and the risk of heart disease by 30%. It is easy to see just how much of an impact a device like Inspire could make to Asia’s ballooning NCD crisis when fitted into young, healthy patients like Rob who are years away from an NCD diagnosis.
But convincing payors of Inspire’s benefit is no small feat, and reimbursement can be a medical device company’s worst nightmare. Regulation varies significantly per country, is complex to navigate and can hinder innovation. But, Inspire costs SGD $40,000, and someone somewhere needs to foot the bill.
“In the US, all major insurance companies have a positive coverage policy for Inspire. But in Singapore, this is something we are trying to better understand.” Rob’s procedure was covered by a generous company healthcare policy, but not everyone with OSA has private health insurance.
In the US, Inspire’s coverage improved over time, and May expects the same to happen in Asia.
“A lot of convincing providers comes through education. It’s important for us to collect data on patient outcomes to share with insurers so we can prove that the therapy is effective and should be reimbursed.” Inspire’s patient reported outcomes, shown below, are extremely impressive. The full patient experience report from 2022 can be viewed here.
What next for Inspire?
Over the last five years, Inspire Medical Systems has seen a 1,600% increase in sales driven by high consumer demand and a lack of competition, with products aiming to rival Inspire being many years away from an FDA approval. The company reported its first profitable quarter in its full year results for 2022, submitting new indications for Inspire’s use in the paediatric population and patients with down syndrome, who have a high Apnoea Hypopnea Index. Last year, Inspire received FDA approval for full body MRI compatibility.
So, what does the road ahead look like for Inspire in Asia? We put the question to Tim Herbert, Inspire Medical Systems’ Chief Executive.
“We are thrilled to bring Inspire therapy to patients in Asia. There is growing acceptance around the world on the importance of a good night’s sleep in both our physical and mental health. There is also increasing awareness on the staggering cost of untreated OSA for health systems around the world. We see tremendous opportunity to serve patients across Asia and we will continue to work with regulators, payors, healthcare professionals and our distributor partners to ensure every patient has access to care while maintaining and improving our patient outcomes.”Tim Herbert, CEO, Inspire Medical Systems
Inspire is keen to continue growing in Asia, and is invested in having the device available in more APAC markets, through setting up dedicated training programs to reach more people with the disease. The first procedures are currently taking place in Hong Kong, and a regulatory application has just been submitted to Australian authorities. The future certainly looks bright for Inspire, and for the millions of patients who are about to benefit from this truly transformational technology.
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