With regulators and particularly payers increasingly moving to outcomes-based models, ways to monitor the use of drugs and technologies provide a better chance of approval and reimbursement. New Zealand’s Nexus6 believes that its technologies, designed to improve the adherence of respiratory disease patients to their drugs, meet these requirements.
And as improved compliance keeps treatment costs down – ever more important in the current economic squeeze – such a technology benefits healthcare systems as well as improving patients’ health. “There’s real value in seeing how patients use their medications,” Garth Sutherland, Nexus6’s CEO, tells EP Vantage.
Filed and monitored
Nexus6 makes devices that clip onto the inhalers that deliver drugs for asthma and COPD. Called SmartInhalers, the range includes reusable monitors to fit standard puffers as well as the proprietary Symbicort Turbuhaler and Advair Diskus devices, among others. They sense the use of the inhaler and record and transmit usage data wirelessly. Mr Sutherland, who has asthma and uses Nexus6’s products himself, says: “The monitoring devices clip onto people’s prescribed respiratory medications, and these report data to a whole suite of apps that run on smartphones and tablets, which in turn send it to our cloud-based reporting database.”
As well as simply improving adherence, the devices facilitate the sharing of information. Nexus6’s cloud-based service permits patients to track their medication usage, but also to send the data to their doctor, or allows parents to ensure their children are using the medication properly.
The company is now working on a next-generation product called SmartTouch, which unlike earlier iterations incorporates a colour touchscreen. “It’s really easy to use, and the battery lasts for a couple of months before needing to be recharged," says Mr Sutherland.
The new technology incorporates audio reminders and visual alerts on both the device and the apps to remind patients to take their preventive drugs. “They’ve proven very effective. Using the preventive therapies is key to disease management. In general, patients take around 30-50% of what’s prescribed – this is the adherence issue,” Mr Sutherland adds.
Checked and cleared
The SmartTouch device is currently under review for approval in Europe and the US. The company expects approval within the next month or two. Most of the firm’s other technologies are CE marked and a smaller number have FDA clearance.
Nexus6 is now moving into another area: sleep apnoea. Because sleep apnoea devices, such as continuous positive airway pressure (CPAP) machines, are sometimes tricky and uncomfortable to use compliance is a major problem, and one that payers are increasingly concerned by.
“As in a lot of the healthcare markets these days, there’s a big drive towards payers moving to outcomes-based payment models and sleep apnoea has been one of the initial markets where that came into play,” says Mr Sutherland. “In the US, one of the primary payers said they were no longer going to pay for [sleep apnoea] equipment if the patients couldn’t demonstrate usage in the initial period. That was anchored around this concept of improving adherence to the therapy.”
Commerce is our goal
The company's business strategy centres on pursuing partnerships, Mr Sutherland said, though he declined to name any of the companies concerned.
The respiratory disease space is changing fast, Mr Sutherland says. “There’ve been some pretty interesting acquisitions recently: Pearl Therapeutics by AstraZeneca, MicroDose Therapeutx by Teva. We’re starting to see big pharma talking about personalised medicine, and for all these types of initiatives coming from big pharma there is a need for monitoring technologies that track how well those new therapies work for specific patients.”
Nexus6’s technology could also have a role in lifecycle management. “Over the last 10 years we’ve seen asthma drugs repurposed into COPD; a handful of therapies are prescribed to all patients. They are truly blockbusters, and the patents are lapsing on many of them. But what works for one patient may not work for another, or it’ll work at a different dose: the way to drive efficacy is through understanding and proving adherence.
“We see this as very important for the pharma world, and the pharma world is starting to recognise that as well. For those companies whose drugs are coming off patent, there’s a need for brand extension. With new drugs few and far between, traditionally they’ve turned to the device.”
Generics are also in the offing; just today the FDA invited comments on draft guidance on bioequivalence recommendations for Advair. In a highly competitive genericised market, an advance in inhaler technology could provide a crucial USP.
Though venture-backed, having closed a NZ$4.6m (US$3.7m) round in February, Mr Sutherland says that Nexus6 is not seeking an exit in the short term. Instead, the company is hiring, shoring up its Australasian base and expanding into Europe and the US. The company will have to form partnerships to sustain it – Mr Sutherland says an announcement is imminent here – but if it can pull this trick off, the company could be around for some time. Unlike the replicants after which it is named, accelerated decrepitude will not be a problem for Nexus6.