Digital Therapeutics (DTx) could be playing a leading role in a healthcare revolution that is occurring almost overnight during the pandemic. The Sidebar looks at how the rapid shift in thinking in healthcare could lead to longer-term changes that encourage their use.
COVID-19 has turned the world on its head, and the impact has been felt in all areas of industry as businesses across the globe had to rethink their operations almost overnight.
Healthcare is one of the industries where COVID-19 has had the largest impact as many pharmaceutical companies, biotechs, and digital and medical technology companies quickly switched their research priorities in response to the pandemic.
The rapidly changing market environment has posed huge challenges to the healthcare sector but has also been a catalyst for change as digital technology allows healthcare professionals to interact with patients remotely, reducing the risks of the disease spreading.
Digital technology is also becoming increasingly important in trials in general: lockdown regulations make it harder for patients to visit hospitals and clinics so remote observation is becoming essential to keep studies running smoothly.
Governments and regulators have responded too. US vice president Mike Pence announced measures that could pave the way for more widespread reimbursement of digital products in health programs funded by the federal government, Forbes noted in an article outlining how COVID could start a ‘digital therapeutics revolution.’
The FDA was already trying to encourage use of technology, such as DTx, before the pandemic began. It had already put in place a pre-certification scheme that means small iterations of devices won’t need constant review, as long as the regulator deems that the manufacturer is behaving in an ethical manner and has high clinical standards.
Technology that helps doctors interact with patients has seen a surge in demand, Forbes reported, with some companies in the space hiring hundreds more doctors to keep pace. DTx may also be bundled together with telemedicine products, introducing them to new patients who could continue to use them after the pandemic subsides.
This all builds on findings of a report from the European venture capital group Mangrove Capital Partners that looked across the whole digital health landscape to see how technological innovation is likely to impact on healthcare.
Its Healthcare Reimagined report dedicated a chapter to the value of DTx and found that the sector is poised to become increasingly influential.
There are many players in digital health, with the ability to quickly make technology, but who lack the capacity to clinically prove their safety and efficacy, the authors wrote
They cited a 2018 analysis of published randomized controlled trials that found just 23 of apps available at the time had been tested in trials and less than half of those showed positive health effect from the app in question.
The interest pharma is piqued by the potential of DTx to create new revenue streams at a much lower cost than their traditional products – it is much more efficient to distribute software than medicines.
Citing Juniper Research, the Mangrove suggested the DTx market could be worth more than $32 billion by 2024, as the technology becomes more mainstream and embedded into health systems globally.
Many DTx products harness the power of AI to help with their decision-making. The report’s authors noted that while AI is already helping during drug development, there is potential for more use of the technology as a predictive tool.
AI could be used to predict cardiovascular risk factors, spotting mental health conditions, and the technology could be used to detect and predict potential health issues.
Access to data
A big attraction for pharma companies is that DTx offer them access to data – far more data than was previously available through conventional randomized controlled trials.
DTx could give them access to data from millions of patients, not just during the clinical development process but once products have made it onto the market.
According to Mangrove this “data influx” could improve management of side-effects, improve R&D and improve patient adherence to therapies.
The FDA is now considering DTx as medical devices and granting market exclusivity extensions, Mangrove noted
This can help drug companies to improve conventional drug treatments and keep them on the market for longer without generic competition.
Current scientific knowledge has led to DTx to focus on certain areas – mental health, cognitive behavior conditions including substance abuse, depression and anxiety, Mangrove noted.
These areas are treatable with strategies rooted in cognitive behavioral therapy (CBT), with the therapeutic tool helping to reinforce behaviors that can produce positive outcomes in a range of diseases.
An issue identified by Mangrove are delays getting products approved by regulators because of the sheer volume of requests for approval.
Regulators are struggling to keep up, and they can lack the different skills and expertise required to approve DTx, which can differ from conventional medical devices in the way they are assessed.
Right place right time
Much of the groundwork for the DTx revolution has already been put in place, and according to Forbes the COVID-19 pandemic could be the catalyst for change.
Health systems and businesses have had to reconfigure their working arrangements rapidly and digital technology has provided solutions to many of the problems that healthcare providers faced as the pandemic took hold.
DTx could become an essential part of the toolkit to manage patients during the pandemic and those pharma companies already using this technology in areas such as type 2 diabetes are already seeing benefits.
The current situation plays to the strengths of DTx, and thanks to the groundwork already done the sector’s many startups could become increasingly influential as the COVID-19 situation develops.
Across all industries the speculation is that the pandemic will change the way many organizations work, with more remote working and an increase in use of video technology to handle meetings.
The speculation is that DTx will remain in use once the COVID pandemic has subsided, and patients will continue to feel the benefits.
This revolution will not be televised – it will be digitized.