30/11/2022 | Point of view
We are in what we can call a phase 2 of Digital Therapeutics: the scale-up.
Three major factors are crucial in the large-scale adoption of these digital tools: validation through clinical trials, global access, and education.
It is important to generate evidence and gain scientific validation of DTx to drive trust and adoption within clinical care. While a limited number of RCTs were previously focusing on DTx, there are solutions with strong clinical validation that should be acknowledged and in the last two years there has been a markedly increasing trend of clinical studies focusing on digital health solutions and DTx.
From a regulatory perspective, amongst the EU-5 countries, 3 have at least one DTx accessible and reimbursed.
In the USA, the Digital Therapeutics Act (2022) has been introduced and is currently under review. If the bill is approved, it would make Digital Therapies reimbursable by Medicare and Medicaid.
40 percent of physicians are open to using digital therapeutics within the next year, and it will be critical to ensure many more physicians are aware and educated about DTx in order to drive the scale-up phase further.
The acceleration of digital tools brought by COVID is irreversible, but it certainly needs to be managed and integrated into existing systems of care.
At the center of the care model is the person, who, thanks to telehealth, manages his or her own care pathway in a more user friendly and proactive way with well articulated care pathways that are digitized, data-driven, and remotely monitored.
It is certainly no coincidence that the FDA and WHO have published Guides for Digital Health use and development of strategies.
The pharmaceutical industry is ready for this transformation. But there are many areas we need to work on to implement a paradigm shift from an acute, observation-based, fragmented health system to one that is prevention-based, data-driven, and highly integrated.
We are facing exponential growth in the use of digital interventions even in drug definition and development.
From innovative and precision drugs supported by innovative solutions to stand-alone digital interventions, through mature adopted drugs integrated by digital and digital-first interventions complemented by drugs.
The more we incorporate digital into the drug development pipelines, the larger the population we can reach.
The funding landscape has also changed.
While we saw strong growth in 2020 and 2021, now funding for health innovation is recalibrating to pre-pandemic levels. An especially significant trend in 2022 is Early-Stage funding.
According to Galen Growth's Digital Health 2022 mid-year ecosystem report, 124 deals were closed in Europe, mostly involving Early Stage, Series A and B startups.
This is a demonstration of continued investments in teams that have bright ideas and solid talent.
Partnerships and M&A also continue to be seen as a strategic asset and expertise building asset: M&As also grew in Europe in the first half of 2022, up 10 percent from the cumulative volume of mergers and acquisitions in 2021 and we expect this activity to continue to grow.
It is a new phase, but full of opportunities in different ways.
Digital Health, however, is a broad domain - it is not just telemedicine or digital therapies.
There are many digital innovations that are finally coming to fruition and that are set to enhance health outcomes, experiences and research. The power of Virtual Reality (VR), for example, that, when used properly, can enhance care experiences, rehabilitation and health outcomes. Explainable artificial intelligence (that lets humans understand and articulate how an AI system made a decision) can allow for the vast amounts of health data to be put at the service of informing clinical and health decisions and research.
And, cutting-edge computational techniques, multi-omics, and innovative passive sensors - all set to transform the healthcare experience and make way for empowering digital health opportunities.
All these innovations will pave the way for further explorations in health as well.
Digital Health is increasingly developing innovative experiences that really matter.
Just think of hypertension and diabetes. Both increasingly common diseases that we are addressing with innovative, digital solutions helping patients in ways we couldn’t have just a few years ago.
Technology can influence so many different aspects of human health. It’s up to all of us to ensure we continue to catalyze technology in new and different ways and to ensure access to meaningful solutions wherever those patients may live.
We are proud to be a part of this vibrant global community of health innovators.