Digital therapeutics and the changing face of healthcare
Written by Tom Varghese
Historically healthcare has been delivered offline. This is changing with the emergence of digital therapeutics (DTx). Worldwide, there are over 318,000 mobile health apps available, and around 200 apps are being added to app stores each day. To ensure patient and consumer safety, it is important that health apps are assessed for safety, functionality, quality, data protection, data security, and positive effects on care.
DTx aims to deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases. They are subject to the same regulatory oversight that traditional medicines undergo and must demonstrate product safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact. The value of DTx lies in being able to optimise clinical and health economic outcomes, deliver high quality therapies to underserved populations, easily scale and be accessible through patient-owned devices and lower overall costs of care. They can also be prescribed independently or in unison with other medications or treatments in order to optimise patient outcomes. The idea is to extend providers’ reach by overcoming time, place and personnel constraints that limit health-care delivery. It’s about access, convenience and efficiency.
DTx do not undermine the efficiency of classic therapies that exist today but represent an alternative when these interventions, for various reasons, fail to achieve the desired outcomes. A crucial value of DTx is the native integration with value-based care processes. Patient-Reported Outcome Measures (PROMs) are an integral part of most digital therapy solutions.
In December 2017, the FDA issued new guidelines clarifying types of product that will no longer be deemed regulated medical devices, such as apps that promote general wellness. In the UK, NICE is working with the NHS to expand its provision of digitally enabled therapy for common mental-health conditions, such as depression and anxiety disorders, through a new assessment programme.
Among OECD countries, Germany’s DVG represents a first-of-its-kind opportunity for large-scale reimbursement of evidence-based digital health applications. As New Zealand looks to implement policies and assessment processes for digital health solutions, further developments and resolution of questions about the DVG will certainly provide valuable insights. With an increasing focus on digital tools and services, there is opportunity for NZ to make that shift as well. We do this by incentivising quality and outcomes alongside performance. Our health sector should give itself the mandate to take the first step.
