We summarise a recent article, published in npj Digital Medicine, that characterised the current pipeline of digital therapeutics and explored the barriers to their adoption. These insights will help inform future regulatory policy, prescribing decisions and scope of real-world evidence collection.
The Digital Therapeutics Alliance defined digital therapeutics (DTx) as “evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage or treat a medical disorder or disease”. Like biopharmaceuticals and medical devices, DTx undergo review and are approved by the FDA. They are then either available over the counter or prescribed by physicians.
To date, the FDA has approved multiple DTx on the basis of superiority trial data. For example, Welldoc’s BlueStar for the management of type II diabetes in 2010. Due to the ongoing COVID-19 pandemic, the FDA has relaxed regulatory requirements to increase access to digital health products for remote monitoring and management of psychiatric conditions. The European Medicines Agency is yet to design a regulatory pathway for evaluation and commercialisation of DTx.
DTx companies currently target chronic, behaviour-modifiable conditions. These include type II diabetes, substance use disorder, autism spectrum disorder and major depressive disorder. Most of these indications are currently treated with evidence-based behaviour or psychological management. DTx are able to package these otherwise in-person services into digital products. For example, reSET is a service that delivers virtual cognitive behaviour therapy through a smartphone or tablet to treat patients with alcohol, cannabis, cocaine or stimulant use disorder.
In cases where DTx is prescription-only, physicians have to complete and send a patient enrolment to the DTx manufacturer. Clinicians can monitor their patients’ progress and input-related information on a dedicated web dashboard. DTx also allow clinicians to remotely collect real-time data from patients. Additionally, as DTx are software-based, patient progress and treatment adherence can be more accurately measured.
DTx may serve as a useful complement, and in some cases, replacement, to biomedical therapeutics. To date, DTx have largely targeted neurological and psychiatric conditions with significant unmet needs. Nonetheless, some manufacturers have begun to transition the scope of their products into acute conditions. For example, Click Therapeutics is developing a DTx for Acute Coronary Syndrome
Researchers have yet explored the comparative effectiveness between DTx and conventional therapeutics. Understanding and overcoming obstacles to effective regulation and reimbursement of DTx is key for the movement of DTx into the clinic. Moreover, considerations of cybersecurity and data rights are important preconditions for the mass adoption of DTx. As DTx transfer information over the internet, risk of unauthorised access and manipulation of these products and underlying data could be compromised.
As DTx companies continue to expand indications and reach the clinic, it will be crucial to educate stakeholders about their clinical value and ensure that they hold their products accountable to the same level of scientific rigor as traditional prescription drugs.
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