Overview of Digital Therapeutics
Within the past ten years, a flurry of new therapies that use digital technology and software to treat, manage and prevent a variety of ailments have emerged, adopting the general branding: Digital therapeutics (DTx). Written by Andrés Melendez, Katie Ceraso, Arijit Nukala, Nina Tedeschi, and Rohini Singh
Digital therapeutics must be proven to be safe and effective and must deliver meaningful clinical results. Digital therapies that are similar to existing therapies are able to acquire FDA approval by proving equivalence to currently used software. However, novel therapies must endure the rigorous randomized clinical trial pathway in order to obtain approval.2
While DTx are often compared to digital health apps such as MyFitnessPal for example, they differ in that the therapies are held to the same standards as traditional medications. Digital health apps are often unregulated and do not need to prove their efficacy whereas clinical testing is required for digital therapeutics.
DTx most often seek to address chronic conditions or neurological disorders which are not well addressed by healthcare currently. After collecting health data provided by physicians or patients, or collected through medical devices and smart devices, DTx rely on algorithms to analyze health data. An area of interest for DTx is how diseases such as diabetes and or disorders such as obsessive-compulsive disorder can be treated through behavioral changes.3
The most notable method for delivering this objective is cognitive-behavioral therapy (CBT), a type of intervention that seeks to shift patient behavior as a treatment for disorders and diseases. CBT has been clinically demonstrated to be an effective treatment for many neurological disorders already and is being tested as a treatment for diabetes and other chronic conditions.4
Examples of current DTx include Welldoc’s Bluestar, a treatment for type 1 and type 2 diabetes, Happify’s Ensemble, a prescription treatment for major depressive disorder and generalized anxiety disorder, and Pear’s reSET6, a prescription treatment for substance abuse disorder.1
Prescription Digital Therapeutics vs Prescription Drugs
Prescription Digital Therapeutics, or PDTs, are a subsection of digital therapeutics that need to be prescribed by a physician. They provide evidence-based therapeutic intervention for managing, tracking the symptoms of, or preventing diseases.5 They differ from traditional DTx in that they are FDA authorized through the 510(k) premarket notification, and are developed using standard good manufacturing practice.6 With FDA authorization, companies have to demonstrate that their PDTs are safe and effective.7
PDTs typically consist of four parts: remote monitoring, telemedicine, healthcare IT, and health and wellness apps.8 They are becoming increasingly relevant, especially in light of the COVID-19 pandemic, as a way to address inequities in access to healthcare. For example, PDTs for diabetes and pre-diabetes management typically involves tracking blood sugar readings and insulin dosages, along with monitoring food intake and exercise. Some examples of PDTs for diabetes include Bluestar by Welldoc, Insulia by Voluntis, and Pear products including reSET6, Somryst9, and reSET-O8.
The clear difference between PDTs and prescription drugs is that PDTs involve only software, and use a therapeutic approach to treat the same diseases one could take a prescription drug for. While PDTs have to demonstrate their effectiveness and can be a more user-friendly, cost-effective option than traditional prescription drugs, several factors hold PDTs back from being as widely used as prescription drugs. To start, they are simply not as well-known or trusted yet by physicians and insurers. In a survey that questioned 180 payers and self-insured employer groups, only 30 payers and 10 self-insured employers knew about PDTs.7 In addition, many of them struggle to establish coverage and reimbursement processes/ pathways, which is a huge barrier to entry into the US healthcare system.
Future of Prescription Digital Therapeutics
Advances in the increasingly dominant role of artificial intelligence and technology have broadened the use of digital therapeutics in today’s atmosphere. This promising development bolsters active awareness of health and disease management, refining health outcomes and alleviating the demands by pharmacological interventions alone.9 The DTx market has an expected market value of $9 billion USD by 2025; however, the large growth gives rise to increasing challenges in technology regulation and how healthcare providers will facilitate this shift.10
The first of the challenges is garnering legitimacy for the product. Of course, the best way of doing this is by securing FDA approval. Companies like Pear won FDA approval after putting it on a regulatory pathway known as the “de novo classification process” created for novel medical devices.11 There is ongoing conflict over whether or not the FDA should develop a regulatory pathway explicitly for digital therapeutics in the future. Likewise, PDT’s are not really going to catch on — and the companies developing them will not be successful — until they have solid backing from insurers.11 There are also patient data privacy concerns. Despite federal initiatives on the issue of data security (HIPAA act), consumers using digital therapeutic platforms are subject to data breaching, which has the opportunity to health the growth of the PDTs market.12
Due to the incidence of COVID-19, the supply and use of PDTs has increased and created alertness regarding the importance of health management using digital therapeutic platforms. Emerging markets exist in third-world countries such as India and China, giving promising growth opportunities for PDTs. Furthermore, the lack of skilled medical practitioners in developing regions underscores the significance of a connected healthcare platform.12 With the DTx market expected to grow tenfold over the next three to five years, this exciting advancement shows promise in the healthcare industry.13
Takeaways
With recent advancements in digital technology and the onset of COVID-19, the global market for PDTs will grow rapidly. As regulatory challenges are addressed, PDTs stand to offer advanced healthcare solutions to people in the comfort of their homes, regardless of location, helping mitigate current healthcare inequities. The potential for PDTs to treat chronic conditions and neurological disorders not well addressed by healthcare currently with CBT and increasingly advanced artificial intelligence systems is enormous.
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