Digital Therapeutics: Why Your Next Pill May Be an App…

By: Steven Berman

Although clinical therapy has long been the cornerstone of the Healthcare industry, the Digital Therapeutics subset of digital health is slowly-but-surely establishing its own foundation. The nascent industry offers patients and doctors alike the ability to treat chronic diseases without solely relying on prescription medication. This disruptive technology is empowering patients while redefining how healthcare is delivered – and doing so for a large assortment of chronic conditions with minimal downside risk.

What are Digital Therapeutics?

Digital Therapeutics are essentially software tools that can improve a patient’s health much in the same way a drug can, minus the side-effects. Although such software has been around for nearly a decade, it wasn’t until 2013 that the term ‘Digital Therapeutics’ first entered the public lexicon. That was when Sean Duffy, CEO of Omada Health, began floating the concept at conferences and marketing events which he used to promote his pre-diabetic coaching software aimed at preventing full onset of the disease by encouraging patients to exercise more and lose weight.

Digital Therapeutics have since become something of a Shangri-la of modern medicine; the long-awaited bridge between Silicon Valley and Big Pharma. Veejay Pande, partner at prominent venture capital firm Andreessen Horowitz, even predicts that the industry will evolve into “the third phase” of medicine (the first two being small-molecule drugs and protein biologics). One key difference between Digital Therapeutics and traditional prescription drugs: launching an online platform involves jumping through many less hoops then launching a physical drug, and can cost billions of dollars less.

Because Digital Therapeutics don’t have to run through a battery of clinical trials, nor do they require FDA approval, the cost of bringing them to market is a fraction of that of traditional medicine. This should mean that the industry can scale rather quickly, as more and more platforms are provided for consumers with illnesses ranging from diabetes to asthma, to ADHD and depression. Yet despite the rapid scalability, traditional medicine need not be alarmed. With few exceptions, Digital Therapeutics serve to complement and even enhance a patient’s pharmaceutical experience, rather than supplant it altogether.

Types of Digital Therapeutics

We can classify Digital Therapeutics into three categories, based on their interaction with traditional medicine:

Digital Services: These platforms help guide consumers through lifestyle changes that greatly improve their patient outcomes. The aforementioned Omada Heath, which offers a 16-week weight loss program that guides pre-diabetics through daily nutrition and exercise routines, is a prime example. As a stand-alone service, this classification of Digital Therapeutics can neatly coexist with traditional medicine, and need not infringe on the doctor-patient relationship.

Pharmaceutical Support Devices: These therapeutics indirectly enhance the benefits of traditional pharmaceuticals. For example, Proteus Digital Health’s Discover medication adherence platform offers products such as miniature ingestible sensors and small wearable sensor patches that patients either ingest or wear on their clothing. The platform monitors relevant health and lifestyle information via digital technology, and the findings can be incorporated into the patient’s future prescriptions (type of medication, dosage, frequency, etc.). These platforms are meant to work in-tandem with traditional pharmaceuticals, by utilizing patient-specific data to foster more educated decision-making on the part of physicians.

Pharmaceutical Replacements: Here we have the exception to the rule. These therapeutics are actually looking to supplant traditional medicine altogether by providing clinical benefits via digital technology, without the need for additional forms of treatment. One example is Pear Therapeutics’ reSET application, which treats substance use disorder. In a recent clinical trial, the reSET app has been proven to promote a higher rate of abstinence than the traditional standard of care, which for substance use disorder happens to be outpatient face-to-face counseling. Because the trial’s results were approved by the FDA, Pear’s reSET app can be properly termed a prescription Digital Therapeutic, meaning a physician must prescribe the app, and patients receive the same coverage options as they would with traditional pharmaceuticals. Of course, much like the first two categories of Digital Therapeutics, the reSET app can be prescribed in-tandem with other substance use disorder treatments, but the fact that physicians can prescribe the treatment in-lieu of traditional medicine relegates the app into a third classification.

Wellness 2.0? Not So Fast…

Given that most Digital Therapeutics companies focus on lifestyle adjustment, it’s easy to see how the sector could be hastily lumped into the more comprehensive ‘Wellness’ space. However, Digital Therapeutics differs markedly from Wellness in that the latter is an imprecise category that broadly applies to the general public – think yoga, meditation, sleep and exercise apps – while the former is engineered with specific ailments in mind. Think apps for asthma sufferers, or patients with Crohn’s Disease.

In order to further distinguish themselves from the Wellness industry, Digital Therapeutics startups have begun embarking on clinical trials in addition to seeking regulatory approval from the FDA. Welldoc, for example, offers a prescription-only version of its BlueStar phone app for managing diabetes, which it claims is the “first FDA-cleared mobile prescription therapy.” Other platforms, such as the aforementioned reSET app, provide the industry a veneer of legitimacy that the Wellness space is still struggling with.

One area in which Digital Therapeutics mimics its more popular Wellness cousin, however, is in data collection. By their very nature, Digital Therapeutics are data aggregators. The platforms track patient populations across a range of metrics, and deliver results which can be harvested by professionals across the entire spectrum of Healthcare, from Big Pharma to hospitals and physicians.

A prime example is Oshi Health. Oshi delivers a platform that helps IBD sufferers examine their symptoms and explore lifestyle factors which can help contribute to a better quality of life. Patients continually input variables such as diet, stressors, sleep pattern, and activity/exercise routine. The app then delivers a wellness score, which indicates how likely the patient is to experience IBD symptoms in the near future. Patients can leverage the wellness score to learn what their IBD triggers are, and can tailor their daily regimen to reduce the frequency and severity of outbreaks. Currently, Oshi has over 35,000 members. The beauty of the platform is that as that number grows larger, the data becomes more relevant, since a greater patient population implies more statistically significant results. Those results not only help patients, they assist pharmaceutical makers and physicians looking to optimize their treatment of the disease.

Thanks to platforms like Oshi, user feedback, in certain instances, is the new clinical trial.

The Road Ahead

Despite the low barriers to entry and added health benefits, the road to mainstream adoption of Digital Therapeutics remains a bumpy one. Look how long it took to get on board with telemedicine! The key challenge facing the industry is breaking the longstanding belief that in order to improve their health, patients need to take a pill prescribed by a physician. This is a reality that’s been coded onto our collective Healthcare DNA for generations, and will likely take some time and effort to reverse.

To confront this immense challenge, the industry has begun advertising much in the same way any startup would – through targeted ads, social media campaigns, and via thought leadership articles on various third party publishing platforms. Some Digital Therapeutics companies are going the extra mile and allying with Big Pharma. Propeller Health recently partnered with GlaxoSmithKline on a “digitally guided therapy” platform. The company produces sensors which attach to asthma inhalers and provide patients feedback on their condition as they inhale. Patients have been shown to use their inhalers less often as they leverage the new technology.

The good news for the Digital Therapeutics industry is that the low cost of adoption ties in nicely to the self-funded employer model. Employers looking to reduce Healthcare expenditure are adopting these low-cost technologies in the hopes that platform utilization will lead to reduced member expenses down the road. Many in the private sector understand the notion of spending now to save later, and the value-prop of Digital Therapeutics fits neatly into that paradigm.

The Future of Healthcare

Although Digital Therapeutics is a relatively new industry segment populated by a handful of niche players, the regulatory inroads already established, as well as partnerships formed with the likes of Big Pharma and insurance companies, are harbingers of future growth if there ever were any. Last year, for example, Cigna invested $50 million into Omada Health, and included the platform in their subscriber plan as a measure of chronic disease prevention and cost control.

By educating patient populations on their symptoms and triggers, as well as pharmaceutical companies and healthcare providers on the lifestyle choices of their patient populations, Digital Therapeutics offer a window into the opaque world of how patients interact with their specific medications. Given the lower barriers of entry to launch a Digital Therapeutic, and the widespread positive impact they can have on patient populations, it’s likely we will see more big name players in the Healthcare space making significant investments into this field over the coming years. That means it’s looking more and more likely that your next prescription may be for an app instead of a pill.