Digital Therapeutics: Searching for Their Place in Healthcare

With the digital world connecting more and more directly to the physical world, it was only a matter of time before healthcare would be affected. In digital therapeutics, we are beginning to see how software can work in conjunction with traditional healthcare and therapeutics to deliver cost savings and better patient outcomes. Here are some examples:

  • A sensor placed on an inhaler or pill bottle enables an app to track a person’s medication usage.
  • An app teaches people good sleep hygiene, encourages changes in behavior, and tracks the results.
  • A software package delivers drug and alcohol addiction treatment, teaching new coping skills and reporting progress to a clinician.

The development of these and many other digital therapeutics is leading to major changes in the healthcare landscape that will impact every healthcare player, from pharma and regulators, to payors and providers, and, ultimately, patients. As a result, pharma and its regulators find themselves scrambling to realize the potential of this new force in healthcare.


Digital Therapeutics Use Cases

Digital therapeutics (sometimes written DTx) bring together software and a medical intervention, drug, or device to better manage, monitor, or prevent illness. When put together, these components are expected to produce better patient outcomes at lower costs. Clinical trials and regulatory clearance are expected to substantiate the efficacy of digital therapeutics.

Prescription digital therapeutics are designed specifically to enhance clinical outcomes.

To-date we’ve seen digital therapeutics being developed to address:

  • Type 2 diabetes prevention and management
  • Substance abuse
  • Asthma
  • Insomnia
  • Schizophrenia
  • ADHD, major depressive disorder (MDD), autism spectrum disorder (ASD)
  • PTSD
  • Heart disease

Peter Hames, CEO of Big Health, says that the effect of digital therapies can be categorized in two ways:

  • Medication augmentation
  • Medication replacement

People with asthma who used Propeller’s digital therapeutic, used their rescue inhaler up to 79% fewer times – Source


Propeller’s sensor and app for respiratory health management is an example of medication augmentation. It couples its digital therapeutic with inhalers to improve the patient’s adherence to taking their medication and produces fewer asthma or COPD episodes.

A person living with asthma or COPD attaches the Propeller sensor to their inhalers and syncs the sensor to an app on their smartphone. The sensor gathers information each time the person uses their inhaler. That information is transmitted to the app which tracks when the inhaler was used and how many puffs were administered, analyzes the information, looks for patterns, and then sends the person reminders to use their inhaler, along with suggestions about how to reduce their chances of an asthma or COPD episode.

Propeller reports people using their digital therapeutic experience up to 79% fewer asthma attacks and up to 50% more doses are taken on schedule.

Big Health used a placebo-controlled clinical trial to document the effect of its Sleepio digital therapeutic aimed at improving sleep quality – Source


Big Health’s Sleepio app is an example of medication replacement. Its digital therapeutic completely replaces any sleep-inducing medication.

In place of sleeping pills, Sleepio uses a behavioral medicine approach. The person experiencing difficulty sleeping learns healthy sleeping behaviors and habits via the Sleepio digital platform. With the help of the Sleepio platform and a sleep journal, the person collects information about their sleep habits and quality. Sleepio then helps the person analyze the information gathered to uncover patterns and aid in sleep-supporting behavioral changes.

Sleepio reports it has helped 76% of its users achieve healthy sleep.


Digital Therapeutics: Potential Market

Digital therapeutics as a technology and market is in the very early stages of development. And yet, it’s expected to become a massive market globally, and in the US, over the next decade.

The US market for digital therapeutics is expected to grow consistently over the next decade by addressing common chronic illnesses – Source


Grand View Research estimates the 2016 global market for digital therapeutics is $1.7 billion. With the continued growth in smartphone and internet use as drivers, it’s expected that the market for digital therapeutics worldwide will grow to $9.4 billion by 2025.

And yet, a smooth road ahead for digital therapeutics isn’t assured.


Digital Therapeutics: Facing Obstacles to Adoption

McKinsey, in its article Digital Therapeutics: Preparing for takeoff, identified two major obstacles to the growth and adoption of digital therapeutics:

  • Distinguishing digital therapeutics from the health and wellbeing market
  • Misaligned incentives in the healthcare ecosystem

Distinguishing digital therapeutics from health and wellness apps

Digital therapeutics seek to differentiate themselves from health and wellness apps by validating their capabilities through clinical studies and by regulatory agency approvals.

Digital therapeutics companies are already taking on the challenge and responsibility of conducting randomized trials to collect clinical data. In publishing this data, they substantiate the efficacy and impact of their digital therapeutics and distinguish them from health apps.

The FDA’s software precertification program was developed in direct response to the unique regulatory needs of the emerging digital therapeutics industry – Source


Regulatory is also moving toward resolving issues around distinguishing digital therapeutics. In late 2017, the FDA established its software precertification pilot program which is aimed at demonstrating a streamlined approval process that is more in line with the needs of emerging digital health technologies. Additionally, the FDA cleared its first prescription digital therapeutic around the same time.


Addressing the misaligned healthcare system incentives

Addressing incentives is more complex. Each player in the healthcare system is focused on its own distinct obstacles, with each one needing to be addressed individually.

For providers, digital therapeutics don’t easily integrate with the systems and processes that are in place. While the patient can capture and generate a lot of data using a digital therapeutic, once that data gets to the clinician, it’s generally not easily accessible or usable. EHR systems tend not to easily integrate this data, and providers don’t have established protocols for using data from digital therapeutics. This results in an avalanche of overwhelming, non-standardized, and largely unusable data.

Payors still need to be convinced of the value delivered by digital therapeutics and for their reimbursement schemes to be defined. It’s possible that the payor market for digital therapeutics will be, at least initially, narrow. One possible market scenario is employers interested in encouraging their employees to adopt healthful habits to avoid chronic illness, which may be a stronger initial target market for digital therapeutics.

For traditional pharmaceutical companies, digital therapeutics represent a whole new kind of business, i.e., software. Developing, maintaining, and marketing software is nothing like developing and marketing pharmaceuticals. Software development demands more than just engineering skills. Software development also requires agile development cycles that are dramatically shorter and more volatile than anything pharma is used to.

Even though the regulatory environment has made some progress, it still needs further evolution to serve the needs of digital therapeutics companies. Currently, regulatory presents companies with long, complicated approval processes. These processes don’t support agile product development. And, unlike with traditional pharmaceuticals, the current regulatory system doesn’t provide digital therapeutics companies with clear protections from direct competition.


The Digital Therapeutics Industry’s Response

The digital therapeutics industry recognizes and acknowledges these obstacles. In response, they’ve formed the Digital Therapeutics Alliance. This consortium was founded in 2017 by four companies at the forefront of digital therapeutics: Akili Interactive, Propeller, Voluntis, and WellDoc.

In addition to building an understanding of, and encouraging adoption of, digital therapeutics, the Alliance is working to prove the legitimacy of digital therapeutics as verified and approved medical treatments. The Alliance is doing this by working on defining industry standards, regulatory frameworks, and standards for clinical testing.


Digital Therapeutics: The Defining Moment

Even with the industry coalescing to respond to the many challenges and obstacles digital therapeutics face, there is still a great deal of uncertainty. Many point to what is considered a defining moment for digital therapeutics as a sign of hope for the industry’s future.

In September 2017m, Pear Therapeutics’ reSET received the first software-only prescription digital therapeutic clearance from the FDA.

A defining moment for digital therapeutics: when reSET, a software-based treatment for substance abuse, received FDA clearance – Source


The clearance was for reSET, a 12-week treatment program for drug and alcohol addiction and dependency (excluding opioids). The reSET software delivers assessment tools and interventions to the patient via mobile. The data collected from the patient is reported to the clinician via a dashboard. In its randomized trials, Pear Therapeutics demonstrated that for patients using reSET, twice the number, compared to the control group, remained abstinent at nine and twelve weeks.

Now that it has entered the market with FDA clearance, reSET will be closely watched by the healthcare industry. Its success will be taken as an indicator of the potential success level for the digital therapeutics that follow.


Looking Ahead

As with every new technology in healthcare, the path forward for digital therapeutics is uncertain. While digital therapeutics promise better outcomes for patients at lower costs, many obstacles remain.

The initial work done by the FDA and the Digital Therapeutics Alliance to encourage the development and adoption of digital therapeutics is a good first step. But many players still need to be convinced that this new force in healthcare will produce the promised results.

What do you think? Will digital therapeutics force fundamental changes in healthcare? Or will it end up being just one more therapeutic approach to be used within an established medical practice?

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