Two Main Subcategories of Digital Therapeutics (DTx)

Bernhard Kappe
Bernhard Kappe

This blog contains Chapter 3 of the Orthogonal eBook titled:  Digital Therapeutics (DTx): Accelerating Success Using Fast Feedback Loops. The following are links to each chapter of this eBook:

There are many types of new DTx that treat, manage, and prevent a host of medical conditions. To aid in classifying and understanding this new area of medicine, it is useful to recognize two broad subcategories of DTx, while noting that these categories gloss over certain distinctions and are not necessarily mutually exclusive. The first subcategory encompasses digitization and automation of proven, offline, non-digital therapies. The second subcategory features digital therapies that create and deliver novel interventions not possible in traditional human-to-human patient care.

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Subcategory 1: Digitization and Automation of Proven, Offline, Non-Digital Therapies

This subcategory of DTx endeavors to supplement, or even replace, long-standing, proven therapies. It uses the power of technology to scale up and make these time-tested, real-world therapies available to more people who need them, generally at lower cost and reduced administrative burden compared to their traditional counterparts.[1] This digitization of proven “offline” therapies is currently the most prevalent type of DTx in development today.

For example, mental health therapies such as talk therapy and cognitive behavioral therapy (CBT) are typically administered offline in a psychologist’s office. Years of accumulated clinical trials data prove the effectiveness of these non-digital interventions.[2]

Large-scale cognitive therapies are generally delivered through in-person professional services by a trained therapist (e.g., behavioral, physical, occupational, optometry). As with any skilled professional service that requires formal clinical training and certification resulting in a highly reimbursed clinician, this type of one-on-one delivery is based on costly, labor-intensive economics. In addition, each therapy session requires a relatively high transaction overhead for both patient and provider due to scheduling and transportation coordination, e.g., missed work or childcare challenges. A stigma associated with mental health disorders and behavioral conditions may also keep some patients from seeking in-person care. These are some of the challenges that explain why cognitive therapies, in their current form, cannot be expanded at a population health management scale. Indeed, we are seeing, in part due to the mental health fallout from the COVID-19 pandemic, that the United States is experiencing an already significant shortage of mental health professionals relative to the current demands of the population.[3], [4]

The value of DTx for scaling existing, offline, non-digital therapies extends beyond cost and time savings. Digital therapy delivery offers opportunities for innovation based on the iterative, interactive, data-driven nature of software development. To a consumer, email may seem like computer-based postal delivery and Facebook a computer-based place to hang out with friends, but these platforms are continually learning and evolving based on user interaction. Similarly, DTx are not simply robotic health professionals. Combining digital and offline therapies enables new possibilities for holistic engagement that may provide clinicians with insight into patients’ lives outside of the typical 45- to 60-minute, once-per-week appointment. Patient data trends can be analyzed over time and may help the clinician and patient identify individualized triggers. Additionally, the on-demand nature of the DTx may be more effective when administration can occur on a more flexible and personalized basis (e.g., 10 minutes every two hours, every time you begin to get agitated, or 30 minutes before each meal). Personalized and just-in-time CBT that could reach the growing population of mentally ill in the U.S. via DTx technology is thought-provoking. The potential to increase access to care at an affordable cost bolsters national health equity goal.

Although not every form of therapy is a candidate for adoption on a DTx platform, as the following two case studies (metaMe Health and Click Therapeutics) illustrate, its early use with CBT is showing promise.

 

DTx Case Study #1: metaMe Health

metaMe Health is a prescription DTx company focused on the treatment of gastrointestinal conditions. Pending FDA clearance, the first DTx to be released on their platform will be Regulora, an all-digital, self-administered behavioral therapy for the treatment of patients with symptomatic Irritable Bowel Syndrome (IBS). Regulora received FDA clearance in November of 2021.

Regulora is a digital hypnosis product with the potential to greatly scale affordable access to gut-directed hypnotherapy, a therapy that addresses the root causes of IBS. There are a limited number of clinicians in major urban medical centers who are trained to deliver this treatment. Regulora, in contrast, allows patients to self-administer a proven online hypnosis intervention from their own home on their own schedule, after being diagnosed and prescribed the Regulora treatment.

 

DTx Case Study #2: Clickotine by Click Therapeutics

Clickotine, by Click Therapeutics, is a smartphone app for smoking cessation, designed to deliver the essential features of the US clinical practice guidelines (USCPG) and engineered to engage smokers by personalizing intervention components.[5] The program provides a personalized 8-week program for each patient that can be combined with nicotine-replacement therapy including gum, patch, or lozenge.

Some key features advertised as part of the Clickotine app include:[6]

  • Personalized messaging
  • Controlled breathing
  • Real-time social support
  • Replacement distractions
  • Money saved

Subcategory 2: DTx as novel therapeutic techniques

The digitization of therapies also creates the opportunity for novel techniques and approaches to therapy. Applications that support longitudinal capture of patient data can also analyze these data to individualize patient therapy using methods not previously employed due to lack of data and resulting insight.

Developers of novel therapies using DTx face challenges familiar in technology-driven enterprises, such as the need for infrastructure to capture, manage, and disseminate data sets and deliver data-driven insights. Application of these processes in the healthcare environment requires iteration and a patient-centered focus at each step in the development process to avoid patient safety concerns. Companies that remain agile and open to identifying ways to incorporate these new data streams will benefit from the fast feedback loops common in software development and possible in DTx development, unlike traditional therapeutics. Business model-based challenges surrounding data interoperability and sharing are slowing the learning curve on how to best leverage these news types of DTx-provided data.

The following two case studies (Akili Interactive Labs and Propeller Health) highlight two emerging lessons from this subcategory of DTx. First, best-of-breed DTx incorporate engagement to motivate patients to work towards their health goals. Second, the brain-behavior segment of DTx will continue to be researched and adopted due to the significant ROI potential of digitally scalable mental and behavioral therapies.

DTx Case Study #3: Akili Interactive Labs

Akili Interactive Labs garnered a good deal of attention in 2020 when they announced that the FDA had granted clearance for EndeavorRx® (AKL-T01), a prescription video game treatment for children with attention-deficit/hyperactivity disorder (ADHD). EndeavorRx is built on the Akili Selective Stimulus Management Engine (SSMETM) core technology, a proprietary technology designed for the targeted activation of specific neural systems in the brain to treat diseases with associated cognitive dysfunction.

As with existing offline therapeutic treatments for ADHD, SSME presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function. However, Akili also adds new digitally enabled innovations by using adaptive algorithms to personalize the treatment experience for each patient. This advance allows second-by-second monitoring of patient progress as they complete the treatment sessions and continuously challenges each patient to an optimized level, encouraging them to improve their performance.[7]

In another innovation, Akili’s model sits at the intersection of Tx, SaMD, and interactive video gaming. Akili introduces an action video game model of digital delivery to make the DTx fun and engaging and induce active, ongoing patient participation and compliance among a target population of children who may be more receptive to this delivery format.

 

DTx Case Study #4: Propeller Health

Propeller Health is a DTx company that helps patients suffering from respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD), track their inhaler usage. The platform synthesizes user data into practical insight based on user symptoms, medication usage, and environmental factors. Propeller Health is using data innovatively to offer features that can improve outcomes for patients with asthma or COPD, but with data that is different from that of Akili’s neuroscience-based interactive video games that personalize the treatment of ADHD.

Propeller Health monitors patient activities and, over time, can help patients identify flare-up triggers while empowering them to become experts in managing their symptoms in their own unique environments. This example of agility and openness to feedback loops demonstrates how companies can iterate to align their product with a defined consumer value gap in the market.

Propeller didn’t start out as a DTx. Initially, the academic researchers who founded Propeller were trying to capture data from the minute-by-minute experiences of asthmatic patients, e.g., when did they use an inhaler, what environmental triggers caused their asthma attacks, etc.? The researchers believed that a small IoT electronic adapter connected to an inhaler could provide accurate granular detail and insights into the lives of asthmatic patients and support their research. The researchers obtained NIH-funded support to add sensors to inhalers used in their study. Initially, Propeller tracked the location, date, and time of inhaler use. As part of their research, however, they decided to conduct a study and divide the patients into two groups: Group 1 was given access to their medical data collected by Propeller, and Group 2 had their information withheld. Propeller researchers found that patients with access to their personal data had better health outcomes than those who did not.

This documented outcomes study about patient access and data sharing, showing that patients had proven health and cost benefits, led the company to develop its current DTx platform. The research team then enabled patients to improve self-management of their chronic respiratory issues by delivering personalized inhaler usage data on a smartphone app and patient portal. In controlled clinical trials, they proved that their initial research was correct, and the researchers have continued to build on these insights as they iterate and use fast feedback loops for product development. Propeller innovates creatively and delivers new value from these data to improve outcomes by helping patients manage adherence, make more effective use of their inhalers so that they are using the drug at the times when it can have maximum impact while also reducing low-value-added dosages to their bodies.

By instrumenting the inhaler with a connected medical device, Propeller has enabled new Tx approaches that were previously not possible. The challenge remains to prove the efficacy of such novel therapies, which, by definition, do not have years of studies proving that they are effective. Propeller models a DTx development cycle that uses fast feedback loops, patient engagement, and iteration to deliver a product that aligns with a customer value gap. DTx is uniquely positioned to support rapid iteration as compared to other therapies, and Propeller Health exemplifies how to leverage that competitive feature for success.

Some of the data-driven DTx innovations that Propeller has developed include:

  • Aggregating anonymized data across users so that Propeller can proactively identify geographic areas where, on specific dates, the air quality is likely to be worse and help the patient avoid those areas.
  • Identifying other patterns in the data of the individual patient as well as aggregate sets of patients that could indicate when a specific patient’s needs may be lesser or greater for the inhaler and recommending dosages before any respiratory exacerbations occur.
  • This data-driven approach is similar to Netflix or Amazon identifying TV watching or shopping behaviors, respectively, and then making personalized recommendations building on both personal data as well as data from other people that they have identified as similar in some way, e.g., gender, age, geography, personal interests, or other demographic.

Propeller has succeeded in linking product use to payer support so that insurance companies pay for this novel new therapeutic because it makes financial sense given the larger healthcare incentive structure. Creating this alignment between smart healthcare and smart healthcare economics is a significant accomplishment.

Digital Therapeutics DTx eBook PDF Download
References for Chapter 3

1. Batta A, Khirasaria R, Singh V. Exploring digital therapeutics: The next paradigm of modern health-careindustry.https://www.picronline.org/article.asp?issn=2229-3485;year=2020;volume=11;issue=2;spage=54;epage=58;aulast=Khirasaria. Published 2020. [Accessed August 23, 2021].

2. Chambless D, Ollendick T. Empirically Supported Psychological Interventions: Controversies and Evidence. Annual Reviews. https://www.annualreviews.org/doi/10.1146/annurev.psych.52.1.685. Published 2001. [Accessed August 23, 2021].

3. Costa C. Shortage Of Mental Health Professionals | Health Affairs Journal. Healthaffairs.org. https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.0933. Published 2016. [Accessed December 6, 2021].

4. Hubbard K. Many States Face Shortage of Mental Health Providers. U.S. News. https://www.usnews.com/news/best-states/articles/2021-06-10/northeastern-states-have-fewest-mental-health-provider-shortages. Published 2021. [Accessed September 29, 2021].

5. Iacoviello B, Steinerman J, Klein D et al. Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. https://pubmed.ncbi.nlm.nih.gov/28442453/. Published 2017. [Accessed August 20, 2021].

6. Clickotine.com. 2021. [online] Available at: <https://www.clickotine.com/> [Accessed 19 August 2021].

7. Kollins S, DeLoss D, Cañadas E et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. https://pubmed.ncbi.nlm.nih.gov/33334505/. Published 2020. [Accessed August 20, 2021].

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