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Digital Therapeutics 101: an Introduction and Overview

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Digital Therapeutics 101: an Introduction and Overview Digital Therapeutics 101: An Introduction and Overview Contributing authors: Jeff Liesch, Principal Devin Murphy, Senior Consultant eBook Blue Matter, Copyright © 2021 eBook Digital Therapeutics 101: An Introduction and Overview Contents Introduction 3 Market Definition and Segmentation 4 Product Design 9 Value of DTx 13 Business Models 15 Regulatory Oversight 17 Evidence Generation 19 Reimbursement 21 Distribution, Prescribing Authority, and Channels 23 Ex-U.S. Markets 26 Parting Remarks: Where we are now 27 2 Blue Matter, Copyright © 2021 eBook Digital Therapeutics 101: An Introduction and Overview Introduction Welcome to the interesting world of digital health and health requires incorporation of user experience, engage- more specifically, digital therapeutics! Before diving into ment and usability. In other words, it demands a “patient this guide, it would be helpful to consider why digital centric” experience, which will actually stretch healthcare therapeutics is such a compelling topic these days. There and life sciences into new domains and capabilities cen- are several key factors that have made digital therapeutics tered on the patient. “top of mind” for a diverse range of people and organiza- tions, including biopharmaceutical companies, technology 4. Represent a new class of interventions - We are in companies, healthcare providers, and patients. Consider the early stages of understanding how our interaction that digital therapeutics: with technology can change us for the better (or worse). Part of the interest in digital therapeutics is driven by 1. Challenge the norm - At its most fundamental level, a responsibility to be good stewards by working at the digital health and digital therapeutics are challenging cutting edge of these novel interactions to maximize existing models of care. In so many places around the the good and limit the bad, and along the way protect- world, healthcare systems face great challenges, includ- ing us all from taking too many wrong steps (i.e., Big ing exorbitant costs, poor access, inefficiencies and Tech’s “break things” mindset won’t work in healthcare). more. As digital technologies have transformed industry Furthermore, these interventions work in unique “mech- after industry, healthcare has been somewhat resistant anisms of action” that can often complement existing but it, too, will progress. With that, the hope is to create therapeutics and open up avenues to address unmet new care models and supporting operations that realign needs in numerous disease conditions that were previ- the values and incentives by which healthcare operates ously unreachable. to be more balanced between care and the “business” of care. 5. Are for the mind - A lot of digital therapeutics will be about interventions that affect the mind and how 2. Offer the thrill of ambiguity - Digital Health is literally through focusing on thoughts and sensory information, being built right in front of us. There are few certainties we can change how we feel, think, believe, behave, and in its application and potential despite what you may ultimately experience our lives. This is an area of unmet read in various news outlets. It is not clear which prod- need in the United States if not everywhere. The mental ucts really possess 10x value or which stakeholders are experience of health and disease is poorly managed and the best to shepherd them to success, nor is it clear served, and it is applicable across all therapeutic areas. how to integrate these tools with existing systems and If taken seriously, it could be a real “game changer.” offerings. This leaves room for a lot of creativity. Now that you have insight into why so many innovators 3. Are “patient-centric” - Despite being a common term are passionate about digital therapeutics, let’s get into thrown around these days, “patient centricity” is at best, what you need to know! an uneven reality. However, the software side of digital 3 Blue Matter, Copyright © 2021 eBook Digital Therapeutics 101: An Introduction and Overview Market Definition and Segmentation Definitions in Digital Health broadly—and within Digital useful, but perhaps a bit “buzz-wordy”: Therapeutics—are often ambiguous and contradictory. Digital health connects and empowers people and Below, we briefly review some of the more common ap- populations to manage health and wellness, augmented by proaches as well as the working approach for this guide. accessible and supportive provider teams working within flexible, integrated, interoperable, and digitally-enabled care environments that strategically leverage digital tools, tech- Digital Health nologies and services to transform care delivery. Digital Health is a very broad and amorphous term that’s Segmentation of Digital Health is in some ways a fool’s- often used to differentiate from traditional medical devices errand, as the products and values they provide overlap and and capture the thrill of modern technology disrupting the evolve. For an illustration of this, you can see how various healthcare market. One such definition which will suit our major publications (often investment reports) attempt to do 1 needs is from HIMSS, a major player in the industry . It’s this: By Value Proposition - Rock Health2 By “Function” - Startup Health3 By “Categories” - Mercom4 • On-demand healthcare services • Patient empowerment • Telemedicine • Monitoring of disease • Wellness • Analytics • Treatment of disease • Biometric data acquisition • mHealth apps • Fitness & wellness • Admin workflow • Wearable sensors • Nonclinical workflow • Insurance • Clinical decision support • Consumer health information • Research • Healthcare service booking • Research and development catalyst • Population health • Practice management solutions • Diagnosis of disease • ...maybe more? • Wellness Our Approach to Digital Health Segmentation • Digital Interventions – new products to treat or care for patients Despite segmentation being a messy and time-draining • Digital Therapeutics (e.g. Pear Therapeutics® and Silver- exercise, we still need some ways to organize the land- cloud®) scape to make sense of the world. Some approaches have • Wellness Apps (e.g. Calm App® and MySugr®) been used that categorize by patient journey, by technol- • Digital Medicine (e.g. Abilify MyCite® and Propeller ogy and by data type. But for our purposes, we take a life Health®) sciences approach that identifies the main value / role in • Neuromodulation (e.g. Cala Health®) business for these technologies: • Precision Medicine – new data and analytics to identify patients or inform clinical decisions 1 “HIMSS Defines Digital Health for the Global Healthcare Industry ....” 2 Mar. 2020, https://www.himss.org/news/himss-defines-digital-health-global-healthcare-industry. Ac- cessed 12 Mar. 2021. 2 “2020 Midyear Digital Health Market Update: Unprecedented funding ....” https://rockhealth.com/reports/2020-midyear-digital-health-market-update-unprecedented-funding- in-an-unprecedented-time/. Accessed 12 Mar. 2021. 3 “StartUp Health.” https://www.startuphealth.com/. Accessed 12 Mar. 2021. 4 “9M and Q3 2020 Digital Health (Healthcare IT) Funding and M&A ....” https://mercomcapital.com/product/9m-and-q3-2020-digital-health-healthcare-it-funding-and-ma- report/. Accessed 12 Mar. 2021. 4 Blue Matter, Copyright © 2021 eBook Digital Therapeutics 101: An Introduction and Overview • Digital Biomarkers & Diagnostics (e.g. AliveCor® and The key attributes to understand about the DTA’s defini- Cognoa®) tion are: • ePRO (electronic patient reported outcomes) / eCOA (electronic clinical outcomes assessment) platforms • Medical interventions – These are clinical-grade treat- (e.g. Noona®) ments, not simply related to wellness claims. • Clinical Decision Support (e.g. NAVIFY®) • Directly to patients - Patients should be self-adminis- • Digital Imaging / Pathology (e.g. Heartflow®) tering or using as self-care. A physician is not active in • Virtual Care – new channels leveraging digital, often the intervention, though they may be informed by the new customers software about the patient’s status, experience, and • Telehealth (e.g. Amwell®) symptoms for purposes of administration, oversight, or • Digital Care (e.g. Omada Health®) incorporation into a broader treatment plan. • Digital Clinics (e.g. Hims & Hers®) • Evidence-based, clinically evaluated - Often the mech- • Digital Pharmacies (e.g. Capsule®) anism of action (MOA) of a DTx needs to begin based on • Clinical Trial Optimization – new tools for research and techniques that are considered evidence-based, though development it is hard to truly understand how far this goes. For • Patient recruitment (e.g. Deep6 AI®) instance, APA’s Div-12 has a database of evidence-based • Virtual / site-less trials (e.g. Science37®) psychological treatments that appears fairly robust and • and more… useful, though in previous market research we con- • Health IT and Analytics – new platforms to access ducted, few clinicians were aware of or leveraged the healthcare systems source.8 Rather, they used their own judgement of peer- • Electronic Health Record Technologies (e.g. Cerner®) reviewed academic publications from respected jour- • Tech-enabled care platforms (e.g. Tridiuum®) nals to determine for themselves that something was • Workflow solutions (e.g. Xealth®) evidence-based. “Clinically evaluated” is about conduct- ing double-blinded randomized controlled trials (RCTs) We utilize this approach as it generally aligns with the or other structured evaluations to demonstrate
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