"Take an App for That and See Me in a Month!" The Rise of Digital Therapeutics (DTx)

Irshad Siddiqui MD, Chief Health Information Officer, Blessing Health System

CXOs today are challenged with creating a digital front door for our consumers. As the role evolves from operational IT to strategic partnerships with business and clinical realms, CXOs should become adept at horizon scanning of different emerging technologies and therapies that may change patient behavior and our relationship with consumers. DTx is one such emerging tech that could cause some disruption very shortly. Imagine your physician prescribing you a mobile app instead of a pill. Or a drug that comes with a companion mobile app that can optimize your medication. Do our current digital strategies support such transactions? These type of therapies are already a reality and are causing a lot of excitement in the provider, payer, and pharma world. Innovative health systems now use digital therapies as an adjunct to standard outpatient treatment for mental health, substance use disorder, chronic condition management, cognitive dysfunction, and a host of other interventions.

Digital Therapeutics is a class of interventions that include software programs used independently or in concert with medications, devices, and other therapies to improve outcomes. The Primary function of these software-generated therapeutic interventions is to prevent, manage, or treat a medical disorder or disease. These therapies are developed following internationally-recognized design, quality, and manufacturing standards and are reviewed and approved by regulatory and compliance bodies as required. They also go through clinical validation processes that may include adequately-powered Randomized Controlled Trials with clinically meaningful outcomes.

According to the Digital Therapeutics Alliance, each digital therapeutic corresponds to one of four categories based on its intended use and official product claims:

1. Address a medical condition

2. Manage or prevent a medical disorder or disease

3. Optimize medication (an individual medication or class of pharmaceuticals)

4. Treat a medical disease or disorder

Digital Therapeutics is a class of interventions that include software programs used independently or in concert with medications, devices, and other therapies to improve outcomes

Here are a few up and coming startups and pharma company solutions that are worth noting - In the substance abuse intervention space, reSET and reSET-O from Pear therapeutics are targeting Substance Use Disorder and Opioid abuse, respectively. Delivering Cognitive Behavioral Therapy as an adjunct to a contingency management system for a specific group of patients. Joyable and Meru Health are up and coming DTx services in the mental health space. With chronic disease prevention and management becoming an imperative for population health management programs, companies like Omada health, Fruit Street, Solera Health, Canary Health, Noom, Blue Mesa and several others, leverage on evidence-based guidelines like the Center for Disease Control (CDC)’s National Diabetes Prevention Program. For diabetic patients, an app called Insulia from voluntis can let physicians remotely monitor progress and set up treatment plan rules that will adjust basal insulin dosing based on the patient’s specific needs. Novo Nordisk, the maker of Insulin NovoPen, is releasing a companion app with the next iteration of its smart NovoPens. Glooko, a partner with Novo Nordisk in the diabetes space, recently got FDA approval for its Mobile Insulin Dosing system that can titrate long-acting insulin for patients with type 2 diabetes. BlueStar by Welldoc is a DTx for diabetes that is clinically validated with 40+ peer-reviewed publications and posters. Their randomized controlled trials proved an A1c improvement of 1.7 -2.0 when integrated with traditional care. AbbVie has a companion app called Complete that is a medication tracker and a patient resource for patients on Humira and Skyrizi.

Sooner or later, our physicians will need an avenue through our patient portals to prescribe these apps. Patients will demand integration of these apps and digital therapies with the digital front door. The DTx space is expanding and maturing. The pharma industry is bullish on this category as it is cheaper and faster to create software than drugs. The software can also help a pharma company strategically extend a patent of a drug. Future states of DTx software may include integration with mobile health platforms, the addition of diagnostic or adjunct interventions, pairing with sensors and devices, and integration into electronic medical record platforms with an augmented or artificial intelligence layer. There has been a flurry of activity in the industry in the past few years. The Digital Health Alliance has emerged as a non-profit trade association engaged in evidence-driven advancement of DTx. For clinical validation, NODE. Health has emerged as the network for Digital Evidence in health with 20+ healthcare systems as partners.

The advent of this new class of interventions and the general rise of consumerism presents an opportunity for CXOs to take a more in-depth look at their digital strategy. The healthcare consumers of today in addition to traditional brick and mortar, and mail-order pharmacies, also need a virtual door to get their digital therapeutic apps. It may be time to look at your digital front door from a new perspective and build capabilities to enable DTx.

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