Digital therapeutics refers an emerging healthcare disciple that through the use of digital and internet based solutions treat a medical condition, either in a standalone fashion or in combination with more conventional medical therapy, and build on the concept of using software to improve a patient’s health equivalently to using a drug therapy, but at a reduced cost and no physical side effects (1) (4). Effective functionality has been linked to medical conditions that have a basis in everyday behaviors, such as diabetes, obesity and hypertension (8). Digital therapeutics present the opportunity to augment or replace prescription drug use as a sole therapy, using tech-based solutions (3)
Several factors have contributed to the rapid development of digital therapeutics, including the Affordable Care Act’s reimbursement shift from volume to value, and subsequently placing the responsibility to deliver quality outcomes with lower costs (2). Employers are increasingly interested in managing employee healthcare costs, and recognize that preventive therapy and chronic care management can be achieved through digital therapeutics, often at a lower cost than traditional treatment/healthcare methods (2). An additional factor is the rapid pace of technological progress, focusing specifically on the ubiquitous nature of smartphones and high speed internet access (2).
The following is a list of digital therapeutics that were cited in article or studies that discussed digital therapeutics. Due to the rapidly evolving nature of the field, this list is not exhaustive or comprehensive.
1. Insomnia/mental illness
a. Sleepio = Web based cognitive behavioral therapy program, owned by Big Health, treats insomnia and alleviates associated daytime symptoms such as anxiety and depression (9).
b. Akili Interactive Labs = Digital interaction through game based application platforms to improve symptoms of inattention, working memory and executive function. Currently seeking approval from FDA via the STARS-ADHD study, to impact autism, depression, Alzheimer’s disease, and traumatic brain injury (15)(16).
c. COBALT (Magellan) = Owned by Magellan Health, Inc. computer based cognitive behavioral therapy delivered via a web based platform, focused on medical and behavioral health issues, including addictions, anxiety, Obsessive Compulsive Disorder, depression, and insomnia (17).
2. Diabetes, obesity, cardiovascular disease
a. Virta Health = Online specialty clinic focused on reversing effects of Type 2 diabetes through tracking applications, phone based application, customized nutrition plan, 1:1 coaching, and physician online counseling (10).
b. Transform = Owned by Blue Mesa Health Inc. Online based program focused on pre-diabetic/Type 2 diabetic patients, accepted by Medicaid/Medicare, available in Spanish. Utilizes wireless scale, activity monitor, phone-based application and online peer support groups alongside diabetes prevention certified health coaches (11).
c. Noom, Inc. = Online based weight loss/diabetes prevention program. Online health coach access and peer support groups, web based challenges, phone based application (12).
d. Prevent = Owned by Omada Health, utilizes behavioral science including online learning, online peer support group and coach access, and phone based tracking applications (wireless scale, activity monitor), as well as data science to analyze results (13)
e. Twine Health Inc = Online based health activation platform, in conjuction with University of Pennsylvania, involves in person screening, online coaching plan, telemedicine blood pressure cuff, and phone base app which communicates with patient’s clinical team (14).
Difference from mHealth applications and wearable technology
Companies providing these ‘digiceuticals’ are beginning to utilize rigorous clinical trials to demonstrate value as drug companies use to validate their products (3). Big Health created a digital therapy program web-based cognitive behavioral therapy, Sleepio, which was included in a randomized, placebo-controlled trial to validate effectivity in treating insomnia (3)(5). This trial concluded sleep efficiency and quality in addition to associated daytime functioning of adults with insomnia disorders (5).
Digital therapeutics can provide therapy at a reduced cost. Comparing Sleepio, a CBT based insomnia treatment with Ambien, a commonly prescribed insomnia medication, Sleepio costs approximately $33 per month, contrasting with an average price for Ambien of $292 ($73 for six tablets) (4). Not dissimilar to devices creating patient generated health data, the adoption and integration of this data can improve the delivery of value-based care, as well as improved quality (19).
While digital therapeutics may be less expensive compared to traditional drug and medical therapies, health insurance companies as a whole have not updated covered services to include the cost of digital therapeutics (4). A notable exception occurred in 2016 when Medicare extended covered services to include the reimbursement of the cost of a digital diabetes prevention program provided by Omada Health (4). This may signal a shift in covered services from health insurance providers, but this is an undetermined variable at this time. It may prove difficult in the immediate future to distinguish digital therapeutics from mHealth applications and wearable technology, which could further complicate adoption of these technologies as covered services with insurance providers. Studies, such as one published in Journal of Medical Internet Research, recognize the need for further analysis and research on overall effectivity of internet based behavioral therapies, but that with extended use, digital therapies are proving effective (18).
Digital therapeutics, alongside other non-traditional technology solutions (wellness apps, health trackers, home health devices, ingestibles, etc.), generate patient health data, which ultimately should be integrated into clinical workflows effectively, safely, and efficiently (6). Digital therapeutics are another stream contributed to the rapid rate increase of healthcare data volume, projected to grow at a rate of 48%, based on a report from EMC, IT storage hardware solutions company, and International Data Corporation, a global market intelligence firm (7). This data ultimately has to be integrated into EHRs and clinical workflows.
1. Hixon, Todd. "Digital Therapeutics Have Huge Promise And They Are Real Today." Forbes. Forbes Magazine, 09 Dec. 2015. Web. 18 Apr. 2017. <https://www.forbes.com/sites/toddhixon/2015/12/09/digital-therapeutics-have-huge-promise-and-they-are-real-today/#174893d926f0>.
2. Kvedar, Joseph C., Alexander L. Fogel, Eric Elenko, and Daphne Zohar. "Digital Medicine's March on Chronic Disease." Nature Biotechnology 34.3 (2016): 239-46. Nature Biotechnology. Nature.com, 10 Mar. 2016. Web. 18 Apr. 2017. http://www.fiercehealthcare.com/mobile/replacing-pills-apps-digital-health-becoming-pharma-s-newest-competitor
3. Sweeney, Evan. "Replacing Pills with Apps: How Digital Health Is Becoming Pharma's Newest Competitor." FierceHealthcare. N.p., 07 Apr. 2017. Web. 19 Apr. 2017. <http://www.fiercehealthcare.com/mobile/replacing-pills-apps-digital-health-becoming-pharma-s-newest-competitor>
4. Farr, Christina. "Digital Treatments Can Be Real Medicine." MIT Technology Review. MIT Technology Review, 07 Apr. 2017. Web. 20 Apr. 2017. <https://www.technologyreview.com/s/604053/can-digital-therapeutics-be-as-good-as-drugs/?set=604110&utm_source=MIT%2BTechnology%2BReview&utm_campaign=a4a76fe8ec-The_Download_2017-04-07&utm_medium=email&utm_term=0_997ed6f472-a4a76fe8ec-154811813>.
5. Espie, C. A., S. D. Kyle, C. Williams, J. C. Ong, N. J. Douglas, P. Hames, and J. S. Brown. "A Randomized, Placebo-controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-rich Web Application." Sleep. U.S. National Library of Medicine, 01 June 2012. Web. 21 Apr. 2017. <https://www.ncbi.nlm.nih.gov/pubmed/22654196>.
6. Carabello, Christina. "Patient Generated Health Data: Addressing Concerns and Moving Forward." HIMSS. N.p., 29 Dec. 2016. Web. 18 Apr. 2017. <http://www.himss.org/news/patient-generated-health-data-addressing-concerns-and-moving-forward>.
7. Corbin, Kenneth. "How CIOs Can Prepare for Healthcare 'Data Tsunami'." CIO. CIO, 16 Dec. 2014. Web. 22 Apr. 2017. <http://www.cio.com/article/2860072/healthcare/how-cios-can-prepare-for-healthcare-data-tsunami.html>.
8. Kvedar, MD Joseph, Arundhati Parmar | 11:43 Pm April 6, Stephanie Baum | 6:56 Am April 29, Juliet Preston | 2:44 Pm April 28, and Erin Dietsche | 3:02 Pm April 28. "It's Time to Break Free of the Traditional Paradigms of Disease Management." MedCity News. N.p., 25 Aug. 2016. Web. 24 Apr. 2017. <http://medcitynews.com/2016/08/time-break-free-traditional-paradigms-disease-management/>.
9. https://www.sleepio.com/ . Web. 22 Apr 2017
10. https://www.virtahealth.com/ . Web 24 Apr 2017
11. https://www.bluemesahealth/individuals/ . Web 24 2017
12. https://www.noom.com/ . Web 24 Apr 2017
13. https://www.omadahealth.com/ Web 24 Apr 2017
14. "Controlling Hypertension." Controlling Hypertension | Penn Medicine Center for Health Care Innovation. N.p., n.d. Web. 24 Apr. 2017. <http://healthcareinnovation.upenn.edu/projects/controlling-hypertension>.
15. http://www.akiliinteractive.com/ Web. 24 Apr. 2017.
16. "UCSF Study Shows Akili's Project EVO Game Improves Cognitive Control in Children with Sensory Processing Disorder." MobiHealthNews. N.p., 05 Apr. 2017. Web. 24 Apr. 2017. <http://www.mobihealthnews.com/content/ucsf-study-shows-akilis-project-evo-game-improves-cognitive-control-children-sensory>.
17. Magellan Health to Offer Expanded Computerized Cognitive Behavioral Therapy Services." N.p., 21 July 2014. Web. 22 Apr. 2017. <http://ir.magellanhealth.com/releasedetail.cfm?releaseid=860980>.
18. Using the Internet to Promote Health Behavior Change: A Systematic Review and Meta-analysis of the Impact of Theoretical Basis, Use of Behavior Change Techniques, and Mode of Delivery on Efficacy." Journal of Medical Internet Research. JMIR Publications Inc., Toronto, Canada, n.d. Web. 22 Apr. 2017. <http://www.jmir.org/2010/1/e4/>.
19. Edwards, Chris. "Progress and Purpose in Healthcare Driven by Patient-Generated Health Data." HIMSS. N.p., 29 Dec. 2016. Web. 20 Apr. 2017. <http://www.himss.org/news/progress-and-purpose-healthcare-driven-patient-generated-health-data>.
Submitted by Christina Malone