FDA Approves Digital Therapeutics Technologies to Treat Patient Behavioral Conditions That Interfere with Positive Healthcare Outcomes
Clinical laboratories with strong digital and information technology capabilities may find opportunities in this growing field of healthcare
Digital therapeutics (DTx), a growing trend in life sciences technology, is emerging as a popular form of connected healthcare physicians can use to transform patient behavior and improve clinical outcomes. This development may create opportunities for IT-savvy clinical laboratories.
The software applications (apps) and hardware monitoring devices involved in digital therapeutics enable physicians and patients to target and alter specific behaviors that affect certain medical conditions, such as substance abuse or depression. Combined with or without drugs, digital therapeutics are achieving positive results, according to the United Kingdom’s PwC (PricewaterhouseCoopers) Health Research Institute (PwC HRI).
Clinical laboratory leaders engaged in precision medicine and pharmacogenomic initiatives will be intrigued by potential opportunities to support digital therapeutics. The FDA’s Digital Software Precertification Program has already begun awarding approvals for digital therapeutics that address diabetes and central nervous system disorders, in addition to substance abuse and birth control.
And more FDA approvals for digital therapeutics are expected in 2020, PwC HRI predicted.
Pharmaceutical and Tech Companies Collaborate on Digital Therapeutics
A PwC report, titled, “Top Health Industry Issues of 2019: The New Health Economy Comes of Age,” describes digital therapeutics is “an emerging health discipline that uses technology to augment or even replace active drugs in disease treatment.”
The report goes on to state that digital therapeutics “is reshaping the landscape for new medicines, product reimbursement and regulatory oversight … [and that] new data sharing processes and payment models will be established to integrate these products into the broader treatment arsenal and regulatory structure for drug and device approvals.
“Connected health services,” the report continues, “enabled by devices that transmit data or connect to the Internet, give additional visibility into care delivery and new ways to improve patient outcomes.”
Digital therapeutics combine apps and monitoring devices for the management and treatment of medical conditions. While similar to customer wellness apps, digital therapeutics focus on specific clinical outcomes.
The non-profit Digital Therapeutics Alliance says that, unlike common “wellness” apps, digital therapeutics “possess the unique ability to incorporate additional functionalities into a comprehensive portfolio of synchronous products and services. This includes potential integration with mobile health platforms; the provision of complementary diagnostic or adherence interventions; the ability to pair with devices, sensors, or wearables; the delivery of interventions remotely; and integration into electronic prescribing, dispensing, and medical record platforms.”
“Digital therapeutics are the next frontier,” Sai Jasti, Chief Data and Analytics Officer, GlaxoSmithKline (NYSE:GSK), told PwC HRI. “I think we will see a lot more collaboration between pharmaceutical and technology companies to drive this forward, ultimately to the benefit of patients.”
Digital Therapeutics That Already Have FDA Approval
Digital therapeutics and their connected devices are subject to the approval process of the federal Food and Drug Administration (FDA), and some have already received that coveted clearance:
- reSET from Pear Therapeutics is a 90-day prescription digital therapeutic (PDT) for substance use disorder (SUD). The Boston-based company also worked with Sandoz Inc., a division of Novartis, to receive FDA approval for reSET-O, a PDT for treating individuals with Opioid Use Disorder (OUD).
“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” said Richard Francis, Division Head and CEO, Sandoz, in a press release. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes.”
Both reSET and reSET-O are software mobile apps that use cognitive behavioral therapy (CBT) to help individuals struggling with addictions.
“Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics, in the press release following receiving FDA approval. “There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.”
- Natural Cycles is a birth control app created by a Sweden-based company of the same name. It was approved by the FDA in 2018. This mobile app helps women track their fertility to prevent unwanted pregnancies via the rhythm method. The app analyzes data from past menstrual cycles and body temperature readings to determine when the user is most fertile. On the days the user is most likely to be ovulating, the app displays “Use Protection” on the mobile device’s screen.
“We know that women are more likely to use contraceptive methods when they have a variety of methods available to them, and the reality is that not every method is going to work for every woman,” Rebecca Simmons, PhD, Research Assistant Professor, Department of Obstetrics and Gynecology, University of Utah, told Health. “This is really exciting, in the sense that the more methods we have, the more likely it is that people can find something that works for them—and then can avoid unwanted pregnancy.”
- Apple, headquartered in Cupertino, Calif., received FDA clearance in 2018 for an electrocardiogram (ECG) app for its Apple Watch Series 4 that allows users to take an ECG from their wrist to detect irregular heart rhythms and atrial fibrillation (AFIB).
“The role that technology plays in allowing patients to capture meaningful data about what’s happening with their heart—at the moment when it’s happening, like the functionality of an on-demand ECG—could be significant in new clinical care models and shared decision-making between people and their healthcare providers,” said Nancy Brown, CEO of the American Heart Association, in a press release.
Patients, Providers, and Big Pharma All Like Digital Therapeutics
There is some evidence that patients and healthcare providers are intrigued and willing to try digital therapeutics. In a PwC HRI survey, more than 50% of respondents said they “would be somewhat or very likely to try an FDA-approved app or online tool for treatment of a medical condition.”
Pharmaceutical companies also are interested in digital therapeutics. A 2018 PwC HRI survey found that 80% of pharmaceutical executives had plans to invest in digital therapeutics in the near future.
A 2019 PwC article, titled, “Digital Health Products Need Evidence and Buy-In to Succeed,” states that drug companies see the following opportunities for DTx to improve the patient experience:
- Digital product support and educational tools,
- Patient adherence and compliance programs,
- Remote patient monitoring,
- Data sharing with healthcare providers, and
- Caregiver tools and support.
With precision medicine and pharmacogenetics, clinical laboratories could play an essential role in supporting digital therapeutics in the future. But to truly be competitive in this space and take advantage of the opportunity, medical laboratories will need to increase their information technology and digital capabilities.