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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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:

“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.”

The graphic above is taken from the PwC HRI 2019 annual report on digital therapeutics and connected care. It shows that “a majority of consumers surveyed are interested in FDA approved digital apps or online tools to treat their medical conditions.” (Graphic copyright: PwC HRI.)

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.

—JP Schlingman

Related Information:

Digital Therapeutics and Connected Care Reshape the Life Sciences Industry

The Emerging World of Digital Therapeutics

Top Health Industry Issues of 2019: The New Health Economy Comes of Age

Digital Therapeutics: Combining Technology and Evidence-based Medicine to Transform Personalized Patient Care

Everything You Need to Know About the Controversial New Birth Control App

Digital Health Software Precertification (Pre-Cert) Program

Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for Reset-O to Treat Opioid Use Disorder

Everything You Need to Know About the Controversial New Birth Control App

More than Half of Patients Willing to Use Digital Therapeutic, Study Says

ECG App and Irregular Heart Rhythm Notification Available Today on Apple Watch

Digital Health Products Need Evidence and Buy-in to Succeed

Life Sciences May See Accelerated Digital Health Pathway as Soon as 2020

Medical Laboratories Find Opportunities as Digital Therapeutics Companies Leverage Mobile Applications for Treatment of Chronic Conditions

Digital Therapeutics combined with clinical laboratory oversight testing could help chronic disease patients avoid surgeries and expensive drug therapies

One area of technology that has fundamentally changed the healthcare industry involves mobile devices. But those early “wellness” tools have evolved. Today’s modern mobile health devices feature software applications (apps) designed to remotely treat chronic conditions by helping modify patient behavior, as well as monitoring drug intake and physical condition biomarkers. These devices are dubbed “Digital Therapeutics,” and they present opportunities for anatomic pathology groups and clinical laboratories.

For if mobile apps are going to be used to monitor patients’ adherence to therapy—including prescription drugs—there will be a need for clinical laboratory tests that work in harmony with these apps. Otherwise, how will providers and insurers know for certain patients’ biomarkers have improved or regressed?

Massive Investments in Digital Therapeutics Companies

Today’s digital therapeutics (AKA, software for drugs) can be tailor to specific treatments of chronic conditions, such as:

·       diabetes mellitus;

·       cardiovascular disease;

·       hypertension; and,

·       chronic obstructive pulmonary disease (COPD).

Forbes states that the “future of healthcare will be app based.” That seem likely given the massive influx of capital being directed at the mobile healthcare industry.

The graphic above is taken from a 2015 report by PricewaterhouseCoopers Health Research Institute  (PwC), which sourced the data from the 2014 clinician workforce and consumer surveys. Since then, the demand for mHealth products has increased exponentially. Today’s digital therapeutics market includes clinical laboratory and pathology group treatments and drug therapies. (Graphic copyright: PwC.)

The global digital therapeutics market is projected to grow to about $9 billion by 2025. That’s up from $1.7 billion last year, according to a report by Grand View Research. Driving the popularity of digital therapeutics are the benefits it affords patients, explained the report’s summary. They include:

·       Continuous monitoring of vital signs;

·       Medication management; and,

·       Current healthcare reminders.

This is where pathologists and clinical laboratories come in. The medical laboratory can be the source for baseline blood tests before apps are used. And then, ongoing testing can determine if patients are taking drugs according to treatment guidelines and making the appropriate lifestyle changes.

Start-ups Raise Millions, Define Digital Therapeutics Space

One unique aspect of digital therapeutics is its ability to promote health improvements through behavioral changes alone. And millions are being invested in the concept.

For example, Virta Health Corp. raised $37 million in funding for an app that coaches diabetics on a diet to reverse their condition without drugs or surgery, according to MIT Technology Review.

“[Digital therapeutics] is still a fluid space that everyone is trying to categorize,” Peter Hames, co-founder and Chief Executive Officer of Big Health noted in the MIT Technology Review article. Among other programs, Big Health developed Sleepio, a sleep improvement program or insomnia app. Hames says most apps fall into two categories: “medication augmentation” or “medication replacement.”

Omada Health secured $127 million to conduct a clinical trial with Humana that investigates prediabetes, noted Forbes.

The study findings, which appeared in the Journal of Aging and Health, suggest that Omada Health’s digital behavior change program can help people to reduce chronic disease risk, noted a Humana news release.

The study involved Humana Medicare Advantage insurance members, who were enrolled in Omada Health’s Diabetes Prevention Program. The app enabled them to partake in online courses, use wireless scales, and tap other digital health tools as they worked to improve health and reduce risk of type 2 diabetes. Human coaches also were accessible.

“Few efforts have explored the feasibility and effectiveness of using technology to deliver diabetes prevention programs specifically for older adults,” the study researchers wrote.

According to the researchers:

·       501 people with average weight of 208 pounds participated;

·       Hour-long lessons were made available and expected to be completed by smartphone, laptop, or tablet;

·       Coaches monitored the information participants provided and their requests for counseling;

·       92% of participants completed at least nine of the 16 core online courses, which focused on topics such as changing food habits and increasing physical activities;

·       People lost 7.5% of body weight after 12 months, or 13 to 14 lbs.;

·       A subsample (69 individuals) who had lab tests performed improved glucose control as evidenced by a -0.14% reduction in glycosylated hemoglobin, and a decrease of -7.08 mg/dL in total cholesterol.

“These results support the clinical validity of the program with Medicare-eligible, at risk older adults. They are added evidence that chronic disease risk reduction is achievable through a variety of modalities, including digital-based programs with human coaching,” the researchers noted.

And because digital therapeutics amasses data that can be leveraged, Omada Health’s program acts as a “continuous learning system,” Sean Duffy, Omada Health’s co-founder and Chief Executive Officer, noted in Undark.

App Tracks People After Heart Attack

Johns Hopkins Medicine’s Corrie Health app is aimed at helping patients recover from heart attacks. A study at Johns Hopkins Bayview Medical Center in Baltimore explored the effectiveness of app-enabled information and resources made available to patients early in the heart attack recovery process, according to Corrie Health’s Website.

Results from the clinical study of 50 patients show no one was readmitted to hospital in the first 30 days, Undark reported.

“We can actually enroll patients who are six or seven hours out of having a stent placed in the ICU. We’re giving [the Corrie Health app] to patients when they have the time to spend watching the videos and asking questions about their medications … We’re getting them to buy-in and learn the skills while they care the most,” Francoise Marvel, MD, an internist affiliated with Johns Hopkins Bayview Medical Center, told Undark.

A Role for Medical Laboratories

So, is there a role for medical laboratories where digital therapeutics are being used? We think so. Pathologists and lab leaders may even want to reach out to venture capitalists working on mobile apps that combine adherence to therapies with medical lab tests.

As our population ages and the shortage of physicians becomes more evident, digital therapeutics may be a smart way to address select patient needs in a quality and cost-effective manner.

—Donna Marie Pocius

Related Information:

Digital Therapeutics: The Future of Health Care Will Be App-Based

Digital Therapeutics Market by Application, End User, and Segment Forecasts 2014 – 2025

Can Digital Therapeutics Be as Good as Drugs?

Digital Therapeutics Market 2017: Omada Health, WellDoc, Livongo Health, Noom Inc., 2Morow, Inc., Canary Health

Prevention Program Resulted in 7.5% Weight Loss in Humana Medicare Advantage Population

Outcomes of a Digital Health Program with Human Coaching for Diabetes Risk Reduction in a Medicare Population

Putting Digital Health Monitoring Tools to the Test