Digital Therapeutics: Treating Patients Outside Hospital Walls

Technology is changing the world around us, including health care, where industry leaders are looking for new ways to reduce cost while improving both efficiency and quality. This has only intensified in the past few years as the federal government, Congress, insurers, employers, and consumers voice concerns over the rising costs of health care services and prescription drugs. But amidst these concerns, one innovation is striving to provide high quality care in a cost-efficient manner: digital therapeutics (DTx).

How DTx works

According to the Digital Therapeutics Alliance, DTx delivers evidence-based therapeutic interventions to patients, often via an app on their mobile devices. DTx is driven by high-quality software programs and is used to prevent, manage, or treat a medical disorder or disease.

It is important to note that DTx differs from existing health apps in several key ways by offering patients:

• Targeted intervention based on their individual needs
• Treatment options supported by clinical trials, scientific research, and U.S. Food and Drug Administration (FDA) approval
• Instant and continuous feedback on their adherence to a prescribed treatment plan from their doctor
• An alternative method to treating and managing a medical disorder between regular doctor visits

One major advantage of DTx is that it provides patients the option to receive treatment anywhere and at any time. As a result, DTx allows the health care system to expand services beyond the walls of a clinic or hospital, leverage innovation in technology to create lower-cost treatment options, fill current treatment gaps, and encourage patients to strive for better health. There are situations where DTx can even be used in place of a prescription drug.

Examples of DTx in practice

Although DTx are new and still considered emerging in practice, a few companies are on the forefront of this new and exciting technology.

Pear Therapeutics

Pear Therapeutics is one of the leaders in prescription digital therapeutics (PDTs) and is currently performing research and product development on a variety of innovative products. Their pipeline of therapeutic products target a variety of crucial treatment areas including substance use disorder, opioid use disorder, depression, and insomnia. Pear Therapeutics is most notably known for two PDTs (reSET and reSET-O), both of which are interactive-based therapy offerings that patients can complete at home in conjunction with supervised therapist sessions to provide treatment for drug addiction and abuse. The FDA has authorized these offerings after rigorous clinical trials provided research-based evidence to support the efficacy of the treatment option in controlled environments.

Akili Interactive Labs

Akili Interactive Labs is combining modern medicine with digital entertainment, such as video games, to aid children who struggle with ADHD and autism. Even new technology, like virtual reality and augmented reality, has been incorporated into some of the video game products to further expand treatment. Akili’s products focus on deploying sensory-inducing stimuli to trigger the brain to react in a manner that can provide relief and allow children to refocus their attention. Additionally, Akili is in the early stages of developing other therapeutic products that provide treatment for autism spectrum disorder, major depression disorder, and help slow the impairment of cognitive abilities often coupled with the onset of multiple sclerosis.

Propeller Health

Propeller Health is a leader in DTx that is focused on providing treatment to patients suffering from various forms of chronic respiratory disease. Propeller is helping those who suffer from respiratory diseases like asthma and COPD via a sensor that attaches to the patient’s inhaler to help control their symptoms. The sensor allows the patient to monitor their inhaler use and provides them real-time feedback on environmental factors that may be triggering their symptoms. The product has been found to reduce the use of rescue inhalers, which allows patients to lead a healthier and more enjoyable life. According to a peer-reviewed study published by the World Allergy Organization Journal, use of Propeller’s wireless inhaler product resulted in a 54% decrease in asthma-related emergency room visits compared to the previous year.

Omada Health

Omada Health is a leader in designing therapeutic programs that support people who are at risk for, or are already living with, chronic health conditions such as type II diabetes, high cholesterol, and high blood pressure. Genetics and family history can predispose an individual to developing these conditions; however, lifestyle choices are also a factor. In order to help those who already have these health conditions or are at risk of developing them, Omada created an app-based platform that has been scientifically proven in clinical trials to assist people in making and maintaining heathier lifestyle choices. Omada Health’s platform has been so successful in treating patients who are at risk for developing type II diabetes that it received full recognition status as a Diabetes Prevention Program from the Center for Disease Control and Prevention (CDC). Their program has been found to significantly reduce the cost of health care for enrolled patients when compared to traditional treatment options.

Providers can better track patient progress

DTx provides doctors and nurses with a whole new way to reimagine treatment for some of the most chronic conditions. Providers want to know and understand how patients interact with various treatment plans, how well they are adhered to, and whether a patient is seeing positive results. DTx can offer providers all of these things through new advanced monitoring programs.

One example of this is Proteus Digital Medicine’s technology platform paired with mHealth ingestible sensors or wearable devices, which has reimagined how providers monitor medication adherence. A study in the PLOS Medicine Journal found that when using the Proteus Digital Medicine health platform combined with an ingestible sensor and wearable technology, the accuracy of tracking patient adherence to taking prescribed medication was 93% accurate when tracked by the sensor, versus only 63% accurate when being tracked by a medical professional observing the patient. This difference in accuracy could prove to be crucial in achieving treatment for some conditions.

In practice, Froedtert & the Medical College of Wisconsin’s regional health network began prescribing this platform to selected patients who suffer from conditions like diabetes, hypertension, and hepatitis C. This has allowed providers to track a patient’s adherence to prescribed medication and monitor internal reaction to the medication (an app linked to the sensors sends information in real-time to both the patient and the provider). This allows both the patient and the provider to take medical services and treatment outside of the clinic.

Four major benefits of DTx

DTx capabilities continue to positively impact numerous stakeholders in the health care system. By providing a quality treatment alternative at lower cost, consumers, payers, and providers are able to reap the benefits of this new innovation.

With a wider application, DTx can:

• Break barriers related to socioeconomic status or level of insurance coverage. DTx can provide consumers with clinically-proven treatment options that are accessible to more people around the world, including low-income families, seniors, and the physically and mentally disabled. These at risk individuals and groups may not be able to afford treatment for their medical conditions. By having a lower-cost alternative that can be covered by both private insurance as well as federal programs like Medicare and Medicaid, or even purchased outside of insurance, more people will have the opportunity to seek treatment that is sustainable and within their means.
• Provide patients with catered treatment plans. With DTx, patients receive feedback and important care information instantaneously through software via personalized updates and notifications. By having a tailored approach that targets the needs of each patient individually, rather than applying a general approach to all users, these programs will allow patients to receive consistent access to a treatment plan that can be adapted as their condition and symptoms change.
• Reduce the volume of prescription drugs consumed by patients. These software-based interventions do not carry the same toxicity risks and related side-effects that come with taking pharmaceuticals. The United States is facing an opioid and prescription pain killer epidemic. DTx has the potential to be part of the solution to reduce the abuse and dependency of these strong prescription drugs by providing an alternative to surgery and prescription drugs. However, this does not mean that DTx is without risk, and any treatment option should be carefully evaluated by a licensed physician.
• Lower the cost of treating chronic disease. Currently, in-person doctor and hospital visits are costly and thus limit the number of times a patient can meet with their health care provider to obtain treatment services. Certain forms of DTx have been found to significantly lower health care service costs by allowing treatment to continue outside the walls of the clinic, such as the use of Propeller Health’s asthma monitoring device. Numerous studies have found that uncontrolled asthma is significantly more expensive than the costs incurred to control asthma, and that use of their device leads to significantly fewer incidents requiring the use of an inhaler or a hospital visit.

Disrupting the health care system with lower-cost options

According to the CDC's 2018 National Health Interview Survey, there are approximately 30.4 million people in the United States who are uninsured. Without health insurance, Americans struggle to obtain access to important medical services or treatments like DTx, as they require a prescription. Even for Americans with health insurance, the cost of health care continues to be a concern.

As new options for digital treatment are tested and released to the public, insurance companies should consider them as lower-cost alternatives. Current research shows that many of these treatment options are not only successful at treating or aiding in relieving symptoms of chronic diseases, but also that the costs are significantly lower than prescription medication options.

By providing a lower-cost option, insurance companies that bring these products on as part of their covered offerings would be able to lower their operating costs and improve the health and lives of their insured through preventative products, and thus pass on savings through lower premiums. It should also be noted that certain DTx programs have even caught the attention of the Centers for Medicare and Medicaid Services (CMS) as effective lower-cost treatment options. In 2019, CMS added three new CPT codes related to Remote Patient Monitoring (RPM) of physiological data. These codes separate DTx products that offer RPM from CMS’s telehealth regulations, which are far more restrictive in coverage and reimbursement.

How we can help

The health care system is undergoing a period of significant change and innovation, and DTx will continue to provide new non-invasive, drug-free treatment options that will serve as cost-efficient alternatives to what is available today. CLA can help you analyze and assess how these changes will play into your organization’s future.