The COVID-19 pandemic has put a spotlight on the foundational cracks of the US healthcare system, and the need to rethink how healthcare is delivered in the 21st century. While the majority of the global population was quarantined at home, physical access to the healthcare system was limited, and digital alternatives, such as telehealth, quickly became the primary source of communication between the doctor and patient. The mandated stay-at-home orders and the emergency passing of the Telehealth Modernization Act, spearheaded the partnership of technology and medicine with a 63-fold increase in virtual patient visits from 2019 to 2020.1,2
In addition to telehealth, the pandemic accelerated perceived benefits of combining artificial intelligence (AI) with evidence-based treatment models to revolutionize how people not only consume health educational content, but how they engage with digital platforms designed to help change behavior and reduce negative health outcomes. These platforms are called digital therapeutics (DTx) and they are emerging as an effective tool for healthcare professionals to implement as part of their overall treatment plan for people diagnosed with chronic conditions.
Challenges Healthcare is Facing
Chronic Disease is on the Rise
Chronic disease in the United States is a public health emergency, with six in ten Americans living with at least one chronic condition such as heart disease, diabetes, obesity, and cancer.3 Not only are chronic conditions the leading cause of hospitalizations, disability, and death in the United States, they contribute to $3.8 trillion in annual healthcare costs, and account for 10% unemployment for people living with a disability.3,4 While the leading cause of death in the United States progressed from infectious diseases to chronic conditions during the 21st century, the priority of healthcare spending focused on treating symptoms and advanced stage chronic disease, while only pledging $1.2 billion to explore prevention programs.5
Unless effective changes in healthcare delivery emerge, the problem is going to get worse as the large baby boomer population ages. Starting in 2030, one in five Americans will be older than 65, widening the expensive toll on the healthcare system, workplace, and increased need for assisted living.6
Prevention is Possible
It is not a secret that chronic diseases are preventable, and the key to effectively treating these conditions depends on upstream proactive interventions, not the current downstream reactionary plan that waits for people to become symptomatic and hospitalized before treatment is offered.
The root cause of many chronic diseases is unhealthy lifestyle choices such as: smoking, alcohol consumption, poor nutrition, and sedentary lifestyle. Targeting these behavioral risk factors directly with the use of clinically-validated, highly engaging DTx solutions, can be an effective stepping stone in helping 133 million Americans successfully manage their chronic disease from the comfort of home.7,8
What Are Digital Therapeutics?
Technology is empowering people to take control of their health, and demand for high-tech access to the healthcare system is on the rise. To meet the moment, DTx have become an effective digital health tool for healthcare professionals to use as part of a broader treatment plan.
The Digital Therapeutics Alliance, founded in 2017, defines DTx as a “new category of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”9 Because DTx solutions are promoted as a therapeutic intervention, they are subject to rigorous regulation by the U.S. Food and Drug Administration (FDA) and must be clinically proven to provide real world positive health outcomes.10,11
The goal of DTx is to change patient behavior and promote positive long-term health through the disease-specific programs. While basic wellness applications target general health, DTx solutions target a person’s specific medical condition such as diabetes, hypertension, atopic dermatitis, cancer, etc. Depending on a person’s treatment plan, the solution might manage a specific diet or exercise routine, sleep, stress, and medication reminders.
Sidekick Health’s digital solution utilizes gamification, behavioral economics, and AI to provide individualized support to people diagnosed with various chronic health conditions. With the use of videos, tasks, reminders, coaches, and motivational messaging, Sidekick acts as a highly effective prevention, empowerment, and disease management tool. With its embedded remote monitoring capabilities, the Sidekick platform allows healthcare providers to be in constant contact with their patients, and track their progress in real time.
How Digital Therapeutics Are Beneficial
With the increasing popularity of digital health and DTx specifically, investors are taking note and have already contributed $12.5 billion to help fund various digital health companies. Experts project that by 2025, DTx will be a $56 billion global market, proving that DTx is a permanent trend in digital health that will help expand traditional healthcare outside of the brick and mortar setting.12,13
The shifting of healthcare to effective advanced digital platforms has positive implications for payors to improve both treatment and patient outcomes. The data collected from DTx solutions can provide payors with a snapshot of treatment progress and can easily be integrated into existing case management workflows allowing payors to analyze the effectiveness of prescribed treatments. Other strategic benefits DTx offers payors include:14
- Reduce cost of care
- Enhance current medical treatments
- Improve member engagement and satisfaction
- Extend healthcare outside the traditional brick and mortar setting
- Prioritize value-based health initiatives
A survey conducted by Clarivate15 showed that 25% of payors surveyed already reimburse various DTx solutions, while 45% indicate that their organizations are interested in future coverage for their members.
In an attempt to diversify portfolios and meet expanding digital expectations from consumers, many pharma companies are turning to DTx solutions to add value, and generate new avenues of revenue. While the clinical effectiveness of digital therapeutics is becoming widely known, the question pharma companies now face is not if they will add DTx solutions to their list of assets, but how.
Currently, the most popular options available for pharma companies to move into the DTx space include:16
- Creating a DTx solution in-house
- Licensing an existing third-party product
- Partnering with a digital health company
Many pharma companies are embracing the partnership route with recent announcements coming from Bayer, Novartis, and Sanofi to join forces with various digital health companies to provide DTx solutions for a variety of health conditions including diabetes, mental health, and cardiovascular disease.17
In 2020, Sidekick and Pfizer announced a landmark partnership deal to bring the Sidekick digital solution to the European market to help manage various chronic conditions including: inflammatory bowel disease, rheumatoid and psoriatic arthritis, and atopic dermatitis. Sidekick and its existing pharmaceutical partners also have plans to expand into the US, Canada, and Japanese markets in the near future.
Partnerships can offer insightful collaboration and skill sharing that help bridge the knowledge gaps between pharmaceutical and digital health companies, with the two teams working together to enhance the customer experience and improve critical health outcomes for those experiencing chronic diseases.
The success of digital therapeutics depends on the healthcare professional and patient relationship and buy-in that remote monitoring of health symptoms benefits all parties involved. For healthcare providers, the benefits of DTx span across multiple areas of patient care and include:18
- Expand continuum of care outside the traditional clinic
- Close gaps in care
- Deliver interventions for undertreated conditions
- Foster patient engagement
- Access to disease management data that can contribute to positive outcomes
- Lower healthcare costs
Workflow integration between the DTx platform and the provider’s existing care management system allows seamless sharing of data, allowing real-time observation, and the ability to track and record patient outcomes and progress. The benefits of DTx solutions in the clinical setting both strengthen the patient-provider relationship, and improve quality of care contributing to enhanced disease management and overall patient satisfaction.
Challenges that Lie Ahead for DTx
There are still challenges and barriers that need to be addressed before DTx becomes mainstream in changing the way healthcare is globally delivered. The core challenges the DTx marketplace is facing include accessibility, digital literacy, and reimbursement.19
A patient’s ability to access DTx solutions is a big barrier to the success of digital therapeutics. Many people diagnosed with chronic conditions live in rural areas where broadband service is limited or non-existent, with reports confirming that 19 million people living in rural America still don’t have access to the internet.20
Socioeconomic factors also limit many people from affording smartphones that are vital to digital health, and can further divide health equity and social determinants of health that already plague the US healthcare system.
Educating key stakeholders on digital literacy is a core barrier to implementing DTx across healthcare systems. If patients, payors, and providers don’t understand how the technology works, then marketplace buy-in will be low. Professional technical training will have to be a key priority for digital therapeutics to be successful.
Although many payors have shown an interest in including DTx solutions as part of covered patient treatment plans, reimbursement still remains a core challenge for the DTx marketplace. The Centers for Medicare and Medicaid Services have taken limited steps to include reimbursement codes for DTx in collaboration with other treatment plans, but codes have not been provided for DTx as a standalone treatment.21
The COVID-19 pandemic accelerated the demand for digital solutions to communicate with people outside the traditional healthcare setting. Digital therapeutics are on the path to becoming the next generation of healthcare tools to improve both patient outcomes and their engagement with healthcare providers. With chronic conditions on the rise, DTx offers a beneficial solution to address behavior change and prevention measures to help reduce the toll on hospitals and assisted living facilities.
While barriers and challenges to DTx success are still being navigated, the proven effectiveness of digital solutions to help treat people diagnosed with chronic health conditions is spearheading the industry forward.