Digital Therapeutics: Opportunities And Challenges In Digital Health

Digital health creates a new landscape for healthcare delivery

Technological change in healthcare has progressed rapidly in the past couple of years, in part due to the COVID-19 pandemic and the consumerization of healthcare. High deductibles and co-insurance have turned patients into consumers looking for value and convenience. Spurred by ready access to information and preference for user-driven experiences, we want as much control over access to healthcare as we have to online shopping, grocery delivery, and travel arrangements.

Healthcare consumers are most familiar with digital health products commercially available for general wellness and support, like fitness trackers and smart scales. Persons with chronic disease may have experience with digital health products for remote monitoring as well.

Digital therapeutics: software as therapy

Another category of products, digital therapeutics (DTx), provides evidence-based therapeutic interventions to prevent, manage or treat a medical disorder or disease. PDT, or prescription digital therapeutics, is one business model of digital therapeutics. Prescription digital therapeutics apps are prescribed by a physician and used by a patient on their digital device. The FDA reviews PDTs against clinical data, quality, and safety measures consistent with the process for prescription medicines.

The market for digital health and digital therapeutics

Collectively, digital health represents an estimated U.S.$ 201.9 billion global market for tech development companies. Innovation is poised to disrupt traditional healthcare delivery models by complementing, adding value to, or replacing the existing system. One estimation suggests emerging healthcare technologies providing digital interventions could save the U.S. healthcare system almost $400 billion if fully adopted. Interventions providing remote patient support and providing more effective therapies are two areas of care delivery that have a direct, measurable connection to cost savings – approximately $270 billion.

To optimize the cost-savings opportunity represented by a growing digital-savvy patient base, payers and providers will need to provide an integrated and convenient customer experience that can be trusted and has an impact on health outcomes. A McKinsey survey conducted among industry experts found that ninety percent of respondents believe patients seek integrated journeys rather than single solutions to their healthcare.

Converging provider, patient, and payer interests in digital health

Providers have begun to realize the vast potential digital health tools like digital therapeutics present for improving disease management and treatment, enhancing their clinical decision-making with data and analytics. These digital health tools also empower patients to take active roles in mapping the trajectory of their healthcare journey, increasing patient engagement.

Payer support for digital health delivery models is predicated on cost-effectiveness and quality of outcomes. Early clinical indicators are favorable that digital health holds strong promise, although payers may seek larger bodies of evidence and more explicit regulatory oversight before wide acceptance takes hold.

To that end, the U.S. Food & Drug Administration has established a knowledge center to shape policy, establish best practices, and regulate stakeholders in this rapidly-evolving market. The Software Precertification Pilot Program, aimed at technology developers, takes initial oversight steps. The pilot program will inform the development of a future regulatory model impacting software-based medical devices for quality, safety, and performance measures. Health Advance worked with the FDA on the Precertification Program.

Considering the range of stakeholder interests and the speed of the development of emerging healthcare technologies, can patients, providers, and payers digital health priorities in the near term? Digital therapeutics’ potential to advance health equity may be the key.

Digital therapeutics offers clear benefits to patients, payers, and providers

Digital therapeutics are being developed to prevent, manage, or treat various diseases and behavior-modifiable conditions. DTx often target conditions that are poorly addressed by the healthcare system, including chronic diseases or neurological disorders. Evidence is also emerging that shows the value of DTx in treating substance addiction.

Conditions treated by digital therapeutics

The Digital Therapeutics Alliance identifies several conditions digital therapeutics target, including:

• Diabetes management – devices including blood glucose meters and insulin pumps, and mobile phone-based software allowing real-time information flow between providers and patients.
• Mental health – computerized, interactive self-service cognitive behavioral therapy services for persons managing addictions, anxiety disorders, or depression.
• Weight management – apps focusing on behavioral and mental components of a lifestyle modification intervention.
• Alzheimer’s disease – light and sound therapies stimulating memory and cognition improving functional outcomes and reducing brain atrophy.

The development and implementation of digital therapeutics transforms how providers think about new treatments, how they engage with patients to develop treatment plans, and how payers think about reimbursement.

Challenges in digital health

While there is transformative potential in digital health solutions and tools, multiple barriers to access remain.

Broadband access

Many people still live without broadband access, preventing their access to digital health or digital therapeutics options and denying them the potential benefits of this new model of healthcare delivery. According to the Federal Communications Commission, more than 30% of rural residents lack broadband access. Racial and ethnic minorities, older adults and people with lower education and income are also less likely to have access to broadband.

Smartphone access

Additionally, many people do not have access to a smartphone. Nearly 24% of people living in rural areas own a cellphone but not a smartphone. As a result, they cannot access digital health tools like mobile health apps, patient portals, or other virtual healthcare services.

Digital literacy

Another barrier is digital literacy. Some people may be unable to process and understand digital health solutions, experience cultural or linguistic barriers that limit their use of digital therapeutics, or struggle to comprehend information in digital format.

Tech developers must design inclusive digital health products

Digital health applications may minimize some common barriers to care access, including transportation and communication. But digital health product development must consider how the members of various demographic groups might use a digital health product in their daily lives, including persons with one or more underlying impairments.

Considering the potential digital health applications offer for optimizing patient engagement, patient experience, and health outcomes, it’s important that everyone seeking treatment can access these benefits.

The promise of digital health

As with any emerging health care technology, the promise presented by digital health applications is as valuable as the willingness and commitment of health professionals, patients, and payers to collaborate for further iteration and refinement of tools and services.

By instituting comprehensive design practices, developers will do their part to build a more inclusive, equitable care delivery model.