Why Life Sciences Companies Are Taking the Leap With Digital Therapeutics

It isn't easy to imagine our daily routine without digital technology, which has permeated our lives in every way possible. Even healthcare — which has evolved from isolated, remote monitoring technologies to today's ubiquitous fitness devices and wellness apps — has gone digital for patients and providers alike.

Digital health is the new credo for designing, developing, and marketing healthy life experiences or campaigns for biopharma and medtech for providers and payers alike. It is widely believed that medicine will undergo a paradigm shift from healthcare to holistic health. Clinicians will base their diagnoses and treatment decisions on predictive, preventative, personalized and participatory care.

This shift in focus has been particularly evident in digital therapeutics (DTx), a subset of digital health that has evolved as evidence-based, clinically evaluated software products and services to prevent, manage, or treat a medical disorder or disease. A feature of digital therapeutics is that they require both clinical evidence and evidence from real-world outcomes. As a result, they need to be reviewed and approved by regulatory bodies for claims of safety, risk, and efficacy.

How digital therapeutics technology is changing patient care

Healthy patient outcomes are a critical denominator of successful healthcare delivery underlined by IHI’s Triple Aim of improved access to better quality care at a lower cost. With the growing chorus of value-based reimbursement models by healthcare payers, digital therapeutics have emerged as a viable data source of regulated care delivery, providing qualitative and quantifiable health indicator measurements for submissions to regulators and payers alike.

Digital therapeutics can support patients in self-managing symptoms and improve their quality of life and other clinical endpoints. Digital therapeutics technology also uses digital implements, such as mobile devices, apps, sensors, virtual reality, the Internet of Things, and other tools to spur behavioral changes in patients.

The market for digital therapeutics products is rapidly maturing, prompting many players to test the waters and drive use-cases for adoption across the health delivery value chain, especially for patients. According to the Digital Therapeutics Alliance, “Digital therapeutics (DTx) are changing the healthcare delivery system with evidence-based technologies that improve patient outcomes.”

What are the many benefits of digital therapeutics?

Digital therapeutics improve patient outcomes for a wide range of diseases and disorders with clinically proven technologies accessible through devices such as smartphones and personal tablets. These products may expand access to proven therapies, offer treatment options for untreated or undertreated conditions, and empower patients with self-management tools. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Digital therapeutics products are proven to deliver medical interventions directly to patients or integrate with other digital health technologies, medications, or in-person therapies to:

• Improve patient health
• Deliver a highly engaging and user-friendly experience
• Provide meaningful results and insights on personalized goals and outcomes
• Easily scale and be accessible via smartphones and tablets
• Ensure patient safety and privacy protection

The above care continuum is readily influenced by a cohort of digital therapeutics products across multiple therapeutic areas. While there is straightforward adoption of digital therapeutics in chronic disorders like diabetes and mental health ailments, there is increasing evidence of patient health indicators influencing co-adoption by conventional therapeutics.

Over the past decade or so, there has also been a concerted effort to push digital health products so that digital therapeutics can co-exist or even have a replacement value in the traditional care pathway. The USFDA established the Digital Health Center of Excellence in 2020, succeeded by the Digital Health Innovation Action Plan (Software Precertification Pilot Program) to adapt a regulatory pathway for mainstreaming adoption of digital health products (including digital therapeutics). Global regulatory agencies and channels make such efforts to enable more transparent and faster health cost reimbursements by payer organizations.

Digital therapeutics enables life sciences companies to innovate and thrive

Empirical evidence suggests digital health products have a positive effect when adopted. This effect extends to digital therapeutics, which are competing to be recognized as a primary or secondary influencer in care modalities.

However, there needs to be a clear roadmap for incentivizing biopharma and the medtech industries to develop evidence-based software interventions that cater to the burgeoning needs of chronic/acute care populations. Life sciences companies will need to decide whether to distribute or centralize their expertise, concentrating digital resources within R&D or the commercial function or as a separate center of excellence.

With the boundaries blurring between healthcare and technology companies, it is pivotal for research-driven healthcare companies to identify and partner with the right healthcare technology service provider. This type of partnership, which is powered by a results-oriented business model and innovative solutions to minimize risk and maximize outcomes, is a long-term win-win proposition for any healthcare or life sciences company looking to thrive in the arena of digital health.