Smartphones and tablets have transformed almost every facet of our daily lives, making it nearly impossible to imagine a world without being connected. That same technology has now crossed into health care. Prescription digital therapeutics, or PDTs, are reimagining the way we think about treating disease by using smartphones and tablets to deliver treatment anytime and anywhere.

Prescription digital therapeutics operate at the intersection of biology and technology, with researchers, clinicians, and engineers working in tandem to leverage the power of software to treat disease. They are designed so patients can access treatment when and where they need it. Similar to traditional medicines, PDTs are prescribed by physicians and backed by clinical data and subject to authorization by the Food and Drug Administration.

Prescription digital therapeutics are being developed for an astounding range of conditions, from schizophrenia and multiple sclerosis to chronic insomnia. In January of this year, my company, Pear Therapeutics, commercially launched the first FDA-authorized PDTs, reSET for substance use disorder and reSET-O for opioid use disorder.

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As Pear’s CEO, I have seen how these therapies are shifting the paradigm of care in ways that empower patients and providers. I have also seen the barriers that developers of prescription digital therapeutics must overcome across the health care continuum, such as navigating an evolving regulatory space, securing reimbursement, and educating patients and prescribers.

Prescription digital therapeutics could be a vital part of future treatment models across a range of diseases with unmet medical needs — offering prescription medicines alongside regulated and proven digital therapeutics to better address the full burden of disease. For example, reSET-O provides patients who are taking medication for opioid-use disorder with instantly accessible cognitive behavioral therapy, which is designed to help patients change for the better the ways they think and behave.

At the same time, PDTs may transform treatment by allowing providers to securely collect real-time data from patients and analyze that information to develop personalized treatment plans. These data-driven insights can help patients and providers make better use of their time and increase the impact of office visits.

Overcoming the challenges of introducing a new type of therapy

The health care ecosystem is set up to absorb evolutionary innovations, like new medical devices and drugs that fit into the existing model of delivering care. Truly transformational technologies, like prescription digital therapeutics, must forge a new path.

A novel regulatory pathway. Similar to some traditional medicines, PDTs must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients. Companies aiming to create these new therapies must be prepared not only to make the significant investments of time and money that traditional health care companies make in conducting clinical trials, but also to bring on individuals with the experience and know-how to create successful FDA submissions.

The regulatory pathway for digital therapies is still very much in its infancy and must be tailored for the unique nature of these treatments. The FDA has recognized the need for a nimble approach that will allow these products to be frequently updated. As one of nine companies participating in the FDA’s Digital Health Software Precertification Pilot Program, my Pear colleagues and I are working to help define the regulatory pathway for future PDTs while ensuring they meet appropriate patient safety standards. According to the FDA, the experiences gained from this pilot program will “provide more streamlined and efficient regulatory oversight of software-based medical devices.”

A new paradigm for reimbursement. Ensuring that new drugs and devices are covered by public and private health plans tends to be a lengthy and involved process. A key advantage of digital solutions is that they are expected to be more cost effective than traditional solutions (such as face-to-face cognitive behavioral therapy sessions) and can collect and quantify information about outcomes in real-world settings. By leveraging both of these features, developers can demonstrate to managed care providers the value of these innovative treatments.

Building markets. As with any prescription product, especially a first-of-its-kind innovation, market adoption can be slow. Developers must reach and educate a diverse array of stakeholders — health care providers, advocacy organizations, patients, and more — on the benefits and risks of individual prescription digital therapeutics. It is essential for adoption that patients and physicians learn how these therapies can improve outcomes and understand that the clinical rigor and testing they undergo is similar to the traditional medicines they already rely on.

The future

Prescription digital therapeutics will continue to be a key piece of the emerging global digital market, which some estimate to be worth more than half a trillion dollars by 2025. In fact, in just the last two years, more than $12.5 billion has been invested in digital health startups.

In the coming years, I expect to see new entrants in the PDT pipeline tackling more diseases with innovative approaches that may deliver superior outcomes, bridge crucial gaps in care, and empower patients by being accessible, convenient, and discreet. The question is not if these therapies will receive the widespread acceptance that will enable them to make a substantive difference in health care, but when.

Corey McCann, M.D., is the president and CEO of Pear Therapeutics.

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  • Hi, I have some questions about how your research team was formed and how you started to measure the PDT’s in clinical trials?

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