There has been a lot of buzz around the potential of digital therapeutics (DTx), which can deliver medical interventions directly to patients to manage and prevent a broad spectrum of diseases and disorders, such as heart disease and diabetes. Not yet widely known, digital therapeutics are a subset of “digital health,” which include everything from EHRs and wellness apps to clinically validated therapeutic interventions that mirror or improve upon existing in-person care. These evidence-based software programs have the potential to transform healthcare, allowing healthcare providers to monitor their patients in real-time, make necessary interventions in a timely manner, and ultimately improve health outcomes.

What are digital therapeutics? 

Digital therapeutics are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. The majority of current DTx solutions address the monitoring or treatment of chronic diseases, which are the leading driver of the nation’s $4.1 trillion in annual healthcare spending. DTx solutions are typically delivered through smartphone apps. This makes them more accessible by delivering treatment directly to patients’ homes and removing any stigma that some individuals, for example, may associate with substance abuse and mental health.

Five years ago, the Food and Drug Administration (FDA) cleared the first Prescription Digital Therapeutic (PDTx). PDTx are digital therapeutics prescribed by a physician and paid for by the individual’s health insurance. They are used to treat a wide range of conditions, from schizophrenia, atopic dermatitis, chronic insomnia, attention-deficit/hyperactivity disorder, and substance and opioid addiction.

The promise of digital therapeutics for patients and providers 

Digital therapeutics have enormous potential to transform healthcare, with the ability to treat chronic conditions in a timely manner, lower costs, and improve clinician workflows. Some of the key benefits it may offer patients and providers are outlined below.

Patients: 

• DTx allow patients to access remote healthcare monitoring and treatment, helping them to stay engaged and better manage their disease.
• As a result of the data that is collected, therapies can be more personalized and adapted to patients’ needs.
• Since DTx are software-based treatments, behavior modifications are the core of the therapy, so there are usually no harmful side effects or reactions.

Healthcare providers:

• Physicians would be able to continuously monitor patients’ outcomes and adherence to treatment plans outside the clinical settings.
• These insights could enable providers to make better clinical decisions and quickly optimize treatment.
• Potential to minimize time spent performing administrative tasks and increase interactions between healthcare providers and patients in remote settings.

Barriers to adoption 

Despite its potential to transform healthcare, the process of bringing DTx to patients is complex. Companies need to provide robust clinical trial data to be approved by regulatory agencies, including the U.S. Food & Drug Administration (FDA), which can sometimes take years and require a large amount of capital.

It’s important to keep in mind that even before physicians prescribe prescription digital therapeutics, they want to know that they deliver results – and that they are covered by insurance. Much of this can be accomplished my providing figures that prove DTx can reduce costs for payers, but it is often time consuming to pull the data together, adding yet another hurdle to overcome. Currently, one-off contracts with state Medicaid plans remain the only public coverage of PDTx and large commercial payers have remained hesitant to cover digital therapeutics. To be successful, business models should allow for reimbursement so that therapeutics are accessible for those in need.

Furthermore, DTx developers must increase awareness of their solutions to the important stakeholders: providers, patients, and payers. Products need to fit into the physician workflows to ensure that they are easy to use. Similarly, their user interfaces should be intuitive for patients, allowing for adoption and retention.

Looking ahead: The future of digital therapeutics 

Regardless of these challenges, the implementation of digital therapeutics continues to move in the right direction. Notably, a reimbursement strategy framework is on its way in the US, which will create an incentive for providers to prescribe DTx.

Earlier this year, CMS implemented a new Level II Healthcare Common Procedure Coding System (HCPCS) code for “prescription digital behavioral therapy,” which makes it easier for commercial and Medicaid plans to cover these therapies. Additionally, Congress is considering legislation called the Access to Prescription Digital Therapeutics Act, a bipartisan bill that would establish benefit categories for certain digital therapeutics so that they could be reimbursed by Medicare, Medicaid, and other public payers – a key roadblock that is currently blocking the way towards further adoption.

The future of digital therapeutics is bright, with the DTx market expected to be worth $35.7B by 2030. As a result of the pandemic, the adoption of digital health is higher than ever before, making it an ideal time for implementing new and convenient digital care options. There is still a long way to go toward widespread adoption, however, with a burgeoning reimbursement strategy and increased support from the federal government, digital therapeutics is one step closer to becoming accessible for patients and providers alike.

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