is the founder of GIMBHI (Global Institute of Mental & Brain Health Investment

Shivan Bhavnani, CAIA

The US Food and Drug Administration has approved prescription-only 

 (DTx) for an array of psychiatric issues, including substance use disorder, insomnia, and opioid use disorder. Many DTx that do not address psychiatric indications use psychotherapeutic approaches, such as 

. But while considerable progress has been made over the last 2 years, the question remains whether DTx can successfully and sustainably integrate into the US health care system.

 by the ability of innovators to navigate the various obstacles, from regulatory hurdles to reimbursement challenges. A prescription DTx developer needs to consider ways to overcome these intertwined challenges. Regulatory and payer adoption challenges have dominated the DTx conversation so far, but a crucial, overlooked element that could determine the fate of DTx is adoption. As the future of this nascent industry is intricately tied to the field of psychiatry, the mainstream usage depends on the adoption from psychiatrists, payers, and patients.

From integration into physician workflows, to the steep learning curve, to understanding the technology behind DTx, there are many facets that must be addressed to encourage physician adoption.

First, randomized controlled data should be presented at conferences and published in periodicals. Psychiatrists will need to be 

, and rigorous clinical trials could only help.

Psychiatrist workflows are another consideration. The administrative burden, which can contribute to clinician burnout, cannot be emphasized enough. Electronic health records systems (EHRs) and IT solutions, while well-intentioned, often create more work. If DTx create yet another disparate record system, or do not feed into existing systems, this will create additional strain on the time and capacity of physicians.

To catalyze widespread physician adoption, DTx should integrate seamlessly with existing EHRs and clinical workflows. Any physician dashboards should be extremely simple and offer free customer support for practices during implementation.

Finally, liability will be a concern, as it relates to information that comes in outside of office hours. DTx developers should track such information and have customer support contact practices through their regular workflows to allay these concerns.

Tech literacy in the aging physician population may also present a barrier to DTx uptake and adoption. To achieve widespread adoption among psychiatrists, prescribing software needs to be as user-friendly as possible. Education and training will be critical. Physicians will need to understand what DTx are, the evidence backing each DTx, the way the technology works, how to prescribe it, and ultimately how to monitor patient progress. Effective physician education for DTx may take significantly more time than education for a traditional drug. As such, DTx developers should pay physicians to participate in educational seminars in which they receive 

continuing medical education to learn how to use these new products

Payer awareness of digital therapeutics has skyrocketed just over the last 2 years. Today, many payers have or are considering establishing a digital health formulary. In the early days, payers dipped their toes into reimbursement by providing access to digital health apps and DTx as part of programmatic spend for wellness and disease management. While DTx can be covered under a patient’s pharmacy benefit, today, there is a shift to claims-based reimbursement. (Currently, there are no DTx that are reimbursed by the Centers for Medicare & Medicaid Services, but insurers are considering reimbursement for DTx.)

 are not guaranteed reimbursement by payers. To be reimbursed by a payer, new DTx are reviewed by an internal committee, in which the FDA submission, clinical data, and health economic outcomes are considered. The goal of reviewing this data is to determine the effect of the DTx on health outcomes, and if this will ultimately save them money. Right now, only a handful of DTx have achieved claims-based reimbursement due to lack of strong evidence in terms of clinical, health, and economic outcomes. This has posed a considerable barrier to payer adoption.

For clinical outcomes, it is crucial to show that the clinical effect is long-lasting. There is skepticism that a 3-month DTx program will have lasting positive clinical effects a year later. To demonstrate this, DTx need to be used in studies with longer timelines.

While long-lasting positive clinical outcomes seem to be the first priority, 

 is a close second. Payers prefer that these new technologies offset costs. Without hard proof of the cost effectiveness of DTx, a payer is likely to deny coverage. Comparing the cost effectiveness of DTx against traditional methods of treatment is often overlooked. While long-lasting clinical and economic outcomes are important, the sweet spot is durability of outcomes from 1 to 2 years. Payers assume a member could switch plans after that.

If DTx are reimbursable and if a psychiatrist prescribes them, the last barrier to adoption lies with the patient.

The first and most obvious driver of adoption is price. If the reimbursement model relies on patients to pay too much for DTx, this will obviously hinder usage and adoption among patients. However, there are other obstacles to patient adoption beyond pricing.

If we use telehealth as a proxy for digital health in general, it seems that use of tech-enabled health care is falling. According to 

FAIR Health’s Monthly Telehealth Regional Tracker

, telehealth use fell nationally for the third straight month in April 2021.

: “…despite the availability of evidence-based digital health interventions, a substantial proportion of users does not adhere to them and may consequently not receive treatment.”

 Another issue is data privacy. Coupled with the stigma of mental illness, weak data security measures and the fear of data being leaked could make patients hesitant to use DTx. Gaining the trust of patients is crucial to widespread adoption.

Beyond these issues of pricing, marketing, and data privacy, the actual product needs to be built with the end user in mind: the patient. According to a 

, “Perceived usefulness, user satisfaction, and health status contributed to patients’ intention to make continuous use of mobile health services for self-managing their chronic conditions.”

 Low adherence among DTx users is an issue that need to be addressed by developers to ensure widespread adoption.

Not long ago, a prescription video game that could rewire the brain and lower symptoms of mental illness would have been considered science-fiction. From a technology standpoint, we have advanced considerably. The good news is we have seen the proof that DTx work—these tools have proven that they can offer patients access to mental and behavioral health care that is cost-effective. But implementation and adoption of DTx is the next challenge. While the growth of the DTx is inevitable in a world where many lack access to affordable mental health care, directly addressing the existing challenges given the needs of various stakeholders will only accelerate mainstream adoption.

1. Bhavnani S, Shah RN. Physicians will decide the fate of the digital therapeutics industry. Mobi Health News. November 20, 2020. Accessed August 3, 2021. 

https://www.mobihealthnews.com/news/physicians-will-decide-fate-digital-therapeutics-industry

2. Cox E, Hoult M. Key factors to obtaining reimbursement for digital therapeutics in the US. Eversana. February 4, 2021. Accessed August 3, 2021. 

https://www.eversana.com/insights/key-factors-to-obtaining-reimbursement-for-digital-therapeutics-in-the-u-s/

3. Fair Health. Monthly telehealth regional tracker. April 2021. Accessed August 3, 2021. 

https://www.fairhealth.org/states-by-the-numbers/telehealth

4. Jakob R, Rudolf AM, Harperink S, et al. Prediction and prevention of non-adherence to digital health interventions. September 2020. Accessed August 3, 2021. 

https://www.c4dhi.org/projects/prediction-prevention-non-adherence/

Predicting user adherence to behavioral eHealth interventions in the real world: examining which aspects of intervention design matter most.

Measuring success of patients’ continuous use of mobile health services for self-management of chronic conditions: model development and validation.

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