Considered one of the most innovative areas within digital health, the prescription digital therapeutics (PDT) ecosystem has experienced an accelerated period of progress over the past two years. A prescription digital therapeutic is a prescription-only software that delivers evidence-based therapeutic intervention(s) to prevent, manage or treat a medical disorder or disease.
While considerable progress has been made, the question remains whether digital therapeutics can successfully and sustainably integrate into the U.S. healthcare system. Regulatory challenges and payer adoption are challenges that have dominated the conversation so far in the PDT world, but clinical validation, FDA approvals and reimbursement coverage aren’t enough. Physician adoption is a crucial, yet mostly overlooked, element that will determine the fate of PDTs.
According to Exits & Outcomes, only five PDTs have achieved FDA approval. Other startups have created digital therapeutics that treat digestive disorders, musculoskeletal pain and cancer symptoms.
The final frontier – adoption
The FDA has generated a process to approve PDTs, and broad insurance coverage will soon follow. Now, PDTs must develop and implement go-to-market strategies. More than 80% of healthcare costs are controlled by physician decisions and the resulting downstream effects. In this way, getting PDTs into a patient’s hands (or phones) is not a unique challenge in that they must first be prescribed by physicians, like a prescription drug.
However, simply modeling a strategy for physician adoption based on marketing plans for traditional prescription drugs will not work, because a PDT is still different from a traditional small-molecule drug in many respects. From integration into physician workflows, to the steep learning curve, to understanding the tech behind PDTs, there are many facets that must be addressed to develop physician buy-in and to change behavior. For PDT developers and their potential pharma partners, this is completely new territory.
Our recommendations to PDT developers
1. Consider different approaches for specialists and primary care doctors.
Primary care physicians (PCPs) and specialists serve different patients, deal with different administrative burdens and have varying levels of therapeutic area expertise. For these reasons, it is critical that PDT developers devise unique strategies for these two groups.
PCPs are busier and less likely to be interested in a single PDT focused on one condition, but at the same time, they treat the lion’s share of the population and cannot be ignored. For mental health-oriented PDTs, positioning PDTs as a starting tool to help patients while they await specialist evaluations may be a helpful angle to improve PMD adoption, especially as they are under pressure to treat mental health conditions to maintain their patient-centered medical home (PCMH) designation.
Specialists rely on their expert colleagues and specialist societies to validate new treatments. Presenting randomized controlled data at specialist conferences and advertising in specialist periodicals will be critical to developing buy-in. Finally, specialists will need to believe that offering PDTs is part of being at the leading edge of their field, and an expectation from patients.
2. Consider how your product will fit into existing physician workflows and provide support.
The administrative burden, which can contribute to clinician burnout, cannot be emphasized enough. There are frequent complaints from physicians about the work that EHRs and well-intentioned IT solutions create.
The deluge of clinical data coming from EHRs poses a massive challenge to physicians as it is. If PDTs create yet another disparate record system or report data that does not feed into existing systems, this will create additional strain on the time and capacity of a physician.
To catalyze widespread physician adoption, PDT developers need to make sure that PDTs integrate seamlessly with existing EHRs and clinical workflows. Given this will not always be possible, PDT developers will need to ensure any physician dashboards they create are extremely simple and offer free customer support for physician practices during implementation.
Finally, physicians will be concerned about liability as it relates to concerning information that comes in outside of office hours. PDT developers should be tracking such information and having customer support contact practices through their regular workflows to allay these concerns.
3. Partner with data intermediaries.
Each PDT developer offering varying levels of EHR integration will create more headaches for providers. Partnerships with intermediary platforms can solve this problem. Intermediary platforms can provide physicians with the ability to easily compare and prescribe PDTs, while also feeding directly into EHR systems. For example, Xealth allows providers to prescribe PDTs and serves as a data intermediary between the PDT and EHRs.
4. Reduce the financial and time burden for physicians to be trained in using your PDTs with patients.
In the context of COVID-19, many have suggested that telehealth adoption that would have taken 10 years occurred in less than 10 months. The broadband technology and video capability were already there, but physicians simply did not adopt telehealth. PDT developers should see this as a cautionary tale when it comes to altering physician behavior towards prescribing PDTs.
On top of that, the aging physician population may present a barrier to PDT uptake and adoption. If they want physicians to adopt this new technology, they are going to have to make it as easy as possible. Education and training will be critical to increasing physician adoption. The education for a prescription digital therapeutic involves understanding what a PDT is, the evidence backing the PDT, the way the technology works, how to prescribe it and ultimately how to monitor patient progress.
Clearly, effective physician education for PDTs will take significantly more time than education for a traditional drug. As such, PDT developers should pay physicians to participate in educational seminars in which they receive continuing medical education (CME) to learn how to use these new products.
5. Pilot PDTs for free with large physician practices and solicit feedback from clinicians.
Physicians are like any social group. They want to know what their peers are doing, and they don’t want to be (too far) behind. As such, piloting PDTs with large academic medical centers with cash and large, well-known practices will be an important way to validate PDTs as leading-edge care.
While there will always be slow adopters, the key is to identify and nurture early adopters so that the middle of the pack will follow in time. Given that several companies already have FDA approval for their PDTs, they should be focusing on developing these early adopters now if they are looking to see real growth in use over the next decade. Creating financial incentives, such as offering the product for free to patients, may be a required first step to developing these relationships.
According to AMA Digital Health Research, published in February 2020, physician adoption for remote monitoring and care jumped from 13% in 2016 to only 22% in 2019, so it is clear that physician adoption will not happen overnight.
While FDA approvals are great news for the digital therapeutics industry, this is not enough. Without physician buy-in, patients won’t experience the benefits of these innovative therapeutics. PDT developers need to address the challenges to physician adoption because, ultimately, PDTs should empower physicians, and not be an impediment to care.
About the authors:
Shivan Bhavnani is the Founder & CEO of the Global Institute of Mental & Brain Health Investment (GIMBHI), which provides data, insights, and analysis on the mental, behavioral and brain health startup ecosystems. In addition, he is a Venture Partner at Vynn Capital and has over six years of experience in leveraged finance from his time at Morgan Stanley, Moody’s Investors Service, S&P Global, and Willis Towers Watson. He has advised digital health & AI startups, and is a board observer at Scientech Laboratories. Shivan is a CAIA charterholder and graduated with a B.A. in economics from Wesleyan. Currently, he is pursuing an M.B.A. at the Fuqua School of Business at Duke University, concentrating in healthcare management and finance.
Ravi N. Shah, MD, MBA, is a Columbia University psychiatrist with extensive experience in mental health technology and innovation. As the Founding Director of Columbia Psychiatry Mind Ventures, he works to invest the department’s wide and deep intellectual capital (in the form of faculty experts) into partnerships with innovators, startups and venture capital firms looking to transform mental health and addiction care. In addition, he is an Assistant Professor of Psychiatry and the Medical Director of Columbia University’s Psychiatry Faculty Practice. Dr. Shah is also the cofounder of Mantra Health, a telemedicine mental health startup looking to solve the college mental health crisis. Ravi graduated from Princeton University with a degree in public and international affairs. He graduated from the MD/MBA program at the University of Pennsylvania School of Medicine and The Wharton School. During that time, he worked at McKinsey & Company in the health care practice. He completed residency in Adult Psychiatry at Columbia University, where he served as chief in his final year.