What Will Accelerate Adoption?
By Tricia Lee (Wilkins) Rolle, PharmD, MS, PhD
Government Affairs and Health IT Strategist
Digital Therapeutics (DTx) — also known as digiceuticals and software-as-a-drug — are rapidly gaining momentum and are a trend to watch. This two-part blog series provides some answers as it explores the DTx landscape. Part 1 focused on defining DTx (what they are and what they aren’t) and outlining the benefits of DTx. This article (Part 2) highlights drivers for change as well as opportunities and challenges facing the nascent industry.
Although DTx are just getting off the ground, they are expected to have a large and disruptive presence—both in the United States and globally—within the near-term horizon. According to one estimate, the worldwide market for DTx is expected to reach $9.4 billion by 2025.
As with many new and disruptive technologies, DTx isn’t assured smooth sailing as it transforms healthcare. What lies ahead?
Drivers for change. To be sure, DTx is in its infancy. Yet experts believe it has enormous potential to lower costs, improve outcomes and capitalize on the rise of consumerism in healthcare. Drivers for adoption include:
Federal oversight. There are several kinds of federal oversight activities that will drive DTx development and adoption. Paramount for uptake and use by providers and patients, is FDA clearance and approval. A growing number of DTx are in the pipeline and several have been FDA cleared or approved. Additional FDA guidance and policy also will fuel development and adoption of DTx. These include promoting patient-focused drug development, as required by the 21st Century Cures Act, and the FDA’s efforts to develop a framework for regulating software applications disseminated by drug sponsors in relation to prescription drugs.
Value-based care (VBC). DTx will have appeal to providers and organizations delivering value-based care. As mentioned previously, compared to traditional medicine, use of DTx may provide more efficient ways to engage patients, inform decision making and drive quality outcomes for specific patient populations. Additionally, the ability to capture outcomes of care in order to measure quality is central to VBC reimbursement models and provides a new opportunity for organizations pursing value-based contracts, among other VBC risk arrangements.
Consumers. Consumers also will drive adoption. DTx give consumers the means and the opportunities to be more informed and engaged in shared decision making. In addition, growing reliance on mobile devices as a part of everyday life will making it easier to accept these new therapies as a way to treat disease and improve one’s health. In fact, one study found that the majority of consumers are interested in FDA approved apps or online tools to treat their medical conditions.
Challenges and opportunities. Like any innovation, DTx are facing a number of opportunities and challenges. They include:
Pharmaceutical Companies aren’t techies. Platforms for DTx require technical expertise and an understanding of related issues, such as health information technology standards, usability and human factors research, EHR interoperability, and privacy and security specifications, not typically found within pharmaceutical manufactures. Since pharmaceutical companies lack such technical expertise, it is more likely that they will partner with technology vendors and DTx start-ups in the near term than start de novo. According to one analysis, DTx is a way to differentiate pharma products with relatively low capital investment, especially compared to R&D costs normally associated with a traditional drug or medical device. Many companies are shifting R&D investments away from core product lines toward transformational innovation. The analysis also pointed out that DTx also offer an opportunity to extend product life cycles, differentiate products in development, and fill gaps in the market that traditional medicine might be unable to address.
Reimbursement. Reimbursement for DTx is an issue that payers and other stakeholders are grappling with. Payers are looking to find value in covering a drug and device. They want to know that products are safe, efficacious and cost effective before they are covered. Convincing them is another issue; DTx are too new and payers have not yet settled on the kinds of clinical, outcomes and cost data on which to base coverage decisions. The availability of real-world data from DTx is a plus; however, the volume of this data is often unavailable at the time of approval or clearance, when payers are faced with coverage decisions. While the Academy of Managed Care Pharmacy is tackling benefit design and reimbursement of DTx for commercial payers, CMS is opening the door by including digital therapy tools in its new Medicare Diabetes Prevention Program.
Privacy and security. The privacy and security of health-related data are already hot-button issues. Fears about the privacy and security of DTx products and the data they generate pose a barrier to adoption. According to one study, patients may be afraid to adopt DTx because the data might be compromised, information may be sold to third parties or the product may result in unwanted personal surveillance. Other questions and concerns surround who has access to the data, such as DTx vendors and caregivers, and how that data may be securely accessed and managed.
Changes to electronic health records (EHRs) and workflow integration. DTx-related changes will be in store for EHR vendors. First, they will have to adapt to various DTx products by making configurations to capture and analyze health data from these products. Turning this data into actionable insights and incorporating this new information within provider workflow for patient care and quality improvement will be next. Those are only pieces of the puzzle because clinicians and payers have not yet decided on what DTx-related data they need and what performance-related information will be required. Standardized billing and product codes will be required for electronic prescribing (ePrescribing) workflows. Payer’s decisions to cover DTx under medical or pharmacy benefits, and pharmaceutical manufacturers’ distribution channels all impact how these products are to be folded into physician workflow and electronic billing and prescribing systems.
The digital divide. The digital divide also presents challenges and opportunities. Despite the widespread availability of broadband and Internet access, there still are segments of the population (such as the elderly, low income and rural populations) with limited access to dependable wi-fi and internet technologies. Use of DTx could exacerbate health disparities among those populations with limited access to technology and or internet service. On the other hand, DTx offers opportunities to bridge the gap for vulnerable populations outside the traditional touch points of care. For example, certain patient segments may benefit from being provided with a smart phone in order to benefit from digital therapies. That was the thought behind an Advisory Opinion authored by the Office of the Inspector General at the Department of Health and Human Services to a pharmaceutical company seeking to provide access to a DTx by working with potential prescribers to give at-risk low-income patients who could benefit from the treatment refurbished mobile phones. For organizations willing to face the digital divide head on with practical solutions, there are ways to work around current legal and statutory barriers such as seeking an OIG opinion.
Conclusion. To be sure, DTx are poised for disruption and rapid expansion in the health care sector. Point-of-Care Partners (POCP) is tracking developments. Let us put our expertise to work for you in assessing the DTx landscape and understanding how DTx impacts your organization’s portfolio. Drop me at email, tricialee.rolle@pocp.com.
