HIT Perspectives: Digital Therapeutics: Transforming Care Through Technology

Experts expect digital therapeutics (DTx), a new category of medication, to revolutionize how specific conditions are prevented, treated and managed using evidenced-based software applications, primarily through mobile applications (apps). As one industry analysis summed it up: DTx are disruptively poised to shift medicine’s emphasis from physically dosed treatment regimens to end-to-end disease management by leveraging mobile technology. DTx—also known as digiceuticals and software as a drug—are gaining momentum and a trend to watch.

What are DTx? While DTx bear similarities to digital health and wellness programs, they are not synonymous. According to the industry group Digital Therapeutics Alliance, DTx products have distinct properties. They must have rigorous quality controls, undergo randomized clinical trials and obtain approvals by a regulatory body, such as the Food and Drug Administration (FDA). DTx must collect, analyze and apply real-world evidence and product performance data, as well as engage end users in product development and usability processes. Unlike many wellness apps and personal health trackers on the market today, DTx must be prescribed for use.
Most DTx target specific conditions that have an unmet need such as limited treatment options, or conditions, where engaging patients outside usual sites of care will impact their adherence and clinical outcomes. These include chronic diseases (whose treatments account for a huge chunk of the health care budget), neurological disorders and mental health conditions. In fact, as this emerging field of digital medicine grows, DTx may replace current treatment options or even supplement them due to their added ability to help modify patient behavior and provide remote monitoring to improve long-term health outcomes.

The following examples are eye opening. Propeller uses a sensor placed on an inhaler for asthma or chronic obstructive pulmonary disease that syncs to an app in the patient’s smartphone. The battery is active for about a year and sends patients reminders and tracks doses. This improves medication adherence and significantly reduces the patient’s need for a rescue inhaler. reSET® is an FDA-cleared software package that delivers substance use disorder treatment, teaches new coping skills and reports progress to a clinician. It combines patient-facing interventions and assessments via a mobile device, with clinician-facing dashboards and data analytics on the back end. Then there’s Abilify MyCite, the first FDA-approved pill with an embedded sensor to track medication adherence. It will be used for treatment of schizophrenia, acute treatment of bipolar I disorder and as an add-on treatment for depression. When the medication is swallowed, a sensor in the pill will send a message to an abdominal patch, which then transmits the information to a mobile app. Patients can then track their compliance on their smartphones. With the consent of the patient, caregivers and doctors can also retrieve the information online.

Benefits. DTx offer numerous potential benefits. For example, digital therapeutics may:

• Deliver treatment more efficiently than traditional therapies by enhancing provider-patient engagement and capturing health data for clinical decision making.
• Address certain access to care issues by making treatments more widely available to patients through mobile devices
  and technologies.
• Reduce the stigma attached to traditional therapies, such as for mental health conditions.
• Support precision medicine by capturing data for actionable insights and customized therapies.
• Support national health care quality efforts to empower patients with access to their health data and incorporate use of patient-reported outcomes in health care.

The DTx landscape. To be sure, the digital therapeutics market is in its nascent stages and pales in size when compared with other sectors of the health care economy. According to one estimate, the global DTx market was $1.7 billion in 2016. It is projected to grow at rate of 21% over the next few years, bringing it to nearly $9.4 billion by 2025. One unnamed source shared that although overall investments in digital health are growing, investments in DTx account for just 2% of venture capital funding in the United States.

Drivers include:

• Federal oversight. Several federal oversight activities 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 with 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 pursuing value-based contracts, among other VBC risk arrangements.
• Consumers. Consumers also will drive adoption. DTx give consumers the means and opportunities to be more informed and engaged in shared decision making. In addition, the growing reliance on mobile devices as a part of everyday life will make it easier to accept these new therapies as a way treat disease and improve one’s health. In fact, one study found 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.
These include:

• Pharmaceutical companies aren’t techies. Platforms for DTx require technical expertise and an understanding of such related issues as health information technology standards, usability and human factors research, electronic health record (EHR) interoperability, and privacy and security specifications, not typically found within pharmaceutical manufacturers. Since pharmaceutical companies lack such technical expertise, it is more likely they will partner with technology vendors and DTx startups 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 research and development (R&D) investment 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 with which payers and other stakeholders are grappling. 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 these 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, the Centers for Medicare and Medicaid Services is opening the door by including digital therapy tools in its new Medicare Diabetes Prevention Program.
• Privacy and security. 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 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 such data may be securely accessed and managed.
• Changes to 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 these 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 the medical or pharmacy benefit, as well as 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 offer 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 a smartphone in order to benefit from digital therapies. That was the thought behind an advisory opinion authored by the Office of the Inspector General (OIG) 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.

Recommendations. Many actions are needed to make the DTx landscape evolve in ways that benefit all stakeholders. These include:

1. A standardized, well-understood definition of DTx that differentiates these FDA-approved products from wellness and other health-related interventions, software and apps. While the Digital Therapeutics Alliance has created a definition, it still has not been widely adopted. The lack of such a definition is creating confusion in the marketplace. It may also open the door for emergence of ineffective or potentially harmful products/services/software masquerading as DTx. This can pose a harm to patients and can limit the ability to demonstrate value for bona fide DTx. The FDA should seize the opportunity to create a definition that will be used and accepted by all stakeholders.

2. Standards for reliably determining the quality of safety DTx need to be established. The U.S. Pharmacopeia, FDA and DTA are working in this space to determine how to provide a level of confidence in products and services of the future. Interested stakeholders should support these efforts.

3. DTx need to be integrated within current electronic prescribing processes and EHR workflows. Standards are needed for products, transactions and billing. Payers, clinicians and others must decide what DTx-related data they need so they can be captured, analyzed and shared in a standardized manner. Consider the standard for real-time prescription benefit check that allows providers to know how much a prescribed drug will cost their patients. No doubt, patients will want to have these cost conversations for DTx also. This capability for DTx will only be possible through standards and codification.

4. Stakeholders need to continue to address the digital divide. DTx are just the beginning of technology- enabled care of the future. A multistakeholder approach is needed to ensure that innovations are accessible for all who can benefit from them.

5. Pharmaceutical companies should get up to speed on DTx, potential R&D, and their ability to fill gaps in the current standard of care using technology. Partnering with organizations with technologic expertise is one way to do so. •

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 impact your organization’s portfolio. Drop me an email: tricialee.rolle@pocp.com.