Digital Therapeutics (DTx) can facilitate patient access to care and provide effective chronic care management for a growing list of conditions. Over the last decade, the array of conditions using DTx has expanded, particularly in the behavioral health arena for anxiety, postpartum depression, insomnia, and substance use disorders. In a review of DTx trials conducted between 2010 and 2019, more than 40% were carried out in patient mental health, underlining the momentum in this area.
Among the earliest prescription digital therapeutics that received approval from the Food and Drug Administration (FDA) was a mobile app for treating substance use disorder developed by Pear Therapeutics. Several companies followed suit, including Otsuku Pharmaceutical with approval of Abilify MyCite for the treatment of schizophrenia, bipolar disorder, and depression, and Proteus as an ingestible sensor.
Evaluation & regulation of digital therapeutics products
Digital therapeutics products must undergo rigorous standards of evaluation and regulatory oversight, adhering to 10 core principles. Recently, the Digital Therapeutics Alliance created the DTx Value and Assessment & Integration Guide as a blueprint to help developers clinically validate their product, meet regulatory requirements, and ensure quality and security. The guide also addresses economic assessments needed to secure reimbursement.
Although there are currently more than 40 FDA-approved DTx applications on the market, we are at an inflection point. Tools must demonstrate a return on investment and value to payers and providers, as well as integration into standard clinical workflows.
Digital therapeutics face adoption challenges
Adoption of digital health tools, including DTx, remains dismal. A recent study of 1,300 physicians by the American Medical Association found that only 3.8% of physicians are utilizing digital health tools, which is a meager 1.6% increase since 2015.
Dr. Kamal Jethwani, managing partner and CEO of Decimal.health recently presented at the DTx East Conference in Boston. In a provider survey, his team found that even though fewer than 22% of providers had prescribed a DTx product, more than 87% indicated that they would be interested in prescribing DTx in the future.
Even after successfully navigating the regulatory process, DTx developers still face many challenges on the care delivery side. Most of the adoption challenges surrounding digital therapeutics products are rooted in organizational change and clinical acceptance, including:
- Poor awareness among providers and payers
- Perceived challenges for patient engagement and adoption
- Challenges with workflow integration of technology
- Uncertainty about reimbursement models by payers
- Burden on providers for additional training
- Lack of sufficient evidence about clinical outcomes
- Insufficient funding
- Patient technology literacy levels
- Digital health inequities and access to broadband and necessary hardware
- Ambiguity about personal health data privacy and security
Let's take a closer look at three of these challenges: (1) rethinking the pharma model and uncertainty about reimbursement, (2) challenges integrating into clinical workflows, and (3) patient engagement and adoption.
Rethinking the traditional pharmaceutical model
Although many digital therapeutics companies have attracted significant venture capital and private equity dollars, the average funding is very low compared to pharmaceuticals. It is estimated developing and bringing a new drug to market at scale costs $985M. Yet, the average funding for a DTx company pales in comparison. Similar to pharma, in-person channels (e.g., regional medical representatives) are still required to increase provider awareness and provide necessary training.
Incorporating digital therapeutics into routine clinical care is not a simple extension of the traditional pharmaceutical prescription model. DTx goes beyond medication dosing and adherence and may require provider and patient input, spanning additional steps to adoption. Factors like user-engagement and new reimbursement strategies have to be considered.
However, according to Dr. Jethwani, the reimbursement landscape for DTx solutions is evolving. DTx can be reimbursed as a medical or pharmacy benefit. Providers can prescribe the DTx and bill using CPT codes or create a new code. And, as the number of DTx applications expand, new reimbursement models should be considered. Those new models may include pay-for-outcomes or pay-for-adherence. DTx developers seek placement on the Pharmacy Benefit Manager's (PBM) formulary, which could maximize physician access and patient reimbursement.
Integrating digital therapeutics into existing clinical workflows and workflow management
The provider survey from Decimal.health also revealed that the overwhelming majority of physicians have never prescribed DTx due to a lack of integration into clinical workflows. DTx solutions have the potential to expand capacity and access, as well as treatment adherence. However, DTx does create another disparate system of record. The integration of a digital therapeutic into routine care can look vastly different from practice to practice, depending on its technology architecture. Configuring the solution by clinic or provider can make it difficult for digital therapeutics developers and buyers to scale.
Internally, providers, clinical, and office staff must have IT support where all implementation, integration, and adoption steps are mapped, beginning with the DTx prescription (e.g., care pathway, reimbursement process) to adoption and use of the tool by patients (e.g., education, reporting, and review of intervention outcomes).
Additionally, DTx often have multiple end users, i.e., provider dashboards and patient modules, which developers must address in design, prototyping, and beta testing to ensure they fit with existing clinical and operational workflows. From the provider's perspective, the key questions to answer include “Does the DTx save clinical time?", “Add commensurate revenue to the practice?", and “Is it effective in achieving the desired patient outcomes?"
Monitor treatment progress requires providers to have access to actionable data at the point of care. Not only will developers need to understand how and when providers will require data access, but also consider whether the data can be embedded into the EHR system to increase provider uptake. Large volumes of DTx data will require robust data feeds not only for clinical documentation, but for data analysis, quality measures, and audit capabilities.
Patient engagement and adoption of DTx
DTx can reduce access barriers to healthcare while normalizing societal acceptance of treatment, in the case of behavioral or substance use disorders, for example. Yet, patient engagement and adoption remain central factors to DTx success. Poor patient engagement and experiences can come from many factors. Lack of access to in-home WiFi, patient concerns around data collection and security, and low technology literacy and the inability to afford needed hardware all work against DTx goals for improved care and outcomes.
On the other hand, the digital nature of DTx allows real-time or asynchronous data collection and monitoring of patient adherence and activity. These actionable insights support timely interventions and behavioral nudges to more deeply engage patients. Companies like Akili use gamification to achieve greater patient involvement. The company regularly conducts evaluations of product changes to ensure there is equitable access and benefit for all users.
The road ahead for digital therapeutics
The global DTx market has seen rapid expansion with much activity tied to the COVID-19 pandemic. The breadth and pace of development for DTx, despite temporary economic challenges, will continue to grow with an estimated market size more than $41B by 2030 and a 30.1% CAGR. The momentum was evident at the DTx East conference where developers and healthcare organizations share their successes as they continue to tackle post-regulatory approval roadblocks.
Provider involvement in the software development process, and their acceptance of DTx into clinical practice – like any new clinical standard – can be easily overlooked in the long regulatory and go-to-market journey. However, addressing physician and patient adoption – which are very different issues – are paramount to demonstrate real-word value and need.
Although providers say that they are excited about the use of DTx for patient care, developers should consider the entire prescriber experience from prescription, integration into care, data management, billing and reimbursement. Creating DTx physician champions will have a ripple effect where providers share, use, and publish, enabling evidence-based software tools to get into the hands of patients.
Develop DTx that meets physician, patient, and regulatory priorities
RTI Health Advance brings together seasoned experts, clinicians, and scientists across disciplines like digital health, data analytics, population health, and health equity to work ensure developers create and healthcare organizations adopt the right tools and technologies to achieve their clinical and strategic objectives. Contact us.
Author's note: My thanks to Dr. Jethwani for generously sharing his time and thoughts with me to develop this article. Meet him and the Decimal.health team at the HLTH conference in November.
About Decimal.health: Decimal.health provides end-to-end solutions that help companies navigate the complicated healthcare ecosystem and become a market leader rather than a market follower.