Digital therapeutics deliver evidence-based interventions driven by high-quality software programs to treat, manage, or prevent a disease or disorder. Digital therapeutics have the potential to fundamentally change how patients interact with their therapies, often helping to fill the void left by a lack of options or resources in a traditional clinical setting. 

Digital therapeutic solutions have been developed for a multitude of mainly chronic conditions.  Theoretically, they remove many of the barriers associated with traditional care models (physical access, etc.) and are scalable and readily available, making them ideal particularly for underserved and under-resourced populations, however, these solutions are not always accessible or inclusive for the populations that could benefit from them the most. 

What do we mean by accessible and inclusive? 

The W.H.A.T. Digital Therapeutics Validation Criteria defined accessible as, able to demonstrate engagement and retention among “representative samples of the target clinical population” and scalable to the entire targeted population. Exclusion from digital services refers to the lack of access skills and capabilities necessary to engage, as well as logistical challenges, such as lack of access to the internet, and digital devices. 

Groups commonly considered excluded, lack access and experience poorer care, and typically include, people from low socioeconomic backgrounds, older people, people in rural areas, and those with low digital or literacy skills, among others.  

What specific challenges do DTx face in accessibility? 

One of the key challenges for digital therapeutics, especially when compared to pharmaceutical interventions is low patient accessibility due to the digital barrier. Operating on a digital platform, it is essential for users to have access to and understand digital devices. Lower socioeconomic status is often associated with lower levels of digital literacy linked to lower levels of use of digital therapeutics. Age is also an important factor, as older individuals are less likely to own or be familiar with smart technologies, with an increased lack of access due to a lack of guidance for using these solutions. 

At a more basic level, the design of digital therapeutics can contribute to the exclusion of a large proportion of the population. Cultural nuances and language differences for example can not only reduce accessibility for digital therapeutic solutions that are on the market, but can also exclude some groups during the process of evidence generation. 

Clinical evidence is a key component for digital therapeutics, with published clinical evidence a fundamental factor used to distinguish digital therapeutics from more general digital health solutions. Randomized clinical trials (RCTs) account for the majority of digital therapeutic evaluations, with real-world evidence often collected thereafter. To ensure clinical effectiveness, study participants should reflect the population for whom the product is intended. However, it is likely that accessibility issues previously mentioned will also affect trial participation in some cases. 

For machine learning or artificial intelligence (AI) in particular, evaluating the safety and efficacy of algorithms in a diverse population creates another technical challenge. Recognising and removing biases are fundamental to ensure that digital therapeutics are inclusive and effective for the demographic they are intended to serve. 

A lack of awareness among healthcare professionals (HCPs) around the benefits and availability of digital therapeutics has been documented, specifically the efficacy of these solutions, and whether they have robust clinical evidence to support their use.  A lack of HCP knowledge reduces accessibility for patients, especially access to prescription digital therapeutics. Some digital therapeutics companies have chosen to tackle this by taking more of a direct to consumer (D2C) approach, creating direct demand and indirectly raising awareness. However, comparably, D2C models further alienate those struggling to access the digital therapeutics due to the additional cost barrier. 

The  further lack of awareness among HCPs regarding the unique healthcare challenges faced by vulnerable groups, creates an opportunity for digital therapeutics to promote inclusivity in these populations. For example, LGBTQ+ communities often face factors such as a lack of specific training and sparse clinical research, among others. Digital therapeutics companies can help to bridge this gap, using more inclusive language, culturally appropriate information and offering increased support to LGBTQ+ communities. 

Pricing is a barrier to access for many patients and one of the most complex challenges for digital therapeutics. Out of pocket payments for these solutions can be significant, for example Akili’s EndevourRx costs $99/month. Reimbursement through public or private payers can alleviate cost burden for patients, increasing accessibility, however navigating reimbursement can be extremely challenging and time-consuming for digital therapeutics companies. National reimbursement pathways such as Germany’s DiGA provide universal coverage for specific solutions, however, listing is difficult to obtain, (up to May 2022, of 130 applications made, only 31 were added to DiGA). Furthermore, very few countries have national reimbursement pathways available. In the U.S, there is no existing benefits category for digital therapeutics under Medicare and extremely limited coverage on a case by case basis through Medicaid. Many companies therefore opt to pursue reimbursement through private or employer sponsored healthcare, however, this pathway requires real-world and health economic data, as well as clinical evidence increasing the burden placed on digital therapeutics companies. 

The bottom line 

As healthcare systems continue to struggle for resources, digital therapeutics have the potential to provide more effective treatments for chronic diseases, breaking down barriers associated with traditional healthcare, increasing accessibility and inclusivity of treatments.  

To ensure digital therapeutics are accessible and inclusive for their target population is key to creating successful treatments. Involving patients and healthcare providers when designing and evaluating these solutions will ensure they are effective and usable in the population for which they are intended. 

Increasing access to digital therapeutics through national reimbursement pathways will not only support patients to afford these solutions, but will also increase visibility and trust among HCPs, further improving accessibility for patients.  

In the U.S, financial accessibility through insurance or Medicare/Medicaid has the potential to increase accessibility considerably. The Access to Prescription Digital Therapeutics Act of 2022,

which was introduced in the US Senate in March 2022, includes a proposal for Medicare/Medicaid to provide coverage, expand access and establish a payment methodology for manufacturers. Initiatives such as this, show initial attempts by the government to provide broader access to these solutions. However, research on real-world impact would be needed if the act was to be implemented, as well as more government support to mitigate other factors impacting accessibility, such as expanding digital literacy programs in the community. State and federal governments should also align to provide more comprehensive regulatory frameworks and the infrastructure to support these solutions. 

Digital therapeutics developers can also contribute to increasing accessibility of solutions, by ensuring compatibility with all devices, providing solutions in multiple languages, as well as easy to read formats, and multimodal formats. 

Expanding access and ensuring inclusivity has the potential to encourage patients to take increased ownership of their healthcare, as well as potentially saving costs and resources for healthcare providers.