Challenges of Improving Access to Digital Therapeutics in Healthcare

What Are the Benefits of Digital Therapeutics?

Using evidence-based and clinically evaluated software, digital therapeutics (DTx) provide medical interventions directly to patients to treat, manage, and prevent a wide range of diseases and disorders. DTx can be used independently or with medications, devices, and additional therapies to treat physical and behavioral health conditions, including pain, diabetes, anxiety, post-traumatic stress disorder, and asthma.

This form of digital health technology is giving medical providers and researchers a more holistic view of patient health using real-time data and, more importantly, provides many opportunities for success as it reduces cost, increases the quality of care, improves access and efficiency, expands the reach of healthcare professionals, and provides sustainable and responsive healthcare.

Additionally, DTx can be leveraged to manage physician burnout through digital tools, simultaneously expand patient options, and enhance predictive analytics, ultimately decreasing costs and saving providers time.

Adoption of Digital Therapeutics

With the rise of telehealth fueled by the COVID pandemic, “patients have learned to engage and develop relationships with healthcare professionals in a virtual environment,” said Komathi Stem, Chief Operating Officer at Glooko, in an interview with PharmaNewsIntelligence.

In 2022, the global digital health market size was valued at $211 billion and is projected to grow at a compound annual growth rate of 18.6% between 2023 and 2030, according to a Grand View Research report.

In this increasingly digital environment, the DTx market has gained serious momentum, but many companies have taken the unregulated approach to get their products to the market quicker. This lack of FDA clinical oversight creates a problem for providers and payers and makes it hard to distinguish the clinical benefits of each therapeutic.  

As it can be challenging to prove the efficiency of real-world data (RWD)-related DTx, payers and providers may also experience reimbursement complications, leading to barriers between providers and the use of DTx. And since the digital ecosystem is large and loosely regulated, the differentiation between the clinical validity of various applications can be difficult to discern without the help of the legislators and the FDA.

Proving Clinical Efficacy

Over the last five years, the FDA cleared more than 35 DTx. As developers of DTx continue to seek FDA clearance, they are often confronted with challenges that reveal a pressing need for a new regulatory framework.

“With technology making it much easier to gather the necessary information, clinical data collection is happening in the home, as opposed to having to go to a clinical setting,” explained Timon LeDain, Vice President of Customer Solutions at Emids LeDain, in an interview with PharmaNewsIntelligence.

As digital tools and software as a medical device (SaMD) proliferate, the FDA and other legislative bodies have an essential responsibility to quickly implement scalable processes and policies to assess and regulate software-based medical devices.

Meanwhile, several companies are focusing on confirming clinical validity and gearing up for expanded use. Clinical research determines the effectiveness of treatment through clinical trial evidence, real-world outcomes, and peer-reviewed publications and is an integral part of conveying the benefits of prescription digital therapeutics (PDTs) — DTx that gain FDA clearance and are prescribed by clinicians.

Cost Reimbursement

Suppose a therapy can effectively show that it decreases healthcare costs, minimizes complications, reduces acute-care utilization, or swaps expensive in-person provider visits with a cheaper telehealth solution. In that case, payers are more likely to be reimbursed by their insurance provider, and clinicians will be more likely to recommend it to their patients.

“Insurance coverage is absolutely critical,” Ben Lewis, co-founder and CEO of Limbix, a digital therapeutics solution for adolescent mental health, told Fierce Healthcare back in October.

Because DTx reimbursement policies are defined at a national level, these fragmented policies create hurdles for providers, payers, and developers worldwide, increasing costs, delays, and complexity. While SaMDs are evaluated for treatment efficacy and cost-effectiveness, reimbursement policies for DTx remain under development.

DTx manufacturers who can successfully navigate regulatory guidelines, encourage adoption, exhibit clinically impactful results, and ensure patient data safety are crucial to providing more accurate, efficient, and personalized treatments that will continually improve as digital therapies evolve.

Addressing these regulatory, socio-economical, and technical challenges will help successfully scale DTx to the healthcare marketplace and foster a digital health ecosystem that promotes patient access.