Role of Digital Therapeutics in Chronic Disease Management

What Are Digital Health Therapeutics? 

Digital health is an umbrella term to include everything from mHealth, EHR, wearable devices, telehealth, and personalized medicine. Digital therapeutics deliver medical interventions directly to patients using evidence-based software to manage, treat, and prevent diseases and disorders.

Specifically, digital therapeutics concentrate on chronic conditions, including type 2 diabetes, Alzheimer’s disease, dementia, congestive heart failure, stroke, cancer, etc. 

There is a growing demand for digital therapeutics across the healthcare ecosystem due to the role of mobile technology and artificial intelligence (AI) in everyday life.

But McKinsey & Company attributes the growth in demand to two main trends. 

First, technological development makes greater amounts of data available, which allows for advanced analytics and insights. This enables the rapid increase in personalized hardware, including smartphones and wearables. 

Second, there is a growing body of evidence indicating digital interventions work. Many studies have shown improved outcomes from digital therapeutics in various chronic diseases. 

For example, a diabetes prevention study using digital therapeutics found that participants lost an average of 4.7 percent of baseline body weight after one year (4.2 percent after two years) and underwent a 0.38 percent reduction in A1c levels in the same time frame.  

Overall, digital therapeutics have the potential to address unmet patient needs that traditional treatments and therapies have been unable to provide. 

And for pharmaceutical companies specifically, digital therapeutics offer an opportunity to extend product life cycles, differentiate products in development, and fill in any gaps in the market for traditional medicine.

Digital Therapeutic Products on the Horizon    

Many start-ups and big-name technology companies are introducing digital therapeutics to enable patients to better control their care. The rapid growth in these therapies is due to the COVID-19 pandemic, which helped companies carve out a space for their products.

In May 2021, Northwell Health and Pear Therapeutics collaborated to provide new treatment options for patients with opioid and substance use disorders.

Through the collaboration, patients seeking treatments will have access to an innovative FDA-authorized treatment option, called prescription digital therapeutics (PDTs). 

Northwell Health will provide digital care to patients through Pear’s reSET and reSET-O PDTs through substance abuse treatment programs offered in the provider’s behavioral health facility. 

reSET and reSET-O will give patients 24/7 access to evidence-based tools to complement their remote or in-office addiction therapy provided by their therapist. 

Stroke is the top cause of long-term disability globally and over one-third of stroke survivors live in the US. According to the CDC, nearly 800,000 individuals in the US suffer from a stroke each year. 

Digital therapeutics is a potential treatment option that enables the “early verticalization” of stroke patients and is more effective when compared with other therapies alone.

In May 2021, MedRhythms launched a clinical trial to study its digital therapeutic, MR-010, for stroke patients. 

In partnership with UMass Memorial Healthcare, the trial will split into two phases and examine the eligibility of MR-010 to address the walking impairments in individuals in the acute phase of stroke. 

The first phase will look at the impact of MR-010 within the acute hospital setting, while the second phase will examine the continued impact of the therapeutic post-discharge. 

Another top digital therapeutics company is Akili Interactive, which focuses on prescription digital medicine. Akili leverages scientific and clinical rigor with the tech industry to reinvent digital treatment options. 

Experts estimate that the prescription digital therapeutics market will be worth more than half a trillion dollars by 2025. 

At the end of May, Akili announced that it received $160 million in funding to drive research efforts for digital therapeutics to treat acute and chronic cognitive disorders.

The funding will support a go-to-market approach that brings Akili’s digital treatment options to families and healthcare professionals at scale. The funding will also help expand Akili’s global footprint within ADHD and beyond.

According to an Insider Intelligence analysis, the digital therapeutics market is expected to increase tenfold in the next three to five years, with a projected market value of $56 billion by 2025. 

Challenges of Digital Therapeutic Treatments 

Although digital therapeutics give patients better treatment options and allow individuals to take control of their health, unlocking the potential of digital therapeutics requires companies to navigate many challenges.

A Deloitte blog post noted that companies need to develop cross-industry connections to find and negotiate deals based on criteria, diligence focus, valuation approach, and terms that fall outside what pharmaceutical and lifestyle companies are already familiar with. 

Life science companies also need to better understand incorporating technology products in the research & development pipeline, establish new trial designs, develop more go-to-market strategies, the Deloitte authors said.

“Digital therapeutics are poised to shift medicine’s emphasis from physically-dosed treatment regimens to end-to-end disease management based on behavioral change,” experts said in the post. 

“Pharmaceutical, biopharma, and Medtech companies can respond by combining their health care knowledge with software technology know-how to co-define the life sciences technology market and capitalize on the growth potential of digital therapeutics,” they continued. 

The ultimate goal of regulation is to ensure that digital therapeutic applications are safe and effective. But gaining FDA approval is also a challenge due to new agency guidelines on regulation and software precertification programs. 

FDA approval requires that products undergo rigorous clinical safety and efficacy trials. Many digital therapeutics companies partner with pharmaceutical companies to better their experience and understanding. 

But digital therapeutics are facing new FDA approval pathways with the arrival of the agency’s therapeutic-focused software precertification approval program. The challenge with new pathways is that pharmaceutical companies have little experience and digital therapeutics companies must make their own way. 

In addition to the regulatory challenges, the digital therapeutic industry also faces pricing and reimbursement challenges. With traditional pricing models, providers are paid based on the amount of service they deliver. 

But this type of model is not well suited for digital therapeutics because it is not a sustainable long-term strategy. So, companies are exploring other channels to generate revenue, including the business-to-business-to-consumer approach of selling products through online retail outlets.

The rapid growth in research of digital therapeutics has resulted in the commercialization of evidence-based applications, which experts expect to become major disrupters to healthcare markets over the next decade.

But companies must continue to look for other channels for pricing and reimbursement models to increase market competition and generate more sustainable revenue.