As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation.

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. This is partly due to the differing business models used by pharma companies and digital therapeutic developers. Securing reimbursement for digital therapeutics also continues to impede its uptake.

According to the Digital Therapeutics Alliance, digital therapeutics can be described as software programs that manage and treat conditions through an evidence-based approach. Digital therapeutics can be also categorised based on their regulatory journey. Prescription digital therapeutics must go through regulatory agencies and have clinical data, says Chris Wasden, chief strategy officer (CSO) of Twill Health, a US-based digital therapeutics company. In contrast, non-prescription digital therapeutics do not need clinical data to enter the market, says Wasden, adding that evidence from observational studies suffices. Lastly, wellness products can address symptoms, but do not manage and treat them, he adds.

However, others in the field, like Nikolaj Sørensen, CEO of Orexo, a Swedish company that develops both pharmaceuticals and digital therapeutics, say securing clinical data is a key priority. And this is not always being adequately done right now, says Joaquin Anguera, PhD, associate professor of neurology at the University of California, San Francisco.

A broadening, accelerating field

Given the wide scope of digital therapeutics, the landscape remains equally broad, says Dr. Riley Bove, associate professor of neurology at the University of California, San Francisco. Essentially, however, a digital therapeutic must improve a specific aspect of a patient’s life, says Bove.

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According to Anguera, the field is in its infancy, particularly when it comes to testing approaches in clinical trials. However, Bove notes the sector has gone through significant change in the past decade. “We’ve really seen things change in the last few years. Five to 10 years ago, it was a lot more of the wild west,” she says. Many companies in the space are now in their acceleration phase, says Wasden. Initiatives that consider digital therapeutics through an approach that is informed by their eventual implementation, which are now increasingly seen in Europe, have helped with the development, says Bove.

In March, the UK’s National Institute for Health and Care Excellence (Nice) shared draft guidance with recommendations for eight digital therapeutics for depression and anxiety. In the US, a group of lawmakers recently reintroduced the “Access to Prescription Digital Therapeutics Act of 2023” in the US Senate. If passed, the bill would include prescription digital therapeutics for coverage by Medicare and Medicaid.

In June 2022, Biogenannounced its collaboration with Twill Health to develop a platform for multiple sclerosis (MS) patients. In the same month, Twill, previously known as Happify Health, also launched a digital platform with Almirall to improve the mental health of psoriasis patients using cognitive behavioral therapy and other approaches. Almirall markets the IL-23 inhibitor Ilumetri to treat moderate to severe plaque psoriasis in Europe.

Several years ago, Bove led a pilot efficacy study on a videogame-based digital therapeutic and its use in MS patients. The study tested a videogame-based digital therapy for children with attention-deficit hyperactivity disorder (ADHD) that is sold by Akili Interactive as EndeavoRx.

Such a digital therapy approach would be especially interesting if combined with a medication that treats attention and fatigue, Bove says. In conditions like multiple sclerosis, there is a lot of interest in exercise and driving the remyelination of nerve fibers by activity, and EndeavoRx could be used with repurposed medications aimed at myelin repair, notes Bove.  

In the future, digital therapeutics could serve as a complementary option that makes patients’ lives easier, says Dr. Jochen Klucken, chair of digital medicine at the University of Luxembourg. Generally, a cocktail approach of mixed approaches in the right combination can be beneficial to one’s health, Anguera adds. These tools could also be used to manage patient care and their medication, which is one of the challenges in today’s healthcare, says Klucken.

Regulatory and reimbursement challenges

The ideal interaction between medications and digital therapeutics would require their joint development, says Klucken. But creating a combined product is tricky from a regulatory perspective, says Sørensen. If a company wants to promote a digital therapeutic and its medication as a combined offering, they will need to register it as a combined product at the FDA, he says. Companies would need to show these products deliver something in conjunction, adds Sørensen. Also, a synergistic approach is not the ultimate goal of the field, says Anguera.

Nevertheless, companies can develop these platforms in parallel, says Sørensen. Orexo is doing that with Zubsolv, a sublingual combination of buprenorphine/naloxone for opioid use disorder (OUD). Alongside Zubsolv, Orexo offers a digital web-based therapy called Modia intended for OUD.

But there is a difference between offering these products in parallel and as part of a single package, explains Sørensen. To do that, the company would need to do clinical research that features both therapies, he adds. The company is now studying Modia in a 437-participant trial in combination with sublingual buprenorphine/naloxone for OUD.

In late January, the US-based company MedRhythms shared preliminary results from a feasibility study of its digital therapeutic MR-005 for Parkinson’s disease. MR-005 aims to improve patients’ gait through the combined use of music and real-time gait tracking, which is fed into software that tracks movement.

The potential cost of these approaches is also an obstacle. Since Zubsolv is a relatively cheap treatment, combining it with a digital therapeutic is challenging, says Sørensen. Combining a digital therapeutic with an expensive biological treatment is easier and would create a better business case for pharma, he adds.

According to Wasden, the interests of digital therapeutics developers and pharma companies can also clash. It is unclear how much value a digital therapeutic can add to a drug, he says. While pharma players can use digital therapeutics to improve adherence and sell more treatments, the question is if they want to go through a regulatory process to develop a companion product for this benefit, he says.

The reimbursement of these therapies also remains difficult, which will be an issue as the sector becomes increasingly rigorous, says Anguera. The structure of the American healthcare system makes reimbursement for digital therapeutics difficult, as companies have to negotiate with different states and programs, says Wasden. Nevertheless, Orexo’s digital therapy Deprexis is available within the Veterans Affairs Health System, the Indian Health Service, and the Department of Defense, as per a July 2022 update. The opinions of doctors who would prescribe digital therapeutics play a big role, says Anguera. Looking into the future, improvements in AI and access to even larger datasets will allow for a much more precise, targeted approach, he notes.