Over the last decade, digital therapeutics have been gaining steam. In part, this shift is aided by the adoption of connected medical tools during the COVID-19 pandemic and the ongoing push toward more of a hybrid care model. However, the technologies have largely not yet hit the mainstream market.

Today, industry players are looking to get stakeholders from the provider, payer and life science industries onboard. 

A panel of health tech executives sat down at DTx East in Boston to talk about opportunities, challenges and the future of digital therapeutics.

“I see this space of remote monitoring and digital therapeutics as a new opportunity to train and educate our physicians and get this information into the hands of medical students, residents, medical education training, CME [continuing medical education], in helping physicians understand this world of digitally enabled healthcare,” Tania Elliott, chief medical officer for virtual care at Ascension, said on the panel. 

The life science industry is one of the key stakeholders in digital therapeutics. For example, Otsuka has been involved in the digital health world for over a decade. The Japanese life science company historically creates treatments for serious mental illnesses. Innes Meldrum, SVP and chief commercial officer at Otsuka Pharmaceuticals North America, said that the company is involved in treating mental illness through new modalities. 

“I think there is a crisis in the U.S. with the treatment of mental illness that has only been exacerbated by COVID. One of the things that has been highlighted is the underserved patient populations and health equity,” Meldrum said. “So, for example, populations in rural settings [and] populations of color already were disadvantaged to qualified psychiatrists. That has only become worse as a result of COVID.

"I really think that digital therapeutics can play a key role in actually providing treatments to patients where they are, when they need the treatment, and delivering personalized treatment over time. This is the advent of personalized medicine. I think that is the promise of digital therapeutics.” 

The technology could also change the doctor-patient relationship in the future. 

“I think it can also strengthen the therapeutic alliance between physicians, especially psychiatrists, and their patients, which is actually critical to outcomes. Technology has the opportunity to bring efficiencies to the healthcare system,” Meldrum said. “Arguably, the U.S. healthcare system is the least efficient in the world because of the fragmentations. I think digital therapeutics have a key role to play there.

“As we gather more data on the population health level, digital therapeutics are the first opportunity from a pharmaceutical perspective to gather this information, feed it back into the system to drive better outcomes and increase efficiencies.”

While there may be a lot of use cases for the technology, to get buy-in from public payers like Medicaid, digital therapeutic companies must also show data. 

“The punch line if you take nothing else away from this, if you are trying to sell into Medicaid, is to have Medicaid [beneficiaries] in your sample when you are doing research. Real-world evidence is nice to have, but you need randomized control trials,” said Andrey Ostrovsky, managing partner at Social Innovation Partners. 

“If you don’t have those, you aren’t going to get reimbursed at scale. Three months of outcomes data is not enough. Get at least six months, ideally 12 months, and then you’ll be taken seriously. Then if you have a common disease like diabetes or other highly prevalent diseases that your therapeutic is trying to address but you only have a sample size of 50 in your RCT [randomized controlled trial], that isn’t going to be taken seriously.”

While getting the various health stakeholders onboard with a digital therapeutic may be critical, it can also be difficult in the notoriously fragmented U.S. health system. 

“There are lots of stakeholders involved. That's kind of the problem to be honest. I think the challenge with bringing a novel therapy that is not understood, such as a digital therapeutic, to market is trying to align with those stakeholders and get them a current understanding. I fundamentally believe that you need to have a common goal, and that needs to start with the patient,” Meldrum said. 

Using the patients as the starting point can help align stakeholder motives and propel the industry into the future. 

“What is the desired outcome around improved care and quality of life for the patient? I think if we can all align around that, that can help drive stakeholders together,” Meldrum said. 

“I do agree, particularly for prescription digital therapeutics, you need to have controlled trials that are getting you clinical information that payers are used to seeing. If you are going to have a prescription DTx, you need to fit in with the existing model. That means that it is expensive to conduct these studies. But I think if you can focus on the patient and figure out how to get it paid [for], that makes the path a whole lot easier.”