Spotlight On: Digital therapeutics “pretty close” to being well-integrated into practice

Digital therapeutics are finding their way into a growing number of formularies, sitting alongside traditional pharmacotherapies. And it won’t be long until they become well integrated into medical practice, believes Megan Coder of the Digital Therapeutics Alliance.

The DTA was established three years ago, with the mission to educate stakeholders - patients, physicians, payers, policymakers and regulators - on what distinguishes digital therapeutics from other categories of products in the vast digital health marketplace, and the value they bring. 

“People generally understand that with traditional medication, two pills are able to serve different purposes even if they look alike or they're the same color. But with digital it's much more difficult - if [the solution] comes via digital, people don't always understand that it could be for monitoring and it could be for diagnostic, it could be for therapeutic or just a wellness product,” Coder told FirstWord HealthTech. 

The DTA’s priority was to create distinctions between the different types of digital health products out there, as well as to set standards so that patients and clinicians know what to expect and what value to look for in these tools. 

And in the relatively short time since its founding, the alliance has made significant inroads in its education and awareness efforts, and underlining the important role digital therapeutics play as part of the armamentarium in a post-COVID reality. 

“The idea that a clinician can prescribe or authorise a product that's either a medication, an in-person therapy or digital product for the treatment of a specific condition is really crucial - this understanding that there is a category of digital products, which are not health and wellness apps, but [can bring value] at a different level of intervention,” said Coder.

In the edited transcript below, Coder chats to FirstWord HealthTech about attitudes to digital therapeutics pre- and post-COVID; appetite for these tools in Asia; and whether the day would come when we drop the digital from ‘digital therapeutics’.

 

FirstWord HealthTech: We've all seen how the COVID pandemic greatly propelled the uptake of digital health technologies, especially around telehealth and chronic care management. Digital therapeutics also benefited from the relaxation of certain regulations in the US due to the public health emergency. Would you say the pandemic has helped to shift the needle permanently for digital therapeutics, like it has for telehealth or remote monitoring/chronic care platforms?

Megan Coder: I think COVID has really shown the need and the ability for digital therapeutics to really address a lot of unmet demands. So the notion that you have therapies that are scalable and accessible by patients who may not otherwise be able to receive care by going into a clinic, or who are in an underserved area or a rural health area - digital therapeutics are really showing their ability to actually enter into this. 

What I love about the industry is that they feed data back to the patient and to the clinicians as appropriate to optimise therapy, to actually make changes, to identify where there are different issues that could be changed or improved upon. 

But one of the struggles we've hit upon, even in the US, is just prioritisation. 

So, on Capitol Hill, we went from senators having minimal understanding of what we were talking about in February last year, to saying at the end of December that they really want to do this and it was the right thing to do. But the caveat is, they still have so many other things to look at [to manage the pandemic]; staffing levels, hospitals trying to stay open, PPE, oxygen tanks, respirators...So there's a lot of things that are still in this acute phase that we're dealing with. 

I think on the chronic side, digital therapeutics are really going to shine through. In terms of chronic diseases, mental health, for paediatric indications all the way through to adult indications - that’s where I see us coming through in the long haul and really showing the benefit of the digital therapeutics industry there. So while we have value now - and I can definitely point to so many examples of how the value is being demonstrated - I really see us growing stronger as the new [post-pandemic] normal really starts to become a significant factor.

 

FWHT: Among the objectives the DTA had set itself, which do you think the alliance has made the most significant progress with over the last three years? 

MC: It's a balance. I think the notion that people are recognising that digital therapeutics really are actually making medical claims and that they're going to be a part of therapy for the long haul. 

We did a policy effort last year, where we went to Capitol Hill and made a lot of progress in the Senate and the House, educating on what digital therapeutics are and the need for a new benefit category. At this point, Medicare and Medicaid in the US do not have a way to recognise these products. So our efforts have really helped to try to bring this along. 

On the European side and then more globally, since we have about 40 members across 15 countries, we launched a policy campaign there last year with COVID and wrote multiple letters in six different languages, really trying to engage with policymakers. So there's a lot of things we've been doing, but every single step of the way has been trying to figure out who really needs to be brought into the conversation and how do we really help them in that process.

FWHT: As you pointed out, the DTA has expanded geographically since its founding in 2017 and the organisation just launched regionally-focused work groups in Europe, the US and also in Asia. What’s the appetite for digital therapeutics among consumers in Asia? FirstWord last year reported findings from a global consumer survey conducted by AstraZeneca that showed China outranked all the other markets in terms of readiness for adopting digital therapeutics. Does this align with what you’re seeing?

MC: So what we've seen is our work has expanded significantly in South Korea. Up until this past August, digital therapeutics and telehealth were actually illegal in the country. But because of COVID, the government has created an entire new pathway for digital therapeutics to be recognised, regulated, and I think even paid for in the country. So we've had a large number of companies come into existence and really start to engage and are embarking on that pathway, 

We've also seen Japan grow and Singapore has been growing. 

What makes digital therapeutics both an interesting and somewhat tricky field is that oftentimes, since these are medical therapies, they have to have some version of authorisation - be it from an employer, a payer, a clinician, or somebody else who has some authorisation rights to say, this is the right treatment for the right patient at the right time. It's hard for us to go directly to a patient and say, "you should use this." Because we as an association, we don't have that jurisdiction or authority to be able to say what is right for what patient or not. 

So while we've seen some patients be interested in it, a lot of this effort is still at that policymaker, payer and clinician level to really help them understand what these are, why their patient and populations need them, the benefits they can provide, the value that's there, how to integrate them into workflows and all of those logistics.

 

FWHT: You’ve mentioned previously how it would be great if we got to a point where the ‘digital’ in ‘digital therapeutics’ was dropped and these products were simply ‘therapeutics’. When’s this likely to happen? 

MC: It would happen within our lifetime, definitely. We are already seeing digital formularies being developed and I'll just use the US as an example. Express Scripts, CVS Health, and a few other [pharmacy benefit managers] already have digital health formularies. So the notion that a clinician is sitting down with a new type 2 diabetes patient and looks through the [therapy] options…[one of those options would be] having insulin as medication and having a digital therapeutic to help dose insulin for the patient in real-time for the first three months of their being onboarded to insulin - I don't think that notion is that far off. 

Whether digital therapeutics keeps its moniker long-term or not, I'm very flexible on that one. But the idea of it actually being integrated into a singular formulary, being integrated into  practice, that’s pretty close. 

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