Platform Accelerates Evaluation, Access to Digital Therapeutics

In an interview with First Report Managed Care, Whitney Stewart, director of clinical project management, Curebase discussed the challenges of bringing digital therapeutics (DTx) to market and outlined methods to improve guidance and standards for DTx studies. 

Can you please describe some of the challenges associated with bringing DTx to the market? Are there unique challenges for prescription digital therapeutics compared with nonprescription?

I like to think of the challenges in three different areas. There's regulatory—so getting FDA approval or regulatory body approval, reimbursement—which is getting set up with payers where they'll reimburse and provide access to patients for those digital therapeutics, and adoption—both by clinicians and patients. 

There have been a lot of strides in the regulatory side, although there are still some challenges. It is not a direct pathway. The FDA has been finding ways to get these products approved. I think everyone understands that as long as you start early and set your regulatory strategy within the current kind of pathways, you have likelihood of success as long as your product is effective.

For the difference between prescription digital therapeutics (PDTs) and nonprescription, think of prescription as requiring clinician involvement. The community talks a lot about fitting into the clinician workflow, which can be very complicated. There are formularies or specific options that hospitals list. There are required billing codes and physician oversight for some of them. Overall, PDTs set a higher bar, very similar to drugs where you have more evidence, you have more involved processes around providing prescriptions.

Nonprescription DTx can provide an opportunity for health insurers and payers to adopt it and offer it to a larger user base. But there are examples of not fully allowing the use of a digital therapeutic to be prescribed or used without a prescription. 

To increase access, sometimes the pathway is to remove components. For example, a digital therapeutic option for diabetes recently removed an insulin calculator to make it nonprescription, which kind of limits the scope of it, but it is a good option to increase access overall.

How is Curebase addressing these challenges with its new offerings?

Curebase helps with the regulatory, but also with the reimbursement side. We're executing clinical trials and helping companies create their evidence for whatever claims they are making. We are a vendor that understands the unique journey of digital therapeutics, and the unique characteristics of running a digital therapeutic study. Our job is to help speed up the processes and ensure the evidence is of high quality, and that you won't hit any roadblocks further down the line after executing some of these pivotal trials.

What populations do you envision DTx helping the most?

So that's one of the most exciting things about digital therapeutics—there's not a limit on the populations it can help. Obviously, the market is currently centered around treating people with conditions, diseases, and disorders that would normally be receiving medical care. 

An excellent thing about them is also that they are very low risk and easy to access. So you think of some of the access issues we have on a large scale, like access to mental health treatment, there's a lot of digital therapeutics in that space that can kind of help provide necessary treatment when there aren't providers that can provide that kind of one-on-one treatment that we're used to.

Essentially, it is a new treatment modality. It can help digitize current treatments, and it could create new types of treatments. 

Curebase is working with the Digital Therapeutics Alliance. Can you tell our readers more about that project? What sparked the partnership and what are the goals of your collaboration?

Curebase and the Digital Therapeutics Alliance came together to work on a recent white paper, and it's about a fit-for-purpose guide for evidentiary standards for digital therapeutics. It included a lot of background information on executing trials, the different types of trials that you may see in the digital therapeutic space, and different types of outcomes. It also had recommendations for types of evidence that could appeal to a variety of stakeholders. It is a great piece that is advocating for digital therapeutics to have their own framework, and mostly in the clinical evidence space, because it doesn't really fit within the traditional medical device space, or the pharmaceutical space. It is kind of a bit in between. There are a lot of health care decision-makers out there, and they all are looking for something different. As digital therapeutics are coming into the mainstream, they need to have a good foundation of what is unique to digital therapeutics that they might not understand from other experience. So the Digital Therapeutics Alliance wanted to create the background for this framework.

Curebase is very present in the digital therapeutic space as executing trials and working with companies, so it was a nice complement to each other for this particular topic. 

What is something that you wish payers or other stakeholders better understood about digital therapeutics?

In the paper, the Digital Therapeutics Alliance and Curebase identified the major stakeholders as regulators, payers, and clinicians. DTx and PDT are unique. If you stick to your understanding of medical devices and the evidence that you see in medical devices or pharmaceuticals, there is going to be something potentially missing in the evaluations of these products. What we all need to settle on is how evaluate them and understand what sufficient clinical evidence is for their claims.

And then additionally, stakeholders need to understand their value. Digital therapeutics have a lot of unique features to them, and that could include a unique placement in therapy. They could be used alone or in conjunction with other therapeutics. Value-based care comes up a lot in the DTx conversation. Understanding that as long as the outcomes are positive for these patients, the road could be unique for each patient, and they could fit in a number of ways on that journey to better health.