PDTs vs DTx: What’s the Difference?

Russell Spjut, PharmD, director, formulary management, Magellan Rx Management, offers some insight on the difference between digital therapeutics terminology and the current landscape for these products. 

Read the transcript:

That is a really good question and one where the terminology probably hasn't been standardized completely yet. If we take a really broad view, if you think about your phone or your computer, you can get all sorts of apps. Not all of these are necessarily digital therapeutics, but they're in the digital health space. There's a lot of meditation apps and those sorts of things that are meant to be general wellbeing, health kind of apps.

I personally would say that those don't really fall in the digital therapeutic area because they're not really aiming to be therapeutic in the way we think of drugs or other medical procedures being therapeutic. They're more a self-help kind of an area.

So if we zoom in a little bit from that really general digital health area, there are a number of apps or app connected devices that are looking to actually be a treatment or a diagnostic for a specific disease state, and I think that's where most people mean when they talk digital therapeutic. We're talking about a digital app, a digital device that's connected to an app that's meant to treat a disease or diagnose a disease and is really looking to a specific problem and trying to solve that problem.

Within that subset, there are pathways that the FDA has created for manufacturers of those products to run clinical trials and submit that information for FDA approval. Those pathways create a place where there is now an FDA approved diagnostic agent or an FDA approved therapeutic agent in this digital format that is now something that's going to require a prescription because it's been evaluated, not just like a drug, but in that similar fashion where we've done clinical trials, it's been evaluated by the FDA, it's gotten approval by the FDA, and so now it's going to require a prescription.

Interestingly, the terms of digital therapeutic and prescription digital therapeutic are starting to be used interchangeably. So even though prescription digital therapeutics are something that probably should have a really specific meaning, the prescription part's very valuable, I think you'll see a lot of people just talk about digital therapeutics in an exchange there.

It'll be interesting to see what the final terminology lands on being is. Some of that will probably be driven by the FDA and what they allow manufacturers to say about their products. That's my view of that landscape and what each of those terms might mean.