The Digital Therapeutics Alliance (DTA) and USP recently announced a collaboration to explore the development of appropriate standards and guidelines for digital therapeutics. You might think that’s a particularly good idea if, like me not long ago, you now have visions in your head of swallowing circuit boards.
As it happens, a lot of digital therapeutics don’t involve your body at all aside from your eyes and your brain, seeing as many of them are apps or other software.
As DTA and USP put it: “Digital therapeutics deliver medical interventions via clinically validated technologies to prevent, manage and treat medical conditions and may be used stand-alone or in conjunction with therapeutic pathways to optimize patient care and health outcomes. From device and medication sensors to patient-focused applications and software, digital therapeutics create opportunities to strengthen current clinical interventions and disease management options for patients with diabetes, asthma, heart disease, substance abuse, pain, sleep disturbances and other conditions.”
If that sounds like a mouthful, it is. And that’s in part because the whole idea of digital therapeutics, or “digiceuticals,” is still a bit fuzzy. In September 2017, Pear Therapeutics generated major buzz when the FDA cleared its reSET program for the treatment of patients with substance use disorder and the company proclaimed that this was the first-ever FDA clearance for a digital therapeutic for disease treatment. Pear did legitimately include clinical trial results—and the company openly claims therapeutic benefits.
But then you also have Proteus and Otsuka jointly publicizing Abilify MyCite—approved two months later—as the first FDA approval of a digital medicine system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor from Proteus embedded in the pill that records whether the medication was taken.
But in the Abilify MyCite case, while Abilify itself may tout therapeutic benefit as an approved drug, Otsuka’s labeling for Abilify MyCite makes it clear that the system’s ability to improve patient compliance or modify aripiprazole dosage has not been established.
Does the lack of any of anything physical, like with reSET, make a digital therapeutic less therapeutic? Does the lack of being able to claim therapeutic benefit of an ingestible sensor, as with Abilify MyCite, keep the digital therapeutic from truly being digital?
I think these are questions we need to answer before we start throwing around terms like “digital therapeutics or “digital medicine” too often. Hopefully DTA and USP can be part of helping us get there.