I recently had a chance to chat with Vijay Pande and Justin Larkin at Andreessen Horowitz about digital therapeutics. They were looking for experts but all of them were busy, so they found a person that makes memes instead. The podcast comes out just as Akili, a video game to treat ADHD, has been approved by the FDA.
One aspect of the open/OTC model is the potential for abuse. The regulation of the traditional therapeutic pipeline keeps quack medicine at a minimum. In a world of real world trials for digital therapeutics, what prevents game makers from taking advantage of consumers? "Farmville, now effective against diabetes."
The part of digital therapeutics I'm most interested in is the formulary and prescription aspect. Who will emerge as the FDB for digital therapeutics? Express Scripts just announced theirs in Decemver, but to be first is not necessarily a guarantee of market adoption. Who will be the Surescripts, sending prescribed digital therapeutics to app makers/consumers and enabling feedback loops (maybe Xealth)?
I agree on you classification. But DTx can also address some of the unmet needs, which makes //digital therapeutics companies might not outperform a placebo,// into question. For example, JOGO (my company) uses neuroplasticity based VR + gaming to help patients recover from stroke and other neuro-muscular conditions. There are no drugs in some of these categories. Our placebo is physiotherapy, which we have shown JOGO to be outperforming in trials. Also another condition we treat is dyssnergic defacation (a chronic constipation condition that is purely behavior related), there are no drugs in this category either, placebo is surgery. We are showing JOGO to be superior in this case as well.
I would have to agree with Brendan. We, as the Digital Therapeutics Alliance, only count that first bucket as Digital Therapeutics. If a product does not have a defined therapeutic outcome, it's not a therapeutic. Right? Proteus is an adherence tool. There's nothing therapeutic in the software. Diabetes products (bucket 3) can be DTx if they have a clinical trial backing up that it was their software that instigated the intervention. They can have coaches, but the software must be influencing the outcome. Otherwise yes, it is just telemedicine.
One aspect of the open/OTC model is the potential for abuse. The regulation of the traditional therapeutic pipeline keeps quack medicine at a minimum. In a world of real world trials for digital therapeutics, what prevents game makers from taking advantage of consumers? "Farmville, now effective against diabetes."
The part of digital therapeutics I'm most interested in is the formulary and prescription aspect. Who will emerge as the FDB for digital therapeutics? Express Scripts just announced theirs in Decemver, but to be first is not necessarily a guarantee of market adoption. Who will be the Surescripts, sending prescribed digital therapeutics to app makers/consumers and enabling feedback loops (maybe Xealth)?
Has Akili published any research on long-term change in AHDH symptoms for its patients? So far I've only seen short-term results.
Mind = BLOWN
I agree on you classification. But DTx can also address some of the unmet needs, which makes //digital therapeutics companies might not outperform a placebo,// into question. For example, JOGO (my company) uses neuroplasticity based VR + gaming to help patients recover from stroke and other neuro-muscular conditions. There are no drugs in some of these categories. Our placebo is physiotherapy, which we have shown JOGO to be outperforming in trials. Also another condition we treat is dyssnergic defacation (a chronic constipation condition that is purely behavior related), there are no drugs in this category either, placebo is surgery. We are showing JOGO to be superior in this case as well.
I would have to agree with Brendan. We, as the Digital Therapeutics Alliance, only count that first bucket as Digital Therapeutics. If a product does not have a defined therapeutic outcome, it's not a therapeutic. Right? Proteus is an adherence tool. There's nothing therapeutic in the software. Diabetes products (bucket 3) can be DTx if they have a clinical trial backing up that it was their software that instigated the intervention. They can have coaches, but the software must be influencing the outcome. Otherwise yes, it is just telemedicine.
Amen on "only bucket 1 actually counts as a therapeutic"