The FDA just approved the first ever videogame that can now be legally marketed and prescribed as a medicine. It’s a game called EndeavorRX (formerly known as Project EVO and developed by Akili Interactive based on technology licensed from a neuroscience lab at the University of California San Francisco) — and is for 8-12 year olds with Attention Deficit Hyperactivity Disorder or ADHD.
So where does this fit in the broader category of “digital therapeutics”, which have proven to be effective as therapeutics as in the case of the Diabetes Prevention Program administered by Omada Health (which itself was one of the first to get Medicare reimbursement 4 years ago) — and are especially lauded for their scalability and accessibility (and without toxicity). But… what is a digital therapeutic, really? The term was advanced initially to distinguish the category from wellness gadgets, now, however the question is how standalone does it have to be, how targeted does it need to be? The current example was approved after 7 years of clinical trials with 600 children, but how do we know the results, which were mixed, sustain over time — especially given that these are administered very differently from pills… or are they? [We also go deep on the data, design of the study, and more in our sister show for research papers, Journal Club.]
Finally, what are the implications for value-based pricing, regulation, and where does real-world evidence come in here? We debate and discuss all this in this week’s episode of 16 Minutes on the News, with a16z partners Vijay Pande and Justin Larkin (former physician and entrepreneur who was most recently at Google Verily) and external guest Nikhil Krishnan (who covered digital health as an analyst at CB Insights, and now publishes the industry newsletter Out of Pocket). So what happens when software becomes a drug?
Justin Larkin is an investing partner on the Bio + Health team, focused on healthtech, including care delivery and horizontal infrastructure.
Vijay Pande is the founding general partner of the Bio + Health team at Andreessen Horowitz, focused on the cross-section of biology and computer science.
Sonal Chokshi is Editor in Chief of Crypto at Andreessen Horowitz.
16 minutes is a short news podcast covering the top headlines of the week, separating what’s real from what’s hype.