Digital therapeutics is on the map, but still hammering out tough questions

It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it’s grappling with existential questions including regulation, reimbursement models and, as always, the definition of a digital therapeutic.

This week in Boston at DTx East, some of the leading names in digital therapeutics came together to discuss a variety of digital health and digital therapeutics topics. Included among these were debates on the state of digital health investment, relationships with pharmaceuticals, developing successful business models, patient engagement, risk management and — very frequently — the need for evidence and data that can satisfy providers, regulators, pharmas and payers alike.

Here is a scattershot of thoughts and insights on the maturing digital health market MobiHealthNews heard from stakeholders throughout the event.

On the growing need for robust data … “In previous meetings, I think [the data conversation] has been left a little bit to the side, and actually I am really quite excited and encouraged that everyone is talking about data and the importance of data,” Spencer Jones, VP of global medical affairs at Sandoz, said. “What I have heard is everyone talking about data for regulatory purposes and then reimbursement. Actually, there are other groups of stakeholders that you could be reporting for too. Pricing groups, reimbursement policies, and we mustn’t forget that it’s important for the doctors, patients and other groups as well. It’s very exciting that we’re talking about these things, but the context of the conversation we’ve had has to go much further.”

“You need a data portfolio, you need an evidence portfolio that’s really validating you from different angles,” Medisafe CEO and co-founder Omri Shor told MobiHealthNews when describing the company’s latest large-scale pilot. “At Medisafe, we did some real-world evidence based on claims data on thousands of patients, we did pre-post analyses where we saw when we did the intervention how the patient did before and after the intervention. Then we did two RCTs. After that, we participated in comparative studies. So it really creates an umbrella, and I hope this one is really one of the last bricks in the wall … that we’re building. You want to have evidence, the ROI that this specific program actually worked.”