On Friday, the Digital Pharma Innovation Day, Joel Sangerman, Chief Commercial Officer for Click Therapeutics, spoke on the topic of “Digital Therapeutics: Software As Treatments.” This is an exciting new area of digital health – apps that may serve a palliative or treatment purpose, much like their analog medication counterparts. We’ve already seen the introduction of digital medications from Proteus and Abbvie with the digital Abilify pill, approved last year.
If you’re not sure what “digital therapeutics” means, think of the widely popular app Headspace, which has introduced the art of meditation to millions of iPhone and Android uses. Click Therapeutics has developed Clickotine, a digital therapeutics app for smoking cessation. As the company looks to a future of FDA submission and approval, they have conducted a study that showed improvement for those who used the app. For example, 45.2% of users stopped smoking at the end of the study (no cigarettes for at least 7 days) and 35.3% having still quit by the 6-month mark.
With digital medicine on the horizon, it’s no surprise that companies like Novartis and Johnson & Johnson are developing digital incubators to foster this new wave of treatment. In the session, I posed a few questions that will come, when these companies actually try to get these digital therapeutics approved by FDA …
- To what extent could a digital therapy app be customized for an individual users, when it’s been approved only within the confines of its label and MOA?
- How do you handle the management of the list of possible drug interactions, when you introduce a new class of therapy?
- Who will pay for these digital therapies? The users, the health insurance companies, or the prescription coverage providers? And will government payers provide coverage for this?
- How will you be prescribed a digital therapy? Will your doctor write a scrip? From there, you certainly wouldn’t need to go to CVS to have it fulfilled, so would the iTunes App Store and Google Play then add prescription digital therapies to their offerings?
We’re just at the beginning of this exciting new category of digital therapeutics, so keep an eye on this space.