A drug no longer needs to be a tangible object, according to panelist at the BIO 2018 convention in Boston. The way the pharma industry looks at medication is evolving and may be including new tech-focused treatments, such as digital therapeutics.
“If you think about the trajectory of medicine what is a drug these days: is it a pill, is it an injection, is it infusion, is it gene therapy? We’ve created some artificial constructs in the industry,” Jeremy Sohn, vice president and global head of digital business development and licensing at Novartis, said at a panel discussion on Wednesday. “The thing that is always constant, as the FDA will tell us, is it is about data-driven processes that allow us to demonstrate efficacy and truth.”
While the term digital therapeutic has been broadly used, many in the industry are starting to carve out a definition and shed light on what can be considered a digital therapeutic as opposed to some other kind of health technology.
“Digital therapeutics became a term that meant directly digital applied to medicine, and I think what we are talking about here goes a step further to [make it] more clear what we mean by prescription digital therapeutics: digital being the medicine and digital directly treating the condition, having gone through clinical trials with an FDA regulating its treatment, such that it can be prescribed by a doctor, and covered by insurance, just like any medicine today,” Eddie Martucci, CEO of Akili Labs, said at the panel discussion. “So the word medicine doesn't have to mean a pill it can mean something digital as long as it is having a safe treatment effect.”
Much like a physical drug, a digital therapeutic must run through clinical trials, demonstrate efficacy and meet fundamental safety codes, said Corey McCann, founder of Pear Therapeutics, a company that has created a digital prescription treatment for addiction.
Now big pharma has begun to turn to the new technologies as ways of the future. In March Pear Therapeutics, inked a deal with Novartis to develop two digital therapeutics, one for multiple sclerosis and another for schizophrenia.
“If we define digital therapeutics as the best in class drugs that are approved based on clinical efficacy and safety, then it is almost the opposite question we should be asking: why wouldn’t a pharma industry, or a company like Novartis want to, in fact need to, be in the space?” Sohn said.
In terms of the science behind the pills, similar to a traditional drug, digital therapeutics work in a number of different ways.
“There is a little bit of a tendency when people are talking about digital therapeutics to almost substitute in the word pill. So how does pill work? There are thousands of ways these work and as we know there are thousands of ways pill work,” Martucci said.
For example, Akili’s digital therapeutic for ADHD embeds sensory motor stimulation tasks that activate specific neural networks into a video game. Meanwhile, Pear Therapeutics Reset-O uses cognitive behavioral therapy.
The products are tested and regulated. In fact, the FDA is now looking into how medical devices and digital health products, such as digital therapeutics, should be regulated. Unlike traditional drugs, digital products often go through quick iterations.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.
Despite the gaining traction for digital therapeutics, like much of the digital space there have been questions surrounding payment and reimbursement for treatment and services. That’s why data and results are critical, said panelists.
“I view this as something that is approaching exponential change. Typically the human reaction to exponential change is not understanding it or not believing it or thinking that hey this must be some kind of weird initiative,” Mostafa Kamal, CEO at Magellan Rx Management, said on the panel. “I say that because I think when you go out in the market place and you talk to payers and folks that are involved in the supply chain, the first question you get is ‘what is this thing?’ and ‘how do we put our arms around it? and ‘how do we start thinking about managing it? and ‘what are the outcomes going to be?’. I think it is absolutely critical in this case to have data where you are able to demonstrate how effective these products are.”
Although the medication won’t be physical, that doesn’t mean the cost should be very low.
“People say should pharma should be in this if it’s a one dollar app,” Sohn said. “It takes me one dollar to develop that pill too or maybe even less. It’s not about the cost of goods, it is about the data driven processes we invest to bring these things to market and the value that then creates. There is a process for us to adjudicate that. So don’t worry about those things. What we are worried about is getting the best drugs to patients.”
And getting the drugs to the patients might be a little bit easier with digital, said Sohn. Like a traditional medication, doctors need to prescribe the treatment. But unlike physical medication a patient won’t have to pick it up at the pharmacy—it will be right on their phone.
“This is no different than todays medication except that it is wildly different,” Martucci said.
As for the future, there are still a lot of unknowns. The FDA is expected to launch a version of the pre-cert program by the end of the year. Meanwhile, more players continue to explore the industry.
“If it works, people want to follow,” Sohn said.