Can software code treat patients as well as molecular chemistry? For biopharma executives still not convinced that digital therapeutics is real, and according to Goldman Sachs a promising new category in life sciences expected to hit $6 billion in revenues, consider this question: Given a choice between sedating her hyperactive child with a pill or playing a Disney film on a tablet computer, what would be a mother's first choice?
Right. So we know it works. We don't really need studies to convince us that a smartphone can help patients change negative behaviors when we remember that as parents we do it every day using the electronic babysitter.
It becomes only a question of the quality of the software—the stickiness, or sustained patient engagement. Anyone with a teenager addicted to a video game knows that this challenge also can be overcome.
In June, 2018, the FDA approved the first Prescription Digital Therapeutics (PDT)—yes, available exclusively on a doctor's order—to treat substance use disorder.
Is this the inflection point that validates the new category? Will this trigger massive investment in building quality, sustainable software experiences for patients? Perhaps not quite. But please name a major pharmaceutical company that is not already investing in the potential for apps to accelerate clinical development, or for companion apps to accompany drug launches, or for standalone apps to be prescribed as a therapeutic to treat a specific disease.
At BIO-Europe® 2018 in Copenhagen, a panel session organized by Natalie Dakers with Accel-Rx Health Sciences Accelerator featured executives from Pear Therapeutics, which won the FDA approval; Click Therapeutics that raised $17 million in a round led by Sanofi Ventures; and, Denmark-based Leo Innovation Lab that invested $5.5 million in five startups to drive development of digital tools.
According to Antoun Nabhan, VP for Corporate Development at Pear Therapeutics, "Everyone is carrying mobile devices at all times and we all know that at some level that interaction is rewiring our brain with little rewards and little dissuasions. These interactions can change the way we think, the way we act, which can change our physiology. This physiological plasticity is what we are seeking to harness for good to create genuine improvements against gold standard endpoints. That is the promise of digital therapeutics.”
He added, "We specialize in prescription digital therapeutics. We run clinical studies, we obtained FDA marketing authorizations and approvals that are directed to efficacy-based claims. Importantly this allows us to pursue a reimbursement pathway."
And, “we were able to demonstrate in the reSET study with 399 patients a doubling of the rate of abstinence from drug use in a 12-week course of therapy over traditional therapy. In a second clinical trial of the Pear 003 product for depression, anxiety and insomnia we ran a 1,149-patient, two-arm study that demonstrated statistically significant improvements," he said.
Nabhan explained that the dominant paradigm today is that patients with a disease primarily do what their doctor advises them to do to treat a disease. "And they expect their insurance company will pay for these recommended treatments. Our model springs from this observation," he said.
"There are many, many apps out there, yet very few of them have significant patient uptake," he said. "We believe the prescription model is the key to driving physician conviction, which will drive patient uptake. All of this taken together is what will compel payers to reimburse."
Clinical validation is essential for this category, according to Austin Speier, the Chief Strategy Officer for Click Therapeutics. "By definition a digital therapeutic must go through clinical trials.
“There is absolutely a role for apps-plus-drugs to bring those drug candidates through clinical studies," he said. "Our lead investor is Sanofi, which understands that medications will come out with apps in the future. We also have a payer investing, Magellan Health, which has been very insightful as they provide the infrastructure and vision for how we are going to deploy these products through existing channels to reimbursement. They also understand that behavioral interventions such as digital therapeutics can really help not only as stand-alone treatments, but also as a way of managing conditions and building longer term relations with patients."
He added, "There is also an opportunity for stand-alone PDTs. So, there is a lot of interest from pharma to develop these apps."
Digital therapeutics also present a huge opportunity for pharmaceutical companies to transform the way they develop and market products.
Nabhan explained: "We can significantly accelerate the timeline to first-in-human studies, can significantly reduce the risk in the pre-IND phase. Once into clinical studies the ability to collect the key data through a digital app means you don't need to send the patient back to a physician, greatly reducing the per-patient cost for a study. Our partners at Novartis are telling us that on average trials are running about one-third of the cost per patient in a traditional pharmaceutical trial. So we do have significant advantages there."
He added that the attractiveness for investors is that "we do benefit from reimbursement more typical of drugs, as opposed to $2.99 per month people pay for conventional apps in the App Store."
According to John Zibert, Chief Medical Officer at LEO Innovation Lab, "It is super-important to distinguish what we can show in a clinical trial setting and what is the real-life usage of our apps. If you go to a doctor and you add a digital solution, compared to those who do not receive a digital solution, would you then see an improvement?
"What becomes interesting is to look at sustained behavior change, something that lasts more than two months, an app that patients go back to again and again. There are no apps in the healthcare space that people go back to use for more than one year. You have to go into the social media space and look at Facebook and Twitter and Snapchat that actually offer something that users want."
This, he said, is the goal for PDTs. "Adherence is the key to success," he said.