Words by Isabel O’Brien
Prescription digital therapeutics sound and feel futuristic; a new galaxy in the DTx universe, which is comprised of digital devices that act like traditional medications. But despite our global transition into a new era of digital literacy — with 70% of HCPs expected to be digitally savvy by the end of 2020— could it ever become routine for doctors to refer to a technology supplier, rather than a pharmacy, to obtain their prescription?
“Prescription digital therapeutics is where the technology is the intervention itself. The technology is the drug. Although, historically, we’ve thought about drugs as being pills and injections, or infusions, and even increasingly today, cell gene therapy, why not think about the drug being a digital intervention: an app, an interface, or an electrical therapy?” says Jeremy Sohn, Vice President, Global Head of Digital Business Development & Licensing, Novartis, speaking at eyeforpharma Barcelona virtual 2020.
Prescription digital therapeutics is where the technology is the intervention itself
These are not to be confused with straightforward DTx or digital diagnostics: “It’s an improved product that goes through the same rigorous, randomised clinical trial and regulatory submission process that we would take any other drug or modality through,” says Sohn. These are not wellness apps or trackers; these are medical-grade devices that can alter the course of a patient’s condition.
The world’s first FDA-approved prescription DTx only came to market in November 2018, a cognitive behavioural therapy platform called reSET, designed to treat Substance Use Disorder (SUD), and made possible by a pharma–DTx collaboration between Novartis and Pear Therapeutics.
Prescribed in 12-week cycles, patients receive online therapy and fluency training to reinforce their proficiency, and their doctor can monitor progress remotely through the patient self-reporting their substance use, cravings, and triggers.
“It’s not replacing that individual visit with the therapist; it’s augmenting it and putting it in your pocket,” says Sohn. Randomised controlled trial (RCT) results showed that when reSET was used alongside traditional outpatient therapy, patients showed a significantly improved rate of abstinence and even adherence to outpatient therapy itself.
Another example is Cala Health’s Cala Trio™, also supported by Novartis; the first non-invasive targeted therapy that reduces hand tremors. It is a charcoal grey, hand-worn device, alike in aesthetic to a top-of-the-range exercise watch. It can calibrate to a patient’s unique tremor pattern, and when activated, stimulates the nerves that are causing the tremor.
“It can interrupt that electrical current that causes that tremor, and give patients hours of respite, hours of treatment, and give people back their life,” notes Sohn.
Mental health and physical therapy are just two areas where prescription DTx have been launched, but there is scope for these to spring up into other spaces in the coming years. However, this will be dependent on whether physicians can be successfully engaged.
“A typical physician will say: ‘we want to offer our patients access to the best treatment, but we do not have enough time’, or ‘we do not get paid to provide technical app installation and check five different dashboards,’” says Jonas Duss, US CEO and Co-Founder of DTx company, Kaia Health.
In order to progress the roll-out, providers must be trained and incentivised. These are specialised and unfamiliar processes and their time is precious, so they must be allowed to bill for set-up and monitoring, accounting for the additional workload that is not attached to a traditional prescription.
Whilst prescription DTx may feel revolutionary now, with pharma’s help and investment, plus additional physician support, we may soon see doctors’ offices transform from carpeted time warps into digital dashboard paradises where patients go to receive the most cutting-edge care.