Digital Therapeutics are the “tip of the spear” in reimagining how medicines are developed and commercialized in a digital world, according to Brian Clancy, global co-lead for IQVIA’s AppScript digital health app prescribing tool. The Sidebar caught up with him to find out what trends will occur in the next few years in DTx and why pharma companies are so keen to get involved with this technology.
As digital technology plays an increasing role in our lives, it’s not surprising that digital therapeutics (DTx) are forecast to take off over the next few years. And there is a clear consensus in the industry that the rapid spread of COVID-19 will accelerate this trend, as the need for patient empowerment and remote care increases.
Smartphones, smart watches, wearables and other devices are becoming commonplace, making DTx more and more accessible to patients and healthcare systems.
IQVIA’s Brian Clancy said that DTx offer big pharma something that can reach right into peoples’ lives, helping them modify their behavior and maximizing the potential of conventional medicines.
“There really is this opportunity to use the really rich digital media that we have on our smartphones and in virtual reality devices and on our virtual assistants to really teach people new skills that they can then deploy in their life to better manage conditions that they might have,” he told The Sidebar.
Reimagining the Development of Medicines
According to Clancy one of the factors pushing companies towards DTx is that developing them is becoming easier, and this trend is likely to continue in the coming years.
As mobile digital technology becomes ubiquitous, the raw materials necessary to research the efficacy and safety of DTx are becoming more and more abundant.
Every person, who buys a smartphone or digital device could be a potential trial candidate, and as devices become more powerful their ability to gather detailed data will increase.
“We’re seeing massive adaption of virtual trials in the digital therapeutics industry because there is just this perfect fit to develop a digital therapeutic, a digital medicine, using these digital-savvy clinical trial capabilities that are now available. The same goes for commercialization of these products,” Clancy said.
Beyond virtual trials, other areas where DTx developers are early adopters and pioneers in this digital reimagining of medicines development include the use of patient reported data and real world data in regulatory use cases as well as leveraging tech-enabled provider networks to recruit patients into studies.
Holy Grails in the Commercialization of Medicines
The interest does not stop during clinical development – DTx are likely to play an important role in pioneering new models for how medicines are commercialized as well.
For example, pharma companies have had their interest piqued because DTx may help them move towards a “payment by results” model of reimbursement.
What pharma companies would like to do is charge a premium rate when their product works – but accurately measuring outcomes in a timely manner has proven difficult.
This could all change with DTx, which could work alongside a conventional pharmaceutical product to measure adherence or efficacy.
“Pharma has been wanting to do that for a long time, but one of the reasons it’s traditionally been complex is it’s hard to pull together the right data in the right timing, in order for a pharma company to go back to a payer and say, ‘Look, payer, pay me more or pay me what we agreed because this product is working’,” Clancy explained.
“Enter digital therapeutics, enter the advent of real-time data where we know in real-time if the patient is taking that particular medicine. That lends itself to much easier outcomes-based reimbursement. It might be companion apps for individual pharma brands that create some of that real-time data, that creates the opportunity for simpler management of outcomes-based reimbursement.”
Clancy described a series of “holy grails” in the commercialization of medicines to which pharma has long aspired, but DTx companies may be the first to make commonplace. Above and beyond outcomes based reimbursement, digital therapeutic companies are also more broadly in the process of digitizing the manufacturer-payer relationship, integrating deeply into electronic health records on a closed loop basis, and focusing more on best practices guidance and associated clinical decision support to drive product adoption as opposed to traditional large field forces. As the digital therapeutics industry pioneers these new paradigms, the pharma industry may come to see digital therapeutics not only as new assets to add to their portfolios, but leaders in deploying new “digital-first” approaches to the commercialization of medicines.
While the consensus is that DTx are gathering critical mass, there are still some challenges to their adoption. Many health systems lack the software that enables prescription of DTx, Clancy noted.
Only a small proportion of doctors, even in the US, have the capability to electronically prescribe DTx despite the recent technological advances, Clancy said.
Other markets are further ahead, however. For instance, he estimated that thanks to products from IQVIA and partners, around 58% of practitioners in England’s NHS can “find and electronically recommend high quality digital health apps.”
While some may find these barriers frustrating, optimists such as Clancy point towards a bright future for DTx.
“I personally think that we’ve already seen some products in the market today that can be defined broadly as digital therapeutics that will grow into ‘digital therapeutic blockbusters’.”
Diabetes is one area where DTx was adopted quite early and it is in the field of medicine where Clancy thinks the first billion-dollar product will emerge.
“I think that’s a sign to those in the digital therapeutics industry, but also in the pharmaceutical industry that this is a real opportunity,” Clancy said.
It is the patients that will complete the circle, said Clancy, as they are already enthusiastic users of the technology that make DTx possible.
“In general, patients are adopting this much faster than other stakeholders, namely payers and providers. I personally think that if we can solve the payer and provider challenges, the patients are willing to use these products.”