The Dawn Of Digital Medicine

With the approval of the first ‘digital medicine’ last year, a new digital wave is hitting pharma. What does it look like and how transformative is its potential?

The allure of technology is that it makes our lives easier and it affords us more time. The pace of modern-day living seems to pull us in multiple directions at once, and the promise of any order to this chaos is enough to make most of us reach for our credit card.  

Few companies have managed to meet our demand for seamless functionality quite like Apple. The tech giant has rolled out a range of products that augment each other effortlessly. Similarly, Facebook has created a highly efficient ecosystem. The platform, which attracts more than 1.2 billion users monthly, employs ingeniously simple tools to help us organize our social lives. 

Apple didn’t invent the smartphone and Facebook didn’t invent social media, they just vastly improved the models. How? By making highly sophisticated systems easy to use. The result? People use them.

The same philosophy is now the driving force behind digital medicines, for which the FDA gave its first approval in 2017.

What is a digital medicine?
“For us, a digital medicine is a drug that, when you swallow it, generates a signal containing information about what and when you have swallowed and sends that information to other components of the digital system that can also show how your body is responding; that information can be sent to a mobile phone and accessed via an app,” says Andy Thompson, CEO of Proteus Digital Health, the company that teamed up with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to bring the first U.S. Food and Drug Administration (FDA) approved digital medicine—Abilify MyCite® (aripiprazole tablets with sensor) to market.

“As part of the MyCite System, the tablet and digital technology enable patients to engage in their own care and enables care teams to allocate their time based on risk, and to shift their practice from on-time to on-condition.”

The Abilify MyCite tablet is a drug-device combination approved for the treatment of adult patients with schizophrenia, with acute manic and mixed episodes in bipolar I disorder, and for maintenance treatment of bipolar I disorder as monotherapy and adjunctive therapy to lithium and or valproate. Abilify MyCite is also approved as adjunctive treatment of adult patients with major depressive disorder.  It is important to note that there is no evidence that Abilify MyCite will improve a patient’s adherence.  It is approved only as a means of tracking whether a patient is taking their medication as prescribed.

The Otsuka-Proteus collaboration was born out of a shared commitment to address non-adherence in an area where it is particularly high — mental illness, says Andrew Wright, Vice President, Digital Medicine and Medical Device Division at Otsuka.

“We bring the expertise in serious mental illness, Proteus brings the expertise in technology,” he says. “We both recognize that the major challenge in medicine is adherence. Abilify MyCite gives physicians the potential to answer a fundamental question: has the  patient taken the medicine as prescribed by the healthcare professional, or not? That knowledge will allow important decisions to be made without having to question if the patient is taking their medicine.”  

Sensor in a pill
The first step is for patients to enter their medication schedule into the application, so that they are thinking about what the drugs are and what time they should take them,” says Thompson. “It's a simple rubric that starts the behavioral journey.”

When a patient swallows the Abilify MyCite tablet, the sensor inside the tablet comes into contact with the stomach acid and emits a brief signal that is detected by a wearable sensor patch worn on the body, which then communicates the information via Bluetooth to the MyCite app on the patient’s phone. The information then goes up to a secure cloud and with the patient’s permission, can be shared with the patient’s physician’s office and/or select family and friends on a portal.

“The patient can determine what information they share with the healthcare provider and family and caregivers. They can share all of it or none of it, except for the ingestion data — they will need to share that with their healthcare provider,” says Wright.  It’s important to note that the patient has to make the decision to use Abilify MyCite and with whom to share the data.

Thompson likens this part of the process to “putting social networking on top of clinical care”, giving patients a sense of agency over their treatment.

“This is very powerful because it enables people to engage with their healthcare in small increments in the context of a very busy day without it becoming a distraction or something that they have to do by going to see a doctor. It's a very powerful form of engagement,” says Thompson.

Technical wizardry
The makers of digital medicines point to three innovations. “The first is a computing platform that's effectively microscopic, sub-millimeter, that's made entirely out of ingredients in your diet – a new category of computing ‘hardware,’” says Thompson. “Innovation number two is to turn that computer into a medical device, approved by FDA in the US, CE-marked in Europe, approved by CFDA, etc. – a new category of medical device.

“That medical device has now been used to create a new category of pharmaceutical product, where the definition of that pharmaceutical product includes the sensor inside the drug, and software that can be used to engage patients and care teams.”

Digital medicines’ connective tissue is the mobile device. It impacts not only the lives of the patients, but also their carers, and a teetering healthcare system, says Thompson.

“There is an information gap, doctors don't know if the patient is actually taking their medicine as prescribed. There is an outcomes gap, if people don't use their drugs then they don't get appropriately treated. The last thing is an access gap, billions of people are entering the middle class, if we have to build hospitals and train doctors so that they can get care, it'll take hundreds of years,” he says.

“How can we make better and more effective use of the doctors we have already and enable people to access those services without travelling to a building? Let's use a mobile device.”

“One’s doctor knows exactly what drugs you take, and can start to see based on physiologic measurements, how they affect your activity and behavior in daily life.”

The burden digital medicines will lift off healthcare’s unsung heroes cannot be overstated, says Thompson. “The single largest group of healthcare workers in the world is not doctors and nurses, it is a patient’s spouse, parent, sibling, friend who is caring for their loved one. They are by far the most important set of healthcare workers in the world.

“They do enormous amounts, they have no tools, no rewards, no recognition, no nothing, but if you want a heart failure patient to stay out of the hospital tonight, it is because a woman who is that person’s caregiver at home is making that happen,” says Thompson.

“It is about recognizing that when you deliver these kinds of connective solutions around medicines, you have an enormously accepting and desiring customer base that's doing this work.”

Seeing the bigger picture
Thompson is keen to stress that while digital medicines may seem like the industry’s shiny new toy, it is ultimately part of a broader movement. “The whole world is going digital, and the way that humans interact with the world is shifting from buildings, people and products into software, services and mobile devices. It is part of a very big trend in human evolution.”

He is quick to fight in pharma’s corner when it comes to the slow uptake of new technologies.

“Innovation typically comes into healthcare once it has been matured in industrial and consumer markets. This is because healthcare systems are very conservative as a general rule, because they don't want to take on new technologies that are early in their lifecycles where there may be inadvertent risk to patients.

“You want to see the technology mature to the point where you have a very good understanding of both risk and benefit before you start to apply it in a healthcare setting where people's lives are at stake.”

Touch sensitive
Wright says one of the biggest hurdles during development to overcome was the usability of the mobile app. “The goal here was how to make it simple without it being simplistic, and that's the general rule of usability,” he says.

“What was very challenging was the fidelity between a series of tasks from A-Z. We had to do a lot of human practice to get this right, between too much information and too little information, making sure the steps are followed, particularly with the onboarding of the patch, that was one of the challenging areas to get right, if you let out certain bits of information, they may get it wrong. If you put too much information in they may try and rush ahead, so probably the single biggest challenge was the application from a user experience standpoint.”

Dream team
If pharma is to make serious inroads in the digital medicine space, it needs to collaborate with other companies, says Wright.

“You have to find the right partnerships, whether they are a very large technology firm or a small start-up. If you look at the deals going forward in the health start-up space, it is just essential to success. No one company will have the only solution.”

He remains optimistic about the future. “If you look at the rapid uptake of digital in every other industry, for example, in digitizing books and retail, you could end up with it being in many pills, but I think the initial path is to prove is its value.”

Andy Thompson and Andrew Wright will be sharing their insights at the eyeforpharma Philadelphia event in April.