The First FDA-approved Digital Pill — What It Means for Pharma

Last year, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. From there the information is wirelessly sent to a mobile phone app, allowing both the patient and her physician to track how the patient is using and responding to her medication.

L.E.K. Consulting believes that the FDA’s approval of Japan-based Otsuka Pharmaceutical’s Abilify MyCite for certain psychiatric conditions — a first for digital medicine — will be seen as a landmark in patient-centered care. Approximately 50% of patients do not adhere to their medication as prescribed, taking it sporadically or with contraindicated foods or medicines, and 20-30% of prescribed medications are never even picked up at a pharmacy. This nonadherence problem varies in acuity depending on the disease and the population that is affected. The cost of this waste runs into the billions of dollars in unused medication and, in addition, often more expensive medical care.

Bridging gaps in global healthcare

The benefits of digital medicine go beyond the saving of costs to the healthcare system. Over time, we believe that it can help solve three core problems — we call them gaps — bedeviling the development and the delivery of healthcare around the world.

Outcomes. For starters, digital medicine can bridge the outcomes gap. When physicians can track their patients’ compliance with a prescribed medication, and how patients are responding to it, they can manage their care better. The result is superior health outcomes.

Physicians benefit by being able to track their patients based on accurate, continuous data — their heartbeat and temperature, whether they’re sleeping or walking, and whether they’ve taken the right medication at the right time. And patients are empowered with that same data to become more engaged in their overall health. Health outcomes are most likely to be improved when health professionals and patients work in concert.

Access. In many parts of the world, in developed countries and particularly in developing countries, many patients live far from a modern physician practice or a large medical center. Digital medicine, by enabling the remote monitoring of a patient’s medical adherence coupled with physiological data, can alert a physician to events that may require intervention, such as a skipped dose or an alarming side effect. This dramatic improvement in a patient’s remote access to a healthcare professional holds the potential for upgrading the speed and accuracy of medical decision-making.

Proteus Digital Health (which licensed the enabling digital pill technology to Otsuka) has been working to bring its platform to China. The following factors about China make the country ripe for digital medicine: A majority of the population uses the mobile messaging platform WeChat, and the capacity of healthcare services in both urban and rural areas is insufficient.

Innovation. Digital medicine may also play a role in ensuring the sustainability of innovation. First, there is the sheer novelty of the technology: a pill joined with an FDA-approved ingestible sensor made of silicon, magnesium and copper that captures critical data about whether we’re complying with our medications. Second, it securely and wirelessly sends this data to a wearable patch on the patient’s side that adds physiologic measures and transmits the combined information to a physician via the cloud.

Key challenge facing digital adoption

The ability of digital medicine to bridge all the above gaps and become a global standard presupposes that doctors have adopted it, regulators are comfortable with it, patients are demanding it and payers are covering it.

A key challenge is that there is a degree of skepticism among pharmaceutical companies and some physicians. Pharmaceutical companies, like other large organizations, can be notoriously slow to integrate innovative technologies or platforms. Physicians, particularly those in large hospital systems, have barely enough face time with patients and even less time to adapt to new care delivery models or new decision-making paradigms. Many of them will take a wait-and-see attitude toward digital medicine. A few early applications like Otsuka’s Abilify MyCite will raise awareness of the technology and speed its acceptance in the market.

Global pharma’s continued evolution

One thing is for sure — we are entering a brave new world of patient-centered digital health. We believe that digital medicines will play an important role in the evolution of global pharma, from today’s industry that sells products and enables doctors to prescribe medications to tomorrow’s industry that offers servicing solutions and enables consumers to reach health outcomes in partnership with their care team.

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