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

Not a day goes by when we don’t learn of yet another application for mobile phones in healthcare. The list includes using mobile phones to diagnose and manage health-related conditions, to monitor subjects participating in clinical trials, and to conduct remote consultations with physicians and other caregivers.

In mid-November 2017, 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. The problem that digital medicine addresses is profound. 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. In fact, when precise information about an individual’s use of drugs is analyzed and then aggregated, healthcare professionals can gain much better insight about when to intervene with specific patients and how best to allocate nurses’ time with respect to prioritizing care based on need. Imagine Amazon.com algorithms applied to your health instead of your shopping…