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In an effort to seek a novel business model, there has been a significant focus on pharma’s strategies to go “beyond the pill”, creating services and solutions that are complementary to their drugs. To date, the digital revolution in healthcare has mainly focused on the management of chronic long-term conditions where patient compliance is paramount to achieve improved health outcomes. Examples range from wearables to implants, mobile-enabled clinical trials, and pill reminder apps. The ultimate goal is a multi-faceted approach that is changing the traditional patient journey into a digitally-powered one, where manufacturers will have more access to real-world data, and patients are offered more comprehensive healthcare solutions—not just a pill.

The approval of Abilify MyCite represents a new breed of digital innovation. This is the first FDA-approved drug with a digital ingestion tracking system, essentially a drug-device combination of Otsuka’s antipsychotic Abilify (aripiprazole) embedded with California-based digital medicine company Proteus’s ingestible sensor. The sensor is the size of a grain of sand and made of silicon, copper and magnesium. When ingested, the stomach acid activates a small electrical signal that is picked up by the wearable MyCite Patch placed on the ribcage, and in turn, this sends information via Bluetooth to a smartphone application, the MyCite App.

In this way, the physician and up to four people chosen by the patient can monitor dosing and adherence to medication. In addition, the patch also monitors activity levels, sleeping patterns, steps taken and heart rate, so this first-of-its-kind approval can bode well for other sensor-embedded products in development. In fact, the FDA is expecting a potential raft of submissions for other digital pills.

MyCite’s impact not yet clear

However, Abilify MyCite has only been approved to track doses in patients with schizophrenia, manic and mixed episodes of bipolar I, and depression, and has not yet been shown to improve compliance, although this is likely to be demonstrated once it reaches the market. Compliance is a notable challenge for patients taking antipsychotics, so Abilify MyCite aims to address this unmet need.

Key opinion leaders interviewed by GlobalData noted that the first step in the management of an acute manic or hypomanic episode is to determine if the patient is taking their medication, since breakthrough episodes commonly result from poor adherence to maintenance treatment. GlobalData’s physician survey revealed a 53.5% compliance rate for the currently-available oral formulations of Abilify in the US. As such, this product has the potential to improve treatment outcomes in bipolar I patients at risk of manic relapse.

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Despite being a major breakthrough for Proteus, the impact of Abilify MyCite on Otsuka’s bottom line is yet to be determined. Otsuka’s antipsychotic has been available as a cheap generic since April 2015 and patients are already using the longer-lasting version, the injectable Abilify Maintena. Otsuka has not stated the price of its digital pill yet, which will hit the market in 2018, but it seems it will take a cautious approach in its launch strategy, given the company’s plans to liaise with some insurers covering Abilify MyCite and production aimed to be boosted once insurers are secured.

The novel digital pill may not be adequate for all schizophrenia, major depressive disorder and bipolar patients, as the physician should be confident the patient is comfortable with managing the system; furthermore, these patients often present symptoms of paranoia and delusions, so a digital pill to monitor their compliance and behavior might be met with resistance from these patients. Another concern is that some could even fear digital pills and their potential impact on privacy and coercion.

However, despite these hurdles, we have clearly entered a new era in healthcare. With the future influx of digital pills and even more healthcare-related technology, the proliferation of health analytics and wider access to real-world data will have a major impact on the pharma industry.

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GlobalData (2016). PharmaPoint: Bipolar Disorder – Global Drug Forecast and Market Analysis to 2024, March 2016, GDHC124PIDR