Otsuka Pharmaceuticals announced that it has signed a Collaboration Agreement with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. Initially, the rollout will be limited in order to provide Otsuka and Magellan to gather additional real-world data before wider release.
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The Abilify Mycite system includes the ABILIFY MYCITE tablet (an aripiprazole tablet embedded with an Ingestible Event Marker sensor); the MYCITE® Patch (a wearable sensor); the MYCITE® app and the web-based MYCITE® Dashboard.
“We are confident that being able to track drug ingestion in patients with serious mental illness will provide compelling insights for patients and their healthcare provider teams. We are eager for patients, doctors and the healthcare community to experience the ABILIFY MYCITE System in a real-world setting,” said Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business, Otsuka America, Inc. “This Collaboration Agreement is an important milestone in our initial rollout of the ABILIFY MYCITE System to market. We look forward to collaborating with additional payer groups to continue learning as we move toward a data-driven treatment approach.”
The Abilify Mycite system, which received FDA approval in November 2017, is the first treatment delivery system to combine a drug with a digital ingestion tracking system. It is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.
STAT news reported that the treatment will cost $1,650 per month and likely be deployed to Medicaid members living in Florida and Virginia, among other regions.
“Our collaboration with Otsuka is a natural progression for Magellan Health in providing next-generation precision medicine that can empower individuals with serious mental illness,” said Sam K. Srivastava, chief executive officer of Magellan Healthcare. “The opportunity for new insights to drive personalized care for the individual will also allow us to enhance our digital tools and care management model that we offer for our members. This collaboration aligns with our purpose of leading humanity to healthy, vibrant lives through a joint commitment to improving patient outcomes for complex populations.”
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Here’s How the Abilify Mycite System Works
- An aripiprazole tablet is embedded with an Ingestible Event Marker (IEM) sensor. The IEM sensor, about the size of a grain of sand, is made with edible ingredients. The sensor gets activated when it comes in contact with stomach fluid and communicates to a wearable sensor, called the MYCITE Patch. The IEM sensor is then discharged from the body.
- The MYCITE Patch detects and records the date and time of the ingestion of the tablet, as well as certain physiological data like activity level, and sends this and the tablet ingestion data to the MYCITE APP on a running on compatible mobile device.
- Using the MYCITE APP, patients review their objective medication ingestion and daily activity level, as well as enter their mood and rest if they want. They can also share these data with others.
- Web-based dashboards provided to healthcare providers and caregivers enables them to display the individual’s drug ingestion patterns over time. With patient consent, patient-selected caregivers can access all the information shared by the patient.