- Otsuka America Pharmaceutical said its antipsychotic drug Abilify, the first pill to contain an ingestible device that tracks whether the medication has been taken, will launch commercially through Magellan Health's mental health provider network.
- The digital pill, called Abilify MyCite, is indicated for people with schizophrenia, bipolar 1 disorder and major depressive disorder. The pill will cost $1,650 for a 30-day supply, which includes the wearable sensor and MyCite app, according to the company.
- Patients in some regional provider networks contracted through Magellan Health can opt for the treatment in the initial rollout. Otsuka said it hopes to work with other payers to collect data to prove the treatment's value.
As the first sensor-embedded drug, Abilify MyCite has the potential to be a big step forward in tackling the problem of medication noncompliance — but not without some controversy. Psychiatrists told Psychiatric News that patient consent and control of the data the system tracks were the top concerns of a bioethics panel convened by Otsuka for input.
And the FDA, which approved the treatment in November, said the product's ability to improve patient compliance with their medication regimens has not been established. But being able to track ingestion of medications prescribed for mental illness may be useful for some patients, the agency said.
The longstanding challenge of medication compliance is of particular concern for alleviating psychotic symptoms in patients with schizophrenia. Antipsychotic drugs are effective in 70% to 80% of these patients, but an estimated half of those who respond well do not stick with their treatment regimens, according to one study in the National Library of Medicine.
The Abilify MyCite sensor sends data to a wearable patch, which then transmits the information to a smartphone application. Patients can allow their caregivers and physician to access the information through a web-based portal.
The sensor technology, made by Proteus Digital Health, can also collect data on the patient's daily activity level as well as self-reported rest and mood, providing a summary of drug ingestion over time.
The company stressed collection of real-world data to demonstrate the system's value.
"This strategically aligned collaboration between Otsuka and Magellan Health has the aim of providing real-world evidence to demonstrate the value of this drug/device combination product over time," David Nash, dean of the Jefferson College of Population Health at Thomas Jefferson University and chair of the Digital Medicine National Steering Board, said in a statement.
While Abilify MyCite is the first digital medicine to be launched in the U.S. market, capsule technology that can be swallowed in itself is not new. Wireless camera pills the size of a vitamin-sized capsule are being used in diagnosing diseases of the gastrointestinal system in place of an endoscopy or colonoscopy procedure.