Aegis Compliance & Ethics Center, LLP
Digital Medication: A New Era
The first drug in the United States to contain a digital ingestion tracking system has been approved by The Food and Drug Administration (“FDA”). Abilify MyCite is a first-of-its-kind drug system that aims to address the widespread issue of medication nonadherence, a complex and multidimensional health care problem. With the upsides of this system also come hefty concerns including privacy, convenience, and cost.
How Does It Work?
The drug, Abilify (the brand name for the drug aripiprazole) is approved for the treatment of schizophrenia, bipolar I disorder and as an add-on treatment for depression in adults. The Abilify MyCite system contains an ingestible sensor called an Ingestible Event Marker (“IEM”) that can share data related to date and time of medication ingestion with patients, doctors and caregivers. The system tracks whether the medication has been taken and can take between 30 minutes to 2 hours to detect ingestion.
Proteus Health Systems manufactures the sensor using copper, magnesium and silicon so that it activates when the tablet comes into contact with stomach fluids. The patient wears a corresponding patch which receives data from the sensor and then be reviewed and shared through a smartphone application. The patient may consent and grant access to selected individuals to view the data. In addition to medication ingestion information, the patient can record other data such as activity levels, quality of rest and self-reported mood.
There are many reasons for medication nonadherence in patients, yet the general consequence is that substantial numbers of patients do not benefit optimally from their medication, resulting in increased morbidity and mortality as well as increased societal costs. Estimates show that nonadherence to medication requirements costs about $100 billion per year due to patient illness and additional hospitalization and treatment requirements. Current medication adherence tracking options involve tracking the opening of the actual pill bottle. The Abilify MyCite system is especially appealing to caregivers and family members that are concerned with whether their loved ones have actually taken their medications on time rather than simply opening the container that houses them.
As with any transmittal of health information, privacy and data security concerns exist. To address these concerns, Otsuka Pharmaceutical Co. has contracted with several bioethicists. The digital medication is intended as a voluntary service that patients consent to by wearing the patch and using the digital application while permitting them to instantly cut off their physician and others from seeing their data at any time. Although patients control the sharing of their data, health insurers, pharmaceutical companies and even employers may eventually offer incentives to use the digital pill versus a non-digital pill, thus raising questions about the truly voluntary nature of choosing this medication.
Abilify MyCite does not yet have a determined price. According to The Wall Street Journal, the list price for a month’s supply of nondigital Abilify pills is at least $891, and the smallest vial of the injectable version is listed at $1,478. The price of the pill will greatly affect how widely it is used. There is currently no generic form of the pill with the sensor, as Otsuka has the exclusive rights to embed the Proteus sensor into the drug. A higher cost of the digital pill may be a barrier to widespread use until this exclusivity expires and generics come into the market.
Health experts note that it is surprising that the first approved digital drug is an antipsychotic drug, since many patients with conditions requiring this type of medication experience symptoms like paranoia and delusions and may find monitoring and transmitting data from their body to others undesirable.
Although the outcomes are not certain and there are still many unknowns, there is plenty of potential for success and extension of the technology to other medications.