Earlier this week, the US FDA approved Ability MyCite, the first drug with a sensor that alerts doctors when the medication has been taken. While this may ensure better patient compliance, questions remain about patient privacy.
The new pill is embedded with a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient and notifying a digital smartphone app that the medication has been ingested. The digital pill combines two existing products: the former blockbuster psychiatric medication Abilify — long used to treat schizophrenia and bipolar disorder — with a sensor tracking system first approved in 2012.
The intention is to help ensure adherence to medication ingestion guidelines to help prevent manic episodes experienced by those suffering from bipolar disorder.
Otsuka Pharmaceuticals and Proteus Digital Health released a statement last May with the FDA approval submission that "with the patient's consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs."
While patient privacy and HIPAA regulations will need to be adhered to, this action immediately enables a patient support group with real data. However, because patient adherence and outcomes will be understood, this could set the basis for outcome-based pricing. There are several issues with this particular possibility that need to be examined.
First, understanding when medication has not been taken is just as important as understanding when it has. Doing this may not be a trivial task and will require complex event processing that is coupled to patient profiles that include treatment schedules. To be completely effective, a GPS signal ping from the mobile device to the IoT platform will be needed to identify the location of the patient if they did not ingest their medication as required and an extended amount of time has lapsed. This is where the pill can push against patient privacy concerns.
The second issue is pricing/reimbursement concerns. Otsuka currently has an injectable on the marketplace that has an efficacy length of one month. It is going to inevitably be more cost effective than an IoT-enabled medication.
For high risk bipolar disorder cases, is seeing a primary care physician once per month to receive the injection (and conduct an exam) a terrible option? More importantly, will this be more cost effective than an IoT-enabled ingestible medication?
While this is clearly a strong step forward for the healthcare industry, this may be a niche use case until the efficacy of the ingestible as opposed to the injectable is proven.