A recent article by Dr. Lisa Rosenbaum in the New England Journal of Medicine explored both the benefits and drawbacks of Digital Adherence Monitoring. The focus was on the FDA’s recent approval of Abilify MyCite, a medicine technology that combines the medication aripiprazole, used to treat various psychiatric diseases such as schizophrenia, certain features of bipolar disorder and depression, with a digital ingestion tracking system. This voluntary digital health feedback system (DHFS) works by having the patient wear a skin patch that is triggered when the pill contacts the acid in the stomach. This event is then recorded and tracked on the patient’s smartphone. The patient can then permit their caregivers and/or physicians to access the data via a web portal. The company responsible for the DHFS, Proteus, has shown improvement in patient’s systolic blood pressure using DHFS compared with standard care. The article primarily focuses on using the technology to help doctors work with their patients to determine the reasons for non-compliance.
While this presently voluntary technology obviously can track pill ingestion and this data can certainly help doctors and patients improve medication treatment adherence, I wondered about non-voluntary uses of the technology. This particular DHFS confirms that the prescribed pill was actually ingested regardless of what the patient or their caregiver may claim. Would an insurance company be permitted to have access to this data in exchange for payment for a particularly expensive medication? Could a government agency require such a system in exchange for providing coverage for a patient for a procedure whose subsequent outcome is improved with the use a given medication?
Dr. Rosenbaum offered in her article that she thought it unethical to withhold coronary artery bypass from one of her patients with whom she was fairly certain would not subsequently take the dual antiplatelet therapy post revascularization. Using a DHFS eliminates mere suspicion. Prematurely discontinuing of thienopyridine therapy (antiplatelet drugs such as Effient, Ticlid, or Plavix) after a similar cardiac stent placement has been shown to increase the risk of both re-hospitalization and death within the subsequent 12-month period. Given the success of the Proteus DHFS in reducing systemic high blood pressure, mandating this DHFS to monitor antiplatelet therapy immediately post cardiac stent placement should reduce both patient morbidity and mortality during the following 12-month period.
A consequentialist in charge of public health care expenditures might disagree with Dr. Rosenbaum regarding the ethics of providing a revascularization procedure in an individual who is poorly compliant with beneficial post-procedure medication compliance. Bluntly, why spend the money if the patient (for whatever reason) is going to act in a manner to reduce the benefit of her procedure? Thankfully, money is not the only healthcare utility worth measuring and economists are not yet fully in charge of healthcare delivery, though they appear to have an ever increasingly important seat at the table.
So, I think DHFS technologies such as Abilify MyCite will slowly become non-voluntary.