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FDA's approval of the first-ever digital medicine, while sparking legitimate concerns around ethics and trust, could signal improvements ahead to the much-chronicled woes in drug adherence and compliance.
In November, the FDA approved the first “digital medicine system” from Otsuka and Proteus in the form of Abilify MyCite, Otsuka’s antipychotic medication embedded with an ingestible sensor from Proteus that can show if a medication has been digested. The sensor had been “approved” since 2012 by the FDA to be included in the clinical trials, but in the drug’s public debut, interesting opinions emerged. TheNew York Times’ “First Digital Pill Approved to Worries About Biomedical Big Brother” (view here) is certainly an attention-grabber,
and the article did bring up legitimate questions, specifically around ethics, compliance, and trust, as well as some interesting views around the patient population.
For example, while you can’t argue that medication adherence in the schizophrenic population is not stellar-with overall rates roughly at 50% and ranges from 20% to 89%-for the first drug with a sensor that transmits electrical signals outside the body, maybe it wasn’t an inspired choice from the standpoint of the population, whose symptoms include “hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.”
Said Dr. Paul Abppelbaum, director of law, ethics, and psychiatry at Columbia University’s psychiatry department, in the article: “A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”
Leaving that aside for now, the article did profile compliant patients using medications for schizophrenia. One, in the trial for MyCite, didn’t like the rash from the patch (which is worn to collect the data), and says he won’t take it because he is compliant. Another compliant patient explained that he also wouldn’t consider the digital avenue for the medication, but he said those that don’t take their pills unsupervised have to get the medication via a shot. For those individuals, he said, the ingestible sensor alternative might be the way to go.
Adherence for debilitating illnesses such as schizophrenia clearly has benefits for the patient, caregivers, and society. Medication adherence from an overall population health standpoint can be found in the numbers that are most-oft referenced from 2012 data: lack of adherence causes nearly 125,000 deaths, 10% of hospitalizations and costs the US healthcare system between $100 billion to $289 billion a year. The cost of non-adherence to a pharmaceutical company is a loss of $188 billion in potential US sales in 2015, and $637 billion globally.
For the patient, adhering to medicine is a decision around cost and mindset or behavior. For the former, that is one reason pharma invests in access programs for patients, whether in the form of rebates, hubs, or physician education around patient-specific co-pays and tiers because non-adherence is often a decision made around the pocketbook. For the latter, that revolves around patient education and the more trending “patient journey.” This means getting to the core of the patient’s perceptions around their disease, and recognizing clear goals for adherence, whether it’s being able to take a walk with their grandchild without getting winded or preventing future kidney disease and being immobilized by dialysis.
There are quite a number of technologies used to promote adherence. They are as sophisticated as the Proteus IEM technology or AiCure’s facial recognition via smartphone, to apps or text messaging systems that send reminders, to blister packs or bottle caps integrated with chips, to wirelessly transfer open data. The more simplistic technologies can’t measure actual medication ingestion, further blurring the lines of compliance. In the limitations of use for Abilify MyCite, it states that patient compliance improvement has not been established. At the end of the day, any technology must be endorsed by the user. You can opt-out of text messaging services, or disable an app. And you can decline to share data collected via MyCite sensor.
In a statement, Otsuka said that the product launch will be conducted in a limited rollout to select health plans and providers, to identify a group of the most appropriate patients. The hope is to gain feedback and learning for Otsuka’s broader go-to-market plan.
Some initial learnings may come from the views in TheNew York Times article. Potentially, the use of the digital adherence technology could lead to what Otsuka mentions in the release: an opportunity to facilitate a more open dialogue and clarity to better inform medication decision-making for physicians and their patients around benefit, risk, compliance, and behavior.