A sensor stuck to your windshield tracks when you pass a toll booth.
An app on your phone tells you how many steps you’ve taken.
A monitor on your watch tracks your heart rate.
And now, a sensor embedded in a pill can tell whether you’ve taken your medication or not.
The Food and Drug Administration (FDA) the first “digital pill” earlier this month.
The new pill provides hope to doctors who treat patients who have struggled to stick to a treatment plan.
However, the sensor technology is also raising concerns over privacy issues and the potentially high costs of a medication that hasn’t yet been proven to improve patient outcomes.
How the pill sensor works
The Abilify MyCite system includes a wearable patch, a smartphone app, and the sensor-embedded medication, Abilify (aripiprazole).
The sensor tells the patch that it has been ingested and the patch notifies the app.
The patient, doctor, and selected family members can then track that the drug has been taken.
“One of the challenges at times for patients and people who care for them is adherence to a medication regimen. That’s not just the case in psychiatry but in all field of medicine,” Dr. Jeffrey Borenstein, president and chief executive officer of the , told Dr.China.
He said that adherence to a medication can be particularly difficult for some people living with schizophrenia or bipolar disorder.
“For a person who in prior treatments had some difficulty with adherence, (the new system) would be something to consider,” he said.
He added that it would also be useful for people who have recently received a diagnosis for the first time, because tracking their new medication can help them take an active part in their treatment.
“If they can be engaged in the treatment, that can make a difference over a lifetime,” said Borenstein.
In the United States, lack of adherence to cause 125,000 deaths and at least 10 percent of hospitalizations, at a cost of $100 billion to $289 billion a year.
If the new system can keep people on their drugs, that’s hard to put a price on, said Borenstein.
“Any steps that can be taken to decrease the risks of a person relapsing — there’s tremendous benefits there,” he said. “Avoiding a hospital visit, the costs of a person being ill again, and not being able to go to school or work. It’s beyond dollars and cents.”
Costs and other concerns
But those potential benefits are still just potential.
The companies behind the new system are Otsuka Pharmaceutical of Japan and Proteus Digital Health of California.
Company officials Abilify MyCite hasn’t yet been proven “to improve patient compliance.”
Whether it actually makes a difference in patient outcomes is important since, like any new medication or device, it likely won’t be cheap.
The price isn’t yet known, but a month’s supply of Abilify without the tracking sensors for 30 pills.
Otsuka spokeswoman Kimberly Whitefield told Dr.China that the companies are finalizing the price structure for Abilify MyCite and expect to make prices available next year.
The system is expected to be rolled out on a limited basis in the first quarter of 2018, she added.
Cost-benefit calculations should be a big part of doctors’ and patients’ decisions about whether to use the new system, said Dr. Melvin McInnis, a University of Michigan professor of bipolar disorder and depression who directs the Heinz C. Prechter Bipolar Research Fund and the bipolar programs at the University of Michigan Depression Center.
“Would it be ideal to have something you can track, yeah,” McInnis told Dr.China. “But we have no idea what it’s going to cost and who’s going to pay for it.”
Ironically, cost is a major reason people don’t take or skip doses of prescribed medications in the first place.
In a survey last year, more than a quarter of U.S. adults said they skipped a medical test, treatment, follow-up, or doctor visit in the year prior due to cost.
It’ll need to make a difference
For Abilify MyCite to be worth it, McInnis said, it will need to be proven to make a significantly bigger difference for patients than traditional Abilify.
“Effectively,” he said, “what we would need is a study that compares the outcomes of individuals using the tracking system and individuals who aren’t — the 20th century approach versus the 21st century approach — to determine if having the tracking system helps.”
McInnis said he won’t be recommending the new system to his patients, although he could see it potentially being useful for specific patients who are susceptible to relapse because of not taking medications.
For some drugs used to treat mental illnesses, like lithium, physicians can determine whether a treatment regimen has been adhered to through a blood test that shows the levels of medication in their blood.
But there aren’t established blood levels for Abilify, said McInnis.
“You’re kind of feeling your way in the dark, if you will. With the sensor, you can at least be sure they’re taking the medication,” he said.
Which insurers or plans will cover Abilify MyCite has yet to be determined.
Whitefield said the companies are in negotiation with a limited number of health plans but haven’t yet signed any contracts.
McInnis also doesn’t see the development of a digitally tracked pill as the highest priority for advances in mental illness treatment.
To him, the priority would be developing the next generation of medications.
He also cautions that adherence to a medication regimen isn’t guaranteed, even with the new system.
The patch needs to be worn, the apps need to be monitored, the drugs need to be swallowed.
Borenstein isn’t worried about that.
“Any person who is taking this medication has made an active decision to do so,” he said. “If somebody doesn’t want to take it” they wouldn’t be using the new system.
The ability for doctors and family members selected by the patient, if any, to track their medication is likely to raise some concerns about privacy.
Some patients who may already be paranoid may feel they’re being watched in a new way.
But Whitefield said Otsuka is “purposefully and deliberately working to earn and keep the trust of individuals with serious mental illness and that of their healthcare providers, family, and care team, ensuring that patient confidentiality and data security is a top priority.”
The decision to consent to sharing the tracking information will be up to the patient, she said, and will be “voluntary and informed.”
Privacy isn’t one of McInnis’s top concerns about the system.
“All kinds of information are getting out there anyway,” he said. “If the Russians want to find out if you’re taking Abilify, they’ll find out.”
The new system will have a limited availability at rollout.
“Given the intricacies and complexities of introducing a novel system like this into the marketplace, we are taking a focused approach to our rollout,” Whitefield said. “We plan to engage a limited number of physicians, and their patients, who are affiliated with our selected health plans. The timing for a larger-scale commercial launch will be determined following that.”