FDA on Monday approved the world's first so-called "digital drug," which includes a sensor that could help doctors track patients' dosages of the medication.
According to MedCity News, the approval could open a pathway for other companies to seek approval for similar technologies. Mitchell Mathis, director of the Division of Psychiatry Products at FDA's Center for Drug Evaluation and Research, said, "FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers."
FDA approved a joint application from Otsuka Pharmaceutical, which manufactures the antipsychotic drug Abilify, and Proteus Digital Health, which manufactures a sensor that can be embedded into pills and is activated by fluids in the stomach.
Under the approval, providers are permitted to prescribe Abilify embedded with the Proteus sensors, called Abilify MyCite, to patients. Once patients swallow the so-called "digital pill," their stomach acids will activate the chip, which then will send a signal to a patch worn on the patient's torso and ultimately pass through the patient's digestive system. The patch will record the dosage amount and time of ingestion and send that information to a smartphone application.
According to the Associated Press, patients can use the smartphone app to track their dosage and can allow providers and caregivers access to the information via a website. However, FDA in its approval notice said the digital drug "should not be used to track drug ingestion in 'real-time' or during an emergency because detection may be delayed or may not occur."
FDA approved the drug for use in individuals with bipolar disorder and schizophrenia, as well as for use as an add-on treatment for adults with depression.
Questions about insurance coverage
According to the Journal, it remains to be seen whether insurers will cover the digital version of Abilify, which likely will cost more than current forms of the drug. Kabir Nath, who manages Otsuka's drug business in the United States, said the company has not yet determined a price for the digital pill. According to the Journal, Otsuka will reach out to see whether insurers are interested in covering the digital pill before it accelerates the drug's production.
Troyen Brennan, CMO at CVS Health, said insurers likely will not cover the digital form of Abilify unless they see "real-word evidence that this is a better approach."
Some experts say the new technology ultimately could save money and benefit patients.
William Shrank, CMO of the health plan division at the University of Pittsburgh Medical Center, said, "When patients don't adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly."
According to the New York Times, experts say medication nonadherence can cost up to $100 billion annually because patients who fail to take their medications as prescribed could end up in worse health or needing additional treatment.
Ameet Sarpatwari, an instructor at Harvard Medical School, said digital pills have "the potential to improve public health," but also "could foster … mistrust" if information transmitting by the pills are used inappropriately.
Psychiatrist Peter Kramer expressed similar concerns, saying while the technology might benefit "a fully competent patient who wants to lash him or herself to the mast," the medication could be viewed as "a potentially coercive tool" (Rana, Wall Street Journal, 11/13; AP/Sacramento Bee, 11/14; Baum, MedCity News, 11/13; Sharma/Hirschler, Reuters, 11/13; Belluck, New York Times, 11/13).
Advisory Board's take
Lindsay Conway, Managing Director
The "digital pill" has the potential to be a powerful tool for helping patients take their medications as directed, and thereby reduce excess health care utilization and costs. Yet, as with all new innovations, there remain myriad questions about how it will work in practice.
How much will it cost? Drug prices are already the fastest growing portion of health care spending. Adding monitoring capabilities to medications will only exacerbate that trend. Providers and payers will need to determine the circumstances under which it is cost-effective.
How will it impact patient adherence? Patient are non-adherent for many reasons, including cost, side effects, confusion about how and when to take their medications, and disappointment in their results. The digital pill doesn't address any of these issues. Instead, it seems best suited to helping patients who have simply forgotten to take their medications.
Who will monitor the data generated by digital pills? Many stakeholders have already raised privacy concerns, which must be addressed. But will providers want the added responsibility of monitoring patient adherence day-to-day?
The app that accompanies the virtual pill enables patients to report symptoms and side effects to their care team. This is a potentially powerful feature for providers that have assumed financial risk for patient care, as it could help avoid complications. However, in a fee-for-service environment, most providers will struggle to pay for the additional staff needed to monitor patient data.
To learn about other another way that providers are increasing medication adherence, download our research report on how health systems are embedding clinical pharmacists into ambulatory care sites to help patients better understand their regimens.