Facilitating Global Innovation & Partnering

Press Releases

An Update on Digital Health

April 26, 2018

There continues to be a focus on the area of digital health in drug delivery. More, recently, this area of interest has also been referred to as digital therapeutics or “digicueiticals.” In November 2017, the FDA approved a therapeutic pill that is integrated with an ingestible sensor that can capture information about patient compliance. That product, Otsuka’s Abilify MyCite®, is indicated for schizophrenia and bipolar disorder. When the patient ingests this pill, data is sent to a patch worn on the patient’s torso. From there, the data is wirelessly transmitted to a mobile app that can be accessed by both the patient and their physician.

Currently, three out of five schizophrenia patients do not take prescriptions as prescribed. It is the hope that Ability MyCite is another step to increased patient compliance. However, there are still challenges to the use of paired digital health and therapeutics. According to the Proteus chief medical officer Dr. George Savage, many providers have already shown that they’re open to Proteus’ pills but are concerned that the benefits of this new approach could be stemmed by increasing complications to their workflows. Physicians will have keep track of the data. This may increase liability because physicians would have to check that the patient is adhering to the medication every day.

Additionally, Abilify Maintena® is a long-lasting, injectable version that is also available for physicians to prescribe. Otsuka Pharmaceutical and several other pharmaceutical companies have recently developed long-acting antipsychotic injectable formulations that can be administered up to once every three months. The advantage to these long-acting injections is that it does not require daily doses of the medication, which can improve adherence. The MyCite pill does not help with the challenge of daily dosing; just the monitoring of it. However, many people do not prefer injections because they can be painful and injections require the patient to go in a clinic to receive the treatment. Thus, long-acting injections are not an end-all-be-all solution to patient adherence.

As many as 150 firms around the world are developing digital therapeutics, according to the Economist. The MyCite approval will raise awareness of this field of technology. Many advocates are pushing for less strict FDA guidelines for digital technologies so that the approval process is quicker and would enable patients to access these tools sooner. These advocates believe that digital therapeutics, digital trackers, and accompanying apps pose little safety risk. In the best-case scenario, they could dramatically improve adherence rates and speed up health interventions, thereby saving lives and billions of dollars. In the worst-case scenario, the apps would prove ineffective and patients would be no worse off than before.

There are several solutions to helping patients take their medications. These include pill boxes, watch alarms, color changing bottle caps, and sensors in bottle caps. Additionally, pharmacies offer automated reminders to pick up refills of their medication. However, these solutions only ensure that the product gets to the hands on the patient. The larger, obvious issue is trying to make sure that the patient takes their medication. The next digital health approval will most likely gain acceptance more easily than the MyCite pill. However, this will depend on how the pill performs in the market and whether the cost and benefit will actually prove worthwhile to payers and providers.

For more information or assistance on identifying new opportunities in the area of digital health, please contact Shala Doerr to further discuss your needs.

Shala Doerr
Director of Business Development
(703) 531-0257