Could a Direct-to-Consumer Sensor Improve Adherence?

A sensor-based medication monitoring system that has demonstrated effectiveness in improving patient adherence has received clearance for direct-to-consumer sales.

Images courtesy of Adherium

In March, Adherium received 510(k) clearance from FDA for over-the-counter (OTC) sales of its Smartinhaler sensor for AstraZeneca’s Symbicort aerosol asthma inhaler and is now preparing to sell its sensor-based solution directly to patients. The sensor, which has since been rebranded as Hailie, fits around a patient’s inhaler “a bit like a jacket,” explains CEO Arik Anderson. The Bluetooth-enabled sensor can be integrated into any inhaler and pairs with an app on a smartphone (see below right) to provide “coaching support” such as dosing reminders and alerts, he told MD+DI. It can communicate with patients as well as connect to the cloud to reach pharmacists and doctors.

Anderson says the company is dedicated to combatting the problem of nonadherence, which he says amounts to $34 billion in added healthcare costs every year. For instance, “2 million ER visits each year can be attributed to patients not taking their medications as they should,” he said. “Our founder, who suffered from asthma as a child, realized a better approach to asthma management was needed.”

The company spent more than a decade developing the technology and IP as well conducting research. A clinical study published in 2017 on Adherium’s system reported an 80% reduction in the number of children’s visits to the ER, Anderson says, speaking of a study published in Thorax.

Hailie is not “a breakthrough medication, but just makes sure that patients are taking medications as they should,” said Anderson. “We don’t need to come up with a new molecule.”

Hailie is designed for easy use. “We took deliberate steps so that the sensor blends in with the inhaler,” he said. “You don’t even know the sensor is there, until it looks for your attention. The point is you don’t know it’s there until you need it.”

Originally launching the inhaler-monitoring sensor in Europe and Australia with a 2015 agreement AstraZeneca for Symbicort, Adherium gained U.S. FDA clearance for Symbicort in 2017.

“Adherium has U.S. regulatory clearance for sensors that cover about 70% of all inhalers that are shipped each year in the United States,” explained Anderson. “These are the sensors that will initially [be] introduced through our direct-to-consumer channel. Adherium is continuing to work on new sensors that will be released through our direct-to-consumer channel as we receive regulatory clearance. We expect to expand our sensor offerings through 2018 and early 2019 at which point we will have sensors available direct-to-consumer for more than 90% of all inhalers that are shipped in the United States.”

Adherium is also working with insurance companies to drive reimbursement, but until then, “direct-to-consumer sales gives patients some control. We don’t want patients to have to wait for it.

“There’s so much good to do here. We’ve got regulatory clearance and we’re opening up the channels,” he concludes. “We’ve also demonstrated that we can save the healthcare system money.”

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.


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