Jerusalem-based Teva Pharmaceuticals announced this week the U.S. launch of its ProAir Digihaler.
The sensor-laden albuterol dispenser requires a prescription, and is indicated for those aged four years or older with reversible obstructive airway diseases such as asthma and COPD, as well as for the prevention of exercise-induced bronchospasm (EIB) among this same group.
The device connects to a companion mobile app via Bluetooth to record inhaler use timestamps and measures of inhalation. The app can use these data to instruct patients on their inhaler techniques or adherence. With patient consent, the digital tool can share that information with a provider to inform case management.
The company received marketing approval for the ProAir Digihaler device in the tail end of 2018. Its wholesale acquisition cost is $146.67.
WHY IT MATTERS
These respiratory conditions are fairly prevalent in the U.S. The CDC estimates there are roughly 24.7 million adults and children currently living with asthma, and that there are about 12.8 million adult cases of either chronic bronchitis or emphysema. Further, the agency's data indicate that chronic lower respiratory diseases, including asthma, were responsible for 160,201 U.S. deaths in 2017.
While the medication inside the device is already available, Teva sees the additional data-driven features of the ProAir Digihaler as a clear value add for clinicians who normally work in the dark.
“It is our belief that ProAir Digihaler and the companion app will help address an unmet need for [health care providers (HCPs)] by providing objective rescue-inhaler use data when managing their patients,” Sven Dethlefs, EVP of global marketing and portfolio at Teva Pharmaceuticals, said in a statement. “Ultimately, this technology may help patients who use ProAir Digihaler and its accompanying app to have a better-informed dialogue with their HCP about their disease management and treatment decisions.”
The ProAir Digihaler launch is also paving the way for Teva's other Digihaler products: the AirDuo and ArmonAir. The company expects both of these to be available within the U.S. by prescription before the end of 2020.
THE LARGER TREND
Teva's entrance into the U.S. market is predicated by a few other digital inhaler companies.
ResMed's Propeller Health in particular has seen its products included in a number of pharmacy health services' connection tools and apps, and was a headliner for Express Scripts' prominent digital health formulary. Most recently the company's sensor was cleared for use with AstraZeneca's Symbicort, and was announced as a pack-in with Novartis' Enerzair Breezhaler asthma medication.
Another company, Adherium, had also worked with AstraZeneca to develop a connected inhaler for Symbicort. That device was first cleared by the FDA in 2017, and received another 510(k) for over-the-counter sales in 2018.
ON THE RECORD
The launch of ProAir Digihaler and its companion app provides a great opportunity for bringing a new digital health tool to asthma and COPD patients in the U.S.,” Brendan O’Grady, EVP of North America commercial at Teva Pharmaceuticals, said in a statement. “We are especially proud to provide our first Digihaler product at a time when digital health technology is growing and continues to transform patient care, since it will enable patients to electronically record and monitor their rescue inhaler use."