Teva Develops First FDA-Approved Digitally-Integrated Inhaler
By Ed Miseta, Chief Editor, Clinical Leader
In the U.S. alone, 30 million people suffer from asthma, an inflammatory disease of the lungs. To manage their asthma, most patients will use two types of inhalers. The first is a rescue medication inhaler, which dispenses a short-acting active ingredient that opens the lungs and allows for better breathing. This is the inhaler you often see patients using when suffering an asthma attack. The other inhaler dispenses a maintenance medication, which is an oral corticosteroid combined with a longer acting reliever and should be taken on a regular basis even if the patient is feeling fine.
“One of the biggest challenges we face in treating asthma patients is trying to get them to adhere to the maintenance medication,” says Sven Dethlefs, EVP, Global Marketing & Portfolio at Teva Pharmaceuticals. “We believe between 30 percent and 70 percent of asthma patients don't adhere to the maintenance medication. That is a major problem because it is a waste of resources and does not support patients in getting their condition under control. This also leads to potentially avoidable symptoms and asthma attacks and overuse of the rescue inhaler.”
Dethlefs mentions a second challenge, which is improper inhaler technique. The inhalers must be used correctly to ensure the right amount of medication is dispensed and received by the patient. Many asthma sufferers do not use proper technique when using their inhalers.
Fortunately, Teva has developed a system designed to overcome both challenges and support better asthma management for patients.
An Inhaler, Sensors, And An App
The ProAir® Digihaler™ (albuterol sulfate) inhalation powder is the first (and currently only) digital rescue inhaler with built-in sensors. It also incorporates a companion mobile app designed to provide inhaler use information to people with asthma and COPD.
“The inhaler will allow patients and their caregivers to better understand inhaler usage through digital technology,” says Dethlefs. “The sensor technology is already built into the inhaler. It is always ready to go. There is nothing that needs to be added to the inhaler. It does not require a battery change and pairing it with the app is a similar process to other devices. The software is preloaded into the inhaler, which knows what signals to transfer to the app.”
A Complex Approval Process
According to Dethlefs, Teva went through a complex and lengthy FDA approval process. Dethlefs likes to contrast the approval process for the connected respiratory products to what is required of a fitness tracker. With fitness products, a company would develop the device and the app. As soon as the product is ready, it can be sold in pharmacies and sporting goods stores. This is was not the case with the digitally integrated inhaler.
“With a fitness product, you do not have to worry about pharmaceutical documentation and quality management systems,” says Dethlefs. “Fitness devices are generally not FDA-regulated products. However, when you combine a pharmaceutical inhaler and a software system in one product, it becomes an FDA-regulated combination product. That has consequences for the software development. You have to think about documenting actions, you have to consider notifications, and we had many long discussions with the FDA around notifying patients about the data the inhaler is able to capture.”
Teva had to work with three departments within the FDA to get the approval. One department had to approve the drug being used in the inhaler. Another had to approve the medical device itself. And a third department approved the promotional material and app screens being used.
“Throughout this process, we really did not have a clear guideline on how to get this inhaler approved,” states Dethlefs. “We looked at this as a co-development process with the FDA.”
Understanding Patient Needs
Most asthma patients go through an escalation period. They will start out just using the rescue inhaler. As their asthma progresses from mild to moderate or severe, a physician will add the maintenance therapy, which is vital to properly managing asthma.
“With this new digitally-integrated inhaler, we can track how often the patient uses the maintenance therapy,” says Dethlefs. “If a patient is prescribed to take it two times a day, are they actually using it that often, and do they use it correctly? In the past, there was no way for a physician or clinician to know definitively. Now that use can be accurately tracked. We can also know how often patients are using the rescue therapy. This is an indication of how controlled the patient may be, since the rescue therapy is used when the patient is not breathing well, or when having an exacerbation.”
If a patient chooses to share their data with their physician, the technology will allow physicians to know if the patient is taking the maintenance medication as directed and can provide information on a patient’s inspiratory flow. A flow sensor measures how forcefully the patient inhales, which is correlated with drug delivery and lung function.
“That is relevant because many patients inhale but never get the right dose delivered,” states Dethlefs. “Some have inhaler technique errors. Additionally, patients may be unable to coordinate their inhaler use with their breathing. These are problems that may be eliminated with our technology.”
All data collected is stored in the inhaler. This helps ensure that valuable data will never get lost. From there the signal goes to an app which is downloaded by a patient or caregiver. This also allows parents to review their child’s medication use and technique data.
“If a child is away on a school trip or at summer camp, parents can use the app to see if their children are using the inhaler as prescribed,” says Dethlefs. “They also have the option to share the data with a physician via data reports. The reports are a clean display of all the inhaler data that was collected since the inhaler was activated. It can be sent to any physician’s office with a simple click.”
With patient or caregiver approval, the physician can also access the data via a cloud-based system. Data moves from the app into the cloud and can then be accessed by physicians using a digital health platform accessible in the clinic. The physician will be able to see if the patient took the medicine twice a day, when they took it, and how forcefully they inhaled. This data can help to inform patient-physician conversations about asthma management.
“Most physicians are unable to see what patients are doing between visits,” states Dethlefs. “If a patient is not doing well, a physician might escalate the dose, not knowing that the patient’s inhaler technique is the real problem. This may give physicians the insights they need to help properly treat the patient.”
Benefits For Payers
Dethlefs believes the digital inhaler also provides value for payers. The data set Teva is compiling will allow the company to develop an algorithm which correlates the rescue inhaler medication to asthma attacks. He also points to literature published by Teva showing that about a week before an asthma attack, rescue inhaler usage increases, and lung function deteriorates.
“Our sensor technology measures inspiratory flow and volume, and also measures how often the inhaler is used,” says Dethlefs. “By seeing data on inhaler activity five or six days prior to an attack, we believe we may be able to predict the attack. As more patients use the inhaler, we will generate more data and our algorithms will improve.”
Teva believes the potential to prevent asthma attacks will support the health of patients and reduce ER visits. Patients who are not regularly using their maintenance medication can also be prodded with reminders to do so.
“This is one instance where we can show how digital health is providing real benefit to patients, physicians, and caregivers,” adds Dethlefs. “I think we are at the start of a great learning journey for us and for the whole asthma world.”
The Digihaler portfolio of products will be available to patients by prescription in late 2020.