Smart devices are a growing concern in healthcare, and manufacturers of inhaled therapies are forming collaborations to tap into this market opportunity. What is the potential impact of a “smart” inhaler in the context of currently available devices?
Inhaled therapies occupy a somewhat strange niche in healthcare; neither solely a device nor solely a medicine, each one pairs a certain drug with a proprietary delivery device, complicating prescribing decisions. Historically, physicians have chosen the most effective molecule, without taking the device into account. As one physician says, “If the evidence was that a different combination of molecules in a different device was better, then you’d rely on the efficacy of the molecules rather than the device.” This dynamic is beginning to change as more devices become available, and the change will accelerate with the entry of generic versions of market leaders anticipated in the near future. Several manufacturers already have strategies in place to help retain patient share; for example, though the new family of therapies delivered in the Ellipta device will not be under generic threat for many years, the announcement of a collaboration between GlaxoSmithKline and Propeller Health to develop a “smart” inhaler indicates an effort to help the respiratory giant retain its market share.
Current treatment of asthma and chronic obstructive pulmonary disease (COPD) in the US relies heavily on hand-held inhalers. Some devices will be familiar to anyone who has experience with childhood allergic asthma, for which treatment involves the use of an L-shaped inhaler with a canister inserted. Other therapies, such as the Spiriva Respimat or Advair Diskus, on the other hand, are fully integrated systems with advanced design features—including integrated medication capsules that release the correct dosage with a simple twist and click, and mechanical propellers that disperse the medication so it can be easily inhaled into the patient’s lungs. These newer devices have been well-received by both physicians and patients, who often prefer newer devices due to their ease-of-use, indicating that patient-specific limitations are increasingly necessary to consider when prescribing therapies. As a consequence, device design has become more important when selecting a therapy; as one physician remarks, “The device is important to me, and this is going to become much more important in the next years with so many options of different tools or gadgets to give to patients.”
This trend toward a focus on device design will be a critical consideration in the uptake of generic therapies for Mylan and other companies that have already begun to file for FDA approval of new devices to deliver generic versions of older molecules, posing a potentially significant threat to brand-name therapies. Current market leaders are, therefore, expected to aggressively defend their device patents, which may help delay generic erosion. What also might help is the observation that physicians have historically been suspicious of these alternatives, with one such physician indicating: “I have some doubts about the generic powder systems. I’m not very confident, and I know that studies have not been very rigorous.” Any generic manufacturer will have a long slog to convince payers that their device is, at the very least, sufficient; after all, it is unlikely that such devices would be identical to branded devices and they would necessitate additional physician and patient education on proper use. One physician jokes that generics would have a hard time competing with the market leaders’ device, such as Advair’s Diskus: “I would have to see what that proprietary device looks like. I doubt they can make a purple disk without getting sued. And if it’s not purple, it’s just not going to work.”
Additionally, GlaxoSmithKline has staked out a strong position by launching an entire family of therapies in the same device. The Ellipta device can now take a patient from a first-line therapy such as Incruse or Arnuity, through second-line combination therapies such as Breo or Anoro, all the way through the company’s last-line therapy, a triple-combination anticipated to launch in 2019. Physicians have received these launches positively thus far, highlighting the importance of matching a patient with a device; for example, one physician expressed, “It’s the patient who’s going to prefer one device versus another because he knows how to use it and he is more comfortable with one inhaler versus another.” Other physicians note that training patients on a new device is resource-intensive, saying, “The nurses are quite involved in teaching inhaler technique. Everyone would accept it is good practice to try and keep the number of devices as few as possible so that people can remember how to use them.” Capturing patients early in the treatment algorithm may, therefore, help prevent loss of sales dollars to generics by enabling companies to retain patients throughout the progression of their respiratory disease.
The aforementioned collaboration between GlaxoSmithKline and Propeller Health takes the current emphasis on the power of device design one step further with the inclusion of a Bluetooth-connected propeller in the Ellipta inhaler. This inclusion is aimed at both supporting patient adherence to physician-prescribed treatment and aiding GlaxoSmithKline's development of molecules for respiratory conditions to better treat asthma and COPD in the future. There are very few analogue markets we can look to when trying to understand the potential impact of this type of innovation; however, the proliferation of digital health devices and smartphone apps can help illuminate both the opportunities and threats posed by linking traditional inhalers to new technologies. An upcoming blog post will discuss this in more detail, but for now, it’s quite clear that device choice has become an important part of treatment decisions for respiratory diseases.