For the past five years the development buzz has been in adding wireless connectivity to devices to enable digital health benefits for patients. In stark contrast there has been little visible activity in developing new devices that have improved drug delivery or improved use-ability or reduced side-effects for those in need of treatment.
So what do digital health benefits really mean for all those involved?
The Teva image above gives you the overall picture and the recently released user details are on the web at proairdigihaler.com.
The Digihaler device will detect when the inhaler is used and measure inspiratory flow with an on-board flow sensor – both items being logged in local memory. This date and time stamped patient data is then sent from the inhaler to the companion mobile app where it is stored. Teva points out that ‘patients can review their own data over time on their mobile, or chose to share it on-screen with their healthcare professionals.’ A nice feature of the system is that a QR code is printed on the inhaler top and is used to pair the device with the patient mobile.
It is clear with digital health that protection of patient data is of paramount importance, and seeking consent to share patient data with others is legally required.
Overall with a large patient population, this technology has the potential to provide big data to whoever legally owns the patient data.
The general hope is that the digital health big data will show:
- Improved long-term adherence to the prescription
- Improved outcomes for the patient (clinically proven)
- Reduced hospital costs (better preventer adherence reduces asthma exacerbations)
- Good return on the product development investment and substantial COG increase
GSK has already the small-scale but popular (1200 patient) INCA add-on device programme based in Ireland, testing the water for wider-scale inhaler user data gathering. This programme allowed historical sonic patient data to be downloaded monthly at a GP’s surgery while the patient waited fifteen minutes. The device sonic data allowed patient inspiratory flow rate to be assessed against time, as well as whether the patient exhaled into the device. Good features.
The PC analytical programme then gave a heads up to the asthma nurse if the patient had used the inhaler within the guidelines over the last month. The nurse can then advise the patient how to improve technique and/or adherence.
At RDD 2019 in Lisbon, Igor Gonda (who was moderating the digital/smart session) called for a show of hands from the audience about the timeline for universal device connectivity uptake in respiratory. The mostly scientist-by-discipline audience voted a resounding more than ten year wait for this achievement, and a good number voted more than twenty years.
It is worth pausing for a moment to think why experts do not think device connectivity will be universal?
Basic connectivity costs an estimated $5 per device manufactured cost, so it has to achieve something medically useful in a digital inhaler (or another medical device). A time and date stamp on drug delivery and a visual and audible reminder to take your medicine on your phone is the base adherence monitoring goal for these products.
The ~50% of asthma patients (2003 UN WHO adherence to long-term therapies data) who do adhere to their medication prescription typically:
- Have a chronic disease that they fully recognise and accept requires daily treatment.
- Trust their doctor is giving them the correct and best medication.
- Are stable and organised individuals such that they can comply with the required daily timings for taking medication.
- Have been trained enough to use their inhaler correctly and so reliably dose.
The inhaler systems currently in development that UPC is aware of, deal with reminders and time stamping taking medication and some include flow monitoring to make a quantitative judgement on correct device use. None of these devices are going to have any effect on the core problems identified in items 1 and 2 above. No beeping device or mobile is going to change the patient mindset if they do not accept the diagnosis and the treatment.
Patients must 100% accept their diagnosis and treatment before adherence can happen.
Digital health evangelists often propose adding a ‘care manager’ in the loop who will look after patients remotely, based on a triage system from the data. Adhering patients are left to self-treat, those who are well but not complying get the care managers attention, the worst diseased get the doctor’s attention. A system with challenging potential safety problems to overcome and manage.
How is this proposed new ‘care manager’ system going to be regulated, and by what authority?
In the UK NHS we have asthma nurses who are regulated, and work within a doctor’s practice. They obviously save GPs’ time and often are more expert in their field than most GPs are. In private practice a doctor might want to see their patient more often, such as is common in the US. Adding someone new in the patient diagnosis and treatment loop will be met with resistance. What education attainment and examination will these ‘care managers’ require by law before they can practice?
UPC believes that the real advance that digital health can offer those needing treatment for a chronic disease is in disease management – that means monitoring the disease and the treatment at the same time. In diabetes this is just becoming a reality, and the respiratory world should take note of the progress in diabetes management over the next years and respond with digital health that achieves better disease management.
Long-term compliance is a patient state of mind, that often simply requires time and a good personal relationship with a doctor/nurse to achieve.
UPC is optimistic that with better disease management as the goal, novel connected devices with improved performance can play a part in achieving better patient outcomes. Innovative inhalers are still needed to improve co-ordination and reduce side effects amongst other things.