Non-adherence has become a challenge of striking magnitude, that continues to grow despite widespread acknowledgement that ‘adherence is a challenge’. In fact, that statement has almost become a truism, being repeated at every conference over and over again.
But when faced with the alarming figures to be found in this area, it’s hard just to nod, agree and move on. In 2003 the WHO published a study stating that 50% of all medications prescribed to patients with one or more chronic diseases aren’t taken correctly or taken at all. The consequences are fatal, from a healthcare as well as an economic perspective. EFPIA estimates non-adherence causes 200,000 premature deaths every year in the EU and 10% of hospitalisations are estimated to be caused by non-adherence. The pharmaceutical industry and pharmacies face billions in lost sales every year from non-filled prescriptions. And while it is true that adherence rates vary across conditions, it is a misbelief that adherence is not an issue in conditions that put more direct strain on the patient’s well-being or are closely associated with death. The challenge of adherence is real and highly substantial in almost every condition.
Helping transplant patients
A particularly interesting case for medication non-adherence exists among transplant patients. By failing to properly adhere to their treatment, patients risk the loss of the donor organ that they were so lucky to receive. Still, recent research states that non-adherence to medications occurs in 22% of patients with a donor kidney and may be a reason for rejection in 36% of patients. According to Prof Klemens Budde, medical director of the Department of Nephrology at Charité Berlin, “every one in six kidneys is rejected due to poor adherence”. Although adherence to immunosuppressive medication after kidney transplantation greatly influences better clinical outcomes, non-adherence is common in this patient group. Primary factors that influence patients’ adherence may include unpleasant side effects, general attitude towards medicine-taking and forgetfulness.
EFPIA estimates non-adherence causes 200,000 premature deaths every year in the EU
At the same time, kidney transplantation is the treatment of choice for a growing number of patients with end-stage renal disease. Health-related quality of life and overall survival in patients after kidney transplantation are superior to dialysis. In addition, kidney transplantation provides a cost benefit compared to maintaining dialysis. Therefore, over the past ten years, the number of organ transplantations has grown by 33%. More than 20,000 kidney transplantations (one fourth of the worldwide volume) took place in the EU in 2012, about 3,200 of them in the UK. And the incidence is increasing further.
Last but not least, one has to bear in mind that kidney organs are a very a limited resource. On 31 December 2013, approximately 50,000 patients were placed on European kidney waiting lists. Thus for transplant patients, those on the waiting list, and the healthcare system overall, safeguarding adherence and prevention of kidney allograft failure due to rejection is of the utmost importance.
Wanted: An evidence-based app
New tools for supporting patient adherence are necessary. They have the potential to improve the clinical outcome of transplant recipients and reduce the number of rejections, hospitalisations and premature graft losses, as well as re-initiations of haemodialysis treatment, causing enormous healthcare cost. Given their ubiquity, smartphones provide a powerful platform for support. Apps can motivate, remind and educate patients of the implications of non-adherence as well as log vital signs and general health data. They can encourage patients to improve adherence while also providing their healthcare professionals (HCPs) with important data for improving their quality of care.
While conceptually straightforward, the requirements for this kind of app are hard to match, even more so for a research-focused institution like Charité Berlin. The app needs to have some effectiveness shown in studies to make a difference in adherence. Typically, the app should also not only address one condition but holistically cover a patient’s treatment plan. Additionally, it needs to tie in with HCPs’ workflows and retain users on a long-term basis. The effort required for building it from scratch is challenging. Even Apple’s ResearchKit and CareKit frameworks, which are designed to lower the barrier for bespoke clinical apps, are hardly an option. The limitation to iPhones hinders relevance for publications. Also, apps built with ResearchKit so far have struggled to retain users.
Joining forces
One app that specialises in adherence support for chronically ill patients is ‘MyTherapy’ (for Android and iOS). Developed by Munich-based smartpatient gmbh, MyTherapy has quickly established itself as one of Europe’s leading apps for managing medications. MyTherapy reminds and motivates patients to take their medications on time. The app also tracks measurements, such as blood glucose, weight or blood pressure. MyTherapy compiles the gathered health information into a comprehensive health journal, which patients can share with their healthcare professional.
From its inception in 2013, MyTherapy set itself apart as a serious tool for supporting adherence. To gain clinical relevance, MyTherapy went for a triple-sided approach:
- An engaging user experience for patients with one or more conditions
- Seamless integration with HCPs’ workflows
- Effectiveness proven in scientific studies.
In 2014, MyTherapy showed a positive effect on adherence in a first study conducted by Charité Berlin’s Geriatrics research group. Follow-up studies confirmed these results and demonstrated the app’s impact on improving patients’ well-being.
After searching for a tool to digitally support adherence among transplant patients, the Charité’s Department of Nephrology decided to build on the Geriatric research group’s work. But the nephrologists didn’t stop at deploying the app to their patients: they are aiming for a longitudinal study where they will evaluate the adherence of patients using the app after their kidney transplantation as part of their therapy. In a randomised controlled cross-over trial, which began in August 2016, 160 patients will use the MyTherapy app for six months. The app acts as a patient support tool for adhering to their medication regimes, home measurements (eg blood pressure) as well as other treatment-related activities.
[There is] a growing body of evidence that shows the benefits of self-monitoring in chronically ill patients
Besides the challenge of non-adherence after kidney transplantation, the drive behind the study is a growing body of evidence that shows the benefits of telemedicine as well as self-monitoring in chronically ill patients. The primary endpoint is the interaction between patients and technology. Further endpoints will include evaluation of age-specific and gender-specific varieties and clinical parameters such as drug levels, vital signs and a specific parameter of immunosuppressive chemotherapy. Adherence will be evaluated by objective indirect measures (drug level and drug level variability) and subjective measures (surveys and self-reported medication tracking through the MyTherapy app). While one patient group will receive access to the app on the day of their study inclusion, the control group will access the MyTherapy app after six months. By matching parameters of both patient groups and matching data of the control group before and after using the health application, two data sets will be merged. The overall duration of the study will be 12 months.
Moving from research to action
With outcome-based remuneration schemes being all the rage, adherence has become a strategic priority in the pharmaceutical industry. After a first generation of largely marketing-centred, pharma-branded apps, many companies seemed to conclude that it takes more to improve outcomes beyond the pill. Accordingly, pharma took notice of MyTherapy’s evidence-based approach and MyTherapy opened up to industry partners with condition-specific partnerships. Together, MyTherapy and its industry partners tailor the platform to the needs of their patients and HCPs. Partners benefit from the platform’s proven effectiveness and accessibility to patients and HCPs. While the app remains open for all patients and medications, partners can provide additional value for their specific group of users. Through this unique approach, MyTherapy brings the findings of academic adherence research to action, to the benefit of millions of patients as well as its industry partners.
