The story behind an exceptional partnership and innovative product
By Ameya Phadke, Patients Non-Pharma Solutions Leader at Chiesi Group
Earlier this year, Kaia COPD, a digital solution aimed at improving the quality of life for COPD patients, has been listed in the German DiGA directory as a digital health application (DiGA). It can now be prescribed by physicians and psychotherapists and will be covered by statutory health insurance and many private health insurances. A great success for us at Chiesi and even greater success for people suffering from this challenging chronic disease.
The interactive application for the treatment of COPD (chronic obstructive pulmonary disease) and the Kaia-Chiesi cooperation are both“first” in many ways. The partnership stands for one of Chiesi's core values: Focusing on patient outcomes; an earnest move to show that we intend to not only “talk the talk” but truly “walk the walk”. Moreover, the underlying partnership between Kaia and Chiesi can also serve as a blueprint for future alliances in the field of holistic COPD management.
A fortunate coincidence
It was the End of 2018, a world before COVID-19, and a world where digital health was not so widespread. At Chiesi, we were very conscious of the fact that patients’ behavioral needs were largely unaddressed, but at the time, were still looking for concrete and credible ways to solve this.
It was pure coincidence – looking through a journal feed, we saw that a Munich-based start-up company called Kaia Health had published a small feasibility study that evaluated a new digital solution as a way to improve outcomes for COPD patients. We were intrigued! This was the first time we had seen anyone make a serious attempt to solve the behavioral needs of COPD patients with a digital therapeutic that leveraged the key elements of pulmonary rehabilitation.
On a whim, we followed up with a cold email to their CEO. We didn’t yet know what exactly we wanted to do together, but we soon realized within a few short calls that there was an opportunity to do something special together for patients. What started with the initial email from our side was soon followed by an inspiring exchange and collaboration agreement that was well over a year in the making. It was one of the first times a digital and a pharmaceutical company were teaming up to jointly work on a digital therapeutic that supports COPD treatment outcomes through behavior change, rather than relying solely on pharmacology.
Bringing a digital therapeutic to market has its challenges and requires a range of capabilities that very few (if any) single companies possess in entirety. Here, Kaia and Chiesi saw a unique opportunity to play to each others strengths; Kaia had developed a strong product while demonstrating very impressive capabilities to do so in a manner befitting of a credible medical intervention ranging from having systems in place to ensure regulatory compliance, to the expertise to conduct well-designed studies to demonstrate the efficacy of their solutions.
On the other hand, Chiesi has a storied history of providing therapeutic solutions to patients with chronic respiratory diseases - COPD in particular - bringing to the table deep knowledge and capabilities of how to commercialize interventions for these patients at scale. This highly complementary approach allowed each company to bring its strengths to a “1+1=3” partnership that was greater than the sum of its parts.
Challenging the status quo
In Real life, finding solutions to establish healthy routines are never that simple, and what may sound easy in theory can often become a series of barriers for patients. These obstacles can include obtaining a referral for a pulmonary rehabilitation program in the first place, locating a center-based program through what can be long wait times, finding means of transportation to attend the program for several months, and finally ensuring to carry out the rehabilitation activities at home following the conclusion of the programs.
While this is challenging enough for the average person, we must keep in mind that most COPD patients are elderly with limited options of transportation – and that many of them suffer from many comorbidities including behavioral disorders such as anxiety and depression. All of this magnifies the challenges posed by these barriers.
Thus, we realized that the status quo is a result of several issues, namely limited resources of the healthcare system, the restricted capacity of the current rehabilitation infrastructure, and finally, logistical challenges uniquely faced by patients with COPD. It was clear that the current model of physically bringing patients to rehabilitation needed to be re-evaluated.
We then asked ourselves: What if one could flip the current model upside down? Instead of bringing the patients to rehabilitation, could it be possible to bring rehabilitation to patients? In other words, could we enable patients to get access to evidence-based rehabilitation in their homes?
We looked at several possible ways to achieve this and realized that digital technologies seemed to be the most feasible approach. If there was a way to leverage software to bring the key elements of pulmonary rehabilitation to patients in a user-friendly format, we might contribute to a solution for the access gap.
Germany was the first country to provide a dedicated national reimbursement scheme for these technologies. This was a significant step that can serve as an open call for a common approach from the EU healthcare systems to improve access to these technologies. After all, payer adoption is considered a major obstacle to the widespread use of these products, along with regulatory barriers.
A cultural fit and alignment of vision
When you enter into a partnership (particularly one that strays off the beaten track as with this one), how do the companies take into account the risks and unknowns? In particular, there is a real danger of “perfection being the enemy of the good”; in other words, waiting indefinitely for an ideal set of external circumstances. Here, we saw the value in a more proactive approach and putting together a partnership that was cognizant of that.
Kaia and Chiesi spent the better part of a year co-creating a partnership structure before ever entering official discussions. We found ways for the alliance to reflect an aligned set of incentives, and for both organizations to put enough skin in the game to see the partnership through the inevitable ups and downs.
Building a sense of mutual trust between both organizations paid off early on, as COVID-19 hit the world right when partnership discussions started to gain momentum. Rather than taking undue advantage of each other, both companies gave each other some slack to deal with the then newly emerging and highly challenging circumstances the entire world was dealing with. At the same time, both companies kept each other honest in negotiations, resulting in a true partnership of equals.
A look ahead
Our goal is to do something that pushes the envelope in terms of what’s possible for patients that suffer from chronic respiratory diseases- namely, to use digital interventions to bring evidence-backed behavioral therapies to patients. Kaia COPD is a fantastic cornerstone of this strategy. The product uses mobile technology and artificial intelligence to deliver key aspects of Pulmonary Rehabilitation to patients at their fingertips – on their personal smartphone or tablet – with customized daily training sessions. We are hopeful that for patients, this will translate into tangible benefits and improvements in their lives. It is not easy for a pharmaceutical company to expand into non-pharmacological services, especially one that is not directly related to a home-grown offering or owned solution. However, we are at a transformative point in the industry, where companies need to shift their focus from products to outcomes. If we truly want to deliver on this promise, it is necessary to embrace the impact that non-pharmacological interventions can have in addition to medications and become an important solution to the current global healthcare crisis.
The Kaia COPD Digital Therapeutic
…provides important elements of physical pulmonary rehabilitation via smartphone or tablet, enabling patients with COPD to access a comprehensive therapeutic program anytime and anywhere.
The Digital Therapy includes a user-facing mobile application with:
Through the use of artificial intelligence, the Kaia COPD app adapts individually to the user's performance and level of fitness. Using the camera of the smartphone or tablet, the “motion coach” feature uses computer vision & motion tracking to analyzemovements in real time and provides visual and voice correction assistance.
The effectiveness of the digital intervention has been proven in several studies, including a multi-center randomized controlled trial. Patients using the Kaia Health COPD app experienced clinically relevant improvements in health-related quality of life and an increase in physical activity.
The app is CE Marked in Europe as a Class 2a medical device. It is currently being launched in Germany where it can be prescribed by physicians, both as an alternative and an extension to traditional care.
Patient Non-Pharmacological Solutions at Chiesi
At Chiesi, we believe that ultimately, our goal is to deliver better outcomes for healthcare systems and better lives for our patients. We leverage non-pharmacological solutions, in addition to our medications, to achieve this promise. We deeply understand the behavioral issues facing our patients- and assess possible solutions to address those in a scalable manner. We aim to bring the best-in-class behavioral therapies, delivered via technology, to people suffering from the diseases which we serve.
 Spielmanns, M., Gloeckl, R., Jarosch, I., Leitl, D., Schneeberger, T., Boeselt, T., Huber, S. M., Kaur-Bollinger, P., Ulm, B., Mueller, C., Bjoerklund, J., Spielmanns, S., Windisch, W., Pekacka-Egli, A. M. & Koczulla, A. R. (2022, 21. April). Using a smartphone application maintains physical activity following pulmonary rehabilitation in patients with COPD: a randomised controlled trial. Thorax; BMJ. https://doi.org/10.1136/thoraxjnl-2021-218338
Spielmanns, M., Boeselt, T., Huber, S. M., Bollinger, P. K., Ulm, B., Peckaka-Egli, A., Jarosch, I., Schneeberger, T., Schoendorf, S., Gloeckl, R. & Koczulla, A. (2020, 11. Juli). Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance program following Pulmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study. Trials; Springer Science+Business Media. https://doi.org/10.1186/s13063-020-04538-1
 Sami, R., Salehi, K., Hashemi, M. et al. Exploring the barriers to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: a qualitative study. BMC Health Serv Res 21, 828 (2021). https://doi.org/10.1186/s12913-021-06814-5
Brighton, L. J., Bristowe, K., Bayly, J., Ogden, M., Farquhar, M., Evans, C. J., Man, W. D. C., & Maddocks, M. (2020). Experiences of pulmonary rehabilitation in people living with chronic obstructive pulmonary disease and frailty. A qualitative interview study. Annals of the American Thoracic Society, 17(10), 1213–1221.
McCarron, E. P., Bailey, M., Leonard, B., & McManus, T. E. (2019). Improving the uptake: Barriers and facilitators to pulmonary rehabilitation. The Clinical Respiratory Journal, 13(10), 624–629. https://doi.org/10.1111/crj.13068
 American Lung Association. (o. D.). COPD and Emotional Health. https://www.lung.org/lung-health-diseases/lung-disease-lookup/copd/living-with-copd/coping-with-emotions#:~:text=Anxiety%20and%20depression%20are%20both,than%20just%20improve%20your%20mood.