Laura Franzini, Medical Specialist in Internal Medicine, joined Chiesi Italy in 2017 and has been Medical Director of Chiesi Italy since 2019. In her role she also covers direct responsibility on Patient Engagement activities. Prior to her experience at Chiesi, she worked at other international pharmaceutical companies, in particular EliLillyand AstraZeneca, after having spent several years of clinical activity at the University Hospital of Parma as an internist. During his training, he also obtained a PhD in osteometabolic diseases and a second-level master’s degree in research methodology.
For Chiesi Italia, a company that has always been attentive to the quality of life of patients, what are the possible advantages and disadvantages of using digital healthcare and in particular Telemedicine in daily clinical practice?
At Chiesi Italy we have well understood the importance and usefulness of Telemedicine and other digital technologies, and we believe that the world of health care will have to rethink and innovate traditional care models, integrating the services of hospitals, local medicine and home care for the exclusive benefit of an increasingly connected patient. Telemedicine will therefore be at the service of doctors who will be able to monitor their patients, wherever they are. In conclusion, it is data that will move, not people.
The provision of telemedicine services for chronic patients would also make it possible to achieve significant cost savings for the community (patients and their carers), which often remain hidden.
Digital health in its various forms has the great potential to ensure the provision of care and assistance to patients, facilitating access where barriers exist.
Telemedicine comes to the rescue especially in those situations where distance is a critical factor: to people living in remote areas, to compatriots living abroad or travelling there, to those working on ships, and to all those who for physical, family or work reasons cannot travel from their city of residence.
Rather than disadvantages linked to a greater use of digital health, and in particular of telemedicine, I would speak of points of attention that should be taken into account so that there is a real involvement of all stakeholders involved in the care pathway.
Information, dialogue and collaboration are needed within the new organisational processes in order to guarantee increasingly personalised functions that meet the real needs of operators; and these platforms must be included as a means of doctor-patient consultation in the electronic medical record of hospital management systems.
Thus, while there is an expansion in the use of technology, there is also a more cautious approach by payors, both public and private.
Covid-19 has changed the possibilities of access to care, exploding the use of telecare solutions, perhaps without adequate regulation (until May 2021) and training of operators. From your point of view, what is the scenario for the near future? What lessons have we learnt from the remote care experience that has emerged under the Covid-19 drive, and what cannot be managed remotely?
In the last ten years, technological progress, especially in terms of digitalisation processes, has changed every aspect of our daily lives. We have seen a real acceleration that has led many sectors, including the health sector, to be radically transformed, with a direct impact on all the services we use, including access to health care.
Undoubtedly, the health emergency has shown the limits of traditional care systems.
The challenge for the future will be, on the one hand, to provide citizens/patients with digital services that are designed with their needs in mind and that are simple to use and easily accessible; on the other hand, to recognise the limitations of a remote ‘physical’ examination such as, for example, the absence of palpation in some conditions, or in dermatology where the patient is mainly assessed visually. In some specific cases, one could speak of follow-up visits and not of first visit.
Telemedicine has several advantages and can be a great opportunity in chronic care in patients with great travel difficulties, with the great potential to break down these and other inequalities.
Chiesi Italy targets, with its drugs, mainly patients with chronic diseases: how can you imagine the new patient journey?
In the near future, we will move beyond the concept of the drug as a simple product to a vision that sees it as part of the entire process of diagnosis and treatment of the patient. As I said before, it will be the technologies that will serve the doctor and it will be the data that will move and not the people.
As a Benefit Company and the largest B Corp certified international pharmaceutical company, the Chiesi Group pursues the mission of generating shared value between us, the environment and society. To do this, we can no longer “simply” provide effective and innovative therapeutic solutions, but must also focus on non-pharmacological treatments and services.
In providing ‘digital’ services for a new patient journey, we are moving in three different time perspectives, in the short, medium and long term. In the short term we have contributed, and are still contributing, to making digital tools available to better manage some chronic pathologies in Chiesi’s areas of expertise, such as the management of immunosuppressive therapy after kidney and liver transplantation, the management of physical-rehabilitation therapy in Parkinson’s disease, and the management of asthma. Looking at the medium term, at the end of 2020 Chiesi reached a partnership agreement with Kaia Health, a leading company in the field of digital therapies, for the marketing in Europe of Kaia COPD Management, the app for pulmonary rehabilitation in patients suffering from chronic obstructive pulmonary disease (COPD). In Germany, the app is expected to complete the DiGA Fast Track process (a process for approving, testing, trialling and evaluating such apps) by the end of the year and thus be approved for prescription and reimbursement through the national healthcare system. And finally, in a more far-sighted perspective, we are laying the foundations to develop a digital therapy in Italy in the cardiovascular field, taking the first steps in the definition of Software as Medical Device (SaMD) which could become a digital therapy. Digital support in the management of chronic diseases, partnerships in other countries with companies expert in digital therapies, and the commitment to develop in Italy a medical device that could eventually become a digital therapy, are the three fronts on which we are moving to contribute to a real digitalisation of healthcare.
Clinical research during the pandemic was put on hold for a long time, except for the treatment of Covid-19. Did the medical-scientific management of a company like Chiesi, which invests 20% of its turnover in R&D, make use of remote technologies to carry out research projects? Can you describe a virtuous experience?
The Covid-19 pandemic has taught us to believe in so-called “remote trials”, which have been part of the clinical research scene for a few years now but have always been viewed with a certain amount of scepticism, especially with regard to the safety and reliability of the data.
Remote trials go beyond the current model of conducting clinical trials, which is strongly linked to the trial centre and to regular, in-person visits for all patients. It is at this level that technologies come into play in virtual trials. In fact, many of the activities related to the trial centre can be replaced and increased in volume, thanks to mobile technologies such as tablets, wearable devices, smartphones or Telemedicine solutions. At Chiesi, for example, in 2020 we launched a real-world clinical trial using digital technology to assess health status, quality of life and treatment adherence in COPD patients over a 12-month period: TRITRIAL. The level of digitisation supports the entire study, from documentation and data management to the activities of researchers and patients, with significant environmental benefits through the elimination of paper. Through a dedicated portal, the research team has access to all study management tools, with clear benefits on workload and data accuracy. They are also constantly supported by a virtual assistant in all the activities to be followed. The patient can fill in the informed consent and questionnaires via their smartphone, tablet or PC and the data is automatically captured in the study database. In addition, he/she can carry out follow-up visits remotely, an option implemented to cope with this emergency moment due to Covid-19.
There is no doubt that change is often difficult and slow, but the lessons learnt during the pandemic are providing important and useful ideas for overcoming these challenges, encouraging greater openness on the part of regulatory bodies to support such virtual trials, provided that the study design is compatible with them.
Chiesi Italia is supporting the Istud Foundation’s project “Telemedicine between effectiveness, efficiency and humanisation of care” together with other pharmaceutical, biomedical and start-up companies: should this important issue be tackled organically by all the companies involved, given the need to reorganise care pathways in an effective, efficient and humane manner?
The process of digitalisation in healthcare is profoundly changing the world of medicine. Moreover, the health emergency has radically altered scenarios, putting the resilience of our National Health Service to the test.
It is changing the conception of medicine and consequently of how a company will develop care for its patients. Digital technologies can be a great resource because they facilitate hospital-territory integration. For example, by facilitating patient access to care and thus creating an effective integration between general practice, specialist and home care.
It will therefore be important to build synergistic partnerships between start-ups, the pharmaceutical industry, IT and academia to create value for patients, healthcare professionals and the system as a whole.