In the USA, the Digital Therapies market in 2022 exceeded 2 billion dollars and includes 148 clinical studies, almost half of the 295 mapped globally. Europe, with 105 studios, follows close behind, with Germany and the UK as the leading countries. It’s Italy? It has leading scientific, medical and technological resources, but is waiting for an adequate regulatory framework to be able to play its game. The data are extracted from the DTx Monitoring Report 2023, the first made in our country, presented during the day in Rome, at the Chamber of Deputies, in the meeting “DTx as an opportunity for growth and strengthening of the National Health System”.
The occasion brought together all the subjects involved in various capacities in the development of Digital Therapies: Institutions such as the Ministry of Health, Aifa, Agenas, Universities, industry, the world of research and startups, co-protagonists of this revolution in the field of health . DTx (Digital Therapeutics) are digital therapies whose active principle consists of a software or an algorithm and are administered through digital technologies (apps, software, sensors and medical devices), to help patients manage chronic pathologies. «The first DTx Monitoring Report offers the complete picture, from research to the first approved therapies», explained Paola Elena Lanati, CEO of the benefit company Indicon, promoter and coordinator of the Observatory that created the report, developed together with the Department of Pharmacy of the University of Milan. «The therapeutic areas most treated with DTx are anxiety and depression (20.3%), followed by mental health (13.9%) and addictions to alcohol and nicotine abuse (10.17%). At European level, the leading country is Germany, with 51 therapies already on the market and 39 clinical trials in progress; the United Kingdom follows, with 14 therapies under evaluation. In Italy there are two ongoing clinical studies (on psychomotor disorders in children and on obesity), but in order for development potential to unfold, regulatory support is needed, up to the Digital Policy Act already present in other countries».
And we need to act quickly, because Digital Therapies are now a reality: “It is necessary to quickly create a suitable terrain to encourage their development and actual use in Italy”, warned the chairman of the meeting Paola Minghetti, Professor of technology, socio-economics and legislation on medicines at the University of Milan. “To do this, a clear classification is needed, an evaluation process of the single DTx to establish its correct valorisation and the prescription and reimbursement methods established at national level”. A first, important step from the institutional side is represented by the recent birth of the Parliamentary Intergroup on Digital Therapies, on the initiative of the Honorable Simona Loizzo, who is its coordinator and has also proposed to set up a dedicated and incremental fund intended to contribute to the development of DTx and patient access to these therapies.
For Mrs Loizzo, promoter of today’s meeting, «the birth of the Intergroup is evidence of the political will to accelerate the diffusion of these technologies, which have a positive impact in many therapeutic areas and which can improve the lives of many patients. As emerges from today’s comparison, the great innovative scope of these tools requires the rapid identification of an effective regulatory path that allows reimbursement». The DTx, due to their characteristics, create great expectations for the future of an increasingly personalized and interconnected medicine. In fact, they bring multiple advantages both for the patient – thanks to the direct approach with the person and the continuous monitoring by the doctor or caregiver allowed by digital technologies – and for the health system, with cost optimization, thanks to the reduction of medical visits and hospitalizations, and social ones, favoring the sustainability of the NHS.
Digital Therapies are mainly developed by startups, life science companies and other organizations that combine medical, technology and digital design skills. They are first subjected by the regulatory authorities to clinical tests similar to those of traditional medicines to evaluate their efficacy, safety and appropriateness, together with the care and protection of all the typical aspects of digital products such as privacy. But, due to their particular characteristics, they require speed, flexibility and the ability to continuously evolve a regulatory framework which, for the moment, does not yet exist in Italy: in Italy we still refer to the European regulation, which dates back to 2017 and classifies DTx as a medical device, on a par with bandages and plasters.