2023-07-12 11:43:58
by Ruggiero Corcella
Survey by the Life Science Innovation Observatory of the Milan Polytechnic. The most widespread internationally, for anxiety and addictions, diabetes, obesity, rheumatic diseases. However, many obstacles still remain
In the last five years, digital therapies have been heard more and more often. And the vast majority of patients promote them and would be willing to use them. As long as it was the doctor who prescribed them and they didn’t have to bear a cost. This was revealed by the research conducted by the Life Science Innovation Observatory of the School of Management, Politecnico di Milano, which will be presented on 13 July (10-13 hours also in streaming, upon registration
Who). The patients are those of the associations that participated in the survey, including AISC, Alleanza Malattie Rare, APMARR, FAND, FederASMA and Onconauti.
In particular, 48% of patients would not be willing to pay any amount and almost a quarter declare that they are ready to pay no more than 100 euros for a 90-day treatment, which is the average treatment time for therapies digital currently on the market in other countries.
What are digital therapies? Not the apps
«Among the numerous innovations that are redesigning the Life Science sector, digital plays an increasingly fundamental role, allowing the development of new products and services that allow for the improvement and revolutionization of patient care and support methods» explains Chiara Sgarbossa, director of the Life Science Innovation Observatory.
«In this scenario, digital therapies (DTx) represent solutions with high innovative potential – he continues -. To be approved, DTxes must provide evidence of clinical efficacy and subsequent certification and approval by regulatory agencies. A recent ISO standard has defined digital therapies as products that generate and deliver evidence-based medical interventions, with demonstrable positive therapeutic impacts on patients’ health, and produce real-world outcomes. DTx are therefore used in the context of an illness, a pathology or following a trauma. This definition does not include those devices whose use can help the achievement or maintenance of well-being in general, as in the case of health apps”.
The census of Dtx
To outline the state of the art of digital therapies currently on the market in other countries, the Life Science Innovation Observatory of the Milan Polytechnic has carried out a census of the solutions developed internationally, with the aim of mapping the main characteristics of the services offered and the business models adopted by the respective providers. The results demonstrate how DTx are applicable to different therapeutic areas. However, most of the digital therapies considered offer solutions in the psychiatric area (47%), mainly for the management of anxiety and addictions. The wide range of solutions in the field of mental health is linked to the functioning mechanism of many DTx, which is often based on cognitive behavioral therapy (CBT) which aims to identify and correct the dysfunctional behaviors that underlie various pathologies . Also significant is the presence of applications in the field of endocrinology (11%), aimed at patients suffering from obesity or diabetes, and rheumatology (10%), for the treatment of chronic pain.
How digital therapies are “administered”.
«The most widespread delivery method (more than one out of two) is the so-called stand-alone one, which involves the use of DTx independently – says Emanuele Lettieri, scientific director of the Life Science Innovation Observatory -. Alternatively, the digital device is associated with a drug treatment, usually with the aim of optimizing it by increasing its effectiveness and adherence (about 25%), or together with medical devices (e.g. wearables). In this second case, we often talk about digital therapies around the pill to underline their synergistic use with more traditional treatments, for example pharmacological. Finally, considering the purposes of DTx, it is possible to identify two categories: solutions that have the purpose of treating the pathology for which they are used or those that have the objective of improving the management of a pathology or the state of health of the patient in the scope of treatment. The DTx analyzed are divided quite equally between the two categories».
The barriers that limit the diffusion of Dtx
Digital therapies, although promising, pose a series of challenges that will have to be faced in the near future especially in Italy. To date, there is no clear legal and regulatory framework that provides for their reimbursement as occurs in other contexts. For this reason, although the opportunities associated with digital therapies are high and the players in the Life Science ecosystem are very interested, there are some critical elements that could slow down their diffusion on a large scale.
«Thanks to the research conducted in collaboration with Confindustria Medical Devices and Farmindustria – says Chiara Sgarbossa -, the supply companies (e.g. pharma medtech) report almost unanimously as the main element of difficulty the current lack of reimbursement of the solution by of the National Health Service which, according to them, should play a key role for the payment (and sustainability) of the digital therapies produced. From their point of view, there are also other barriers related to the regulatory and normative sphere, including the limited clarity of the Italian regulatory context (87%) and of the necessary clinical evaluation process (71%), as well as the complexity deriving from the ‘use of data collected by DTx for reasons related to privacy (65%)”.
What do the doctors think
Healthcare professionals also identify regulatory uncertainty as an important barrier: three quarters of specialist doctors – involved in the Observatory’s research thanks to the collaboration with AMD, AME, PKE and SIMFER – would prescribe digital therapy if the regulatory framework were clearer. Furthermore, among the factors that would increase the propensity to prescribe digital therapy, the demonstration of a high level of clinical evidence is relevant (an element recognized by 76% of specialist doctors).
«With the aim of overcoming the current regulatory limits and encouraging the development of such solutions in Italy, a Parliamentary Intergroup for digital health and digital therapies was set up in May 2023 with a supporting Technical Scientific Committee (CTS). This demonstrates that there is also strong interest on the part of the institutions in these issues», continues the director of the Observatory.
The challenges to face
Digital therapies, therefore, in recent years have been establishing themselves as technologies capable of offering a new approach to the treatment of various diseases, proving to be a useful tool for both the patient and healthcare professionals. “However, there are numerous challenges that need to be addressed in order for digital therapies to establish themselves at an Italian, but also international level – concludes Emanuele Lettieri -: the scalability of the solutions: the widespread diffusion of DTx would require a significant cultural and organizational change, which should be included in the impact assessment in HTA studies; the collection and exploitation of data: it is important to develop systems suitable for the collection, management and analysis of the data generated by these solutions and to understand how to enable the secondary use of the data; the role of doctors in the distribution model: in order for DTx to be used by patients, doctors need to be adequately informed and trained so that they can understand its benefits and limitations; the need to rethink traditional business models in an innovative way, for example through a platform-based approach, which makes it possible to identify the various actors involved in the provision of the service and the respective exchanges of value».
July 12, 2023 (change July 12, 2023 | 11:43 am)
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