Originally aimed at Italy, the new international edition of the book curated by a panel of Digital Therapeutics experts covers the global DTx landscape, from R&D to scientific validation and go-to-market aspects.
PRESS RELEASE Milan, Italy | September 27, 2021 - Originally published in January 2021 for Italian audiences, the international, updated version of "Digital Therapeutics: An Opportunity for Italy and Beyond" is now available in English. The newly released version of the booklet includes updates to the previous content, expanded insights with a broader European perspective, and a new chapter dedicated to the ethical aspects of DTx.
Promoted by the Smith Kline Foundation, the project is the combined result of a working group consisting of approximately 40 experts from the clinical, academic, regulatory, medico-legal, industrial, and health economy fields, as well as Patient Association representatives and digital health innovation organization Healthware Group.
Included in the many significant topics presented in detail is the primary mechanism by which DTx technology works to achieve therapeutic effects, primarily via user interaction in the correction of dysfunctional behaviors typical of many chronic diseases such as metabolic disorders like obesity, hypertension, and diabetes, and neuropsychiatric conditions such as depression, anxiety, dependencies, insomnia, schizophrenia, autism, and ADHD.
While drug treatment typically interacts passively with a patient’s biology, DTx interacts with their thoughts and behavior patterns, requiring active participation on the part of the patient and/or caregiver. As a component of the treatment pathway, DTx can work as a standalone modality, or in combination with drugs and other treatment measures for the target pathology/clinical condition.
For treatments that can produce a therapeutic effect, basing the development of DTx on randomized, controlled clinical trials, such as those of new drugs, will enable rigorous evaluation of efficacy and safety. Evidence generated by these clinical trials and compliance with technical validation standards would then qualify DTx to receive the regulatory authorization required for clinical use.
Unlike the abundance of freely downloadable wellbeing apps, DTx products are meant to be prescribed for a therapeutic indication and potentially eligible for reimbursement by national health services subject to health technology assessment studies. Fulfilment of these conditions, together with a medical prescription (prescription DTx), can also set digital products apart and give them specific recognition without ruling out the possibility of being reimbursed through private sector agreements such as insurance coverage and/or being marketed to patients directly by manufacturers, as in the case of OTC medicines.
For the working group's complete recommendations, including the identification of institutions, pathways, and processes that can give appropriate recognition to the role of DTx within the various national health services, as well as the clarity needed with respect to the governance of a rollout over a period of years, the full booklet can be accessed here.