The document describes five expert proposals and a possible clinical-organizational process for the integration of Digital Therapeutics across depression care pathways in the Italian national health service, formulated by a multistakeholder panel coordinated by Alberta M.C. Spreafico, Global Head of Digital Health & Innovation at Healthware Group, and Fabrizio Starace, Director of the Department of Mental Health and Pathological Dependencies of the AUSL of Modena
PRESS RELEASE | Milan, Italy, 28 March 2023 - Healthware Group released the Expert Opinion “Digital Therapeutics to enhance the care pathways for depression across the national health service: expert proposals for Italy”1: elaborated by a multistakeholder panel that, accounting for unmet needs and recent evidence-based scientific recommendations for the treatment of depression, proposes integrating Digital Therapeutics (DTx) to enhance care-as-usual within the Italian national health service (Servizio Sanitario Nazionale, SSN) for mild, moderate, and severe depression, as well as for the prevention of relapses and management of subthreshold depression.
The experts also analysed the case study of a DTx indicated for the treatment of unipolar depression or depressive disorders, already accessible and reimbursed in other European countries and supported by substantial clinical evidence (12 Randomized Controlled Trials and a meta-analysis involving over 2900 patients)2, to define a possible clinical-organizational process suitable for the integration, prescription and adoption of DTx in the context of the SSN.
The Expert Opinion is meant to contribute to the current institutional, scientific, and cultural debate on the digital health transformation in Italy.
In Italy, mental health disorders are the fifth leading cause of Disability Adjusted Life Years3 and account for direct and indirect costs that exceed 3% of GDP4. Depression is the most common mental health disorder, with more than 3 million people suffering from depressive symptoms5 and rising prevalence rates due to the COVID-19 pandemic6.
Despite the significant health and socioeconomic impact of depression, numerous unmet needs persist across care pathways and dedicated services remain underfunded within the SSN. Only 8% of patients accessing public mental health services benefit from psychotherapy7, although being amongst first-line treatments for depression8. It is also estimated that the SSN could only address 20% of the need for psychotherapy for anxiety and depression9. There are also challenges and gaps in providing continuous, and integrated care; supporting patients towards gradual autonomy, empowerment, and recovery; and monitoring and intervening promptly in cases of relapses.
In this context, DTx that deliver to patients evidence-based therapeutic interventions driven by high quality software programs to treat, manage, or prevent a disease or disorder, represent an opportunity to complement and enhance care pathways, enabling more effective, personalized, integrated and proximity-based models of care - in line with the priorities delineated by the recent Global Mental Health Summit and the National Recovery and Resilience Plan (PNRR). Particularly, their systemic integration could effectively increase accessibility to validated psychotherapeutic interventions in a scalable manner.
Fabrizio Starace, Director, Department of Mental Health, AUSL of Modena, affirms:
The expert opinion, in the process of being published also in a scientific journal of reference and that can inform local studies and recommendations, highlights the need to enable, from a scientific, regulatory, cultural and structural point of view, the systemic integration of DTx to enhance treatment pathways for depression in the context of the Italian SSN. It also confirms the need for Italy to define appraisal, access, and reimbursement criteria for DTx. An increasing number of European countries have developed regulatory pathways and processes to enable access and adoption of DTx. In Germany, there are currently 45 digital health applications reimbursed, 22 of them indicated for the treatment of mental health disorders10.
Alberta Spreafico, Global Head of Digital Health & Innovation di Healthware Group, affirms:
The multistakeholder expert panel and authors of the document are:
*Clinical-scientific expert healthcare providers with consensus voting power
"Digital Therapeutics to enhance the care pathways for depression across the national health service: expert proposals for Italy” can be accessed HERE.
The document is the result of the initiative “Digitally Enhanced Pathway Program (DEEP): Integrating Digital Therapeutics in the Depression Care Pathway in Italy” carried out by Healthware Group with the non-conditional support of Ethypharm Digital Therapy.