The report, titled "Digital Therapeutics to Enhance the Care Pathways for Depression Across the National Health Service: Expert Proposals for Italy," was 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.
Expert Proposals for the Integration of Digital Therapeutics
The document describes five expert proposals for the integration of Digital Therapeutics across depression care pathways in the Italian national health service. The proposals were developed by the multistakeholder panel in response to the unmet needs and recent evidence-based scientific recommendations for the treatment of depression. The proposals aim to enhance care-as-usual within the SSN for mild, moderate, and severe depression, as well as for the prevention of relapses and management of subthreshold depression.
The expert panel analyzed the case study of a DTx already accessible and reimbursed in other European countries and supported by substantial clinical evidence. They defined a possible clinical-organizational process suitable for the integration, prescription, and adoption of DTx in the context of the SSN.
Impact of Depression on Italy
In Italy, mental health disorders are the fifth leading cause of Disability Adjusted Life Years. Depression is the most common mental health disorder, with more than 3 million people suffering from depressive symptoms, and rising prevalence rates due to the COVID-19 pandemic. Depression also accounts for direct and indirect costs that exceed 3% of GDP. Despite the significant health and socioeconomic impact of depression, numerous unmet needs persist across care pathways, and dedicated services remain underfunded within the SSN.
Digital Therapeutics represent an opportunity to complement and enhance care pathways for depression. They deliver evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a disease or disorder. Their systemic integration could effectively increase accessibility to validated psychotherapeutic interventions in a scalable manner.
Need for Italy to Define Appraisal, Access, and Reimbursement Criteria for DTx
The expert panel 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.
The report 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. The expert panel comprised of stakeholders from various backgrounds, including mental health professionals, associations, and scientific committees.
Conclusion
The Expert Opinion contributes to the current institutional, scientific, and cultural debate on the digital health transformation in Italy. It highlights the need for Italy to define appraisal, access, and reimbursement criteria for DTx, and enable their adequate, equitable, and timely integration within the context of
"Digital Therapeutics to enhance the care pathways for depression across the national health service: expert proposals for Italy” can be accessed here.
