Description
This comprehensive report outlines how to successfully navigate the Italian healthcare system for molecular oncology diagnostics. Italy’s decentralized public healthcare system features a multi-tiered structure involving national, regional, and local stakeholders who collectively shape access and reimbursement for in vitro diagnostics (IVDs). At the national level, the Ministry of Health (Ministero della Salute) defines health priorities and the Essential Levels of Care (LEA), while the National Programme for Health Technology Assessment of Medical Devices (PNHTADM) serves as the central body for evaluating the clinical and economic value of new diagnostics. AGENAS (Agenzia Nazionale per i Servizi Sanitari Regionali) provides technical guidance and coordinates HTA activities with the MoH and regional authorities. AIFA (Agenzia Italiana del Farmaco), although primarily focused on pharmaceuticals, also contributes to companion diagnostic (CDx) evaluations and co-manages HTA processes under PNHTADM. At the regional and local levels, the Regioni (Regional Governments) are responsible for planning, financing, and delivering healthcare services, while the Local Health Authorities (ASL) manage funding decisions and service implementation. IRCCSs (Scientific Institutes for Research, Hospitalisation and Healthcare) are key centers for innovation, generating clinical evidence and piloting early access to novel diagnostics. Molecular Tumor Boards (MTBs), now mandatory, act as gatekeepers for NGS reimbursement and access to targeted therapies. Among non-governmental stakeholders, the Italian Association of Medical Oncology (AIOM) influences clinical guideline development, and patient advocacy groups such as AIMaC (Associazione Italiana Malati di Cancro, Parenti e Amici) are increasingly involved in access policy and innovation equity. The report also addresses system-wide challenges like fragmentation and delays, and provides strategic recommendations for diagnostic manufacturers, emphasizing the importance of evidence generation and collaborative engagement. Additionally, it contextualizes the Italian model within broader European healthcare frameworks and reflects on the growing cancer burden and related EU policy initiatives.
🎧 Listen: Navigating Italian Oncology – Access and Reimbursement for Diagnostics
