The DM77 and Rare Diseases: Analysis of Regional Legislation in Italy
Author(s)
Andrea Marcellusi, PhD, Martina Managò, Master Degree, sara manellari, Master Degree.
University of Milan, Milano, Italy.
University of Milan, Milano, Italy.
OBJECTIVES: Ministerial Decree 77/2022 redefined community healthcare within the Italian National Health Service, promoting innovative organizational models for patient management, including for individuals affected by rare diseases. These conditions require continuity of care and multiprofessional integration—key elements in the architecture of DM77.
METHODS: A systematic review was conducted on regional legislation and healthcare planning acts issued by Italian Regions and Autonomous Provinces between 2022 and 2025.
The search strategy included a query dedicated to rare diseases, later refined to extract only regional regulatory documents. A time filter was applied to include only documents published from the entry into force of DM77 up to 2025. In total, 679 official resolutions were analyzed.
RESULTS: A total of 36 documents were identified as addressing both DM77 and rare diseases. The analysis revealed strong heterogeneity among Regions. Some developed specific care pathways, integrating rare diseases into local health networks through Community Health Centers (Case della Comunità), multidisciplinary teams, and home care services.
In Campania, 12 referral centers for specific rare diseases or disease groups and 6 centers of excellence were identified; the regional framework also defined the organizational structure based on the hub-and-spoke model and care pathways for individuals with rare conditions. A similar approach was adopted by the Piedmont Region.
Other Regions made only formal references to rare diseases, without operational measures. Innovative regional experiences were also recorded, such as early management models introduced in Lombardy.
This variability reflects divergent approaches to healthcare planning and different stages of DM77 implementation at the regional level.
CONCLUSIONS: This analysis represents the first national mapping of the integration between DM77 and rare diseases, highlighting the need for interregional coordination and systematic monitoring to ensure equity and quality of care across the country.
METHODS: A systematic review was conducted on regional legislation and healthcare planning acts issued by Italian Regions and Autonomous Provinces between 2022 and 2025.
The search strategy included a query dedicated to rare diseases, later refined to extract only regional regulatory documents. A time filter was applied to include only documents published from the entry into force of DM77 up to 2025. In total, 679 official resolutions were analyzed.
RESULTS: A total of 36 documents were identified as addressing both DM77 and rare diseases. The analysis revealed strong heterogeneity among Regions. Some developed specific care pathways, integrating rare diseases into local health networks through Community Health Centers (Case della Comunità), multidisciplinary teams, and home care services.
In Campania, 12 referral centers for specific rare diseases or disease groups and 6 centers of excellence were identified; the regional framework also defined the organizational structure based on the hub-and-spoke model and care pathways for individuals with rare conditions. A similar approach was adopted by the Piedmont Region.
Other Regions made only formal references to rare diseases, without operational measures. Innovative regional experiences were also recorded, such as early management models introduced in Lombardy.
This variability reflects divergent approaches to healthcare planning and different stages of DM77 implementation at the regional level.
CONCLUSIONS: This analysis represents the first national mapping of the integration between DM77 and rare diseases, highlighting the need for interregional coordination and systematic monitoring to ensure equity and quality of care across the country.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HSD106
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Disease
Rare & Orphan Diseases