Innovation and sustainability in immune-mediated diseases: An Italian multidisciplinary consensus across gastroenterology, dermatology, and rheumatology.

BACKGROUND

Advanced therapies (ADTs) have transformed the management of chronic immune-mediated inflammatory diseases (IMIDs) across gastroenterology, dermatology, and rheumatology. Their growing use pressures universal, regionalized systems such as the Italian National Health System, challenging sustainability, equitable access, and integration of innovation. To address these challenges, an interdisciplinary Italian consortium (Latium Net) developed consensus-based recommendations on sustainability and innovation in IMIDs care.

METHODS

Three-phases: (1) targeted literature review; (2) round-table discussions involving clinicians, pharmacists, administrators, and patient-representatives, then a modified Delphi survey with iterative voting and refinement; (3) final discussion and approval (consensus: ≥80% agreement on a 5-point Likert-scale).

RESULTS

After three Delphi-rounds, 31 of 37 preliminary statements achieved consensus. Recommendations addressed: cross-stakeholder responsibilities within a regional system; sustainability indicators (biosimilar uptake, persistence, hospitalization rates, PROs/PREMs, direct and indirect costs); criteria for innovation and timely drug availability; and multidisciplinary management for complex IMID patients. Emphasis was placed on biosimilar adoption in biologic-naïve patients, harmonized data collection, and mitigating regional inequalities in access to therapies, key issues in the decentralized Italian SSN.

CONCLUSIONS

This consensus provides a pragmatic multidisciplinary framework to guide sustainable, innovative ADT use in IMIDs, supporting equitable access, optimized resource allocation, and long-term healthcare sustainability within regionalized health systems.