Immune-Mediated Inflammatory Diseases (IMIDs) and the Sustainability of Care

Sustaining care for chronic IMIDs, including inflammatory bowel disease (IBD), psoriasis, and rheumatoid arthritis, requires coordinated governance across all stakeholders in the healthcare system.

This issue is particularly relevant in Italy: The regionalized structure of the National Health Service (NHS) leads to interregional disparities in access to biologics, biosimilars, and small-molecule drugs, with potential implications for treatment pathways and clinical outcomes for patients with similar needs but residing in different regions.

The interdisciplinary Italian consortium (Latium Net) — a network in Lazio of centers authorized to prescribe biologics for IBD, later expanded to include dermatologists and rheumatologists — has developed consensus-based recommendations to guide the responsible use of advanced treatments for IMIDs, balancing innovation, clinical appropriateness, and economic sustainability. Franco Scaldaferri, MD, PhD, of the Department of Internal Medicine and Gastroenterology Division at the Catholic University of the Sacred Heart, Faculty of Medicine and Surgery, Rome, Italy, is the first author of the study and helped oversee the work, which is about to go to press in Digestive and Liver Disease.

Three Rounds of Voting on 31 Recommendations

The recommendations were developed in three stages: a literature review that narrowed 490 studies to 102, in-person meetings with 50 experts, and a modified Delphi process carried out over three rounds of anonymous voting, with consensus defined as at least 80% agreement. The panel brought together gastroenterologists, dermatologists, rheumatologists, health economics and health technology assessment experts, bioethics and policy specialists, hospital pharmacists, an administrator, and a patient representative.

Of the 37 draft statements, 31 reached consensus. Biosimilars emerged as a major focus: The panel said that, at a system level, biosimilar use should account for more than 75% of all prescriptions for a given molecule (81% agreement). They also recommended tracking the share of biosimilar prescriptions among biologic-naive patients (93% agreement). In addition, once a biosimilar becomes available, all new prescriptions should generally begin with the biosimilar, with exceptions handled on a case-by-case basis for specific clinical situations (86% agreement).

The panel also unanimously (100%) recognized drug availability and access times as key indicators of the system’s capacity for innovation. Among other recommendations were making new therapies available within 1 month of approval by the national health authority (93% agreement); establishing a dedicated budget for patients with multiple immune-mediated comorbidities requiring multidisciplinary management (93% agreement); and systematically monitoring patient-reported outcomes and experience measures, along with the frequency with which patients, after switching to a biosimilar, revert to using the original biologic (switchback rates to the originator). The authors note that in Italy, the median time to reimbursement following approval by the European Medicines Agency is approximately 7.6 months.

Among the study’s limitations were the panel’s largely single-region composition, which may limit how broadly the findings can be applied geographically, and the drop in participation across the Delphi rounds, with the number of panelists declining from 46 in the first round to 39 in the third.

A Guide for Physicians and the NHS

The authors conclude that the recommendations “aim to reconcile therapeutic innovation with equitable access and a sustainable allocation of resources within Italy’s regionalized healthcare system, while also offering general principles useful to other federal or decentralized healthcare systems facing similar challenges.”

For clinicians and primary care physicians, the document specifically recommends initiating new prescriptions with biosimilars, except in specific clinical exceptions evaluated on a case-by-case basis, and monitoring the rate of use among biologic-naive patients; establishing early multidisciplinary care pathways in the presence of overlapping immune-mediated comorbidities; and strengthening the standardized collection of real-world data, including direct and indirect costs and measures of patient experience — measures that could help reduce interregional disparities in access to advanced therapies, a well-documented structural issue within the NHS.

This story was translated from Univadis Italy, part of the Medscape Professional Network.