Abstract / Summary
Multiple sclerosis (MS) is a chronic and progressively disabling neurological disease associated with a substantial clinical and socioeconomic burden. The introduction of an increasing number of new innovative therapies has further intensified concerns regarding the long-term sustainability for the Italian National Healthcare Service (NHS). Despite substantial therapeutic progress in MS management, with several treatments available for most MS patient populations, no definitive cure is currently available, and a critical therapeutic gap persists for non-relapsing secondary progressive MS (NR-SPMS), for which no approved treatments are specifically indicated. The objective of the present research is to estimate the Italian NHS expenditure for MS disease-modifying therapies (DMTs) between 2025 and 2029. Building on a published horizon-scanning model (i.e., Oracle), this study updates projections of expenditure and treatment patterns for MS DMTs through 2029, integrating clinical inputs (i.e., treated patients, patient shares for each reimbursed therapy) with economic inputs (i.e., annual therapy costs). Assumptions and input data were derived from IQVIA® proprietary databases and informed by clinical and pharmacoeconomic expert inputs. Results were validated in a multi-stakeholder roundtable. This study shows that the number of treated patients is projected to rise to about 77,000 by 2029, i.e., approximately + 10% from 2024. Traditional platform therapies are projected to decrease by more than ten percentage points between 2024 and 2029, reflecting a shift toward high-efficacy and innovative therapies. New options include Bruton’s tyrosine kinase (BTK) inhibitors (e.g., tolebrutinib, fenebrutinib, remibrutinib), projected to reach approximately 16% patient share within 3 years of first launch. Despite higher patient volumes and new launches, total DMT expenditure is expected to decline from €784 million in 2024 to €622 million in 2029, mainly driven by losses of exclusivity and price renegotiations. Results support the sustainability of the NHS and the reallocation of resources toward innovation, including innovative therapies for currently underserved populations such as NR-SPMS.