journal articles
EQUITY AND BUDGET CHALLENGES ASSOCIATED WITH THE EMPLOYMENT OF ANTI-AMYLOID MONOCLONAL ANTIBODIES FOR EARLY ALZHEIMER’S DISEASE IN ITALY: A SCENARIO ANALYSIS
Maurizio Giorelli, Pasquale Di Fazio, Tiziana Dimatteo
J Aging Res & Lifestyle 2026;15
BACKGROUND: Anti-amyloid monoclonal antibodies (lecanemab and donanemab) represent the first disease-modifying therapies for early symptomatic Alzheimer's disease (AD)- Italy's National Health Service (SSN) must determine whether to include these therapies within Essential Levels of Care (LEA), requiring reimbursement across all regions.
OBJECTIVE: To conduct a three-year budget impact analysis and implementation feasibility assessment for anti-amyloid therapies in Italy. The analysis was scenario-based rather than empirical.
METHODS: Deterministic budget modeling, combined with Proctor's 8-Domain Implementation Outcomes Framework and the Consolidated Framework for Implementation Research (CFIR), was employed. Four implementation scenarios were modeled based on cumulative patient uptake rates. Cost analysis incorporated diagnostic pathways, drug acquisition, clinical surveillance, and management of amyloid-related imaging abnormalities (ARIA). Infrastructure capacity was assessed through national survey data of Centers for Cognitive Disorders and Dementia (CCDDs).
RESULTS: An estimated 42,000 patients in Italy are potentially eligible for anti-amyloid therapy. The moderate scenario (5–10–15% uptake over three years, reaching 14,100 cumulative patients) represents the optimal policy target, with estimated three-year total costs of €557.3 million (0.4% of the annual SSN budget), penetration of 33.6% of eligible patients, and a feasibility score of 1.5, underscoring a high implementation success probability. The moderate scenario remains financially sustainable but requires targeted infrastructure investment in the Central and Southern regions.
CONCLUSIONS: Anti-amyloid therapy implementation is feasible within Italian healthcare system constraints under a moderate uptake scenario. However, achievement of equitable access requires substantial capacity building in underserved regions, clarified reimbursement policies, integrated diagnostic networks, and robust workforce planning before full LEA inclusion is recommended.
CITATION:
Maurizio Giorelli ; Pasquale Di Fazio ; Tiziana Dimatteo (2025): Equity and budget challenges associated with the employment of anti-amyloid monoclonal antibodies for early Alzheimer’s Disease in Italy: A scenario analysis. The Journal of Aging and Lifestyle (JARLife). https://doi.org/10.1016/j.jarlif.2026.100076