Budget Impact Analysis (BIA) negli antiemicranici a somministrazione domiciliare: esempio di analisi integrata dei dati tra ospedale e territorio al fine di ottimizzare i modelli prescrittivi

Introduction. The introduction of anti-CGRP monoclonal antibodies has marked a significant shift in the therapeutic landscape of migraine, affecting both specialized care and territorial management. The objective of this study was to conduct a budget impact analysis (BIA) of galcanezumab, fremanezumab, and erenumab to evaluate the impact on healthcare resource utilization in scenarios with and without the use of anti-migraine monoclonal antibodies. Materials and methods. The analysis included patients treated at a Local Health Authority in the Abruzzo region, naïve to treatment, during the period between January 1, 2023, and January 31, 2025, undergoing therapy with anti-migraine drugs classified as calcitonin gene-related peptide antagonists (ATC codes N02CD01, N02CD02, and N02CD03). All ATC-classified drugs dispensed to these patients within 60 days prior to starting monoclonal antibody therapy and within 60 days following the end of therapy were analyzed. The impact on drug consumption was calculated using Defined Daily Doses (DDD). A BIA model was developed considering two main scenarios: one based on median persistence, reflecting the median treatment duration for each monoclonal antibody, relative to the actual number of treated patients; the other based on a full annual treatment cycle for a single patient. Results. A total of 64 patients were eligible for analysis: 11 treated with erenumab, 32 with fremanezumab, and 21 with galcanezumab. In the postantibody period, a reduction in overall net expenditure of € 968 (-20,5%) was observed. Overall, DDD increased by 1.8%. The number of patients continuing to use other medications decreased by 7,8%. The comprehensive BIA highlighted a savings in territorial drug costs: in the “World without monoclonal antibodies” the total cost was estimated at € 28.735,00, whereas in the “Worlds with monoclonal antibodies” this cost decreased to € 15.671,00. However, the direct cost of the new treatments led to an overall increase in corporate pharmaceutical expenditure of € 393.536,96. The analysis of a one-year treatment cycle for a single patient showed direct costs of € 8.248,38 for erenumab, € 9.139,63 for fremanezumab, and € 9.348,89 for galcanezumab. Regarding territorial drug costs, the estimated expense in the “World without monoclonal antibodies” was € 448,98, while in the “Worlds with monoclonal antibodies”, the residual costs were € 468,15 for erenumab, € 377,14 for fremanezumab, and €267,95 for galcanezumab. Conclusions. In the analyzed context, monoclonal antibodies are associated with a significant reduction in the use of several categories of symptomatic drugs, suggesting greater efficacy and a rationalizing effect on therapeutic pathways. However, the direct cost of these new therapies leads to an overall increase in expenditure, requiring careful consideration of their economic sustainability.