Asthma is one of the most common non-communicable respiratory diseases, affecting about 6% of the general population. Severe asthma, even if afflicts a minority of asthmatics, drives the majority of costs of the disease. The aim of this study is to create a pharmacoeconomic model to predict the costs of corticosteroid-related adverse events in severe asthmatics and applying it to the first published epidemiologic data from the Severe Asthma Network in Italy (SANI) registry. The analysis was conducted from the perspective of the Italian National Healthcare System (INHS). Model inputs, derived from literature, included: asthma epidemiology data, frequency of adverse events, percentage of severe asthma treated with OCS and adverse event cost (Diagnosis-Related Group (DRG) national tariffs). We estimated costs per different patient groups: non-asthma controls, mild/moderate and severe asthmatics. Final results report estimated direct cost per patient and total direct cost for overall target population, showing economic impact related to corticosteroid complication. Based on epidemiological data input, in Italy, asthmatic subjects resulted about 3,999,600, of which 199,980 with severe asthma. The number of patients with severe asthma OCS-treated was estimated at 123,988. Compared to the non-asthma control cohort and to that with moderate asthma annual cost per severe asthmatic patient resulted respectively about €892 and €606 higher, showing a corticosteroids shadow cost ranging from 45% to 30%.Applying the cost per patient to the target population identified for Italy, the budget impact model estimated a total annual cost related to OCS-related adverse events of €242.7 million for severe asthmatics. In respect with non-asthmatic and moderate population, an incremental expenditure of about € 110.6 million and €75.2, respectively, were shown. Our study provides the first estimates of additional healthcare costs related to corticosteroid induced adverse events in severe asthma patient. Budget impact model results highlighted the relevant economic impact of OCS-related adverse events in severe asthma patients. The future extrapolation of additional data from SANI registry will support the development of a model to investigate the role of corticosteroids sparing drugs.

Introduction: Type 2 diabetes mellitus (T2DM) is a common chronic disease with management, associated with cardiovascular and renal comorbidities. In January 2022, AIFA Note 100 extended prescribing authority for innovative antidiabetic drugs (SGLT-2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors) to General Practitioners, influencing treatment patterns and management of high-risk patients.Methods: A retrospective observational analysis used administrative data from two Local Health Authorities in Italy, comparing three cohorts: Pre-COVID (2018), COVID (2020-2021), and Post-Note 100 (February 1, 2022 to January 31, 2023). Adults (≥18 years) with at least one prescription of non-insulin glucose-lowering drugs (ATC A10B) were included. Profiles were described, focusing on acarbose, DPP-4 inhibitors, metformin, pioglitazone, SGLT-2 inhibitors, GLP-1 receptor agonists, and sulfonylureas. Clinical characteristics included comorbidities, heart failure, hypertension, and chronic kidney disease. Healthcare costs (pharmaceuticals, outpatient specialist care, and hospitalizations) were analyzed.Results: Over 140,000 subjects were included. In the Post–Note 100 phase, GLP-1 receptor agonists and SGLT-2 inhibitors increased among new users (GLP-1 receptor agonists: 1.2% to 9.3%; SGLT-2 inhibitors: 2.6% to 14.1%) and among prevalent users, with a reduction in sulfonylureas and a decline in metformin monotherapy. Among patients with ≥ 2 comorbidities, SGLT-2 inhibitors became the most prescribed class. Use rose in heart failure, while both GLP-1 receptor agonists and SGLT-2 inhibitors increased in chronic kidney disease.Conclusions: Expansion of prescribing eligibility introduced by AIFA Note 100 led to a shift toward innovative therapies, aligning prescribing with guidelines, particularly in comorbid patients. Real-world data highlight the impact and support the evaluation of long-term outcomes.