ArticleGlobal & regional health technology assessment
Impact of AIFA Note 100 on innovative antidiabetic prescribing eligibility in two Italian local health authorities: drug utilization and patient characteristics.
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Abstract
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.
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