Impact of AIFA Note 100 on innovative antidiabetic prescribing eligibility in two Italian local health authorities: drug utilization and patient characteristics.

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.