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Introduction <p>Despite the availability of various anti-vascular endothelial growth factor (anti-VEGF) therapies for diabetic macular edema (DME), high treatment burden remains a significant issue in many European countries, including Italy. This burden impacts healthcare costs, clinic capacities, and patient adherence. Aflibercept 8&#xa0;mg was developed to reduce treatment burden by requiring only three monthly injections before allowing extended dosing intervals up to 6&#xa0;months, without compromising efficacy and safety. This analysis aimed to evaluate the efficacy, safety, and treatment burden of aflibercept 8&#xa0;mg regimens compared to other anti-VEGF options (aflibercept 2&#xa0;mg, ranibizumab 0.5&#xa0;mg, faricimab 6&#xa0;mg, brolucizumab 6&#xa0;mg, and bevacizumab 1.25&#xa0;mg) in Italy.</p> Methods <p>A systematic literature review identified randomised controlled trials of anti-VEGF therapies for DME with a 2-year follow-up. This informed a Bayesian network meta-analysis (NMA) assessing efficacy, safety, and treatment burden. A cost-minimisation analysis (CMA) was conducted from the perspective of the Italian National Health System over a 2-year horizon.</p> Results <p>The NMA, involving nine studies, showed no significant differences in best-corrected visual acuity, anatomical outcomes, and safety between aflibercept 8&#xa0;mg and the other anti-VEGF agents. Aflibercept 8&#xa0;mg required fewer injections than the comparators, with a mean of 9.3 injections over 2&#xa0;years for T&amp;E (Q12) and 8.4 for T&amp;E (Q16) regimens. Economically, aflibercept 8&#xa0;mg was the least costly licensed and reimbursed anti-VEGF in Italy.</p> Conclusion <p>Aflibercept 8&#xa0;mg may be the most advantageous anti-VEGF option for reducing treatment burden in Italian patients with DME, benefiting healthcare providers, clinics, and the healthcare system. Aflibercept 8&#xa0;mg offers comparable efficacy and safety to other anti-VEGF therapies, with fewer injections and potentially lower overall costs.</p>

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Use of Aflibercept 8 mg for the Treatment of Diabetic Macular Edema in Italy: A Cost-Minimisation Analysis Based on an Indirect Treatment Comparison

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月28日

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  • Paolo A. Cortesi,
  • Marwa Mezghani,
  • Mohammed Alshaikheid,
  • Izabella Lunk,
  • Mario Fazzi D’Orsi,
  • Monica Zurria,
  • Francesco Bandello

摘要

Introduction

Despite the availability of various anti-vascular endothelial growth factor (anti-VEGF) therapies for diabetic macular edema (DME), high treatment burden remains a significant issue in many European countries, including Italy. This burden impacts healthcare costs, clinic capacities, and patient adherence. Aflibercept 8 mg was developed to reduce treatment burden by requiring only three monthly injections before allowing extended dosing intervals up to 6 months, without compromising efficacy and safety. This analysis aimed to evaluate the efficacy, safety, and treatment burden of aflibercept 8 mg regimens compared to other anti-VEGF options (aflibercept 2 mg, ranibizumab 0.5 mg, faricimab 6 mg, brolucizumab 6 mg, and bevacizumab 1.25 mg) in Italy.

Methods

A systematic literature review identified randomised controlled trials of anti-VEGF therapies for DME with a 2-year follow-up. This informed a Bayesian network meta-analysis (NMA) assessing efficacy, safety, and treatment burden. A cost-minimisation analysis (CMA) was conducted from the perspective of the Italian National Health System over a 2-year horizon.

Results

The NMA, involving nine studies, showed no significant differences in best-corrected visual acuity, anatomical outcomes, and safety between aflibercept 8 mg and the other anti-VEGF agents. Aflibercept 8 mg required fewer injections than the comparators, with a mean of 9.3 injections over 2 years for T&E (Q12) and 8.4 for T&E (Q16) regimens. Economically, aflibercept 8 mg was the least costly licensed and reimbursed anti-VEGF in Italy.

Conclusion

Aflibercept 8 mg may be the most advantageous anti-VEGF option for reducing treatment burden in Italian patients with DME, benefiting healthcare providers, clinics, and the healthcare system. Aflibercept 8 mg offers comparable efficacy and safety to other anti-VEGF therapies, with fewer injections and potentially lower overall costs.