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

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.