gms | German Medical Science

Background:

• In treating center-involving diabetic macular edema (DME), patients require intensive treatment with intravitreal anti-VEGF compounds, yet a relevant proportion of patients experience an insufficient response.
• In such cases, therapeutic options include corticosteroid implants, which include the longer-acting fluocinolone acetonide (FAc) implant or the shorter-acting dexamethasone implant.
• Based on a cost-cost model and a systematic literature review (SLR) the effectiveness and cost of treatments after initiation of anti-VEGF treatment was assessed.

Methods:

• In 2020 a short-term cost-effectiveness model with a three-year time frame was designed to facilitate a comparative analysis of available DME second line treatments, including ranibizumab (Lucentis^®), aflibercept (Eylea^®), FAc implant (ILUVIEN^®), and dexamethasone implant (OZURDEX^®).
• The model includes drug costs, injection and optical coherence tomography (OCT) costs, and adverse event management costs.
• Effectiveness was based on a systematic literature review (SLR) of randomized controlled trials (RCT). As current German DME guidelines recommend 6 initial anti-VEGF injections (=first line), authors derived for second year 6 injections second line (based on the calculation 12 max. per year – 6 first line). A switch is recommended early, according to EU Guidelines after 3 – 6 months, to avoid irreversible retinal damage due to long-standing DME.
• The values used for the calculation were updated to 2024.

Results: Over three years, second-line DME treatment costs for an average German patient were: 14,806 € (ranibizumab), 13,322 € (aflibercept), 12,244 € (FAc implant), and 12,629 € (dexamethasone implant). In all treatment scenarios, drug costs were the largest expense, followed by injection costs (varied by drug) and OCT costs. Sensitivity analyses showed that costs remained stable as inputs changed. Because of the heterogeneous study populations after first-line anti-VEGF treatment, comparative efficacy could not be assessed. Total costs peaked in the first year and declined in years 2 and 3.

Conclusion: In summary, the 3-year cost comparison shows substantial cost savings with delayed-release corticosteroid implants compared with intravitreal anti-VEGF treatment for DME. The single use of an FAc implant is the most cost-effective of the approved DME injection therapies, saving up to 17% or 2,562 € per treated eye while reducing patient burden from injections.