Efficacy and cost-effectiveness of anti-VEGF treatments for age-related macular degeneration (AMD).

Abstract

Purpose: To study the efficacy and cost-effectiveness of therapy with intravitreal ranibizumab (IVR) and bevacizumab (IVB) in exudative AMD.

Methods: The study was composed by a cost-effectiveness analysis and a prospective randomized clinical trial (RCT) comparing the efficacy of IVR and IVB as therapy for wet-AMD. The cost-effectiveness analysis compared the 2 drugs under the Brazilian Universal Health System with a time horizon of one year. It was calculated the “Quality adjusted life years” (QALY) and the Incremental cost-effectiveness ratio (ICER), according to utility values for VA changes in patients with AMD. For the RCT, forty-five patients with exudative-AMD were randomized (1:1:1) in 3 groups: monthly 1.25mg IVB, every-two-weeks 1.25mg IVB, and monthly 0.5mg IVR. All patients received 3 months loading dose, followed with as-needed regimen. Patients were followed for 1 year.

Results: Based on the ICER, it would be necessary R$941,583.33 (~USD410K) to have one additional QALY when comparing IVR and IVB. Similar results were found when analyzed different treatment strategies. From the 45 patients included in the RCT, 44 have concluded the first year of follow-up. One patient died due to pneumonia. The average initial VA was 52.2, 51.1, and 54.9 ETDRS letters in groups 1, 2, and 3 respectively (p=0.816). At month 12, the average VA increased 7.2, 13.4, and 12.3 ETDRS letters in groups 1, 2, and 3 respectively (Group 1: p=0.054; Group 2: p=0.008; Group 3: p=0.002). This increase in VA was statistically similar among groups (p=0.602). The mean number of injections was 10.5, 16.4, 10.6 in groups 1, 2, and 3 respectively (Group 1 vs. 2: p=0.003; Group 2 vs. 3: p=0.003; Group 1 vs. 3: p=0.980). No significant IOP variation was observed and only 1 eye developed cataract over one year. There was a low rate of ocular and/or systemic adverse events in groups 1 and 2 and no adverse event was seen in group 3. Important design issues for this clinical trial include use of cost-effectiveness as outcome and an every-two-weeks group.

Conclusions: The efficacy of IVB may be comparable to IVR in the therapy of exudative AMD.

Keywords: 412 age-related macular degeneration • 453 choroid: neovascularization • 688 retina