Clinical research, funded by the US National Eye Institute (NEI), and led by a broad consortium of ophthalmology experts at 66 clinical / academic sites across the US, has concluded that, in terms of visual acuity after 6 months, treatment of central retinal or hemi-retinal vein occlusion (CRVO / HRVO) with bevacizumab (Avastin) is non-inferior to aflibercept (Eylea) treatment. The finding represents a significant result for clinicians and patients given the enormous difference in cost between the two treatments – $60 per dose for Avastin, compared to $1,850/dose for Eylea. Longer term follow up on patients will be required to establish if any differences emerge over the longer time frames generally required in the clinical management of CRVO and HRVO.
The objective of the comparative randomized study was to investigate whether Avastin was non-inferior to Eylea for the treatment of macular edema secondary to central retinal or hemi-retinal vein occlusion. The randomized study included 362 patients with macular edema due to CRVO or HRVO, randomized 1:1 to either Avastin (1.25mg; n = 182) or Eylea (2.0mg; n = 180), every 4 weeks until the primary endpoint at 6 months. Researchers evaluated the mean change in visual acuity (VA) letter score (VALS) from the initial clinical visit to the 6 month follow-up visit. The results showed that the mean VALS was 69.3 (a mean increase from baseline of 18.6) in the bevacizumab group and 69.3 (a mean increase from baseline of 18.9) in the aflibercept group (P = .001), indicating non-inferiority between the two treatments. As retinal vein occlusion is the most common retinal vascular disease after diabetic retinopathy, the implications for healthcare budgets could be enormous however, Avastin is not approved for any ocular disorder and is only used off-label, while Eylea is approved for the treatment of macular edema due to CRVO, in addition to other retinal disease indications. A remaining critical question, given the continuing treatment required for such patients, is whether or not the results with Avastin can be maintained over years 1, 2 and beyond, typical of the treatment regimens required in clinical practice.
In an accompanying editorial in JAMA Ophthalmology, Neil M. Bressler, MD, current editor-in-chief of the journal commented, “[G]iven that aflibercept is substantially more expensive than bevacizumab as administered in this trial (mean of 5.8 injections over 6 months), no formal cost-effectiveness analysis is needed to recognize that the incremental cost-effectiveness ratio of aflibercept relative to repackaged bevacizumab would not be within the range of $50 000 to $150 000 per quality-adjusted life-year frequently cited as cost-effective in the United States for treatment of eyes with macular edema from central retinal or hemiretinal vein occlusion.” In addition, the lead author and chair of the study, Ingrid U. Scott, M.D., M.P.H., Professor of Ophthalmology and Public Health Sciences at Penn State University, stated, “[T]his head-to-head comparison of two widely used drugs for treatment of macular edema due to central retinal vein occlusion shows that both are effective in improving vision. The bottom line is that in patients with CRVO-associated macular edema, Avastin was as effective as Eylea in terms of visual acuity after six months of treatment.”