Eyeworld

121 EW RETINA September 2016 diabetic retinopathy in particular," said Kakarla Chalam, MD, Jackson- ville, Florida. "Maybe because of its patho- physiology, OCT-angiography can detect non-proliferative diabetic retinopathy (NPDR) before there are clinical signs," he said. Dilsher Dhoot, MD, Santa Bar- bara, California, analyzed data from VIVID and VISTA, the pivotal studies on aflibercept, and found people with worse baseline diabetic reti- nopathy severity scores (DRSS) had a greater probability of two-step DRSS improvement at 100 weeks. This made sense as "those with the worse scores had the most room to improve." Interestingly, other baseline systemic characteristics associated with higher probability of diabetic retinopathy, such as duration of diabetes and systemic glycemic control, were less useful predictors. Physicians are also anticipating a greater understanding of disease pathophysiology and treatment outcomes in patients with good baseline vision once the Diabetic Retinopathy Clinical Research Net- work's Protocol W is finalized. Neil Bressler, MD, Baltimore, noted that the most cost effective of the anti-VEGF intravitreal drugs, bevacizumab, costs only $60 per injection, while its competitors aflibercept and ranibizumab cost almost 200-fold more, at $1,850 and $1,170 per injection, respectively. "We know all three are generally effective and safe," he said, "but that differences in outcomes are deter- mined by baseline vision," with the two on-label drugs performing much better than bevacizumab. However, cost effectiveness is determined by the incremental cost-effectiveness ratio, where the additional cost for a drug is balanced by the perceived health benefits. In general, less than $50,000 is considered a "good buy" while anything more than $250,000 is not considered a worthwhile investment. "If we use bevacizumab as the baseline, ranibizumab comes out with an ICER of $817,000, and af- libercept with an ICER of $287,000," he said, adding ranibizumab and aflibercept would need to cut costs per injection by 84% and 62%, respectively, to be considered cost effective. "This highlights the challenges of better efficacy and safety be- ing weighed against pricing," Dr. Bressler said. There is a "paucity of data" on how datasets from DME clinical trials can be used in the real world, said Nathan Steinle, MD, Bakers- field, California. For instance, in a retrospective review of his own patient data from 2007 to 2014 (N=237; he limited his analysis to those patients with at least 2 con- secutive years of follow-up), 21% (n=49) had baseline vision of 20/20 and 5% (n=12) had a baseline vision of 20/400 or worse. "The pivotal studies exclude these two groups of patients," he said, which makes it difficult to in- terpret the results appropriately. The real-world reality is that the majority of patients will present with baseline vision between 20/50 and 20/320 on Snellen (bearing in mind the trials also use the ETDRS letter scale, not Snellen). In his analysis, the mean num- ber of injections in year 1 was seven, which dropped to four in year 2. The majority of patients were treated with either bevacizumab or ranibi- zumab, with only 12% treated with aflibercept. "Almost 60% of the patients remain on the same agent," he said, noting he follows OCT to guide treatment. EW Editors' note: Dr. Ciulla has finan- cial interests with Ophthotech (New York). Dr. Kiss has financial interests with Neurotech. Dr. Chalam has no related financial interests. Dr. Dhoot has financial interests with Genentech (South San Francisco) and Regeneron (Tarrytown, New York). Dr. Bressler has financial interests with Bayer (Leverkusen, Germany), Genentech, and Regeneron. Dr. Steinle has no related financial interests. Contact information Bressler: nbressler@jhmi.edu Chalam: kvchalam@aol.com Ciulla: thomasciulla@gmail.com Dhoot: ddhoot@yahoo.com Kiss: anm2135@med.cornell.edu Steinle: nathansteinle@hotmail.com

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