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Adnan Tufail, Cecilia S Lee, Aaron Lee, Catherine A Egan, Dawn A Sim, Robert Johnston, Thomas Butt, UK AMD EMR Users Group; Ranibizumab Therapy for Neovascular AMD in eyes with good vision (>6/12): visual outcomes and cost-effectiveness based on real world outcomes of 92,976 treatment episodes. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5365.
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© ARVO (1962-2015); The Authors (2016-present)
Outcomes of eyes with good vision (>6/12, >70 ETDRS letters) were not evaluated in the pivotal trials for ranibizumab. We evaluated the effectiveness, and cost-effectiveness of treatment with ranibizumab in patients with neovascular AMD (nAMD) with good starting visual acuity using real-world outcomes data.
Anonymised structured data were collected from 14 centers using an EMR system. The primary outcome was the mean VA at year 1, 2, and 3. Secondary measures included the number of clinic visits and injections. A patient-level health economic state transition model based on levels of visual acuity in the better seeing eye was constructed to simulate the costs and consequences of treating nAMD patients. In the model two treatment approaches were compared: immediate intervention with ranibizumab PRN (on detection of nAMD) or delayed intervention (wait until vision fell to 6/12 before beginning treatment).
The study included 12,951 treatment-naive eyes of 11,135 patients receiving 92,976 ranibizumab treatments. A total of 754 patients had baseline VA better than 6/12 and at least one-year of follow up. Mean VA of first treated eyes with baseline VA > 6/12 at year 1, 2, 3 were 6/10, 6/12, 6/15, respectively and those with baseline VA 6/12 to > 6/24 were 6/15, 6/17, 6/20, respectively (p-values <0.001 for comparing differences between 6/12 and 6/12-6/24 groups). For the second eyes with baseline VA > 6/12, mean VA at year 1, 2, 3 were 6/9, 6/9, 6/10, and those with baseline VA 6/12 to > 6/24 were 6/15, 6/15, 6/27, respectively (p-values <0.001-0.005). There was no significant difference in average number of clinic visits or injections between those with VA better or worse than 6/12. Over a two-year time horizon, based on 10,000 Monte Carlo simulations, the early treatment arm accumulated 1.59 QALYs and £8,469.79 cost. The delayed treatment arm accumulated 1.35 QALYs and £7,460.21 cost. The ICER was £4,251.60.
Eyes with baseline VA > 6/12 maintained better mean VA than the eyes with baseline VA 6/12 to > 6/24 at all time points for at least 2 years. An economic model based on real-world data is likely to be a realistic reflection of the health gains and resource use of ranibizumab for nAMD. Initiating treatment immediately in eyes with good vision with ranibizumab is a cost effective strategy.
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