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Diabetes Type 2 Diabetes

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Mortality
Even with the improvements in diabetes control and patient care, Type 2 diabetes is associated with a higher risk of death than the general population. For the current modelling analysis, the relative risk (RR) of death was estimated to be 2.45 for patients with DME and this was estimated based on the results from two studies. Mulnier et al. reported a RR of 1.93 (95%:CI: 1.89 to 1.97) for diabetic patients when compared to the general population.23 In the second study, Hirai et al., determined that the RR of death in diabetic patients with clinically significant macular edema was 1.27 (95%CI: 1.01 to 1.61).24 By combining the two estimates, the overall RR of mortality used in the model was 2.45 (i.e. 1.93 x 1.27).

Valuation of …show more content…

Therefore, patients QOL will likely improve if moderate vision loss is reversed, which will contribute towards greater patient independence and QOL. Health state utilities were not collected during the FAME studies. Therefore, the model used utilities that were reported in the published, peer-reviewed literature. In a study by Brown et al., VA related utilities were derived from a sample of 72 patients from the United States with age-related macular degeneration (AMD) patients using the time trade-off (TTO) technique.29 Most patients (77.8%) had edema (primarily wet AMD), which is clinically like DME (as a result, this was the utility source selected for the base case analysis in the model). In contrast, another report by Brown et al., derived utilities based on a mix of patients with various eye diseases, with only a small proportion having macular edema.30 Other sources of utility data identified in the literature include Czoski-Murray et al.31 and Heintz et al.32. This utility estimates from studies were used in the sensitivity analysis and made available for easy application in the final submitted model. As the Brown et al.29 study did not report utilities associated with BCVA between the range of BCVA35 and BCVA50, the un-weighted average utilities above and below this range of BCVA have been applied (Table 6).

Table 6. Utilities for BCVA health states applied in the model base case analysis.
BCVA Health States
ETDRS

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