Key model inputs and assumptions
Time period | Model input | Combination therapy | Ranibizumab monotherapy | Laser monotherapy | Source |
Year 1 | BCVA progression | RESTORE trial data, adjusted for drop-out rates | RESTORE trial data, adjusted for drop-out rates | RESTORE trial data, adjusted for drop-out rates | RESTORE data on file |
Treatment frequency | 7 injections + 2 laser sessions, as in RESTORE; drop-outs continue in standard care (ie, laser therapy) | 7 injections; drop-outs continue in standard care (ie, laser therapy) | 2 laser sessions; drop-outs continue in standard care (ie, laser therapy) | RESTORE data on file | |
Monitoring visits | 12 | 12 | 4 | SmPC and expert interview (data on file) | |
Adverse events | Negligible | Negligible | Negligible | RESTORE data on file | |
Year 2 | BCVA progression | Equal rates of improvement and worsening (3% in 3 months) | Equal rates of improvement and worsening (3% in 3 months) | Equal rates of improvement and worsening (3% in 3 months) | Supported by DRCR.net and RESTORE data on file |
Treatment frequency | 2 injections + 1 laser session | 3 injections (no laser) | 1 laser session | Supported by DRCR.net | |
Monitoring visits | 8 | 10 | 4 | Assumption | |
Year 3 | BCVA progression | Constant rates of change of BCVA with a majority of patients having a decline in BCVA | Constant rates of change of BCVA with a majority of patients having a decline in BCVA | Constant rates of change of BCVA with a majority of patients having a decline in BCVA | Calibrated to WESDR data (Supplementary Methods) |
Treatment frequency | No additional ranibizumab; laser therapy as required | No additional ranibizumab; laser therapy as required | Laser therapy as required | Assumption | |
Monitoring visits | 4 | 4 | 4 | Assumption | |
Any year | Cost of blindness | When BCVA ≤35 letters is reached in better-seeing eye | When BCVA ≤35 letters is reached in better-seeing eye | When BCVA ≤35 letters is reached in better-seeing eye | Adapted from costing approach by Meads et al16 (Supplementary table 2) |
Patient-level changes in BCVA data in RESTORE were used to derive transition probabilities in year 1.
After year 1, long-term changes in BCVA were simulated assuming categorisation into one of three possible outcomes: ≥10 letters improvement within 3 months (one health state up), ≥10 letters worsening within 3 months (one health state down) or no change exceeding 10 letters within 3 months.
BCVA, best corrected visual acuity; DRCR, Diabetic Retinopathy Clinical Research Network; SmPC, summary of product characteristics; WESDR, Wisconsin Epidemiologic Study of Diabetic Retinopathy.