Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema (DME) causing visual impairment: evidence from the RESTORE trial

Background/aims To evaluate the cost-effectiveness of ranibizumab as either monotherapy or combined with laser therapy, compared with laser monotherapy, in the treatment of diabetic macular oedema (DME) causing visual impairment from a UK healthcare payer perspective. Methods A Markov model simulated long-term outcomes and costs of treating DME in one eye (BCVA <= 5 letters) based on data from the RESTORE Phase III trial. Outcomes measured in quality-adjusted life-years (QALYs) were simulated for a 15-year time horizon based on 12-month follow-up from RESTORE and published long-term data. Costs included treatment, disease monitoring, visual impairment and blindness (at 2010 price levels). Results Ranibizumab monotherapy resulted in a 0.17 QALY gain at an incremental cost of 4191 pound relative to laser monotherapy, yielding an incremental cost-effectiveness ratio (ICER) of 24 pound 028. Probabilistic sensitivity analysis showed a 64% probability of being cost-effective at a threshold of 30 pound 000 per QALY. Combined ranibizumab and laser therapy resulted in a 0.13 QALY gain at an incremental cost of 4695 pound relative to laser monotherapy (ICER 36 pound 106; 42% probability of ICER <30 pound 000). Conclusions Based on RESTORE 1-year follow-up data, ranibizumab monotherapy appears to be cost-effective relative to laser monotherapy, the current standard of care. Cost-effectiveness of combination therapy is less certain. Ongoing studies will further inform on disease progression and the need for additional ranibizumab treatment.