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Anti-VEGF monotherapy more cost-effective in treating diabetic macular edema
Ranibizumab monotherapy is more cost-effective than laser photocoagulation monotherapy to treat diabetic macular edema, according to a study, and the cost-effectiveness of combined therapy is uncertain.
“Our economic model, which was based on data from the RESTORE clinical trial, shows that ranibizumab monotherapy provides superior improvements in visual acuity and is cost-effective relative to the current standard of care, laser photocoagulation,” the study authors said.
The phase 3 RESTORE trial examined 345 patients 18 years of age or older with type 1 or type 2 diabetes mellitus and visual impairment due to diabetic macular edema (DME). Patients received Lucentis (ranibizumab, Genentech), laser treatment, or ranibizumab and laser treatment.
Upon completion of the trial, a Markov model was used to simulate the long-term outcomes and costs of treating DME in one eye. Data were based on 1-year RESTORE results and simulated to a 15-year time span.
The incremental cost-effectiveness ratio was expressed as the additional cost per quality-adjusted life year (QALY) gained by using one treatment over another treatment, the study said.
Compared with laser monotherapy, ranibizumab monotherapy had an incremental gain of 0.17 QALY and an incremental cost of £4,191, with an incremental cost-effectiveness ratio of £24,028 per QALY gained. Combination therapy compared with laser monotherapy had an incremental gain of 0.13 QALY and an incremental cost of approximately £4,695, with an incremental cost-effectiveness ratio of approximately £36,106 per QALY gained.
Perspective
Back to TopThe RESTORE trial utilized ranibizumab, with or without laser, in a PRN fashion similar to the Diabetic Retinopathy Clinical Research Network (DRCR.net) protocol 1 study. The 1-year results from both studies showed significantly greater visual acuity gains compared to laser treatment alone. Because the magnitude of the difference in these gains was great, it is not surprising that the authors found the ranibizumab arms to be more cost-effective over the long run, even though ranibizumab is more expensive and administered much more frequently up front.
One important assumption in the analysis is that, on average, patients randomized to the ranibizumab arms needed much less treatment in year 2 (and beyond) in DRCR.net protocol 1 to maintain their gains. If that was not the case, or if one were to choose continuous monthly injections for 2 years or more, such as what was done in the RIDE and RISE phase 3 US FDA studies, the treatment may not have turned out to be cost-effective even though the visual results for ranibizumab would still be far superior to laser.
The good news is that in clinical practice, retina specialists are much more likely to use ranibizumab to treat DME as it was used in RESTORE and DRCR.net protocol 1 than in the RIDE/RISE studies. Proving to be both more efficacious and more cost-effective as compared with laser, ranibizumab is the new gold standard to treat DME in patients with characteristics similar to what was recruited in these studies.
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Br J Ophthalmol. 2012;96(5):688-693.