BACKGROUND: In clinical trials, ranibizumab has been associated with stabilization and even improvement of visual acuity among patients with neovascular age related macular degeneration (AMD), but its use is also associated with considerable costs. OBJECTIVE: The aim of this work was to compare ranibizumab with best supportive care or photodynamic therapy (PDT) for AMD by means of economic cost-utility and cost-effectiveness analysis from the perspective of Germany's Statutory Health Insurance System. METHODS: Visual acuity data from the Anti-VEGF (vascular endothelial growth factor) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR) and Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) studies were applied, based on a ranibizumab dose of 0.5 mg. A Markov model simulated visual acuity and costs over 10 years (discounted at 3%). The base-case analysis assumed 5 injections per year over 2 years. Treatment costs were based on year-2008 euros (using German prices) and recommendations for procedure reimbursement from a public health insurance perspective. To assess cost-effectiveness, costs per year of legal blindness avoided (ie, vision-year gained [VYG]) and per quality-adjusted life-year (QALY) were calculated. The model assumed each patient's affected eye had better sight than the other eye, and the 2 comparators against which ranibizumab treatment was assessed were best supportive care and PDT. The robustness of the results was investigated in a univariate sensitivity analysis of all relevant parameters and a multivariate probabilistic sensitivity analysis. The multivariate 95% CIs for incremental cost-effectiveness ratios were obtained by conducting 1000 Monte Carlo simulations. RESULTS: Compared with best supportive care, costs per VYG for ranibizumab were euro6767 in occult choroidal neovascularization (CNV) and euro6020 in minimally classic CNV. In classic CNV, costs were euro5734/VYG for ranibizumab compared with supportive care and euro778/VYG for ranibizumab compared with PDT. Costs per QALY for ranibizumab treatment for occult, minimally classic CNV, and classic CNV were euro22,320, euro22,538, and euro25,036, respectively, and euro3294 for classic CNV compared with PDT. Results were sensitive to the cost of blindness, injection frequency, and duration. The multivariate 95% CIs for the incremental cost effectiveness ratios were euro14,438 to euro41,110/QALY for occult CNV, euro13,463 to euro43,614/QALY for minimally classic CNV, and euro15,634 to euro51,106/QALY for classic CNV. CONCLUSION: In this model analysis using costs and clinical trial data from Germany, ranibizumab appeared to be a cost-effective treatment option for all angiographic subtypes of neovascular AMD, from the perspective of Germany's Statutory Health Insurance System. 2010 Excerpta Medica Inc. All rights reserved.
BACKGROUND: In clinical trials, ranibizumab has been associated with stabilization and even improvement of visual acuity among patients with neovascular age related macular degeneration (AMD), but its use is also associated with considerable costs. OBJECTIVE: The aim of this work was to compare ranibizumab with best supportive care or photodynamic therapy (PDT) for AMD by means of economic cost-utility and cost-effectiveness analysis from the perspective of Germany's Statutory Health Insurance System. METHODS:Visual acuity data from the Anti-VEGF (vascular endothelial growth factor) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR) and Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) studies were applied, based on a ranibizumab dose of 0.5 mg. A Markov model simulated visual acuity and costs over 10 years (discounted at 3%). The base-case analysis assumed 5 injections per year over 2 years. Treatment costs were based on year-2008 euros (using German prices) and recommendations for procedure reimbursement from a public health insurance perspective. To assess cost-effectiveness, costs per year of legal blindness avoided (ie, vision-year gained [VYG]) and per quality-adjusted life-year (QALY) were calculated. The model assumed each patient's affected eye had better sight than the other eye, and the 2 comparators against which ranibizumab treatment was assessed were best supportive care and PDT. The robustness of the results was investigated in a univariate sensitivity analysis of all relevant parameters and a multivariate probabilistic sensitivity analysis. The multivariate 95% CIs for incremental cost-effectiveness ratios were obtained by conducting 1000 Monte Carlo simulations. RESULTS: Compared with best supportive care, costs per VYG for ranibizumab were euro6767 in occult choroidal neovascularization (CNV) and euro6020 in minimally classic CNV. In classic CNV, costs were euro5734/VYG for ranibizumab compared with supportive care and euro778/VYG for ranibizumab compared with PDT. Costs per QALY for ranibizumab treatment for occult, minimally classic CNV, and classic CNV were euro22,320, euro22,538, and euro25,036, respectively, and euro3294 for classic CNV compared with PDT. Results were sensitive to the cost of blindness, injection frequency, and duration. The multivariate 95% CIs for the incremental cost effectiveness ratios were euro14,438 to euro41,110/QALY for occult CNV, euro13,463 to euro43,614/QALY for minimally classic CNV, and euro15,634 to euro51,106/QALY for classic CNV. CONCLUSION: In this model analysis using costs and clinical trial data from Germany, ranibizumab appeared to be a cost-effective treatment option for all angiographic subtypes of neovascular AMD, from the perspective of Germany's Statutory Health Insurance System. 2010 Excerpta Medica Inc. All rights reserved.
Authors: M Kernt; S Thiele; C Hirneiss; A S Neubauer; C A Lackerbauer; A Wolf; K H Eibl; C Haritoglou; M W Ulbig; A Kampik Journal: Ophthalmologe Date: 2011-05 Impact factor: 1.059