Brandon G. Busbee

Twelve-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-related Macular Degeneration

OBJECTIVE To evaluate the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients with subfoveal neovascular age-related macular degeneration (wet AMD). DESIGN A 24-month, phase III, randomized, multicenter, double-masked, dose-response study. PARTICIPANTS Patients aged ≥ 50 years with subfoveal wet AMD. METHODS Patients (n = 1098) were randomized to receive ranibizumab 0.5 mg or 2.0 mg intravitreal injections administered monthly or on a PRN basis after 3 monthly loading doses. MAIN OUTCOME MEASURES The primary efficacy end point was the mean change from baseline in best-corrected visual acuity (BCVA) at month 12. Key secondary end points included the mean number of ranibizumab injections, the mean change from baseline in central foveal thickness (CFT) over time, and the proportion of patients who gained ≥ 15 letters of BCVA. Unless otherwise specified, end point analyses were performed using the last-observation-carried-forward method to impute missing data. RESULTS At month 12, the mean change from baseline in BCVA for the 4 groups was +10.1 letters (0.5 mg monthly), +8.2 letters (0.5 mg PRN), +9.2 letters (2.0 mg monthly), and +8.6 letters (2.0 mg PRN). The proportion of patients who gained ≥ 15 letters from baseline at month 12 in the 4 groups was 34.5%, 30.2%, 36.1%, and 33.0%, respectively. The mean change from baseline in CFT at month 12 in the 4 groups was -172.0 μm, -161.2 μm, -163.3 μm, and -172.4 μm, respectively. The mean number of injections was 7.7 and 6.9 for the 0.5-mg PRN and 2.0-mg PRN groups, respectively. Ocular and systemic safety profiles were consistent with previous ranibizumab trials in AMD and comparable between groups. CONCLUSIONS At month 12, the ranibizumab 2.0 mg monthly group did not meet the prespecified superiority comparison and the ranibizumab 0.5 mg and 2.0 mg PRN groups did not meet the prespecified noninferiority (NI) comparison. However, all treatment groups demonstrated clinically meaningful visual improvement (+8.2 to +10.1 letters) and improved anatomic outcomes, with the PRN groups requiring approximately 4 fewer injections (6.9-7.7) than the monthly groups (11.2-11.3). No new safety events were observed despite a 4-fold dose escalation in the study. The pHase III, double-masked, multicenter, randomized, Active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg Ranibizumab administered monthly or on an as-needed Basis (PRN) in patients with subfoveal neOvasculaR age-related macular degeneration (HARBOR) study confirmed that ranibizumab 0.5 mg dosed monthly provides optimum results in patients with wet AMD. FINANCIAL DISCLOSURE(S) Proprietary or commercial disclosure may be found after the references.

Incremental cost-effectiveness of initial cataract surgery

PURPOSE The purpose of this study was to perform a reference case, cost-utility analysis of initial cataract surgery using the current literature on cataract outcomes and complications. DESIGN Computer-based econometric modeling. METHODS Visual acuity data of patients treated and observed over a 4-month postoperative period was obtained from the US National Cataract Patient Outcomes Research Team (PORT). The results from this prospective study were combined with other studies that investigated the complication rates of cataract surgery to complete the cohort of patients and outcomes. These synthesized data were incorporated with time-tradeoff utility values, decision analysis, and econometric modeling to account for the time value of money. MAIN OUTCOME MEASURES The number of quality-adjusted life-years (QALYs) gained was calculated for the study group undergoing cataract extraction in the first eye when the vision was the same in both eyes. This was divided into the cost of the procedure to find the year 2000 nominal US dollars spent per quality-adjusted life-year (

Quality of life associated with unilateral and bilateral good vision

/QALY) gained. RESULTS Initial cataract surgery, compared with observation, resulted in a mean gain of 1.776 QALYs per patient treated. A 3% annual discount rate was used to account for the benefit over time, yielding 1.25 QALYs gained. The mean cost of treatment (also discounted at a 3% annual rate) of each patient totaled 2525 US dollars. The cost divided by the discounted benefit resulted in

Cost-utility analysis of cataract surgery in the second eye.

2020/QALY gained for this procedure. CONCLUSIONS Initial cataract surgery seems to be highly cost-effective compared with procedures across multiple medical specialties. This information, incorporating patient preferences into evidenced-based medicine, will play an increasingly important role in the evaluation of health care in the future.

Quality of life associated with visual loss: A time tradeoff utility analysis comparison with medical health states

OBJECTIVE To ascertain with patient preference-based methodology whether individuals with good visual acuity (20/20-20/25) in one eye have the same quality of life as individuals with good vision in both eyes. DESIGN Cross-sectional comparative study. PARTICIPANTS Consecutive patients seen in comprehensive ophthalmic and vitreoretinal practices with known ocular disease and good visual acuity (20/20 or 20/25) in one or both eyes. METHODS Standardized patient interview. MAIN OUTCOME MEASURES Time tradeoff and utility analysis values. RESULTS The mean time tradeoff utility value in 81 patients with good visual acuity in one eye was 0.89 (standard deviation, 0.17; 95% confidence interval, 0.85-0.93), whereas the mean value in 66 patients with good vision in both eyes was 0.97 (standard deviation, 0.05; 95% confidence interval, 0.97-0.99). The difference between the means of the utility values in these two groups was significant using multiple linear regression (P = 0.001). CONCLUSIONS From the patient preference-based point of view, individuals with ocular disease and good visual acuity in both eyes appear to have a higher time tradeoff utility value, and thus a better associated quality of life, than those with good visual acuity in only one eye.

Cataract Surgery Cost Utility Revisited in 2012: A New Economic Paradigm

OBJECTIVE To perform a reference case cost-utility analysis of second-eye cataract surgery by using the current literature on cataract outcomes and complications. DESIGN Computer-based econometric modeling. METHODS Visual acuity data of patients treated and observed over a 4-month postoperative period were obtained from the U.S. National Cataract Patient Outcomes Research Team report. The results from this prospective study were combined with those of other studies that investigated the complication rates of cataract surgery to complete the cohort of patients and outcomes. These synthesized data were incorporated with time trade-off utility values, which accounted for prior successful cataract surgery in the fellow eye. Cost-utility determinations were made with decision analysis, and present value modeling was used to account for the time value of money and health state consequences. MAIN OUTCOME MEASURES The number of quality-adjusted life-years (QALYs) gained was calculated for the study group undergoing second-eye cataract surgery, assuming that the postoperative vision in the second eye was equivalent to the vision in the first eye after surgery (20/27). This was divided into the cost of the procedure to find the number of year 2001 nominal U.S. dollars spent per QALY gained. RESULTS Second-eye cataract surgery, as compared with unilateral pseudophakia, resulted in a mean gain of 1.31 undiscounted QALYs per patient treated. A 3% annual discount rate, dependent on the duration of benefit, was used, yielding 0.92 discounted QALYs gained over a 12-year life expectancy. The mean discounted cost of treatment for each patient totaled 2509 US dollars. The cost divided by the QALYs gained (benefit) resulted in 2727 US dollars per QALY gained for this procedure. Sensitivity analysis varying costs and utility values revealed a range from 2045 US dollars to 3649 US dollars per QALY gained. CONCLUSIONS Second-eye cataract surgery is an extremely cost-effective procedure when compared with other interventions across medical specialties. The cost-effectiveness of second-eye surgery diminishes only slightly from the 2023 US dollars per QALY gained from first-eye cataract surgery. This suggests that patients with good vision in one eye and visual loss from cataract in the fellow eye derive substantial benefit from cataract extraction.

A cost-utility analysis of interventions for severe proliferative vitreoretinopathy ☆

PURPOSE To assess the visual utility values of patients with ocular disease and to compare these values with those of patients with systemic health states DESIGN Cross-sectional utility value assessment. METHODS Consecutive patients with ophthalmic diseases were interviewed in a one-on-one fashion using a standardized time tradeoff utility value assessment form. These values were compared with utility values for systemic health states present in the literature. INTERVENTION None. MAIN OUTCOME MEASURE Time tradeoff utility value on a scale ranging from 1.0 (perfect visual health) to 0.0 (death). The ophthalmic patient groups were stratified into 4 visual groups dependent on the visual acuity in the better-seeing eye. The groups were as follows: group 1, 20/20 to 20/25; group 2, 20/30 to 20/50; group 3, 20/60 to 20/100; group 4, 20/200 to no light perception. RESULTS A total of 500 subjects were enrolled in the study. The mean utility values for the visually stratified groups were: group 1, 0.88; group 2, 0.81; group 3, 0.72; group 4, 0.61. Comparable respective systemic health state utility values for each of the ophthalmic groups were: diabetes mellitus, status after kidney transplantation, moderate stroke, and moderately severe stroke. CONCLUSIONS Visual loss is associated with a substantial and measurable diminution in quality of life. This diminution in quality of life can be directly compared with that induced by systemic health states.

Vitreous nonsteroidal antiinflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%.

OBJECTIVE To assess the 2012 cost utility of cataract surgery in the United States and to compare 2012 cost-utility data with those from 2000. DESIGN Value-Based Medicine (Flourtown, PA), patient preference-based, comparative effectiveness analysis and cost-utility analysis using 2012 real United States dollars. PARTICIPANTS Previously published Patient Outcomes Research Team Study data and time tradeoff utilities obtained from patients with vision loss. Visual acuity measurements from patients wtih untreated cataract were used as controls. INTERVENTION Thirteen-year, average, first-eye and second-eye cataract surgery cost-utility analysis using the societal and third-party insurer cost perspectives. MAIN OUTCOME MEASURES Patient value gain in quality-adjusted life years (QALYs) and percent gain in quality of life as well as the cost-utility ratio using the dollars expended per QALY gained. Patient and financial value outcomes were discounted at 3% annually with net present value analysis. RESULTS First-eye cataract surgery conferred 1.6212 QALYs over the 13-year model, a 20.8% quality-of-life gain. Bilateral cataract surgery conferred 2.8152 QALYs over 13 years, a 36.2% improvement in quality of life. The direct ophthalmic medical cost for unilateral cataract surgery in 2012 United States nominal dollars was

CME review: A cost-utility analysis of laser photocoagulation for extrafoveal choroidal neovascularization.

2653, an inflation-adjusted 34.2% less than in 2000 and 85% less than in 1985. The 2012 inflation-adjusted physician fee was 10.1% of that in 1985. The 13-year societal cost perspective, financial return on investment (ROI) for first-eye cataract surgery was

Incremental cost-effectiveness of laser therapy for choroidal neovascularization associated with histoplasmosis.

121,198, a 4567% gain. The third-party insurer cost perspective average cost-utility ratio was