Impact of neovascular age-related macular degeneration: burden of patients receiving therapies in Japan.

The chronic eye disorder, neovascular age-related macular degeneration (nAMD), is a common cause of permanent vision impairment and blindness among the elderly in developed countries, including Japan. This study aimed to investigate the disease burden of nAMD patients under treatment, using data from the Japan National Health and Wellness surveys 2009-2014. Out of 147,272 respondents, 100 nAMD patients reported currently receiving treatment. Controls without nAMD were selected by 1:4 propensity score matching. Healthcare Resource Utilisation (HRU), Health-Related Quality of Life (HRQoL), and work productivity loss were compared between the groups. Regarding HRU, nAMD patients had significantly increased number of visits to any healthcare provider (HCP) (13.8 vs. 8.2), ophthalmologist (5.6 vs. 0.8), and other HCP (9.5 vs. 7.1) compared to controls after adjusting for confounding factors. Additionally, nAMD patients had reduced HRQoL and work productivity, i.e., reduced physical component summary (PCS) score (46.3 vs. 47.9), increased absenteeism (18.14% vs. 0.24%), presenteeism (23.89% vs. 12.44%), and total work productivity impairment (33.57% vs. 16.24%). The increased number of ophthalmologist visits were associated with decreased PCS score, increased presenteeism and total work productivity impairment. The current study highlighted substantial burden for nAMD patients, requiring further attention for future healthcare planning and treatment development.

Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy (PDR) treated with ranibizumab is not worse at 5 years than that of eyes treated with panretinal photocoagulation (PRP). Moreover, the ranibizumab group had fewer new cases of diabetic macular edema (DME) with vision loss or vitrectomy but had 4 times the number of injections and 3 times the number of visits. Although 2-year cost-effectiveness results of Protocol S were previously identified, incorporating 5-year data from Protocol S could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system. Objective: To evaluate 5- and 10-year cost-effectiveness of therapy with ranibizumab, 0.5 mg, compared with PRP for treating PDR. Design, Setting, and Participants: A preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety, and resource utilization data through 5 years of follow-up for 213 adults diagnosed with PDR and simulating results through 10 years. Interventions: Intravitreous ranibizumab, 0.5 mg, at baseline and as frequently as every 4 weeks based on a structured retreatment protocol vs PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss. Main Outcomes and Measures: Incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP were evaluated for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent, 20/32 or worse) at baseline. Results: The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white. The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582 268 per quality-adjusted life-year (QALY) at 5 years and $742 202/QALY at 10 years. For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years. Conclusions and Relevance: This study suggests that during 5 to 10 years of treatment, ranibizumab, 0.5 mg, as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for eyes presenting with PDR and vision-impairing CI-DME, but not for those with PDR but without vision-impairing CI-DME. Substantial reductions in anti-vascular endothelial growth factor cost may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME. Trial Registration: ClinicalTrials.gov identifier: NCT01489189.

[Neovascular age-related macular degeneration in Germany. Encroachment on the quality of life and the financial implications]. / Neovaskuläre altersabhängige Makuladegeneration in Deutschland. Beinträchtigung der Lebensqualität und ihre finanziellen Auswirkungen.

BACKGROUND: Approximately 35,000 cases of neovascular age-related macular degeneration (AMD) occur annually in Germany. The neovascular form of AMD (NV-AMD) is responsible for severe vision loss associated with the disease in 90% of the cases. This study was conducted to assess the humanistic and economic burden of NV-AMD in the German population. METHODS: A cross-sectional, observational study of subject self-reported functional health, well-being, and disease burden among elderly subjects with (n=83) and without (n=93) NV-AMD in Germany was conducted. Patients participated in telephone surveys involving the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), the EuroQol (EQ-5D), the Hospital Anxiety and Depression Scale (HADS), and also reported history of falls, fractures, and healthcare resource utilization. Furthermore, the healthcare utilization and unit costs for the NV-AMD patients were calculated. RESULTS: The mean age of NV-AMD patients was 77.2 years and 64% were female. NV-AMD patients reported significantly worse vision-related function and overall well-being than controls (adjusted mean scores: NEI-VFQ-25 overall scale: 51.3 vs 96.3; p<0.0001) and significantly more depression symptoms than controls (HADS depression: 6.2 vs. 2.7; p<0.0001). NV-AMD patients also reported that the need for assistance with daily activities was more than 10 times greater compared to controls (26.5% vs. 2.2%; p<0.0001) and the prevalence of falls was 3 times that of the control group (13.3% vs 4.3%; p=0.031). Annual NV-AMD costs per patient were 9871, 6 times that of elderly patients without NV-AMD ( 1559). Of the NV-AMD costs one-half were direct non-medical-related costs (assistance of ADL or social benefit) and one-third were direct medical costs. CONCLUSIONS: NV-AMD is associated with decreased functional abilities and quality of life, which result in an increase in healthcare resource utilization. Consequently, costs were higher for NV-AMD patients compared to controls. These findings emphasize the need for new NV-AMD treatments that will prevent vision loss and progression to blindness, and lessen the ensuing economic burden. Sponsored by Pfizer Inc. New York, US.

The cost of vision for vitreoretinal interventions.

PURPOSE OF REVIEW: This article reviews the current status of treatments for age-related macular degeneration from a cost-effectiveness perspective. RECENT FINDINGS: Treatments are now available to a broad range of patients with age-related macular degeneration, but they are pharmaceutical based and require repeated evaluation and treatment. The resulting unprecedented levels of cost make cost-effectiveness considerations more prescient. Newer methods to evaluate cost-effectiveness and treatment outcomes have included utility and value-based analyses. These have attempted to utilize accurate, objective parameters, but are calibrated by subjective patient assessments and are limited by certain methodological assumptions. Treatment methods to improve outcomes are increasingly being considered within the context of cost-effectiveness. SUMMARY: Although improved understanding of basic, cellular processes has led to markedly improved treatment options for age-related macular degeneration within the past decade, the high costs and wide applicability threaten the balance and viability of the payor system. Accurate means of assessing cost-effectiveness are critical to defining clinical applications.

The comparative effectiveness and cost-effectiveness of vitreoretinal interventions.

PURPOSE OF REVIEW: The comparative effectiveness of medical interventions has recently been emphasized in the literature, typically for interventions in a similar class. Value-based medicine, the practice of medicine based on the value (improvement in quality of life and/or length of life) conferred by medical interventions, allows a measure of comparative effectiveness of interventions across all of health care, no matter how disparate. This report discusses recent comparative effectiveness studies in the vitreoretinal literature. RECENT FINDINGS: Vitreoretinal interventions have good to excellent comparative effectiveness compared with commonly utilized interventions across health care, such as treatment for osteoporosis and hyperlipidemia. They also tend to be cost-effective when an upper limit of $100 000/quality-adjusted life-year is utilized. SUMMARY: Value can be measured using either or both of two outcomes - the quality-adjusted life-year gain and/or the percentage improvement in value - both of which allow for an evaluation of comparative effectiveness, which can be compared on the same scale for every intervention. This value can also be integrated with costs using the outcome of dollars expended per quality-adjusted life-year ($/quality-adjusted life-year, or the cost-utility ratio), which allows a comparison of cost-effectiveness across all interventions. The majority of vitreoretinal interventions confer considerable value and are cost-effective.

[Cost-utility analysis of ranibizumab (Lucentis) in neovascular macular degeneration]. / Was darf Lebensqualität kosten?--Kosten-Nutzwertanalyse von Ranibizumab (Lucentis) bei altersabhängiger Makuladegeneration.

PURPOSE: Ranibizumab (Lucentis) stabilizes or improves visual acuity in a high percentage of patients with age-related macular degeneration (AMD). As this therapy is associated with significant costs, the aim of this study was to provide a cost-utility analysis, which considers both costs and utility of a therapy with ranibizumab in an economic model. METHODS: The incremental utility for the patient was modelled based on visual acuity data of the MARINA and ANCHOR study. The utility data used assume that the better seeing eye is affected. The study groups used for comparison consisted of patients who only received best supportive care, e. g., low-vision aids. The baseline scenario of the model assumes 6 treatments per year over a 2 year time period - based on the assessment of an expert panel. Treatment costs were based on German pharmacy prices and recommendations for reimbursement of the intravitreal injections. In a univariate sensitivity analysis all important parameters were varied to assess the stability of the results. RESULTS: The baseline scenario yields for predominantly classic lesions 16,882 euro/QALY (quality adjusted life year), for minimally classic CNV 24,766 euro/QALY and for occult CNV 26,170 euro/QALY. If a distribution of the CNV types with 18 - 25 - 57 % is assumed, the mean cost of therapy with ranibizumab amounts to 24,147 euro/QALY. Sensitivity analysis showed that all reasonable variations yielded results which are considered cost-effective ( 0.4) visual acuity, for a variation of costs per treatment of +/- 20 %, and a prolonged treatment duration of 3 years. CONCLUSIONS: In the investigated szenario a therapy of neovascular AMD with ranibizumab is cost-effective for all angiographic subtypes as well as in the sensitivity analysis.