Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling.

PURPOSE: We estimated the potential global economic productivity loss resulting from vision impairment (VI) and blindness as a result of uncorrected myopia and myopic macular degeneration (MMD) in 2015. CLINICAL RELEVANCE: Understanding the economic burden of VI associated with myopia is critical to addressing myopia as an increasingly prevalent public health problem. METHODS: We estimated the number of people with myopia and MMD corresponding to critical visual acuity thresholds. Spectacle correction coverage was analyzed against country-level variables from the year of data collection; variation in spectacle correction was described best by a model based on a human development index, with adjustments for urbanization and age. Spectacle correction and myopia data were combined to estimate the number of people with each level of VI resulting from uncorrected myopia. We then applied disability weights, labor force participation rates, employment rates, and gross domestic product per capita to estimate the potential productivity lost among individuals with each level and type of VI resulting from myopia in 2015 in United States dollars (US$). An estimate of care-associated productivity loss also was included. RESULTS: People with myopia are less likely to have adequate optical correction if they are older and live in a rural area of a less developed country. The global potential productivity loss associated with the burden of VI in 2015 was estimated at US$244 billion (95% confidence interval [CI], US$49 billion-US$697 billion) from uncorrected myopia and US$6 billion (95% CI, US$2 billion-US$17 billion) from MMD. Our estimates suggest that the Southeast Asia, South Asia, and East Asia Global Burden of Disease regions bear the greatest potential burden as a proportion of their economic activity, whereas East Asia bears the greatest potential burden in absolute terms. CONCLUSIONS: Even under conservative assumptions, the potential productivity loss associated with VI and blindness resulting from uncorrected myopia is substantially greater than the cost of correcting myopia.

Treatment compliance and adherence among patients with diabetic retinopathy and age-related macular degeneration treated by anti-vascular endothelial growth factor under universal health coverage.

PURPOSE: To analyze and compare loss to follow-up (LTFU) rates between patients with diabetic retinopathy (DR) and those with neovascular age-related macular degeneration (nAMD) in patients, receiving treatment with anti-vascular endothelial growth factor (VEGF), under universal health coverage. METHODS: We retrospectively analyzed the relevant data of 1264 patients receiving anti-VEGF therapy, in this cohort study. The observation period ranged from September 01, 2015 to December 31, 2018. Intervals between each procedure and the subsequent follow-up examination were measured. Demographic data, visual acuity (VA), the type of transport for treatment access, and distance between the residence and clinic were evaluated as risk factors for LTFU. RESULTS: We collected data for 841 patients with nAMD (age, 81.0 (± 8.1 years)) and 423 patients with DR (age, 67.7 (± 12.1 years)). The rate of LTFU, for at least 6 months, was 28.8% and 2.9% for patients with DR and nAMD, respectively (p < 0.001). In the DR group, 18.9% patients were lost to follow-up exceeding > 12 months. Multivariate regression analysis showed that advanced age, lack of mobility, and need for assisted transport, poor final VA despite treatment, and decrease in vision during the observational period were independent risk factors for LTFU exceeding 12 months (p < 0.05). CONCLUSIONS: We found a high long-term LTFU rate for patients with DR, despite treatment under universal health coverage. Considering the risk of disease progression, particularly in patients with chronic DR, strategies for better compliance and adherence to therapy should be considered for optimized patient care.

Incremental economic burden associated with exudative age-related macular degeneration: a population-based study.

BACKGROUND: The exudative age-related macular degeneration (AMD) causes considerable healthcare costs for patients and healthcare system, which are expected to grow as the population ages. The objective of this study was to assess the incremental economic burden of exudative AMD by comparing total healthcare costs between the exudative AMD group and non-AMD group to understand economic burden related to exudative AMD. METHODS: This retrospective cohort study used the National Health Insurance Service database including the entire Korean population. Exudative AMD group included individuals with at least one claim for ranibizumab and one claim using the registration code for exudative AMD (V201). Non-AMD group was defined as individuals without any claims regarding the diagnostic code of H35.3 or ranibizumab. The exudative AMD group and non-AMD group were matched using a propensity-score model. Incremental healthcare resource utilization and healthcare costs were measured during a one-year follow-up by employing econometric models: ordinary least squares (OLS) with log transformation and heteroscedastic retransformation; and generalized linear model (GLM) with a log link function and gamma distribution. RESULTS: A total of 7119 exudative AMD patients were matched to 7119 non-AMD patients. The number of outpatient visits was higher in the exudative AMD group (P-value < 0.0001), while the length of hospitalization was shorter in exudative AMD group (P-value < 0.0001). Exudative AMD patients had total costs 2.13 times (95%CI, 2.08-2.17) greater than non-AMD group using OLS, and total costs 4.06 times (95%CI, 3.82-4.31) greater than non-AMD group using GLM. Annual incremental total costs were estimated as $5519 (OLS) and $3699 (GLM). CONCLUSIONS: Exudative AMD was associated with significantly increased healthcare costs compared to the non-AMD group. Attention is needed to manage the socioeconomic burden of exudative AMD.

Injections frequency and health care costs in patients treated with aflibercept compared to ranibizumab: new real-life evidence from Switzerland.

BACKGROUND: Previous analyses of real-life data indicated that injection frequency and health care costs did not differ for anti-VEGF treatment with aflibercept and ranibizumab. The objective of this study was to investigate whether this finding persisted when analysing a longer time period after licensing. METHODS: Retrospective analysis of health insurance claims data of two large Swiss basic health insurance plans including 28% of the Swiss population. Patients qualified for inclusion if aflibercept or ranibizumab treatment had been initiated between June 1, 2013 and November 1, 2014. Within this set, patients with at least 12 months of continuous insurance enrolment in the previous year, 12-month follow-up, and without change of anti-VEGF drug were considered. We examined the distribution of demographic data and patient characteristics between those receiving ranibizumab and those receiving aflibercept. Numbers of injections and associated health care expenditures observed during the 12-month follow-up period after incident treatment were the two outcomes considered. In multivariate regression analyses, controlling for possible confounding factors, we compared differences in these two outcomes between patients treated with aflibercept as compared to ranibizumab. RESULTS: A total of 3'058 patients were analysed, 790 (26%) receiving aflibercept and 2`268 receiving ranibizumab (74%). The use of aflibercept (average number of injections 6.2) as compared to ranibizumab (average number of injections 5.7) in the follow-up period of 1 to 12 months, was associated with a 12% increase in the injection frequency (95% confidence interval (CI) 6-17%; p < 0.001). CONCLUSIONS: Real-life data contradicts the assumption that aflibercept is used less frequently as compared to ranibizumab. This results in similar total health care expenditures for both anti-VEGF agents.

Treatment Patterns and Health Care Costs for Age-Related Macular Degeneration in Japan: An Analysis of National Insurance Claims Data.

PURPOSE: To investigate changes in the proportion of patients with age-related macular degeneration (AMD) visiting hospitals and to investigate factors associated with AMD, treatments, and medical expenses, as well as the outlook for AMD in Japan using a large health insurance database. DESIGN: Analysis of national insurance claims data. PARTICIPANTS: People 40 years of age or older who were registered in the Japan Medical Data Center database. METHODS: Patients with AMD were identified from 2005 through 2013 based on International Classification of Diseases, 10th revision, diagnosis codes. Changes in patient proportions, treatment procedures, and medical expenses were investigated during the study period. The data for each year were compared after adjustment based on the 2010 Japanese population annual census. The outlook for patients with AMD was predicted based on the combination of data in 2013 and an official future population prediction report. MAIN OUTCOME MEASURES: Changes in treatment patterns and health care costs in Japan. RESULTS: A total of 3 401 299 participants were included in the analysis, and 3058 AMD patients were identified over the 9-year period. The proportion of patients with AMD increased significantly from 0.084% (95% confidence interval, 0.050%-0.119%) in 2005 to 0.26% (95% confidence interval, 0.24%-0.29%) in 2013 (P = 0.0001, Pearson correlation coefficient test). There were significantly more men than women (odds ratio, 1.25; 95% confidence interval, 1.14-1.37), and the proportion of patients with AMD increased rapidly with age. Photodynamic therapy was replaced by anti-vascular endothelial growth factor (VEGF) therapy as the predominant therapy from 2009 onward. Medical expenses per 10 000 persons increased from $1530 to $137 000 over the 9-year period. The proportion of AMD patients is predicted to increase in the future and will reach a maximum of 223 000 in 2035. CONCLUSIONS: The proportion of AMD patients visiting hospitals, medical expenses, and the frequency of anti-VEGF therapy increased significantly over the 9-year period. These increasing trends are predicted to continue in Japan.

Cost-Utility Analyses of Cataract Surgery in Advanced Age-Related Macular Degeneration.

PURPOSE: To explore the cost-utility of cataract surgery in patients with advanced age-related macular degeneration (AMD). METHODS: Patients who were diagnosed as having and treated for age-related cataract and with a history of advanced AMD at the Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, were included in the study. All of the participants underwent successful phacoemulsification with foldable posterior chamber intraocular lens implantation under retrobulbar anesthesia. Best-corrected visual acuity (BCVA) and utility value elicited by time trade-off method from patients at 3-month postoperative time were compared with those before surgery. Quality-adjusted life years (QALYs) gained in a lifetime were calculated at a 3% annual discounted rate. Costs per QALY gained were calculated using the bootstrap method, and probabilities of being cost-effective were presented using a cost-effectiveness acceptability curve. Sensitivity analyses were performed to test the robustness of the results. RESULTS: Mean logarithm of the minimum angle of resolution BCVA in the operated eye increased from 1.37 ± 0.5 (Snellen, 20/469) to 0.98 ± 0.25 (Snellen, 20/191) (p < 0.001); BCVA in the weighted average from both eyes (=75% better eye + 25% worse eye) was changed from 1.13 ± 0.22 (Snellen, 20/270) to 0.96 ± 0.17 (Snellen, 20/182) (p < 0.001). Utility values from both patients and doctors increased significantly after surgery (p < 0.001 and p = 0.007). Patients gained 1.17 QALYs by cataract surgery in their lifetime. The cost per QALY was 8835 Chinese yuan (CNY) (1400 U.S. dollars [USD]). It is cost-effective at the threshold of 115,062 CNY (18,235 USD) per QALY in China recommended by the World Health Organization. The cost per QALY varied from 7045 CNY (1116 USD) to 94,178 CNY (14,925 USD) in sensitivity analyses. CONCLUSIONS: Visual acuity and quality of life assessed by utility value improved significantly after surgery. Cataract surgery was a cost-effective intervention for patients with coexistent AMD.

Cost-Effectiveness of Screening for Intermediate Age-Related Macular Degeneration during Diabetic Retinopathy Screening.

PURPOSE: To determine whether screening for age-related macular degeneration (AMD) during a diabetic retinopathy (DR) screening program would be cost effective in Hong Kong. DESIGN: We compared and evaluated the impacts of screening, grading, and vitamin treatment for intermediate AMD compared with no screening using a Markov model. It was based on the natural history of AMD in a cohort with a mean age of 62 years, followed up until 100 years of age or death. PARTICIPANTS: Subjects attending a DR screening program were recruited. METHOD: A cost-effectiveness analysis was undertaken from a public provider perspective. It included grading for AMD using the photographs obtained for DR screening and treatment with vitamin therapy for those with intermediate AMD. The measures of effectiveness were obtained largely from a local study, but the transition probabilities and utility values were from overseas data. Costs were all from local sources. The main assumptions and estimates were tested in sensitivity analyses. MAIN OUTCOME MEASURES: The outcome was cost per quality-adjusted life year (QALY) gained. Both costs and benefits were discounted at 3%. All costs are reported in United States dollars ($). RESULTS: The cost per QALY gained through screening for AMD and vitamin treatment for appropriate cases was $12,712 after discounting. This would be considered highly cost effective based on the World Health Organization's threshold of willingness to pay (WTP) for a QALY, that is, less than the annual per capita gross domestic product of $29,889. Because of uncertainty regarding the utility value for those with advanced AMD, we also tested an extreme, conservative value for utility under which screening remained cost effective. One-way sensitivity analyses revealed that, besides utility values, the cost per QALY was most sensitive to the progression rate from intermediate to advanced AMD. The cost-effectiveness acceptability curve showed a WTP for a QALY of $29,000 or more has a more than 86% probability of being cost effective compared with no screening. CONCLUSIONS: Our analysis demonstrated that AMD screening carried out simultaneously with DR screening for patients with diabetes would be cost effective in a Hong Kong public healthcare setting.

Financial return-on-investment of ophthalmic interventions: a new paradigm.

PURPOSE OF REVIEW: Although the patient value gain (improvement in quality-of-life and/or length-of-life) has been highlighted in Value-based Medicine cost-utility analyses, the financial value gain associated with healthcare interventions has received less emphasis. It is important for professional healthcare providers to realize their interventions often confer a large financial return-on-investment (ROI) to society. RECENT FINDINGS: The societal costs associated with vitreoretinal and other ophthalmic interventions include: direct ophthalmic medical costs expended (hospital, physician, drug, diagnostic testing and so forth), direct medical costs saved (decreased costs for depression, injury, skilled nursing facility, nursing home and others), direct nonmedical costs saved (decreased costs for caregivers, transportation, residence costs, moving costs, and others), and indirect medical costs saved (improving employment incidence and wages). The financial ROI for direct ophthalmic medical costs expended for ranibizumab therapy for neovascular age-related macular degeneration is 450%, whereas that for cataract surgery is 4500% and for medical open-angle glaucoma therapy is 4000%. Many costs gained add to the Gross Domestic Product and increase the wealth of the nation. SUMMARY: Many vitreoretinal and other ophthalmologic interventions confer considerable patient value, but also result in a large financial ROI to society. This financial ROI increases the wealth of the nation.

The cost-utility of aflibercept for the treatment of age-related macular degeneration compared to bevacizumab and ranibizumab and the influence of model parameters.

BACKGROUND: Age-related macular degeneration (AMD) is a blinding disease placing considerable burden on society due to blindness-associated costs. Intravitreal anti-vascular endothelial growth factors (anti-VEGFs) are effective in reducing the incidence of blindness, but at potentially high costs, depending on the cost of the drug used. Aflibercept has been introduced as an anti-VEGF equally effective to ranibizumab, but less costly. For this new drug, new cost-effectiveness analyses are needed, and AMD models used today give biased results. We investigated the cost-effectiveness of aflibercept compared to bevacizumab, ranibizumab, and no treatment and studied the influence of commonly used model parameters. METHODS: A patient-level, visual acuity-based, 2-eye model was developed. Data on effectiveness were derived from randomized controlled trials evaluating the outcomes of aflibercept, bevacizumab, and ranibizumab. Utility and resource utilization were assessed in interviews with AMD patients. Costs were based on standard health care cost prices. Time horizons were two and five years. A societal perspective was employed. RESULTS: Over five years, costs associated with aflibercept treatment were 36,030, with 2.15 QALYs. Costs associated with the bevacizumab regimens, ABC study as-needed (PRN); CATT study PRN; and CATT study 1×/month, were 19,367; 26,746; and 30,520, with 2.16; 2.17; and 2.15 QALYs, respectively. Costs associated with ranibizumab PRN and 1×/month were 45,491 and 74,837 with 2.16 and 2.15 QALYs, respectively. 'No treatment' was associated with 9530 and 1.96 QALYs. The incremental cost-effectiveness ratios versus 'no treatment' were: aflibercept-140,274; bevacizumab-51,062 (ABC PRN), 83,256 (CATT PRN) and 110,361 (1×/month); ranibizumab-181,667 (PRN) and 349,773 (1×/month). Results were highly dependent on whether only one or both eyes were included, length of time horizon, and whether the costs of blindness and low-vision were included in the analysis. CONCLUSIONS: Aflibercept is a cost-effective treatment for AMD over ranibizumab. However, aflibercept is not a cost-effective treatment when compared to bevacizumab. Application of inappropriate model assumptions leads to a biased cost-saving estimate of the cost-effectiveness of aflibercept. Therefore, cost-effectiveness analyses should be conducted with appropriate models.

Current knowledge and trends in age-related macular degeneration: genetics, epidemiology, and prevention.

PURPOSE: To address the most dynamic and current issues concerning human genetics, risk factors, pharmacoeconomics, and prevention regarding age-related macular degeneration. METHODS: An online review of the database Pubmed and Ovid was performed, searching for the key words: age-related macular degeneration, AMD, pharmacoeconomics, risk factors, VEGF, prevention, genetics and their compound phrases. The search was limited to articles published since 1985 to date. All returned articles were carefully screened and their references were manually reviewed for additional relevant data. The webpage www.clinicaltrials.gov was also accessed in search of relevant research trials. RESULTS: A total of 366 articles were reviewed, including 64 additional articles extracted from the references and 25 webpages and online databases from different institutions. At the end, only 244 references were included in this review. CONCLUSION: Age-related macular degeneration is a complex multifactorial disease that has an uneven manifestation around the world but with one common denominator, it is increasing and spreading. The economic burden that this disease poses in developed nations will increase in the coming years. Effective preventive therapies need to be developed in the near future.

Health state utilities in patients with diabetic retinopathy, diabetic macular oedema and age-related macular degeneration: a systematic review.

BACKGROUND: Health state utility values (HSUVs) are important in the assessment of the cost effectiveness of new interventions. In the case of visual conditions, models generally tend have tended to be built around a set of health states defined by visual acuity (VA). The aim of this review was to assess the impact of VA on HSUVs in patients with diabetic retinopathy, diabetic macular oedema or age-related macular degeneration. METHODS: A systematic literature search was undertaken in major bibliographic databases to identify articles reporting on the relationship between HSUVs and vision. Data were extracted for population characteristics, visual levels and estimated utilities. Evidence from reported statistical models, where available, was considered in the evaluation of vision in the better-seeing eye and the worse-seeing eye. Due to the heterogeneity of included studies, a narrative synthesis was undertaken. RESULTS: Of the 17 relevant studies, 9 studies had data that could be used in the analysis of the impact of vision on HSUVs. Visual loss was associated with a marked impact on health utilities. However, the relationship was not comparable between conditions or by measure of HSUVs. Key results included the finding that overall, self-rated time-trade off estimates were more likely to discriminate between different VA levels than EQ-5D values. Additionally, a stronger correlation was observed between HSUVs and better-seeing eye VA compared to worse-seeing eye VA. CONCLUSIONS: Visual acuity has a significant impact on HSUVs. Nevertheless, care must be taken in the interpretation and use of estimates in cost-effectiveness models due to differences in measures and population diversity.

Comparative effectiveness and cost-effectiveness of the implantable miniature telescope.

OBJECTIVE: To assess the preference-based comparative effectiveness (human value gain) and the cost-utility (cost-effectiveness) of a telescope prosthesis (implantable miniature telescope) for the treatment of end-stage, age-related macular degeneration (AMD). DESIGN: A value-based medicine, second-eye model, cost-utility analysis was performed to quantify the comparative effectiveness and cost-effectiveness of therapy with the telescope prosthesis. PARTICIPANTS: Published, evidence-based data from the IMT002 Study Group clinical trial. Ophthalmic utilities were obtained from a validated cohort of >1000 patients with ocular diseases. METHODS: Comparative effectiveness data were converted from visual acuity to utility (value-based) format. The incremental costs (Medicare) of therapy versus no therapy were integrated with the value gain conferred by the telescope prosthesis to assess its average cost-utility. The incremental value gains and incremental costs of therapy referent to (1) a fellow eye cohort and (2) a fellow eye cohort of those who underwent intra-study cataract surgery were integrated in incremental cost-utility analyses. All value outcomes and costs were discounted at a 3% annual rate, as per the Panel on Cost-Effectiveness in Health and Medicine. MAIN OUTCOME MEASURES: Comparative effectiveness was quantified using the (1) quality-adjusted life-year (QALY) gain and (2) percent human value gain (improvement in quality of life). The QALY gain was integrated with incremental costs into the cost-utility ratio ($/QALY, or US dollars expended per QALY gained). RESULTS: The mean, discounted QALY gain associated with use of the telescope prosthesis over 12 years was 0.7577. When the QALY loss of 0.0004 attributable to the adverse events was factored into the model, the final QALY gain was 0.7573. This resulted in a 12.5% quality of life gain for the average patient during the 12 years of the model. The average cost-utility versus no therapy for use of the telescope prosthesis was $14389/QALY. The incremental cost-utility referent to control fellow eyes was $14063/QALY, whereas the incremental cost-utility referent to fellow eyes that underwent intra-study cataract surgery was $11805/QALY. CONCLUSIONS: Therapy with the telescope prosthesis considerably improves quality of life and at the same time is cost-effective by conventional standards.

The economics of telemedicine for vitreoretinal diseases.

PURPOSE OF REVIEW: A literature review was conducted presenting the current data on the economics of telemedicine in vitreoretinal diseases. RECENT FINDINGS: There have been an increasing number of studies evaluating the cost-effectiveness of telemedicine for vitreoretinal diseases. The availability of ophthalmologists able to screen for these conditions is limited. Teleophthalmology has been playing a larger role in screening for diabetic retinopathy, retinopathy of prematurity, and age-related macular degeneration. Many telemedicine programs are currently being investigated and implemented. SUMMARY: Telemedicine is a cost-effective means for screening diabetic retinopathy and retinopathy of prematurity. It can alleviate some of the burden of this growing public health problem. However, the large initial cost associated with beginning a teleophthalmology retinal screening program is a barrier to implementation. Additional studies are needed in the area of telemedicine for age-related macular degeneration.

Ranibizumab versus bevacizumab for the treatment of neovascular age-related macular degeneration.

PURPOSE OF REVIEW: This paper reviews the recent literature regarding the effectiveness, efficacy and safety of intravitreal bevacizumab as compared with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD). RECENT FINDINGS: Numerous randomized clinical trials have demonstrated the safety and efficacy of ranibizumab for the treatment of nAMD. Bevacizumab, developed, labeled and approved for the management of colorectal cancer, has been used off-label for the management of nAMD. However, given its lower cost and effectiveness, it is commonly used for many cases of nAMD. Recent clinical trials have demonstrated similar effectiveness between the two compounds in terms of visual acuity and central macular thickness. However, emerging data have suggested that these two compounds may have different ocular and systemic adverse event profiles; bevacizumab has been linked to both a higher risk of severe intraocular inflammation and a higher risk of incident arterial thromboembolic events. This incremental risk for both ocular and systemic adverse events may have an impact on the incremental cost-effectiveness ratio derived from health economic models that directly compare one anti-vascular endothelial growth factor (VEGF) compound to the other. SUMMARY: Numerous clinical trials, including the Comparison of AMD Treatment Trial, are underway examining the comparative efficacy of ranibizumab versus bevacizumab for the treatment of nAMD. While these studies may demonstrate clinical noninferiority of one anti-VEGF compound over another, they may not be adequately powered to detect important differences in ocular and systemic safety. Large-scale, appropriately powered safety studies need to be conducted to evaluate differences in safety.

[Cost-effectiveness of ranibizumab, photodynamic therapy and pegaptanib sodium in the treatment of neovascular age-related macular degeneration in Japanese].

PURPOSE: To perform cost-utility analysis of ranibizumab, photodynamic therapy (PDT) and pegaptanib sodium treatment of neovascular age-related macular degeneration (AMD) with subfoveal choroidal neovascularization. MATERIALS AND METHODS: The analyses were performed on a 75-year old man with the starting visual acuity of letter score of 50 on an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, with the affected eye having better sight than the contralateral eye, for the time horizons of 1 and 11 year (s). Visual acuity data from the large controlled studies for ranibizumab, photodynamic therapy and pegaptanib sodium, were applied. The results were compared with best supportive care (BSC) data. Cost indications included direct medical costs and costs related with social blindness. Utility values were estimated from the time trade off method. This analysis was performed from a societal perspective. RESULTS: In the 1-year model, cost of treatment was dominant in the treatment groups, whereas the cost of blindness was dominant in the BSC. In the 11-year model, influence of cost of blindness resulted in the increasing costs for BSC. Of note, ranibizumab and PDT were less costly and showed an increase in utility compared to the BSC. Pegaptanib sodium was found to be costly. Sensitivity analysis found that the results were robust to changes in various model parameters. CONCLUSION: In the current model, ranibizumab and PDT confer quality-adjusted life years (QALY) gains and are less costly compared to BSC in the lifetime treatment. In contrast, pegaptanib sodium treatment could be considered to be of minimal cost-effectiveness. Ranibizumab and PDT confer excellent value in the models of the lifetime treatment.

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.

A treat and extend regimen using ranibizumab for neovascular age-related macular degeneration clinical and economic impact.

PURPOSE: To evaluate the visual outcome, number of injections, and direct medical cost of a "treat and extend" regimen (TER) in managing neovascular age-related macular degeneration (nAMD) with intravitreal ranibizumab. DESIGN: Retrospective, interventional, consecutive case series. PARTICIPANTS: Ninety-two eyes of 92 patients met the entry criteria from May 2006 to May 2008. METHODS: All patients with treatment-naïve nAMD were treated monthly until no intraretinal or subretinal fluid was observed on optical coherence tomography (OCT). The treatment intervals were then sequentially lengthened by 2 weeks until signs of exudation recurred. The interval was individualized for each patient in an attempt to maintain an exudation-free macula. MAIN OUTCOME MEASURES: Change from baseline visual acuity, proportion of eyes losing < 3 lines and gaining ≥ 3 lines at 1 year of follow-up, annual mean number of injections, change from baseline OCT central retinal thickness (CRT), maximum period of extension, and adverse ocular and systemic events. RESULTS: The mean follow-up was 1.52 years. Mean Snellen visual acuity improved from 20/135 at baseline to 20/77 at 1 year follow-up (P < 0.001) and 20/83 at 2 years follow-up (P = 0.002). The proportion of eyes that lost < 3 Snellen visual acuity lines at final follow-up was 96% and the proportion that gained ≥ 3 Snellen visual acuity lines was 32%. The mean OCT CRT decreased from 303 µm at baseline to 238 µm at 1 year follow-up (P < 0.001). The mean number of injections over the first year and between years 1 and 2 was 8.36 and 7.45, respectively. The mean maximum period of extension was 79.9 days. No adverse ocular or systemic events were reported during the follow-up period. The direct annual medical cost per patient was $16,114.52 for the TER. The direct annual medical cost per patient ranged from $15,880.07 to $28,314.16 based on previous clinical trial protocols. CONCLUSIONS: Eyes with nAMD experienced significant visual improvement when managed with intravitreal ranibizumab using a TER. This treatment approach also was associated with significantly fewer patient visits, injections, and direct annual medical cost compared with monthly injections such as in the phase III clinical trials. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Cost-effectiveness of ranibizumab compared with pegaptanib in neovascular age-related macular degeneration.

OBJECTIVE: To assess the cost-effectiveness of ranibizumab compared with pegaptanib in the treatment of patients with minimally classic/occult neovascular age-related macular degeneration (AMD), from a societal perspective in Spain. METHODS: We constructed a Markov model with five states defined by visual acuity (VA) in the better-seeing eye (Snellen scale): VA >20/40, < or =20/40 to >20/80, < or =20/80 to >20/200, < or =20/200 to >20/400, < or =20/400, and an additional death state. Two cohorts of patients were distributed along the VA states, and treated with either ranibizumab or pegaptanib. Transition probabilities assigned for movement between these states with both drugs were obtained from published randomized clinical trials. Medical costs related to AMD treatment and follow-up, medical costs related to AMD comorbidities, and non-medical-related costs were taken into account. Costs (2008 Euro), health outcomes (Quality-adjusted life years--QALYs), both discounted at a 3.5% annual rate, and incremental cost-effectiveness ratios (ICER: euro/QALY), were determined for a lifetime horizon in the base case analysis. Sensitivity analyses were conducted to explore different scenarios and assumptions in the model. RESULTS: Treating patients with varying degrees of visual impairment with monthly ranibizumab instead of pegaptanib was 71,206 euro more costly and provided 2.437 additional QALYs (29,224 euro/QALY). When administered on an as-needed basis, as in the Prospective Optical Coherence Tomography Imaging of Patients with Neovascular AMD Treated with Intraocular Ranibizumab (PrONTO) trial, the cost per QALY gained with ranibizumab was reduced to 4,623 euro. CONCLUSIONS: The cost per QALY gained with monthly ranibizumab compared with pegaptanib in the minimally classic/occult neovascular AMD population is just below the 30,000 euro threshold below which new drugs are sometimes regarded as cost-effective strategies in Spain. In this model, the key variables with greater impact on the cost-effectiveness results were the selected time horizon and the chosen extrapolation method, the source for data on pegaptanib efficacy and the number of ranibizumab injections. When administered on an as-needed basis, ranibizumab was a cost-effective strategy compared to pegaptanib in this population.

A cost-effectiveness analysis of three treatments for age-related macular degeneration.

PURPOSE: The purpose of this study was to evaluate the cost effectiveness of pegaptanib sodium and ranibizumab injections compared with photodynamic therapy (PDT) with verteporfin for the treatment of choroidal neovascularization secondary to age-related macular degeneration. METHODS: The analyses were performed using outcomes data from the pivotal trials for each treatment and the medicare reimbursable costs for each treatment and associated medical procedures. A multistate transition model with 3-month cycles was created to compare incremental medical costs associated with pegaptanib or ranibizumab versus PDT for patients with starting vision of 20/40, 20/80, and 20/200 Snellen equivalent. RESULTS: Two-year medical treatment costs ranged from $3,100 to $54,100 depending on treatment and lesion type. Photodynamic therapy was less costly and more effective than pegaptanib for predominantly classic and minimally classic lesions. Ranibizumab was not only more effective but also more costly than PDT for all lesion types. CONCLUSION: Compared with PDT, pegaptanib is inferior in both cost and effectiveness, whereas ranibizumab has a greater effectiveness. Because ranibizumab does not meet 1 of the common thresholds for being considered cost effective (<$50,000 per quality-adjusted life year), there is rationale to seek other therapies that are more cost effective.

Cost-Minimization Analysis of Ranibizumab Versus Aflibercept for Treating Saudi Patients With Visual Impairment Owing to Age-Related Macular Degeneration or Diabetic Macular Edema.

OBJECTIVE: The standard-of-care treatment for age-related macular degeneration (AMD) and diabetic macular edema (DME) includes inhibiting blood vessel proliferation and reducing macular edema or swelling using anti-vascular endothelial growth factor therapies, such as ranibizumab and aflibercept. To conduct a cost-minimization analysis of ranibizumab and aflibercept for treating Saudi patients with visual impairment owing to AMD or DME. METHODS: Cost minimization was analyzed assuming that ranibizumab and aflibercept have equivalent clinical effectiveness. The third-party payer's perspective was used in several clinical scenarios. The base-case scenario was DME cases followed monthly using a protocol-specific follow-up. In scenario 1, AMD cases followed a treat-and-extend protocol over 2 years. In scenario 2, AMD cases followed the PRN (pro re nata) regimen over 2 years. In scenario 3, DME cases followed the PRN regimen for 1 year only. RESULTS: Aflibercept yielded cost savings of 25.75%, 31.54%, 51.30%, and 9.28% compared with ranibizumab for the base case, scenario 1, scenario 2, and scenario 3, respectively, which supports the premise that aflibercept is more cost saving than ranibizumab. CONCLUSIONS: From the third-party payer perspective, aflibercept is a cost-containment option that provides substantial savings over ranibizumab for treating Saudi patients with AMD or DME.