Impacto presupuestario de XEN®63 en el tratamiento del glaucoma primario de ángulo abierto en España / Budget impact analysis of the XEN®63 for the treatment of primary open angle glaucoma in Spain

Antecedentes y objetivo Evaluar el impacto económico en España derivado de la introducción del implante XEN®63 como alternativa quirúrgica en el manejo del glaucoma primario de ángulo abierto (GPAA) con o sin cataratas en pacientes refractarios. Materiales y métodos Se diseñó un análisis de impacto presupuestario para estimar los costes del tratamiento quirúrgico del GPAA desde la perspectiva del Sistema Nacional de Salud (SNS) español, en un horizonte temporal de1 año. Los comparadores considerados (trabeculectomía, esclerectomía profunda no perforante, válvula de Ahmed, iStent inject®, Preserflo® microshunt y XEN®45) se corresponden a los empleados en la práctica clínica pública española. Para el cálculo de la población diana, cuotas de mercado y uso de recursos en términos de visitas de seguimiento, procedimientos adicionales y complicaciones poscirugía, se emplearon datos de la literatura y se validaron con un panel de cuatro expertos. Los costes unitarios (€de2021) se obtuvieron de la base de datos ESALUD Resultados la inclusión de XEN®63 podría generar un ahorro de 2.569.737€ tras un año desde su introducción, derivado del ahorro en el coste del implante y del procedimiento (−423.120; −0,7%), de las visitas de seguimiento (−777.407€; −4,5%), de los procedimientos adicionales (−1.048.145€, −20,6%) y de las complicaciones poscirugía (−321.065€, −14,2%). Conclusiones La incorporación de XEN®63 en el arsenal quirúrgico para el tratamiento del GPAA refractario con y sin cataratas podría generar ahorros para el SNS (AU)

Background and objective To evaluate the economic impact in Spain derived from the introduction of the XEN®63 implant as a surgical alternative in the management of primary open angle glaucoma (POAG) with or without cataract in refractory patients. Materials and methods A budget impact analysis was designed to estimate the costs of surgical treatment of POAG from the perspective of the Spanish National Health System (NHS), over a time horizon of 1year. The comparators considered (trabeculectomy, deep non-perforating sclerectomy, Ahmed valve, iStent inject®, Preserflo® microshunt and XEN®45) correspond to those used in Spanish public clinical practice. For the calculation of the target population, market shares and resource use in terms of follow-up visits, additional procedures and post-surgery complications, data from the literature were used and validated with a panel of 4 experts. Unit costs (€2021) were obtained from the ESALUD database. Result The inclusion of XEN®63 could generate savings of €2,569,737 after one year since its introduction, derived from savings in the cost of the implant and procedure (−€423,120; −0.7%), follow-up visits (−€777,407; −4.5%), additional procedures (−1,048,145; −20.6%) and post-surgery complications (−€321,065; −14.2%). Conclusion The incorporation of XEN®63 in the surgical arsenal for the treatment of refractory POAG with and without cataracts could generate savings for the NHS (AU)

A Brazilian cost-utility analysis of trabecular micro-bypass with iStent inject® for the treatment of open-angle glaucoma / Análise de custo-utilidade do implante trabecular iStent inject® para o tratamento do glaucoma de ângulo aberto no Brasil

ABSTRACT Purpose To evaluate the cost-utility of the iStent inject® for the treatment of mild-to-moderate open-angle glaucoma (OAG) within the Brazilian Unified Health System (SUS). Methods A Markov model was developed, in which the effectiveness outcome measure was the incremental cost-effectiveness ratio (ICER: R$ / QALY quality-adjusted life-year). Direct medical costs were obtained from the SUS perspective. The base case comprised of a hypothetical cohort of patients with OAG using topical medication and being managed according to the Clinical Protocol and Therapeutic Guidelines (PCDT) and a real-world setting based on data from Datasus. The model's robustness through sensitivity analyses was tested. Results In the PCDT base case setting, the trabecular micro-bypass implant provided gains of 0.47 QALYs and an ICER of R$7,996.66/QALY compared to treatment with topical medication. In the real-world setting based on data from Datasus, the trabecular micro-bypass implant, provided gains of 0.47 QALYs and an ICER of R$4,485.68/QALY compared to treatment with topical medication. The results were robust to sensitivity analyses. Conclusion Incorporating iStent inject® to SUS provides an improvement in the patient's quality of life with an additional cost that warrants the benefit provided to patients. Results may be considered cost-effective compared to topical medication.

RESUMO Objetivo Avaliar a relação custo-utilidade do iStent inject® para o tratamento do glaucoma de ângulo aberto leve a moderado no Sistema Único de Saúde. Métodos Foi desenvolvido um modelo de Markov, no qual a medida de resultado de efetividade foi a razão custo-efetividade incremental (razão de custo-efetividade incremental: R$/ano de vida ajustado pela qualidade). Os custos médicos diretos foram obtidos por meio da perspectiva do Sistema Único de Saúde. O caso base foi composto de uma coorte hipotética de pacientes com glaucoma de ângulo aberto em uso de medicação tópica tratados de acordo com o Protocolo Clínico e Diretrizes Terapêuticas e um cenário do mundo real baseado em dados do Departamento de Informática do Sistema Único de Saúde. Foi testada a robustez do modelo por meio de análises de sensibilidade. Resultados No cenário base do Protocolo Clínico e Diretrizes Terapêuticas, o implante trabecular micro-bypass proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$7.996,66/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. No cenário real baseado em dados do Departamento de Informática do Sistema Único de Saúde, o implante trabecular proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$ 4.485,68/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. Os resultados foram robustos para análises de sensibilidade. Conclusão A incorporação do iStent inject® ao Sistema Único de Saúde proporciona melhora na qualidade de vida do paciente com um custo adicional que garante o benefício proporcionado a eles. Os resultados podem ser considerados custo-efetivos em comparação com a medicação tópica.

Comparative efficacy and cost-utility of combined cataract and minimally invasive glaucoma surgery in primary open-angle glaucoma.

PURPOSE: To assess the comparative efficacy and the long-term cost-utility of alternative minimally invasive glaucoma surgeries (MIGSs) when combined with cataract surgery in patients with primary open-angle glaucoma (POAG). METHODS: Treatment effects, as measured by the 1-year reduction in intraocular pressure (IOP), were estimated with an adjusted indirect treatment comparison. Evidence from randomized clinical trials was identified for four different MIGS methods. A disease-transition model was developed by capturing clinically relevant POAG stages and the expected natural disease evolution. Outcomes of the disease-transition model were the comparative utility [quality-adjusted life years (QALYs)], cost and cost-utility of included strategies in a lifetime horizon. RESULTS: Estimated 1-year IOP reductions were: cataract surgery - 2.05 mmHg (95% CI - 3.38; - 0.72), one trabecular micro-bypass stent - 3.15 mmHg (95% CI - 5.66; - 0.64), two trabecular micro-bypass stents - 4.85 mmHg (95% CI - 7.71; - 1.99) and intracanalicular scaffold - 2.25 mmHg (95% CI - 4.87; 0.37). Discounted outcomes from the disease-transition model appraised the strategy of two trabecular micro-bypass stents with cataract surgery in the moderate POAG stage as the one providing the greatest added value, with 10,955€ per additional QALY. Improved outcomes were seen when assessing MIGS in the moderate POAG stage. CONCLUSIONS: When indirectly comparing alternative MIGS methods combined with cataract surgery, the option of two trabecular micro-bypass stents showed both a superior efficacy and long-term cost-utility from a German perspective. Moreover, outcomes of the disease-transition model suggest POAG patients to beneficiate the most from an earlier intervention in the moderate stage contrary to waiting until an advanced disease is present.

Prospective evaluation of penetrating deep sclerectomy in advanced open-angle glaucoma: Filtration surgery adapted to resource scarcity in developing countries.

PURPOSE: Two of the hurdles that are facing ophthalmologists in developing countries are scarcity of resources and patient follow-up. Deep sclerectomy (DS) has proven less costly and more effective than topical therapies and has a more favorable safety profile than trabeculectomy. The main factors preventing its use in developing countries are the need to perform laser goniopuncture in 40-80% of cases to maintain filtration and the risk of postoperative iris incarceration. The purpose of this study is to assess the efficacy and safety profile in advanced open-angle glaucoma of a relatively new surgical technique designed to overcome this limitation: penetrating DS. SETTING: This was an investigator-initiated, prospective, interventional study, conducted at a single ophthalmology center in Kinshasa, Congo. The study was conducted in full compliance with the Declaration of Helsinki. METHODS: Fifty-one eyes (34 patients) with uncontrolled advanced primary open-angle glaucoma (visual field mean deviation<-10 dBs) were enrolled between October 2012 and June 2016. Age, gender, comorbidities (hypertension/diabetes), best-corrected visual acuity, topical medications, medicated and unmedicated intraocular pressure (IOP) were recorded. All patients underwent penetrating DS, during which, following standard dissection of the scleral flaps, the anterior chamber was penetrated through the trabeculo-Descemet membrane and an iridectomy was performed. Patients attended postoperative appointments at months 1, 3, 6 and 12. Surgical success was defined as a 20% reduction of IOP from baseline in conjunction with a 12-month unmedicated IOP≤12mmHg. RESULTS: The mean age was 64.5±14.0 years (44.1% female, 100% African). Mean IOP decreased from 20.2±6.1 (medicated) and 30.7±9.8mmHg (unmedicated) preoperatively to 12.1±4.1 at 12 months. Concomitantly, the number of topical medications decreased from 1.5±0.7 to 0.0. Complete surgical success was achieved in 64.7%. Four eyes (7.8%) were considered surgical failures due to uncontrolled IOP. None of the eyes lost light perception or required additional surgery. A significant association between surgical failure and hypertension was observed (HR=1.49; P=0.008). There were no intraoperative complications. Postoperatively, 4 bleb encapsulations (7.8%) and 1 iris incarceration (2%) were observed. CONCLUSIONS: The present study demonstrates that penetrating DS achieved similar efficacy and safety results to traditional non-penetrating DS. In addition, it showed a lower potential for intraoperative complications, which might be associated with a more benign surgical learning curve. Finally, the rates of serious postoperative complications (iris incarceration, choroidal effusion and hypotony) were significantly lower than in DS and trabeculectomy, and this technique does not require subsequent Nd: YAG laser goniopuncture to maintain filtration, making frequent follow-up visits less critical. In view of these findings, perforating deep sclerectomy could offer a viable option for glaucoma management in developing countries as well as worldwide.

Direct costs of glaucoma: Relationship between cost and severity of the disease.

OBJECTIVES: To estimate the direct medical costs associated with the management of patients with primary open-angle glaucoma and to compare the costs of patients according to the degree of severity. METHODS: A longitudinal retrospective study was carried out using all patients with primary open-angle glaucoma that recorded follow-up from May 2010 to June 2013 at the Hospital Privado de Córdoba. We estimated the cost of the disease from the perspectives of the institution, with a bottom-up approach. RESULTS: The three-year follow-up after treatment of 104 patients revealed that the average cost of care for a patient with primary open-angle glaucoma was US$2746 ± 1560. The first year of treatment was significantly more expensive than subsequent ones (US$1100-$810-$827). Cost was related to the degree of severity of glaucoma; patients in "Stage 0" had significantly lower costs than those in other groups (Kruskal-Wallis test, p < 0.01). This was a consequence of lower costs associated with medication and a lower percentage of patients undergoing surgery. DISCUSSION: The direct medical costs of a patient with primary open-angle glaucoma vary according to the severity of their disease and the year of treatment. We found that costs increased with disease severity, but decreased over time.

Cost-Utility Analysis of Glaucoma Medication Adherence.

PURPOSE: The majority of patients with glaucoma do not take their medications as prescribed. Estimates of the cost-utility value of adherence to prescribed glaucoma medication are vital to implement potentially effective interventions. DESIGN: Cost-utility analysis using Monte Carlo microsimulations incorporating a series of Markov cycles (10 000 iterations per strategy). PARTICIPANTS: Patients with glaucoma aged ≥40 years with a full lifetime horizon (up to 60 years). METHODS: The analysis estimated glaucomatous progression on the basis of data from the United Kingdom Glaucoma Treatment Study. Participants with glaucoma entered the model at age 40 years with a mean deviation in the better-seeing eye of -1.4±-1.9 decibels (dB) and -4.3±-3.4 dB in the worse-seeing eye. Participants whose glaucoma worsened each year accumulate -0.8 dB loss compared with -0.1 dB loss for those who remained stable. Data from the Glaucoma Laser Trial and the Tube versus Trabeculectomy Studies were used to assign probabilities of worsening disease among treated patients. Claims data estimating rates of glaucoma medication adherence over 4 years were used to assign probability of adherence. Those with poor adherence were modeled as having outcomes similar to the placebo arm of the clinical trials. As patients' mean deviation deteriorated, they transitioned between health states from mild (≥-6 dB), to moderate (<-6 to ≥-12 dB), to severe glaucoma (<-12 to ≥23 dB), to unilateral (<-20 dB) and bilateral blindness. At each health state, patients incurred the costs of treatment and established health utilities; ultimately, societal costs of low vision and blindness were included. MAIN OUTCOME MEASURES: Cost and quality-adjusted life year (QALY) of glaucoma medication adherence. RESULTS: Beginning at an initial glaucoma diagnosis at age 40 years, patients proceeded to single-eye blindness as early as 19 years among those who were nonadherent and 23 years for those remaining adherent. Total healthcare costs for adherent patients averaged $62 782 (standard deviation [SD], 34 107), and those for nonadherent patients averaged $52 722 (SD, 38 868). Nonadherent patients had a mean loss of 0.34 QALYs, resulting in a cost-effectiveness ratio of $29 600 per QALY gained. CONCLUSION: At a conservative willingness to pay of $50 000/QALY, there is room to expand services to improve patient adherence.

Custos não médicos diretos e indiretos relacionados ao glaucoma primário de ângulo aberto no Brasil / Non-medical direct and indirect costs related to primary open-angle glaucoma in Brazil

RESUMO Objetivo: Identificar os custos não médicos diretos e indiretos em uma população de pacientes portadores de glaucoma primário de ângulo aberto (GPAA) em tratamento no Brasil. Métodos: A pesquisa dos custos neste estudo transversal foi realizada através de entrevista a uma população de pacientes portadores de GPAA em acompanhamento em um centro de referência para o tratamento do glaucoma na cidade de Juiz de Fora - MG. Para avaliação dos custos não médicos diretos, as seguintes variáveis foram investigadas: gasto com transporte, hospedagem, alimentação e acompanhante para cada consulta. Já na análise dos custos indiretos, avaliou-se: recebimento ou não de benefício social por causa do glaucoma (aposentadoria ou auxílio-doença) e qual o valor anual e perda de dias trabalhados pelo paciente e/ou pelo acompanhante. Os valores médios anuais foram calculados para todo o grupo e para cada estágio evolutivo do glaucoma. Resultados: Setenta e sete pacientes foram incluídos nesta análise (GPAA inicial: 26,0%; GPAA moderado: 24,7% e GPAA avançado: 49,3%). A média do custo não médico direto foi (em reais): 587,47; 660,52 e 708,54 para os glaucomas iniciais, moderados e avançados, respectivamente. Já a média do custo indireto foi: 20.156,75 (GPAA inicial); 26.988,16 (moderado) e 27.263,82 (avançado). Conclusão: Os custos não médicos diretos e indiretos relacionados ao GPAA no Brasil foram identificados. Os custos indiretos são superiores aos custos não médicos diretos e ambos tendem a aumentar com o avanço da doença.

ABSTRACT Objective: To identify direct and indirect non-medical costs in a population of patients with primary open-angle glaucoma (POAG) receiving treatment in Brazil. Methods: In this cross-sectional study, we obtained the costs through an interview with a population of patients with POAG at a glaucoma referral clinic in the city of Juiz de Fora - MG. In order to assess the direct non-medical costs, we investigated the following variables transportation expenses, lodging expenses, food and companion expenses for each visit. In the indirect costs analysis, we assessed the following variables: whether or not social benefits were received because of glaucoma (retirement or sickness benefit) and the annual value and loss of days worked by the patient and/or the companion. We calculated the mean annual values for the whole group and for each glaucoma stage. Results: Seventy-seven patients were included in this analysis (initial POAG: 26.0%, moderate POAG: 24.7% and advanced POAG 49.3%). The mean non-medical direct cost was (in reais): 587.47; 660.52 and 708.54 for the initial, moderate and advanced glaucomas, respectively. The mean indirect cost was: 20,156.75 (initial POAG); 26,988.16 (moderate POAG) and 27,263.82 (advanced POAG). Conclusion: We identified the direct and indirect non-medical costs related to POAG in Brazil. Indirect costs are higher than non-medical direct costs and both tend to increase with disease progression.

A Comparison of Resource Use and Costs of Caring for Patients With Exfoliation Syndrome Glaucoma Versus Primary Open-Angle Glaucoma.

PURPOSE: To characterize differences in resource utilization and cost of managing enrollees with exfoliation glaucoma (XFG) compared to primary open-angle glaucoma (POAG). DESIGN: Retrospective utilization and cost comparison using Medicare claims data. METHODS: We identified Medicare beneficiaries with XFG or POAG and ≥5 years of continuous enrollment from January 2008 to December 2014. We distinguished newly diagnosed cases from those with preexisting disease. We compared ophthalmic resource utilization and costs over 2 years of follow-up for persons with newly diagnosed and preexisting XFG vs those with POAG. Main outcome measures were number of clinic visits, diagnostic procedures, medication fills, laser and incisional surgery, and mean eye care costs per beneficiary. RESULTS: Among 192 eligible enrollees (median age 77.6 years) with newly diagnosed XFG and 7339 enrollees (median age 77.3 years) with newly diagnosed POAG, those with XFG had more office visits (mean, 9.1 vs 7.9; P = .001), cataract surgery (34.9% vs 19.0%; P < .0001), and glaucoma surgery (28.7% vs 19.7%, P = .002). They also experienced 27% higher mean total eye care costs ($3260 vs $2562, P = .0001) over 2 years of follow-up. Among 2745 enrollees (median age 80.5 years) with preexisting XFG and 89 036 persons (median age 79.5) with preexisting POAG, persons with XFG had more office visits (mean 9.3 vs 7.3; P < .0001), perimetry (85.3% vs 79.8%; P < .0001), cataract surgery (23.4% vs 12.3%; P < .0001), laser trabeculoplasty (18.6% vs 9.6%; P < .0001), and trabeculectomy (8.1 vs 1.8%; P < .0001) and experienced 37% higher total mean eye care costs ($3764 vs $2739; P < .0001). CONCLUSIONS: Healthcare resource utilization and costs are substantially higher for managing patients with XFG compared to POAG.

The cost-effectiveness of medication, laser trabeculoplasty, and trabeculectomy for treatment of open-angle glaucoma in South Korea.

OBJECTIVES: Open-angle glaucoma (OAG) imposes high disease burden in South Korea. Although various effective interventions are available to manage the progression of OAG, there is limited data on the cost-effectiveness of these treatment strategies in South Korea. METHODS: Using a Markov cohort model, we evaluated the cost-effectiveness of 3 major treatment strategies (medication, laser trabeculoplasty, and trabeculectomy) for South Korean patients with OAG. We projected a 25-year time horizon to study a hypothetical cohort of 10,000 patients of age 40 with mild OAG. The outcome measures were quality-adjusted life-years (QALYs) gained, cost from the societal perspective, and the incremental cost-effectiveness ratio (ICER) of medication, laser trabeculoplasty, and trabeculectomy. Interventions were evaluated at a willingness-to-pay (WTP) threshold of 30,000,000 KRW ($29,152) per QALY gained. Deterministic and probabilistic sensitivity analyses were conducted to address the model uncertainty. RESULTS: The mean costs for medication, laser trabeculoplasty, and trabeculectomy were 29,661,740 KRW, 17,34,1342 KRW, and 22,275,438 KRW, respectively. The mean QALYs gained were 15.7, 15.3, and 14.8 for medication, laser trabeculoplasty, and trabeculectomy, respectively. Surgery was strongly dominated because it generated fewer expected QALYs but incurred greater expected cost than laser. The ICER was 30,885,179 KRW per QALY for medication versus laser trabeculoplasty. Laser was cost-effective, however, at a lower WTP threshold of 21,000,000 KRW per QALY gained or below. The results were most sensitive to the progression rates from mild to moderate glaucoma under laser treatment. CONCLUSION: Under the WTP threshold of 30,000,000 KRW per QALY, medication was cost-effective compared with laser trabeculoplasty and trabeculectomy for treating mild OAG in South Korean population. Laser, however, can be a cost-effective alternative in more resource-limited settings.

A cost minimisation analysis comparing iStent accompanying cataract surgery and selective laser trabeculoplasty versus topical glaucoma medications in a public healthcare setting in New Zealand.

PURPOSE: To produce an economic comparison of the iStent ab interno trabecular microbypass implant accompanying cataract surgery and selective laser trabeculoplasty (SLT) as first-line treatment versus topical medications for open-angle glaucoma in New Zealand in 2016. METHODS: The current annual costs of 19 available fully subsidised topical glaucoma medications by Pharmaceutical Management Agency (Pharmac) in 2016 were identified. Adjustments for pharmacist prescribing charges and previously described wastage levels were applied. The costs to perform iStent implantation and the cost to perform SLT were obtained from the local distributors, with the latter taking into account staff and consumable cost. Procedure costs divided by eye drops' cost produced a break-even level in equivalent years of eye drops use. RESULTS: The range of annual eye drop cost was NZD$42.25 to NZD$485.11, with an average of NZD$144.81. Comparison of annual eye drop cost with iStent cost revealed 3 of 19 (15.8%) drops breaking even within 5 years, 9 of 19 (47.3%) within 10 years, and 12 of 19 (63.2%) within 15 years. The cost of bilateral SLT performed by a consultant was NZD$102.30 (breaking even in 0.71 years). The equivalent cost for a registrar was NZD$97.59 (breaking even in 0.67 years). CONCLUSION: Economically, the iStent would appear to be a reasonably cost-effective treatment for glaucoma patients undergoing cataract surgery in a public healthcare setting in New Zealand, particularly for those using more expensive topical glaucoma medications, whilst SLT appears to be a worthwhile consideration as a first-line treatment for glaucoma in New Zealand.

Shared Cared for Stable Glaucoma Patients: Economic Benefits and Patient-centered Outcomes of a Feasibility Trial.

PURPOSE: The purpose of this article is to assess the quality of care and economic benefits of a shared care model managing patients with stable glaucoma in a primary eye care (PEC) clinic compared with a tertiary specialist outpatient clinic (SOC) in Singapore. PATIENTS AND METHODS: A randomized equivalence feasibility trial was preformed comparing the PEC with SOC models. Participants recruited from the SOC had no visual field progression or change in management for at least 3 years, were on a maximum of a single glaucoma medication, had no previous tube-shunt implant and were at least 3-year posttrabeculectomy surgery.Primary outcomes were clinical assessment and management, economic benefits, and patient satisfaction. Differences were analyzed using equivalence testing and generalized odds ratios. RESULTS: The trial included 233 patients, consisting of 42.1% glaucoma disc suspects (PEC: 47.4%; SOC: 36.8%), 27.5% primary angle closure suspects (PEC: 25.0%; SOC: 29.9%), 13.7% with ocular hypertension (PEC: 13.8%; SOC: 13.7%), 3.9% with primary angle closure glaucoma (PEC: 4.3%; SOC: 3.4%), and 3.0% with primary open angle glaucoma (PEC: 1.7%; SOC: 4.3%). Glaucoma clinical care for patients at PEC was as good as SOC [rate difference, 6.83%; 95% confidence interval (CI), 2.84-11.12) and management (rate difference, 7.69%; 95% CI, 3.21-12.17). In 23 cases (9.9%), 5.2% at PEC and 14.5% at SOC, there was disconcordance with the gold standard of senior consultant. Patient satisfaction at the PEC was equally high when compared with SOC (generalized odds ratio, 1.43; CI, 0.50-2.00). Direct costs per patient visit were 43% lower at PEC compared with SOC. CONCLUSION: Managing stable glaucoma patients at a primary care setting is a cost saving, safe, and effective shared care while enhancing professional collaboration between hospital and community settings.

Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

BACKGROUND: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. AIM: To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). METHODS: Design: A prospective, pragmatic multicentre randomised controlled trial (RCT). SETTING: Twenty-seven UK hospital eye services. PARTICIPANTS: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. INTERVENTION: Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). MAIN OUTCOME MEASURES: The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. RESULTS: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. CONCLUSIONS: Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. TRIAL REGISTRATION NUMBER: ISRCTN56878850, Pre-results.

Changing Initial Glaucoma Medical Therapy Increases Healthcare Resource Utilization.

PURPOSE: To determine the frequency and economic impact of changing initial glaucoma therapy for patients with newly diagnosed open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: This retrospective longitudinal cohort study identified individuals within a large managed care network in the United States, who were newly diagnosed with OAG or OHT from 2001 to 2012 and were prescribed either a topical beta blocker (BB) or a prostaglandin analog (PGA). Claims data were analyzed over the 12-month period following their index prescription to determine physician prescribing habits, healthcare resource utilization patterns, and sociodemographic factors which may have contributed to changing the initial treatment strategy. RESULTS: A total of 15,019 beneficiaries were identified with newly diagnosed OAG or OHT and whose index therapy was either a topical BB or PGA. Among these enrollees 80.9% were started on PGAs, while 19.1% were started on BBs. Of these beneficiaries, 29.2% of those started on PGAs and 39.5% of those started on BBs underwent a change in therapy within 12 months of their index prescription. Those in the topical BB treatment group had a 38% increased odds of changing glaucoma therapy relative to those started on PGAs (odds ratio [OR] 0.61, 95% CI:0.56-0.68). Patients who changed therapy required more frequent office visits (P < 0.0001) and incurred higher median eye care related charges (P < 0.0001) compared to those who remained on the index therapy unchanged. CONCLUSIONS: Changing initial ocular hypotensive therapy is common. Individuals who undergo a change in therapy required more frequent face-to-face monitoring and incurred higher healthcare related costs. Identifying strategies capable of optimizing the process of initiating ocular hypotensive therapy are appealing and possess the potential to improve patient outcomes and reduce healthcare costs.

Maximizing cost-effectiveness by adjusting treatment strategy according to glaucoma severity.

BACKGROUND: The aim of this study is to determine the most cost-effective strategy for the treatment of primary open-angle glaucoma (POAG) in Brazil, from the payer's perspective (Brazilian Public Health System) in the setting of the Glaucoma Referral Centers. METHODS: Study design was a cost-effectiveness analysis of different treatment strategies for POAG. We developed 3 Markov models (one for each glaucoma stage: early, moderate and advanced), using a hypothetical cohort of POAG patients, from the perspective of the Brazilian Public Health System (SUS) and a horizon of the average life expectancy of the Brazilian population. Different strategies were tested according to disease severity. For early glaucoma, we compared observation, laser and medications. For moderate glaucoma, medications, laser and surgery. For advanced glaucoma, medications and surgery. Main outcome measures were ICER (incremental cost-effectiveness ratio), medical direct costs and QALY (quality-adjusted life year). RESULTS: In early glaucoma, both laser and medical treatment were cost-effective (ICERs of initial laser and initial medical treatment over observation only, were R$ 2,811.39/QALY and R$ 3,450.47/QALY). Compared to observation strategy, the two alternatives have provided significant gains in quality of life. In moderate glaucoma population, medical treatment presented the highest costs among treatment strategies. Both laser and surgery were highly cost-effective in this group. For advanced glaucoma, both tested strategies were cost-effective. Starting age had a great impact on results in all studied groups. Initiating glaucoma therapy using laser or surgery were more cost-effective, the younger the patient. CONCLUSION: All tested treatment strategies for glaucoma provided real gains in quality of life and were cost-effective. However, according to the disease severity, not all strategies provided the same cost-effectiveness profile. Based on our findings, there should be a preferred strategy for each glaucoma stage, according to a cost-effectiveness ratio ranking.

Cost of glaucoma treatment in a developing country over a 5-year period.

The aim of the study was to disclose a realistic estimate of primary open-angle glaucoma treatment, follow-up costs, and patients' monthly glaucoma-economic burden in an ophthalmology hospital in Mexico City.Prospective survey of 462 primary open-angle glaucoma patients from 2007 to 2012 was carried out. Costs from visits, glaucoma follow-up studies, laser, and glaucoma surgical procedures were obtained from hospital pricings. Education, employment, and monthly income were interrogated. Total cost was divided into hypotensive treatment cost, nonpharmacologic treatment cost (laser and surgeries), and follow-up studies and consults. Average wholesale price for drugs analyzed was obtained from IMS Health data; monthly cost was calculated using: Monthly cost  = ([average wholesale price/number of drops per eye dropper] × number of daily applications) × 30 days.Patients were classified according to their glaucoma severity, and data were analyzed based on monthly income (average annual exchange rate: 12.85 Mexican pesos = 1 USD).The mean age was 70 ±â€Š10 years, women = 81%, elementary school = 39%, and unemployed = 53%. Low-income group = 266 patients (57%), 146 with mild glaucoma; moderate-income group = 176 patients (38%), 81 with mild glaucoma; high-income group = 20 patients (4.3%), 10 with mild glaucoma. Patients' monthly average economic burden in glaucoma treatment: low-income patients = 61.5%, moderate-income patients = 19.5%, and high-income patients = 7.9%.Glaucoma-economic burden is substantial not only for health systems, but for the family and the patient. Therefore, screening plans for earlier diagnosis, and health policies that lessen the cost of disease management and increase adherence to treatment, and reduce the prevalence of blindness attributed to glaucoma are essential. These would improve quality of life, reduce personal and national expenditure, and help increase national economy.

More frequent, more costly? Health economic modelling aspects of monitoring glaucoma patients in England.

BACKGROUND: Chronic open angle glaucoma (COAG) is an age-related eye disease causing irreversible loss of visual field (VF). Health service delivery for COAG is challenging given the large number of diagnosed patients requiring lifelong periodic monitoring by hospital eye services. Yet frequent examination better determines disease worsening and speed of VF loss under treatment. We examine the cost-effectiveness of increasing frequency of VF examinations during follow-up using a health economic model. METHODS: Two different VF monitoring schemes defined as current practice (annual VF testing) and proposed practice (three VF tests per year in the first 2 years after diagnosis) were examined. A purpose written health economic Markov model is used to test the hypothesis that cost effectiveness improves by implementing proposed practice on groups of patients stratified by age and severity of COAG. Further, a new component of the model, estimating costs of visual impairment, was added. Results were derived from a simulated cohort of 10000 patients with quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) used as main outcome measures. RESULTS: An ICER of £21,392 per QALY was derived for proposed practice improving to a value of £11,382 once savings for prevented visual impairment was added to the model. Proposed practice was more cost-effective in younger patients. Proposed practice for patients with advanced disease at diagnosis generated ICERs > £60,000 per QALY; these cases would likely be on the most intensive treatment pathway making clinical information on speed of VF loss redundant. Sensitivity analysis indicated results to be robust in relation to hypothetical willingness to pay threshold identified by national guidelines, although greatest uncertainty was allied to estimates of implementation and visual impairment costs. CONCLUSION: Increasing VF monitoring at the earliest stages of follow-up for COAG appears to be cost-effective depending on reasonable assumptions about implementation costs. Our health economic model highlights benefits of stratifying patients to more or less monitoring based on age and stage of disease at diagnosis; a prospective study is needed to prove these findings. Further, this works highlights gaps in knowledge about long term costs of visual impairment.

Manchester iStent study: 3-year results and cost analysis.

PurposeTo evaluate the safety, efficacy, and the cost of combined phacoemulsification and single iStent insertion in open angle glaucoma (OAG) at 3-years follow-up.MethodsThis was a prospective, uncontrolled, interventional case series. All subjects underwent single iStent implantation combined with cataract surgery by a single surgeon and were followed up over 3 years. Primary outcome measures were the reduction in intraocular pressure (IOP) and number of glaucoma drops at 1, 2, and 3 years. The costs of the procedure vs the cost of continuation of glaucoma drops were calculated and compared in patients who completed 3-years follow-up.ResultsForty-one patients were included in the study and thirty-six patients completed 3-years follow-up. Mean pre-op IOP was 21.2 mm Hg on 2.1 medications. Mean IOP was reduced to 15.9 mm Hg on 0.5 drops, 16.1 mm Hg on 1.0 drops, and 17.1 mm Hg (P<0.001) on 1.3 drops (P<0.001) at 1, 2, and 3 years, respectively. The overall cost of combined cataract surgery and iStent was estimated to be £829.32 more in total than conservative management with brand name eye drops over 3 years (£7.70 per patient per year) and £14 176.9 more if generic drops were used. (£131.3 per patient per year).ConclusionsCombined phaco-iStent proved to be a safe and effective way of managing patients with OAG over our 3-year follow-up period. The cost-effectiveness of the procedure may vary depending on whether brand name or generic eye drops are used.

Improving Access to Eye Care among Persons at High-Risk of Glaucoma in Philadelphia--Design and Methodology: The Philadelphia Glaucoma Detection and Treatment Project.

PURPOSE: The Wills Eye Glaucoma Research Center initiated a 2-year demonstration project to develop and implement a community-based intervention to improve detection and management of glaucoma in Philadelphia. METHODS: The glaucoma detection examination consisted of: ocular, medical, and family history; visual acuity testing; corneal pachymetry; biomicroscopy of the anterior segment; intraocular pressure (IOP) measurement; gonioscopy; funduscopy; automated visual field testing; and fundus-color photography. Treatment included laser surgery and/or IOP-lowering medication. A cost analysis was conducted to understand resource requirements. Outcome measures included; prevalence of glaucoma-related pathology and other eye diseases among high-risk populations; the impact of educational workshops on level of knowledge about glaucoma (assessed by pre- and post-test evaluation); and patient satisfaction of the glaucoma detection examinations in the community (assessed by satisfaction survey). Treatment outcome measures were change in IOP at 4-6 weeks and 4-6 months following selective laser trabeculoplasty treatment, deepening of the anterior chamber angle following laser-peripheral iridotomy treatment, and rate of adherence to recommended follow-up examinations. Cost outcomes included total program costs, cost per case of glaucoma detected, and cost per case of ocular disease detected. RESULTS: This project enrolled 1649 participants (African Americans aged 50+ years, adults 60+ years and individuals with a family history of glaucoma). A total of 1074 individuals attended a glaucoma educational workshop and 1508 scheduled glaucoma detection examination appointments in the community setting. CONCLUSIONS: The Philadelphia Glaucoma Detection and Treatment Project aimed to improve access and use of eye care and to provide a model for a targeted community-based glaucoma program.

Impact of Socioeconomic Status on the Diagnosis of Primary Open-Angle Glaucoma and Primary Angle Closure Glaucoma: A Nationwide Population-Based Study in Taiwan.

PURPOSE: To understand the impact of socioeconomic status (SES) on the diagnosis of primary open-angle glaucoma (POAG) and primary angle closure glaucoma (PACG) in Taiwan. METHODS: Subjects with glaucoma were identified from the National Health Insurance Research Database of year 2006, which included one million randomly selected insurants. Individuals who had ≥4 ambulatory visits within one year which had the diagnosis code of POAG (ICD-9-CM 365.11 or 365.12) or PACG (365.23) and concurrent prescription of anti-glaucoma medication or surgery were selected. Individual SES was represented by monthly income calculated from the insurance premium. Neighborhood SES was defined based on neighborhood household income averages. Urbanization level of habitation was categorized into 3 levels. The odds ratio of having POAG or PACG in subjects with different SES was evaluated by using multiple logistic regression analysis. RESULTS: In total, 752 and 561 subjects with POAG and PACG, respectively, who were treated on a regular basis, were identified. The diagnosis of glaucoma was affected by age, gender, frequency of healthcare utilization, individual SES, and urbanization level of habitation. With the adjustment of age, gender, healthcare utilization, neighborhood SES and level of urbanization, subjects with lower income were more likely to be diagnosed as PACG, but less likely as POAG. CONCLUSIONS: Subjects with more frequent healthcare utilization were more likely to be diagnosed with glaucoma. Subjects with low SES were more susceptible to PACG, but subjects with high SES were more likely to be diagnosed as POAG. This information is useful for the design and target participant setting in glaucoma education and screening campaign to maximize the efficacy of limited resources in preventing glaucoma blindness.

Custo-utilidade do tratamento do glaucoma primário de ângulo aberto no Brasil / Cost-utility of primary open-angle glaucoma in Brazil

RESUMO Objetivo: Determinar a estratégia mais custo-efetiva para o tratamento do glaucoma primário de ângulo aberto em fase inicial, comparando-se as seguintes alternativas: observação, tratamento clínico ou tratamento com laser. Métodos: Por meio de um modelo de Markov, sob a perspectiva do Sistema Único de Saúde (SUS) e um horizonte da expectativa de vida média da população brasileira. Comparou-se a razão de custo-utilidade incremental (ICUR) entre 3 alternativas de tratamento, assim como seus custos e o ganho em qualidade de vida, medido em QALY (Quality-adjusted life years). Resultados: A ICUR do tratamento inicial com laser e do tratamento inicial com colírios, em relação a não tratar foi de R$ 2.811,39/QALY e R$ 3.450,47/QALY, respectivamente. Ambas as estratégias foram custo-efetivas, com uma discreta vantagem para o tratamento a laser. Esta diferença diminui ainda mais quando se aumenta a idade de entrada no modelo. As duas alternativas propiciaram ganhos significativos de qualidade de vida (em torno de 2,5 QALYs para o tratamento com laser e de 5,0 QALYs para o tratamento com colírios). Conclusão: Tanto o tratamento primário com trabeculoplastia a laser quanto com medicações foram custo-efetivos e proporcionaram ganhos reais de qualidade de vida quando comparados com o não tratamento do GPAA.

ABSTRACT Objective: To determine the most cost-effective strategy for the treatment of early-stage primary open-angle glaucoma, by comparing the following alternatives: observation, medical therapy or laser treatment. Methods: Using a Markov model, from the perspective of the Brazilian Public Health System (SUS) and a horizon of the average life expectancy of the Brazilian population, we compared the incremental cost-utility ratio (ICUR) among the three treatment alternatives, as well as their costs and the gain in quality of life as measured in QALYs (Quality-adjusted life years). Results: The ICUR of initial laser treatment and initial medical treatment over observation only, was R$ 2,811.39/QALY and R$ 3,450.47/QALY, respectively. Both strategies were cost-effective, with a slight advantage for the laser treatment. This difference decreases further when increasing age into the model. The two alternatives have provided significant gains in quality of life (around 2.5 QALYs for the laser treatment and 5.0 QALYs for treatment with eye drops). Conclusion: Both primary treatments, with laser trabeculoplasty as well as with medications, were cost-effective and provided real gains in quality of life when compared with no treatment of POAG.