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.

Impacto financeiro no tratamento cirúrgico do glaucoma / Financial impact on glaucoma surgical treatment

Resumo Objetivo: Segunda maior causa de cegueira mundial, o glaucoma, ocasionalmente necessita de procedimento cirúrgico para controle. Tendo o Brasil um Sistema Único de Saúde (SUS), e crise político-econômica em 2016, objetiva-se avaliar o impacto financeiro na decisão terapêutica do glaucoma nos últimos 6 anos no Brasil, e considerar atual discussão sobre indicação de procedimentos intervencionistas precocemente no seu algoritmo terapêutico. Métodos: Estudo ecológico da população brasileira, com base no Sistema de Informações Hospitalares do SUS, avaliando comportamento temporal dos procedimentos cirúrgicos do SUS para tratamento do glaucoma, e variação do dólar como influenciador da tendência temporal sobre os procedimentos. Realizada a análise de Regressão Linear Simples, com significância estatística de P<0.05. Resultados: Entre 2013 e 2018 foram internados 24888 indivíduos por glaucoma, prevalência do sexo masculino (51.68%), brancos (32,57%) e idosos (57.84%). Regiões Sudeste (45.61%) e Nordeste (26.36%) com maior número de internações, sendo a Trabeculectomia (84,18%) principal procedimento realizado. Houve associação da Trabeculectomia e Implante de Válvula, individualmente e atrelados, com os valores do dólar nas regiões Centro-Oeste (β= 1,103 com P= 0,007 para Trabeculectomias e β= 1,105 com P=0,012 para ambos os procedimentos) e Sul (β= 16,727 e P= 0,006 para os Implantes), e associação entre aumento de Implantes na região Sul e maior cobertura na atenção básica (β= 0.64 e P= 0.009). Conclusão: Observou-se não interferência do dólar, e aumento dos procedimentos na região Sul e Centro-Oeste. Os resultados corroboram tendência intervencionista, podendo ser representada pelo possível uso dos procedimentos disponibilizados pelo SUS de forma precoce.

Abstract Objective: The second leading cause of blindness worldwide, glaucoma, occasionally requires surgical procedure for control. Given that Brazil has an Unified Health System (SUS) and a political-economic crisis in 2016, we aim to evaluate the financial impact on the therapeutic decision of glaucoma in the last 6 years in Brazil, and to consider the current discussion about early interventionist indication in its therapeutic algorithm. Methods: Ecological study of the Brazilian population, based on the SUS Hospital Information System, evaluating the temporal behavior of SUS surgical procedures on glaucoma treatment, and dollar variation as influencing the temporal trend on the procedures. Simple Linear Regression analysis was performed, with statistical significance of P <0.05. Results: Between 2013 and 2018, 24888 individuals were hospitalized for glaucoma, male prevalence (51.68%), whites (32.57%) and elderly (57.84%). Southeast (45.61%) and Northeast (26.36%) Regions with the largest number of hospitalizations, and Trabeculectomy (84.18%) being the main procedure performed. There was an association of trabeculectomy and valve implantation, individually and linked, with dollar values in the Midwest (β = 1.103 with P = 0.007 for Trabeculectomies and β = 1.105 with P = 0.012 for both procedures) and South (β). = 16,727 and P = 0,006 for Implants), and association between increased Implants in the South region and greater coverage in primary care (β = 0.64 and P = 0.009). Conclusion: Non-dollar interference was observed, and increased procedures in the South and Midwest. The results corroborate an interventionist tendency and may be represented, possible, by the use of procedures provided by the SUS in an early manner.

A Canadian Cost-Utility Analysis of 2 Trabecular Microbypass Stents at Time of Cataract Surgery in Patients with Mild to Moderate Open-Angle Glaucoma.

PURPOSE: To assess, from the Canadian public payer perspective, the cost-utility of implanting iStent Inject trabecular bypass stent (TBS) devices in conjunction with cataract surgery versus cataract surgery alone in patients with open-angle glaucoma (OAG) and visually significant cataract. DESIGN: Cost-utility analysis using efficacy and safety results of pivotal randomized clinical trial. PARTICIPANTS: Modeled cohort of patients with OAG (83.1% with mild disease, 16.9% with moderate disease) and visually significant cataract. METHODS: Open-angle glaucoma treatment costs and effects were projected over a 15-year time horizon using a Markov model with Hodapp-Parrish-Anderson glaucoma stages (mild, moderate, advanced, severe or blind) and death as health states. Patients in the mild or moderate OAG health states received implantation of iStent Inject during cataract surgery versus cataract surgery alone. On worsening of visual field defect and optic disc damage, patients could receive selective laser trabeculoplasty and trabeculectomy. We measured treatment effect as reduction in intraocular pressure (IOP) and mean medication use and estimated transition probabilities based on efficacy-adjusted visual field mean deviation decline per month. Healthcare resource utilization and utility scores were obtained from the literature. Cost inputs (2017 Canadian dollars [C$]) were derived using the Ontario Health Insurance Plan, expert opinion, medication claims datasets, and Ontario Drug Benefit Formulary medication consumption costs. We conducted deterministic and probabilistic sensitivity analyses to examine the impact of alternative model input values on results. MAIN OUTCOME MEASURES: Incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Compared with cataract surgery alone, TBS plus cataract surgery showed a 99% probability of being more effective (+0.023 QALYs; 95% confidence interval [CI], 0.004 to 0.044) and a 73.7% probability of being cost-saving (net cost, -C$389.00; 95% CI, -C$1712.00 to C$850.70). In 95% of all simulations, TBS plus cataract surgery showed a cost per QALY of C$62 366 or less. Results were robust in additional sensitivity and scenario analyses. CONCLUSIONS: iStent Inject TBS implantation during cataract surgery seems to be cost effective for reducing IOP in patients with mild to moderate OAG versus cataract surgery alone.

Selective laser trabeculoplasty vs. topical medications for step-up treatment in primary open angle glaucoma: comparing clinical effectiveness, quality of life and cost-effectiveness.

INTRODUCTION: The aim of this study was to investigate the clinical effectiveness, health related quality of life (HRQoL) and cost effectiveness of selective laser trabeculoplasty (SLT) compared to topical anti-glaucoma medications in step-up treatment of patients with primary open angle glaucoma (POAG). METHODS: Seventeen POAG patients with suboptimal IOP control despite pre-existing topical medications were subjected to adjunct SLT (50 applications 180 degrees) or second line medical therapy. Current medications were continued, and patients were followed up for 6 months for degree of intraocular pressure (IOP) lowering. HRQoL was assessed using Glaucoma Quality of Life 36-item (GlauQoL-36), Assessment of Quality of Life-7D (AQoL-7D) and Vision related Quality of Life (VisQoL). Costs involved were calculated and compared to the effect (IOP reduction) achieved in each arm. RESULTS: Ten patients were in the SLT group and 7 in the topical medication (MED) group. Mean baseline intraocular pressure (IOP) was 18.90±3.48mmHg in SLT group and 15.57±2.23mmHg in MED group. Mean reduction of IOP was 4.30±1.64mmHg in SLT group and 2.71±2.56 mmHg in MED group at 6 months which was not statistically significant (p=0.14) between two groups. All the HRQoL questionnaires did not show significant changes in the groups or between groups when compared baseline with 6-month post treatment (p-values ranging from 0.247 to 0.987). For every 1mmHg reduction in IOP, cost involved in MED group (RM53.61) was 165% of the cost involved in SLT group (RM32.56). DISCUSSION AND CONCLUSION: This study has shown that SLT was as effective clinically and tolerable as topical anti glaucoma medications and was possibly more cost effective in the step-up treatment of patients with POAG at 6 months follow- up.

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.

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.

Cost-effectiveness analysis of standalone trabecular micro-bypass stents in patients with mild-to-moderate open-angle glaucoma in Canada.

OBJECTIVES: To estimate the cost-utility of two trabecular micro-bypass stents (TBS) implantation vs standard of care (SOC) in patients with mild-to-moderate open-angle glaucoma (OAG) in the Canadian healthcare setting. METHODS: The deterioration in visual field (VF) defect over a 15-year time horizon was tracked using a Markov model with Hodapp-Parrish-Anderson stages of glaucoma (mild, moderate, advanced, severe/blind) and death as health states. Meta-analyses of randomized clinical trials were conducted to estimate the pooled reduction in intraocular pressure (IOP) and medication use due to TBS and SOC. The rate of decline in VF loss was adjusted by the extent of IOP reduction to estimate transition probabilities. Healthcare resource utilization, unit costs (2017 CAD), and progression-related utility scores were obtained by literature review, and medication costs with wastage were obtained from IMS Brogan PharmaStat. The impact of parameter and methodological uncertainty on costs and quality-adjusted life years (QALYs) was examined using probabilistic and 1-way sensitivity analyses. RESULTS: The meta-analysis showed an additional reduction of 1.13 medications/patient and an additional decrease in IOP of -1.10 mmHg at 36 months favoring TBS. TBS strongly dominated medication alone, due to higher improvement in quality-of-life (0.068 QALYs), fewer blind eyes (-0.0031), and a decrease in total healthcare costs of C$2,908.3 per patient over the time horizon (C$9,394.1 TBS vs C$12,302.4 medication alone). Sensitivity analyses showed that results were robust to the uncertainties in model inputs and assumptions. Time-to-dominance was 44 months (3.7 years). CONCLUSIONS: The TBS procedure was cost-effective over SOC in a 15-year time horizon, with quality-of-life gains.

A Worldwide Price Comparison of Glaucoma Medications, Laser Trabeculoplasty, and Trabeculectomy Surgery.

Importance: Medical and surgical interventions for glaucoma are effective only if they are affordable to patients. Little is known about how affordable glaucoma interventions are in developing and developed countries. Objective: To compare the prices of topical glaucoma medications, laser trabeculoplasty, and trabeculectomy relative with median annual household income (MA-HHI) for countries worldwide. Design, Setting and Participants: Cross-sectional observational study. For each country, we obtained prices for glaucoma medications, laser trabeculoplasty, and trabeculectomy using government pricing data, drug databases, physician fee schedules, academic publications, and communications with local ophthalmologists. Prices were adjusted for purchasing power parity and inflation to 2016 US dollars, and annual therapy prices were examined relative to the MA-HHI. Interventions costing less than 2.5% of the MA-HHI were considered affordable. Main Outcomes and Measures: Daily cost for topical glaucoma medications, cost of annual therapy with glaucoma medications, laser trabeculoplasty, and trabeculectomy relative to MA-HHI in each country. Results: Data were obtained from 38 countries, including 17 developed countries and 21 developing countries, as classified by the World Economic Outlook. We observed considerable variability in intervention prices compared with MA-HHI across the countries and across interventions, ranging from 0.1% to 5% of MA-HHI for timolol, 0.1% to 27% for latanoprost, 0.2% to 17% for laser trabeculoplasty, and 0.3% to 42% for trabeculectomy. Timolol was the most affordable medication in all countries studied and was 2.5% or more of MA-HHI in only 2 countries (5%). The annual cost of latanoprost was 2.5% or more of MA-HHI in 15 countries (41%) (15 developing countries [75%] and no developed countries). The cost of laser trabeculoplasty was 2.5% or more of the MA-HHI in 15 countries (44%) (11 developing countries [65%] and 4 developed countries [24%]). The cost of trabeculectomy was 2.5% or more of the MA-HHI in 28 countries (78%) (18 developing countries [95%] and 10 developed countries [59%]). In 18 countries (53%), laser trabeculoplasty cost less than a 3-year latanoprost supply. Conclusions and Relevance: For many patients worldwide, the costs of medical, laser, and incisional surgical interventions were 2.5% or more of the MA-HHI. Successfully reducing global blindness from glaucoma requires addressing multiple contributing factors, including making glaucoma interventions more affordable.

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.

The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics.

PURPOSE: The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT). PARTICIPANTS: 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014. METHODS: Patients were randomised to initial SLT followed by medical therapy or medical therapy without laser. Participants will be monitored for 3 years, according to routine clinical practice. The primary outcome is EQ-5D-5L. Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index (GUI), Glaucoma Symptom Scale, Glaucoma Quality of Life (GQL), pathway effectiveness, visual function, safety and concordance. RESULTS: A total of 555 patients had POAG and 163 OHT; 518 patients had both eyes eligible. The mean age for patients with POAG was 64 years and for OHT 58 years. 70% of all participants were white. Median IOP for OHT eyes was 26 mm Hg and 23 mm Hg for POAG eyes. Median baseline visual field mean deviation was -0.81 dB for OHT eyes and -2.82 dB for POAG eyes. There was no difference between patients with POAG and patients with OHT on the EQ-5D-5DL; the difference between OHT and POAG on the GUI was -0.02 and 1.23 on the GQL. CONCLUSIONS: The LiGHT trial is the first RCT to compare the two treatment options in a real-world setting. The baseline characteristics of the LiGHT cohort compare well with other landmark glaucoma studies. TRIAL REGISTRATION NUMBER: ISRCTN32038223, Pre-results.

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.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

PURPOSE: The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. CONCLUSIONS: The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. TRIAL REGISTRATION NUMBER: ISRCTN32038223, Pre-results.

Cost-effectiveness of Phacoemulsification Versus Combined Phacotrabeculectomy for Treating Primary Angle Closure Glaucoma.

PURPOSE: The purpose of this study is to compare the cost effectiveness of phacoemulsification and combined phacotrabeculectomy for lowering intraocular pressure (IOP) in primary angle closure glaucoma (PACG) eyes with coexisting cataract. METHODS: Real-life data of 2 previous randomized control trials that involved 51 medically uncontrolled PACG eyes and 72 medically controlled PACG eyes were utilized to calculate the direct cost of treatment. They were followed-up for 2 years. Cost of preoperative assessments, surgical interventions, additional procedures for managing complications and maintenance of filtration, postoperative follow-up, and cost of medications were considered. Cost data of 3 different regions (The United States, People's Republic of China, and Hong Kong) were used for comparison. RESULTS: The corresponding average costs for treating 1 eye with newly diagnosed PACG by phacoemulsification alone and combined phacotrabeculectomy were US$3479 and US$2439 in the United States, US$1051 and US$861 in China, and US$6856 and US$12087 in Hong Kong. Surgical and medications costs were the 2 key contributors. Combined phacotrabeculectomy was more cost-effective for IOP reduction when calculating with the United States and China cost data, but was less cost-effective when calculating with the Hong Kong cost data. The cost-effectiveness was insensitive to the costs of follow-up visit and investigations, the cost of surgical operations, and the cost of postoperative procedures, but sensitive to the cost fluctuation of medications. Furthermore, for the medically uncontrolled PACG group, phacoemulsification alone became more cost-effective when the cost of medication was reduced by >75%. CONCLUSIONS: Combined phacotrabeculectomy is a more cost-effective option for lowering IOP in PACG eyes with coexisting cataract, over a 2-year follow-up period.

Cost-comparison of two trabecular micro-bypass stents versus selective laser trabeculoplasty or medications only for intraocular pressure control for patients with open-angle glaucoma.

AIM: Patients with open-angle glaucoma (OAG) whose intraocular pressure is not adequately controlled by one medication have several treatment options in the US. This analysis evaluated direct costs of unilateral eye treatment with two trabecular micro-bypass stents (two iStents) compared to selective laser trabeculoplasty (SLT) or medications only. MATERIALS AND METHODS: A population-based, annual state-transition, probabilistic, cost-of-care model was used to assess OAG-related costs over 5 years. Patients were modeled to initiate treatment in year zero with two iStents, SLT, or medications only. In years 1-5, patients could remain on initial treatment or move to another treatment option(s), or filtration surgery. Treatment strategy change probabilities were identified by a clinician panel. Direct costs were included for drugs, procedures, and complications. RESULTS: The projected average cumulative cost at 5 years was lower in the two-stent treatment arm ($4,420) compared to the SLT arm ($4,730) or medications-only arm ($6,217). Initial year-zero costs were higher with two iStents ($2,810) than with SLT ($842) or medications only ($996). Average marginal annual costs in years 1-5 were $322 for two iStents, $777 for SLT, and $1,044 for medications only. The cumulative cost differences between two iStents vs SLT or medications only decreased over time, with breakeven by 5 or 3 years post-initiation, respectively. By year 5, cumulative savings with two iStents over SLT or medications only was $309 or $1,797, respectively. LIMITATIONS: This analysis relies on clinical expert panel opinion and would benefit from real-world evidence on use of multiple procedures and treatment switching after two-stent treatment, SLT, or polypharmaceutical initial approaches. CONCLUSIONS: Despite higher costs in year zero, annual costs thereafter were lowest in the two-stent treatment arm. Two-stent treatment may reduce OAG-related health resource use, leading to direct savings, especially over medications only or at longer time horizons.

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

BACKGROUND: To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. METHODS: This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged <16 years with uncontrolled intraocular pressure (IOP) refractory to medical treatment and considered at high risk of failure following trabeculectomy were recruited. Eligible children were implanted with the AADI. Those completing minimum 6-month follow-up were included. Main outcome measures were IOP reduction from preoperative values and postoperative complications. RESULTS: 34 eyes of 31 patients were analysed. Average follow-up was 18.3±6.9 months. Mean IOP reduced from 27.4±7.5 mm Hg on maximum medication to 14.6±10.74 mm Hg, 13.8±7.5 mm Hg, 12.8±5.6 mm Hg and 14.7±5.8 mm Hg at 1 week, 6 months, 1 year (32 eyes of 29 children) and 2 years (25 eyes of 22 children) postoperatively, respectively (p<0.001). The cumulative probability of success was 91.18% at 6 months and 81.7% at 18-24 months. Mean number of topical medications decreased from 3.1±0.6 to 1.8±1.3 at 6 months and 1.6±1.1 at 24 months (p<0.001). Preoperatively, 25 patients required systemic acetazolamide, decreasing to three patients at 2 years. There was no tube erosion or infection. One eye developed retinal detachment. CONCLUSION: The AADI appears to be a viable low-cost GDD with effectiveness and safety profile comparable with published reports of the BGI and Ahmed glaucoma valve implant in children.

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.

Predictors, Resource Utilization, and Short-term Costs of Laser Trabeculoplasty Versus Medication Management in Open-Angle Glaucoma.

PURPOSE: Adjunctive laser trabeculoplasty (LT) is an alternative to topical medications for open-angle glaucoma (OAG). The purpose was to: (1) identify predictors of LT vs glaucoma medication treatment; and (2) estimate the resource utilization and short-term costs associated with LT vs medication management. DESIGN: Retrospective administrative claims analysis. METHODS: Medical and pharmacy claims data between 2007 and 2012 were analyzed to identify prostaglandin analogue monotherapy OAG patients with an index date LT claim or second medication class claim. Patients were followed for 12 months pre-index and 24 months post-index. Predictive LT attributes included age, sex, employment status, medication adherence, comorbidity status, and geographic region. Short-term costs included glaucoma-specific and comprehensive healthcare encounters. Cohort comparisons were analyzed using χ(2) and Student t tests, logistic regression (predictive), and generalized linear models (cost). RESULTS: The study included 4743 LT and 16 484 medication patients. Baseline demographics were similar but significant differences were identified for comorbidities, adherence, and geography. Younger age (odds ratio [OR]: 1.21; P < .001), low adherence (OR: 1.18; P = .001), high comorbidities (OR: 1.12; P = .006), and region (OR: 1.50; P < .001) significantly predicted LT receipt. Within LT patients, 60% did not have a pharmacy claim 45 days post-index; by 2 years, this reduced to 20%. LT attributed significantly higher medical ($2684 vs $1980; P < .0001), lower pharmacy ($807 vs $1467; P < .0001), and greater overall costs ($3441 vs $3408; P = .325). CONCLUSIONS: Poor adherence, younger age, and more comorbidities were predictors of receiving LT. Despite the potential for LT to address adherence, most patients had a medication claim within 2 years. Overall, LT does not provide glaucoma-specific cost savings.