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.

Intra-Scleral Ciliary Sulcus Suprachoroidal Microtube: Making Supraciliary Glaucoma Surgery Affordable.

PURPOSE: The suprachoroidal space (SCS) has been a successful target to lower intraocular pressure (IOP) in glaucoma patients. We present the results of 4 patients who underwent a novel glaucoma surgical procedure to lower IOP: Intrascleral Ciliary Sulcus-Suprachoroidal Microtube. METHODS: A sterile medical grade silicone microtube (Tube extender, New World Medical) was surgically placed to drain aqueous from the posterior chamber ciliary sulcus of the eye to the SCS. The internal diameter of the tube was 300 um and the length varied from 8-10mm. After informed consent was obtained and witnessed, this procedure was performed in glaucoma patients with pseudophakia. The tube was placed intrasclerally beneath an inferotemporal sclera flap (50% thickness approximately 4mm x 4mm). The anterior end of the tube was inserted into the ciliary sulcus approximately 2mm from the limbus and the posterior end was placed into the SCS approximately 4mm from the limbus. The microtube was sutured to the sclera with a 10-0 nylon suture. 8-0 vicryl sutures were used to close the sclera flap and the conjunctiva inferotemporally. RESULTS: All 4 patients had lower IOP. The average reduction of IOP was 36% at 3 months. The amount of glaucoma medications per patient at 3 months dropped from an average of 3 to 0.25. The risks are similar to traditional glaucoma incisional surgery. CONCLUSION: This new technique of Intrascleral Ciliary Sulcus-Suprachoroidal Microtube in all four patients with mild, moderate, and advanced glaucoma demonstrated a significant lowering of IOP and a decrease in the number of medications. Further research is required to assess long term efficacy and safety.

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.

Surgical Outcomes of a New Low-Cost Nonvalved Glaucoma Drainage Device in Refractory Glaucoma: Results at 1 Year.

PURPOSE: The purpose of this study was to report the early outcomes in terms of efficacy and safety of a new, indigenously manufactured, low-cost nonvalved drainage device [AADI (Aurolab Aqueous Drainage Implant)] in the management of refractory glaucoma in the Indian population. METHODS: Retrospective review of consecutive patients older than 12 years, who underwent glaucoma drainage device surgery (GDD) using AADI, by a single fellowship-trained surgeon, between January 2014 and December 2016, who had at least 3 months of documented post-op follow-up. OUTCOME MEASURES: Primary-intraocular pressure (IOP).Secondary-number of antiglaucoma medication (AGM), LogMAR best corrected visual acuity (BCVA), and complications.Complete success was defined as IOP ≥5 mm Hg and ≤21 mm Hg or reduction of IOP by ≥20% from baseline without AGM; qualified success with use of AGM. Failure was defined as inability to meet IOP criteria, loss of perception of light, explantation or any additional glaucoma surgery. RESULTS: A total of 54 eyes of 51 patients were included. Mean follow up was 12.1±6.3 months. The IOP and number of AGM required was significantly lower at every visit postoperatively (P<0.001). Median LogMAR BCVA remained unchanged (P=0.5). Complications occurred in 22 patients (40.7%). Complete success was seen in 66.6%; overall success was 92.6%. CONCLUSIONS: New nonvalved GDD (AADI) surgery is effective in reducing IOP and need for AGM with a safety profile similar to published reports of prevailing GDDs. It thus has the ability to breach the cost barrier in low-to-middle income countries; further follow-up is required to determine sustainability over time.

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.

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.

Comparative Cost-effectiveness of the Baerveldt Implant, Trabeculectomy With Mitomycin, and Medical Treatment.

IMPORTANCE: The Tube vs Trabeculectomy Trial (TVT) found that the 350-mm2 Baerveldt implant (tube) and trabeculectomy with mitomycin may be similarly effective in lowering intraocular pressure in primary open-angle glaucoma. However, to date, there are no published long-term clinical data on the cost-effectiveness of trabeculectomy with mitomycin vs tube insertion. OBJECTIVE: To assess the cost-effectiveness of these procedures compared with maximal medical treatment. DESIGN, SETTING, AND PARTICIPANTS: We used the Markov cohort model with a 5-year time horizon to study a hypothetical cohort of 100 000 patients who required glaucoma surgery. MAIN OUTCOMES AND MEASURES: Quality-adjusted life-years (QALYs) gained, costs from the societal perspective, and the incremental cost-effectiveness ratio of medical treatment, trabeculectomy, and tube insertion. Costs were identified from Medicare Current Procedural Terminology and Ambulatory Payment Classification reimbursement codes and Red Book medication costs. The QALYs were based on visual field and visual acuity outcomes. The hypothetical societal limit to resources was included using a willingness-to-pay threshold of $50 000 per QALY. Costs and utilities were discounted at 3% per year. Uncertainty was assessed using deterministic sensitivity analyses. RESULTS: The mean costs for medical treatment, trabeculectomy, and tube insertion were $6172, $7872 and $10 075, respectively; these amounts resulted in a cost difference of $1700 (95% CI, $1644-$1770) for medical treatment vs trabeculectomy, $3904 (95% CI, $3858-$3953) for medical treatment vs tube insertion, and $2203 (95% CI, $2121-$2261) for trabeculectomy vs tube insertion. The mean 5-year probability of blindness was 4% for both surgical procedures and 15% for medical treatment. The utility gained after medical treatment, trabeculectomy, and tube insertion was 3.10, 3.30, and 3.38 QALYs, respectively. The incremental cost-effectiveness ratio was $8289 per QALY for trabeculectomy vs medical treatment, $13 896 per QALY for tube insertion vs medical treatment, and $29 055 per QALY for tube insertion vs trabeculectomy. The cost-effectiveness of each surgical procedure was most sensitive to early and late surgical failure rates and was minimally affected by adverse events, rates of visual field progression, or medication costs. CONCLUSIONS AND RELEVANCE: Assuming a willingness to pay of $50 000 per QALY, trabeculectomy and tube insertion are cost-effective compared with medical treatment alone. Trabeculectomy, however, is cost-effective at a substantially lower cost per QALY compared with tube insertion. More research is necessary to reliably account for patient preferences between the 2 operations.

Economic analysis of the Ex-PRESS miniature glaucoma device versus trabeculectomy.

PURPOSE: Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy. This study aimed to compare the 1-year cost differences between the 2 operations. METHODS: Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy. Surgical cost difference and 1-year postoperative costs (follow-up visits, additional procedures, and medications) were determined and compared. The 95% confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method. RESULTS: Forty-three subjects with 1-year follow-up were included. Success rate was not significantly different for Ex-PRESS (65%) versus trabeculectomy (55%, P=0.49). Ex-PRESS had a net surgical cost of $956 greater than trabeculectomy. There was no significant difference in the overall postoperative cost [median (interquartile range); $485 (337, 822) vs. $609 (387, 820), P=0.78], cost of follow-up visits [$303 (275, 358) vs. $317 (275, 385), P=0.75], additional procedures [$182 (0, 365) vs. $182 (0, 365), P=0.69], or glaucoma medication [$0 (0, 68) vs. $0 (0, 90), P=0.8] for Ex-PRESS versus trabeculectomy, respectively. The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $9625 (95% confidence interval, $2435-548,084). CONCLUSIONS: Ex-PRESS is associated with greater surgical cost compared with trabeculectomy. This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy.

Comparison of acquisition costs of surgical supplies in different health care systems for cataract and glaucoma procedures.

PURPOSE: To determine cost identification and acquisition cost comparison of surgical supplies for performing cataract and glaucoma procedures. METHODS: This is a nonrandomized comparative and cross-sectional study. Six health care systems [state-run charity hospital, a private university hospital, 2 ambulatory surgical centers (ASCs), and 2 Veterans Affairs Medical Centers] participated in the study. A list of input prices for disposable surgical items necessary for phacoemulsification with intraocular lens and for trabeculectomy with mitomycin-C (MMC), Ex-PRESS shunt placement, and Ahmed glaucoma valve (AGV) with scleral patch graft was administered to 6 facilities. The total acquisition costs for each surgery at each facility was calculated as the sum of necessary items' costs. All costs are expressed in 2011 US dollars. Total acquisition costs for phacoemulsification/intraocular lens, trabeculectomy with MMC, Ex-PRESS shunt and AGV with scleral patch graft implantation in different health care settings were the main outcome measures. RESULTS: The state-run hospital had the highest overall cost of disposable items for both cataract surgery ($648) and trabeculectomy with MMC ($339), whereas the Veterans Affairs Medical Centers had the lowest acquisition costs for cataract ($386) and the ASC ($96) for trabeculectomy. The ASC system had the lowest cost for both Ex-PRESS shunt ($707) and AGV ($865), whereas the University ($1352 for the Ex-PRESS) and the state ($1338 for AGV) had the highest cost. Average difference between total disposable item acquisition costs and Medicare payment after different surgeries per case is as follows: $544.29 for cataract surgery, $1834.50 for trabeculectomy, $763.30 for Ex-PRESS shunt, and $1315.00 for the AGV surgery. CONCLUSIONS: The ASC system had the lowest acquisition cost for disposable items for both cataract and glaucoma surgeries, whereas the university hospital and the state hospital carried the highest costs on an average. Among the 3 glaucoma procedures compared, trabeculectomy has the lowest acquisition costs for disposable items.

Projected cost comparison of Trabectome, iStent, and endoscopic cyclophotocoagulation versus glaucoma medication in the Ontario Health Insurance Plan.

PURPOSE: To compare the direct cost of treating glaucoma patients with Trabectome, iStent, and endoscopic cyclophotocoagulation (ECP) versus topical medications in Ontario, Canada. Costs are projected over a 6-year period, and presented on a per-patient level from the perspective of the Ontario Health Insurance Plan (OHIP). METHODS: The per-bottle cost of each medication was obtained from the 2011 Ontario Drug Benefit (ODB) formulary. A wastage adjustment fee was added to the cost, as was a pharmacy markup, and an ODB dispensing fee. Previously published medication prescription rates were used to determine the frequency with which each medication is prescribed. We estimated the overall cost by taking a weighted average of the cost of each class of glaucoma medications.The cost of each glaucoma device was determined by contacting local distributors. We then added the cost of disposables used during surgery (viscoelastic and keratome) to the cost of each procedure. Start-up costs for each device and surgeons' fees were excluded from the overall cost. RESULTS: At 6 years, treatment with the Trabectome offered a cumulative cost savings of $279.23, $1572.55, and $2424.71 per patient versus monodrug, bidrug, and tridrug therapy, respectively. A cumulative cost difference of -$20.77, $1272.55, and $2124.71 per patient were found when comparing iStent versus monodrug, bidrug, and tridrug therapy, respectively. Treatment with ECP yielded a cost savings of $779.23, $2072.55, and $2924.71 per patient versus monodrug, bidrug, and tridrug therapy, respectively. CONCLUSIONS: Over a projected period of 6 years, the Trabectome, iStent, and ECP may all offer a modest cost savings to OHIP versus the cost of glaucoma medication. Further analysis of direct and indirect costs to patients as well as quality of life assessments will help further delineate the role of these treatments in the glaucoma treatment paradigm.

The cost of glaucoma care provided to Medicare beneficiaries from 2002 to 2009.

PURPOSE: To estimate payments for glaucoma care among Medicare beneficiaries from 2002 to 2009. DESIGN: Database study. PARTICIPANTS: Data from a 5% random sample of Medicare billing information from 2002 to 2009. METHODS: Medicare beneficiaries, aged 65 years or older, with both Parts A and B fee-for-service (FFS) enrollment comprised the annual denominator. For each year, we included those with a defined glaucoma diagnostic code linked to a glaucoma visit, diagnostic test, or laser/surgical procedure. Open-angle, angle-closure, and other glaucoma were categorized separately. Claims were classified into glaucoma care, other eye care, and other medical care. MAIN OUTCOME MEASURES: Cost of glaucoma care in the Medicare Fee-for-Service Population. RESULTS: In 2009, total glaucoma payments by Medicare were $37.4 million for this subset, for an overall estimated cost of $748 million, or 0.4% of an estimated cost of $192 billion for all Medicare FFS payments. Office visits comprised approximately one half, diagnostic testing was approximately one-third, and surgical and laser procedures were approximately 10% of glaucoma-related costs. Coded open-angle glaucoma (OAG) and OAG suspects accounted for 87.5% of glaucoma costs, whereas cost per person was highest in "other glaucoma." In 2009, <3% of patients with OAG underwent incisional surgery and approximately 5% had laser trabeculoplasty. Laser iridotomy was the highest cost category among patients with angle-closure glaucoma, whereas office visits was the highest cost category among the "other glaucoma" group. The total cost of nonglaucoma eye care for patients with glaucoma was 67% higher than their glaucoma care costs; these were chiefly costs for cataract surgery and treatment of retinal diseases. From 2002 to 2009, FFS glaucoma care costs calculated in 2009 dollars were stable and cost per person per year in 2009 dollars decreased from $242 to $228 (P = 0.01 by test for linear trend). CONCLUSIONS: Annual glaucoma care costs per person decreased in constant dollars from 2002 to 2009. Cataract and retinal eye care for patients with glaucoma substantially exceeded the cost of their glaucoma care each year. Visit payments represented the largest category of costs.

Trabeculectomy with ExPRESS: weighing the benefits and cost.

PURPOSE OF REVIEW: As glaucoma surgeons continue to search for an improvement over trabeculectomy, the ExPRESS miniature glaucoma shunt has gained interest as a possible contender. Peer-reviewed literature on ExPRESS is beginning to accumulate allowing an evidence-based review to assess the potential benefits and limitations compared to trabeculectomy. RECENT FINDINGS: The current surgical procedure for ExPRESS implantation will be described followed by results of studies comparing ExPRESS to trabeculectomy, focusing on the following outcomes: success, intraocular pressure, and complications. Case reports of late complications specific to the ExPRESS device will be summarized. Finally, an economic analysis comparing ExPRESS to trabeculectomy will be provided as additional evidence to contribute to the decision matrix on deciding which filtration procedure to recommend. SUMMARY: Despite a large number of ExPRESS implant procedures worldwide, there is a paucity of high-quality studies comparing ExPRESS to trabeculectomy. From the available literature to date the outcomes (success and early complications) of ExPRESS are similar to trabeculectomy. Reports of late complications related to device extrusion and malposition are beginning to be published; however, the significantly increased cost for ExPRESS surgery is likely to be the main limitation to widespread adoption of this procedure.