Medical Costs of and Changes in Glaucoma Treatment among Patients Newly Starting Glaucoma Care.

Purpose: To use a medical claim database to investigate medical costs and treatment patterns among patients newly starting glaucoma care.Subjects and methods: Subjects registered in the Japan Medical Database Center (JMDC) from January 2005 to March 2016 who were newly diagnosed with glaucoma, started glaucoma treatment, and had treatment records covering more than five years were included in the analysis. All direct medical costs were collected for a period of up to ten years. Factors affecting medical costs were analyzed. Changes in hypotensive eyedrops and choices related to glaucoma surgery were also analyzed.Results: Out of approximately 1.42 million subjects, 2,393 satisfied the inclusion and exclusion criteria. The average total medical cost incurred per patient over a period of ten years was US$9,030, including US$1,214 during the initial year. The proportion of the total cost represented by the cost of hypotensive eyedrops increased from 5.2% to 10.6% over the ten-year period. Medical costs were higher in patients younger than ten years old than in patients of all other age groups. The number of ocular hypotensive eyedrops increased from 0.9 to 1.5 over the ten-year period. Medical costs were higher for subjects with secondary glaucoma than for other subjects. Sixty-three patients underwent trabeculotomy or trabeculectomy, and trabeculectomy was the preferred choice in later years.Conclusions: The total direct medical cost associated with glaucoma was US$9,030 for the first ten years. Drug costs gradually increased with treatment duration and patient age and varied by glaucoma type.

Minimally Invasive Glaucoma Surgery: A Critical Appraisal of the Literature.

Micro- or minimally invasive glaucoma surgeries (MIGS) have been the latest addition to the glaucoma surgical treatment paradigm. This term refers not to a single surgery, but rather to a group of distinct procedures and devices that aim to decrease intraocular pressure. Broadly, MIGS can be categorized into surgeries that increase the trabecular outflow [Trabectome, iStent (first and second generations), Hydrus microstent, Kahook Dual Blade and gonioscopy-assisted transluminal trabeculotomy], surgeries that increase suprachoroidal outflow (Cypass microstent and iStent Supra), and conjunctival bleb-forming procedures (Xen gel stent and InnFocus microshunt). Compared to traditional glaucoma surgeries, such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves), MIGS are touted to have less severe complications and shorter surgical time. MIGS represent an evolving field, and the efficacy and complications of each procedure should be considered independently, giving more importance to high-quality and longer-term studies.

Cost-effectiveness and budget impact analysis of a patient visit support system for blindness reduction in Japanese patients with glaucoma.

AIM: To evaluate the cost-effectiveness (CE) and budget impact (BI) of introducing a patient visit support system (ACT Pack) along with standard of care (SoC), in glaucoma treatment in Japan. METHODS: A Markov model was designed to estimate the CE and BI of introducing the support system from Japanese payer and governmental perspective, respectively. Inputted data for CE and BI analysis were referred from published literature and based on medical specialists' inputs. Base case scenario for CE considered the support system cost of 30,000 yen per patient per year and a time horizon of 45 years. BI analysis compared the financial impact due to introduction of support system with SoC compared to SoC alone scenario on Japanese healthcare system with a time horizon of 20 years. RESULTS: The base case of CE analysis showed the incremental cost per quality-adjusted life years (QALYs) gained with the support system was 3,241,729 yen/QALY (29,470 USD/QALY). The sensitivity analysis showed that the probability of this support system being cost-effective at a threshold of 5 million yen/QALY (45,455 USD/QALY) was 53.26%. Blindness reduction after introduction of this support system was 8.68%. The BI analysis showed that the introduction of support system will lead to a cumulative cost savings of 1,132 billion yen (10 billion US dollars) for Japanese healthcare system over 20 years of time horizon. LIMITATION: Due to paucity of similar comparative studies, some assumptions were made based on medical specialists' inputs. Death status was not considered in the analysis. CONCLUSION: Introduction of this support system with SoC is cost-effective and will lead to blindness reduction in Japanese patients with glaucoma. Over a 20 year period, it will lead to an overall cost savings of 1,132 billion yen (10 billion US dollars) for the Japanese healthcare system.

The cost and quality of life impact of glaucoma in Tanzania: An observational study.

AIMS: To determine the cost and quality of life impact imposed by glaucoma in Tanzania, East Africa. METHODS: An expert panel of eye health professionals was convened to agree current glaucoma practice in Tanzania. In addition a structured patient survey was developed and administered. Supplemental cost and quality of life information was collected using cost questionnaires and validated quality of life measures, including the EQ5D and VFQ-25. RESULTS: Key findings include following. Non-adherence is a major issue, especially in rural settings where over 50% of the patients may fail to return for review. Whilst medical therapy is overwhelmingly the first line treatment, the cost of maintaining this represents up to 25% of a patient's income. There is an impact of glaucoma on patients general well-being as determined by the EQ-5D and more tellingly on visual function with particular impact on role limitations as determined by the VF25. Despite our sample being taken in a private clinic and thus containing a much larger proportion of professionals than the general population, one third of the population earned Tanzanian Shillings (TZS) 170,000 per month which is below the minimum wage. CONCLUSION: These findings are of great importance for health care planners seeking to determine cost-effective, acceptable methods of both identifying and treating this major cause of preventable blindness.

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017.

BACKGROUND: Prostaglandin analogs are the most effective treatment for glaucoma, a common condition among older adults. Despite the availability of generic drugs, the costs associated with these prescription drugs are rising. OBJECTIVE: To characterize Medicare prescription drug plan (PDP) formulary coverage and beneficiary out-of-pocket cost for prostaglandin analogs from 2009 to 2017 and Medicare spending on prostaglandin analogs from 2013 to 2017. METHODS: This study was a retrospective analysis. We used 2009, 2013, and 2017 Medicare PDP formulary, beneficiary cost, and pricing files to determine beneficiary first-prescription out-of-pocket costs and plan coverage (unrestricted, restricted, or not covered) of branded latanoprost 0.005%, travoprost 0.004%, bimatoprost 0.03% and 0.01%, and tafluprost 0.0015% and of generic latanoprost 0.005% and generic bimatoprost 0.03%. We also used Medicare Part D spending data to determine aggregate spend in 2013 and 2017. RESULTS: In 2009, 92% of plans covered branded latanoprost, 83% covered branded bimatoprost; and 49% covered branded travoprost, whereas in 2017, 6% of plans covered branded latanoprost; 95% covered branded bimatoprost; and 96% covered branded travoprost. Although generic latanoprost was universally covered, generic bimatoprost was only covered by 35% of plans in 2017. Median out-of-pocket cost of branded prostaglandins without generic equivalents was $35 (IQR = $29-$40) in 2009, $45 (IQR = $42-$101) in 2013, and $90 (IQR = $45-$159) in 2017. Median out-of-pocket cost of all available generic prostaglandins was $10 (IQR = $5-$33) in 2013 and $10 (IQR = $4-$15) in 2017. In 2013, Medicare spent $733 million on prostaglandin analogs; in 2017, this increased to $1.09 billion, with $943 million (86%) spent on branded prostaglandins and $148 million (14%) spent on generics. CONCLUSIONS: Medicare PDP coverage of branded prostaglandins remained stable from 2009 to 2017. While median beneficiary out-of-pocket costs associated with generic prostaglandins remained stable, those associated with branded prostaglandins increased nearly 3-fold. DISCLOSURES: Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number T35HL007649. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Shah has received research support through Mayo Clinic from the U.S. Food and Drug Administration (FDA) to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517); and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496, R01HL131535), National Science Foundation, and the Patient Centered Outcomes Research Institute to develop a clinical data research network. Ross has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585); the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers of Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I); the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung and Blood Institute of the NIH (R01HS025164); and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and the Collaboration on Research Integrity and Transparency at Yale. The other authors have nothing to disclose.

Acceptability, adherence and economic analyses of a new clinical pathway for the identification of non-responders to glaucoma eye drops: a prospective observational study.

BACKGROUND/AIMS: Assess whether a new clinical pathway for glaucoma was acceptable to patients and healthcare professionals and whether it provided useful clinical information on non-responsiveness and non-adherence to the treatment of elevated intraocular pressure with latanoprost eye drops. METHODS: A single arm non-randomised prospective observational study incorporating new glaucoma/ocular hypertension patients. To assess issues of acceptability, qualitative observation and interviews were conducted with patients and healthcare professionals. To determine clinical responsiveness, intraocular pressures were measured before and 4 hours after a clinician-instilled eye drop over two distinct appointments. Adherence data were collected using a Medicine Event Monitoring System. Economic analyses compared the costs between novel and standard care pathways. RESULTS: Of 72 patients approached, 53 entered the study (74.3%) and 50 completed all procedures (94.3%). Intraocular pressure was reduced more than 15% in 83 out of 92 study eyes by final visit (90.2%). The non-response rate was 5.1% once the effect of low adherence was minimised. For the 1376 drop instillation days under observation, eye drops were instilled as prescribed on 1004 days (73.0%), over-instilled on 137 days (9.9%) and not instilled on 235 days (17.1%). The Cardiff Model of Glaucoma Care involved negligible cost, although acceptance for healthcare professionals showed variation. CONCLUSIONS: The Cardiff Model of Glaucoma Care offers novel clinical and adherence insights at marginal costs while acceptable to patients. Healthcare professionals felt that 4 hour and 4 week follow-up appointments could cause administrative problems. A streamlined version of the pathway has therefore been developed to facilitate clinical adoption. TRIAL REGISTRATION NUMBER: ISRCTNID:ISRCTN75888393.

Assessing Health Care Burden in Glaucoma Patients with and Without Physical or Mental Comorbidities.

BACKGROUND: Glaucoma is a collection of eye diseases that damage the eye's optic nerve resulting in vision loss and blindness. Treatment for glaucoma is primarily pharmacologic; however, studies have shown patients have difficulty adhering to topical regimens. The reasons for potentially poor adherence are numerous, including influence from a myriad of either physical or mental comorbid conditions faced by many glaucoma patients. Neither adherence nor associated outcomes have been estimated in these 2 groups of glaucoma patients. OBJECTIVES: To (a) characterize glaucoma patients with and without select physical or mental comorbidities and (b) estimate differences between the 2 groups for 3 types of outcomes: health care resource use (HCRU; office-based/outpatient-based provider visits, emergency room visits, inpatient stays, home health provider days, prescription fills); health care expenditures; and health-related quality of life (HRQoL) as measured by the physical and mental component scores of the Short Form-12. METHODS: We used first-year data from each glaucoma patient's 2-year panel survey in the Medical Expenditure Panel Survey (MEPS) database, 2003-2014. Two groups were created using ICD-9-CM codes collected by MEPS to compare glaucoma patients with and without at least 1 selected physical or mental comorbid condition. Between-group comparisons in the outcomes of interest (HCRU, expenditure, HRQoL) were estimated using multivariable regression analyses while adjusting for socio-demographic and clinical characteristics at baseline. RESULTS: We identified 2,928 unique glaucoma patients during the 11 years of collected data, including 1,539 (53%) who had at least 1 physical or mental comorbid condition of interest. Comparing those with at least 1 select physical or mental comorbidity to those without (n = 1,389), unadjusted HCRU and expenditures were greater in patients with a physical or mental comorbidity (all P < 0.05). After adjustment, significant associations with increased HCRU remained for office-based provider visits and home health provider days (each P < 0.01). Average total expenditures were $12,324 in those with comorbidities and $8,590 for those without. HRQoL (unadjusted and adjusted) was lower in those with a physical or mental comorbid condition (all P < 0.05). CONCLUSIONS: Some differences in HCRU and expenditures were accounted for by differences in baseline characteristics between those with and those without 1 or more physical or mental comorbid conditions, but differences remained after adjustment. Results suggest that glaucoma patients with physical and mental comorbidities may experience greater HCRU and associated expenditures, and lower HRQoL, when compared with glaucoma patients without these comorbidities With this knowledge, future work may include estimating the effect of the number of these comorbid conditions on each of the 3 types of outcomes. DISCLOSURES: This study received funding support from Allergan. During the time this work was conducted, Serbin was a postdoctoral fellow who was supported by a training grant from Allergan to the University of Washington. Campbell is an employee of Allergan. Serbin, Devine, and Basu each have nothing to disclose. This study was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research Meeting; May 20-24, 2017; Boston, MA.

Health Economic Analysis in Glaucoma.

The pressure on glaucoma services is ever-growing, and policymakers seek robust cost-effectiveness arguments in their decisions around resource allocation. The benefits of glaucoma are in preventing or delaying a future loss of vision and associated quality of life, and this expectation is quantified using a metric called utility which can be compared against other disease states. In recent clinical trials lasting up to 3 years, it has been difficult to show a difference in utility between glaucoma treatments in this limited period of time. When it comes to cost, the direct medical costs are only part of the broad range of costs that glaucoma brings to patients and communities, and the estimation of these costs can be difficult and imprecise. While the cost-effectiveness of glaucoma care, in general, is not in dispute, especially over longer time frames, the inability to measure changes in utility in shorter time frames impedes the uptake of innovations around the world. A number of approaches to improve the sensitivity and specificity of utility measurements are under investigation.

Prescribing trends of glaucoma drugs in six major cities of China from 2013 to 2017.

OBJECTIVE: To evaluate the prescribing trends of glaucoma drugs in six major cities of China from 2013 to 2017. METHODS: A descriptive analysis using pharmacy prescription data was conducted. Outpatient prescription data was extracted from the Hospital Prescription Analysis Cooperative Project. Prescribing patterns, trends of visits, and corresponding expenditures for glaucoma medications were analyzed. RESULTS: A total of 84297 ambulatory prescriptions were included in the current study. Visits by glaucoma patients increased from 13808 in 2013 to 20060 in 2017. Over the same period, the yearly expenditure for glaucoma drugs increased from 2.33 million to 3.95 million Chinese Yuan (CNY). Among all the six classes of glaucoma drugs (prostaglandin analogues, carbonic anhydrase inhibitors, α-receptor agonists, ß-receptor antagonists, cholinergic agonists and fixed combinations), ß-receptor antagonists were the most commonly prescribed in 2013, accounting for 34.3% of patients, but gradually decreased to 27.1% in 2017. Prostaglandin analogues became the most frequently prescribed drugs in 2017, accounting for 30.2% of the visits. Prostaglandin analogues are the most expensive and yielded a total expenditure of 2.34 million CNY in 2017, followed by carbonic anhydrase inhibitors, α-receptor agonists, ß-receptor antagonists, fixed combinations, and cholinergic agonists. Combination therapy became increasingly prescribed in 2017. CONCLUSION: Glaucoma prescribing practices exhibited substantial changes over the study period. The number of glaucoma prescriptions continuously increased from 2013 to 2017, leading to increased prescription costs. These findings implied a similar trend observed in previous studies, as well as recommendations in the appropriate guidelines.

Multiple chronic conditions at a major urban health system: a retrospective cross-sectional analysis of frequencies, costs and comorbidity patterns.

OBJECTIVE: To (1) examine the burden of multiple chronic conditions (MCC) in an urban health system, and (2) propose a methodology to identify subpopulations of interest based on diagnosis groups and costs. DESIGN: Retrospective cross-sectional study. SETTING: Mount Sinai Health System, set in all five boroughs of New York City, USA. PARTICIPANTS: 192 085 adult (18+) plan members of capitated Medicaid contracts between the Healthfirst managed care organisation and the Mount Sinai Health System in the years 2012 to 2014. METHODS: We classified adults as having 0, 1, 2, 3, 4 or 5+ chronic conditions from a list of 69 chronic conditions. After summarising the demographics, geography and prevalence of MCC within this population, we then described groups of patients (segments) using a novel methodology: we combinatorially defined 18 768 potential segments of patients by a pair of chronic conditions, a sex and an age group, and then ranked segments by (1) frequency, (2) cost and (3) ratios of observed to expected frequencies of co-occurring chronic conditions. We then compiled pairs of conditions that occur more frequently together than otherwise expected. RESULTS: 61.5% of the study population suffers from two or more chronic conditions. The most frequent dyad was hypertension and hyperlipidaemia (19%) and the most frequent triad was diabetes, hypertension and hyperlipidaemia (10%). Women aged 50 to 65 with hypertension and hyperlipidaemia were the leading cost segment in the study population. Costs and prevalence of MCC increase with number of conditions and age. The disease dyads associated with the largest observed/expected ratios were pulmonary disease and myocardial infarction. Inter-borough range MCC prevalence was 16%. CONCLUSIONS: In this low-income, urban population, MCC is more prevalent (61%) than nationally (42%), motivating further research and intervention in this population. By identifying potential target populations in an interpretable manner, this segmenting methodology has utility for health services analysts.

Determining patient preferences in a glaucoma service: A discrete choice experiment.

IMPORTANCE: Patient perspectives are crucial in informing design of acceptable services. BACKGROUND: This study determined patient preferences in glaucoma care. DESIGN: A discrete choice experiment was used to evaluate the relative importance of out-of-pocket costs, waiting time, continuity of care, service location and expertise. PARTICIPANTS: Ninety-eight glaucoma suspects or glaucoma patients were recruited from one public and two private clinics in Sydney. METHODS: Twelve choice-tasks were presented in random order and forced-choice preferences were elicited. Choice data were analysed using a multinominal logit model (NLOGIT 4.0). MAIN OUTCOME MEASURES: The relative importance and the likelihood of choosing services with each attribute were determined. Willingness-to-pay and willingness-to-wait were calculated. Analyses were stratified by whether the patient attended a public or private glaucoma clinic and other demographic features. RESULTS: Choice was influenced by four or five attributes: greater clinician expertise, the same clinician each visit, lower out-of-pocket costs and shorter wait times (all P < .05). Respondents were willing to pay an additional (Australian dollars) $325 (95% confidence interval [CI] 188-389) to see a senior eye doctor, and $87 (95% CI 60-116) to see the same clinician each visit. Respondents were willing to wait for these attributes; however, the estimates had wide confidence intervals and were beyond the range tested. Private patients had a stronger preference for expertise and continuity of care compared to public patients. CONCLUSIONS AND RELEVANCE: Expertise and continuity of care were important to glaucoma patients in this setting, and they were willing to pay out-of-pocket and concede longer waiting times to secure these preferences.

Integrating opportunistic glaucoma screening into general health examinations in China: A pilot study.

IMPORTANCE: Under-detection and late diagnosis are major causes of glaucoma-related visual impairment. Cost-effective opportunistic glaucoma screening is of great interest in the early identification and prevention of glaucoma. BACKGROUND: To describe the results of a health examination centre-based opportunistic glaucoma screening and referral model. DESIGN: This single centre cross-sectional study was conducted in a health examination centre affiliated to a tertiary hospital in Shenyang, northeastern China. PARTICIPANTS: From 21 March to 30 September 2016, 14 367 individuals aged ≥ 30 years undergoing routine physical examinations were invited for this glaucoma screening. METHODS: Presenting visual acuity, non-contact pneumotonometry and non-mydriatic fundus photography were evaluated. Fundus photographs were classified as non-glaucoma, possible, probable and definitive glaucoma. Participants with probable and definite glaucomatous discs or intraocular pressure ≥ 24 mmHg were referred for definitive examinations. MAIN OUTCOME MEASURES: Detection rate of glaucoma suspects and ocular hypertension (OHT). Cost to identify a single case with suspected and diagnosed glaucoma was also calculated. RESULTS: Altogether, 277 glaucoma suspects and 327 ocular hypertension suspects were identified. Among 190 participants with probable/definite glaucomatous discs, 93 (48.9%) accepted further examination. Among these, 78 were diagnosed as glaucoma, seven as suspects and eight were excluded. Only 98 ocular hypertension suspects (30.0%) accepted further examinations: eight had primary angle closure and 23 had confirmed ocular hypertension. The cost to identify a single glaucoma suspect and definite glaucoma case were US$135 and US$857, respectively. CONCLUSIONS AND RELEVANCE: This novel screening model provides opportunities to improve glaucoma detection at low cost. Interventions to improve follow-up are needed.

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.

The Cost and Economics of Endoscopic Cyclophotocoagulation in the United Kingdom: A Tertiary Center Experience.

PRECIS: As the only microinvasive glaucoma surgery (MIGS) with a reusable component, the cost per procedure of endoscopic cyclophotocoagulation (ECP) diminishes with each successive use. We present a cost comparison of ECP with other MIGS devices, based on our clinical practice. PURPOSE: ECP delivers diode laser via a reusable probe to the ciliary processes under direct visualization. The aim of our study is to evaluate the direct cost of ECP based on a retrospective review of cases and compare the cost per procedure with other MIGS devices. METHODS: We conducted a retrospective review of ECP procedures performed at St Thomas' Hospital over 4.5 years. The cost of the ECP endoscope and diode laser consoles, reusable probes, and maintenance contracts were obtained from the hospital procurement log. The on-site Central Sterile Services Department was contacted for probe sterilization and repackaging costs. The cost per device for ECP and commonly performed MIGS procedures were obtained from the product specialists of each company. RESULTS: A total of 332 procedures were performed using 37 ECP probes during the study period. Each reusable ECP laser probe was found to give an average of 8.97 laser treatments. The cost per procedure decreased over the course of 4.5 years from £819.43 for the first 42 cases to £341.50 after 332 cases. Compared with other MIGS devices, the cost per procedure of ECP after 100 procedures is second lowest to the Kahook Dual Blade and reduces with each successive procedure performed. CONCLUSION: The ability to reuse each ECP probe significantly lowers the cost per procedure compared with other MIGS devices in the United Kingdom. The cost per procedure continues to reduce with each successive procedure.

Patient-reported Outcomes, Functional Assessment, and Utility Values in Glaucoma.

In clinical glaucoma research, the measurement of patient reported outcomes, functional assessment of disability, and health economic impact is critical. However, valid, time-efficient and comprehensive tools are not available and several current instruments lack in the appropriate precision for measuring the various dimensions of glaucoma-related quality of life (QoL), including functioning and mobility. Furthermore, statistical methods are inconsistently and sometimes incorrectly used in otherwise sound clinical studies. Standardizing and improving methods of patient-centered data collection and analysis in glaucoma studies are imperative. This paper outlines recommendations and provides a discussion of some of the pertinent issues relating to the optimization of patient-reported outcomes research in glaucoma.

Variation in Prostaglandin Analog Prices Paid for Through Medicare Part D.

OBJECTIVE: Determine the prices and price variation of the prostaglandin analogs (PGAs) used in the United States and examine their trends from 2013 to 2016 using Medicare Part D data. DESIGN: This is a retrospective cross-sectional study. PARTICIPANTS: All ophthalmologists and optometrists in all 50 states and DC who prescribed any PGA purchased through Part D from 2013 through 2016. MATERIALS AND METHODS: Outcome measures were calculated using Excel 2016 based off of the 2013 to 2016 Medicare Part D Prescriber Data. MAIN OUTCOME MEASURES: The 2013 to 2016 nationwide prices of 7 PGAs, the states with the 2016 minimum and maximum average prices, the SDs in PGA prices among the cities in each state, and the nationwide average of these SDs for 2013 to 2016. RESULTS: The 2016 nationwide prices of 30-day supplies of bimatoprost, latanoprost, lumigan, travatan Z, travoprost, xalatan, and zioptan in 2016 were: $107.90±25.19, $10.16±1.52, $167.30±17.66, $171.36±19.44, $92.53±15.14, $153.41±15.16, and $162.75±13.22, respectively. Each drug's SD in city prices within each state averaged nationwide for 30-day supplies in 2016 were $10.89, $1.44, $16.68, $17.23, $10.30, $10.07, and $9.48, respectively. Spending on these drugs totaled $861,180,924 in 2016. There was less price variation within each state as compared with the whole country. No substantial decreases in price variation exist for any drug from 2013 to 2016. CONCLUSIONS: There is substantial variation in PGA prices when purchased by Medicare Part D enrollees across the United States and within each state itself. Simultaneously, the prices and total expenditure on these medications are increasing yearly. Physicians should be cognizant of this price variation for these expensive and chronically used drugs and should educate patients to optimize their Part D supplemental plan.

Minimally Invasive Glaucoma Surgery: A Budget Impact Analysis and Evaluation of Patients' Experiences, Preferences, and Values.

BACKGROUND: Glaucoma is a condition that causes progressive damage to the optic nerve, which can lead to visual impairment and irreversible blindness. There is a spectrum of current treatments for glaucoma that aim to reduce intraocular pressure (IOP), including pharmacotherapy (eye drops), laser therapy, and the more invasive option of filtration surgery. A new class of treatments called minimally invasive glaucoma surgery (MIGS) may reduce IOP and offer a better safety profile than more invasive procedures. We conducted a budget impact analysis of MIGS for adults with glaucoma from the perspective of the Ontario Ministry of Health and Long-Term Care. We also conducted interviews with people with glaucoma and family members of people with glaucoma to determine patient preferences and values surrounding glaucoma and its treatment options, including MIGS. We completed this work to complement a health technology assessment conducted in collaboration with the Canadian Agency for Drugs and Technologies in Health (CADTH). METHODS: We analyzed the budget impact of publicly funding MIGS in adults with glaucoma in Ontario. We derived costs from the collaborative health technology assessment.1 We assumed MIGS may be used in three subgroups: (1) MIGS in combination with cataract surgery as a replacement for cataract surgery alone in people with mild to moderate glaucoma; (2) MIGS alone as a replacement for other glaucoma treatments in people with mild to moderate glaucoma; and (3) MIGS (alone or in combination with cataract surgery) to replace filtration surgery (alone or in combination with cataract surgery) in people with advanced to severe glaucoma. We estimated the budget impact over 5 years for two possible uptake scenarios: a slow rate of uptake and a fast rate of uptake. To contextualize the lived experience of glaucoma and treatments for glaucoma, we also interviewed people with glaucoma and family members of people with glaucoma, some of whom had experience with surgical procedures such as MIGS and some of whom did not. RESULTS: Assuming a slow uptake scenario, the annual budget impact of publicly funding MIGS in Ontario over the next 5 years ranges from $1 million in year 1 to $18 million in year 5. Assuming a fast uptake scenario, the annual budget impact of publicly funding MIGS in Ontario over the next 5 years ranges from $6 million in year 1 to $70 million in year 5. The budget impact varies depending on the proportion of people in each of the three subgroups described above. Introducing a new MIGS billing code may reduce the overall expenditures. Interview participants felt that less invasive surgical procedures, such as MIGS, could control glaucoma progression with minimal side effects and recovery time needed. CONCLUSIONS: We estimate that publicly funding MIGS in Ontario would result in additional costs over the next 5 years; however, this may depend on the populations using MIGS and if uptake is restricted or controlled. For the people with glaucoma we spoke with, avoiding blindness was their paramount concern, and MIGS was perceived as an effective treatment option with minimal side effects and recovery time required.

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.

Glaucoma Control Strategies in Sub-Saharan Africa: A Review of the Clinical and Health Economic Evidence.

PURPOSE: A review of the effectiveness, costs, and cost-effectiveness of detection and treatment strategies for glaucoma control in Sub-Saharan Africa (SSA) was conducted. METHODS: Detailed searches were performed using the Ovid Medline, Ovid Embase, The Cochrane Library, Web of Science, Scopus, and LILACS databases up to September 2016. The key Medical Subject Heading search terms used included glaucoma, diagnosis, treatment, effectiveness, costs, cost-effectiveness, and Sub-Saharan Africa. Effectiveness was measured as the proportion of study participants with an intra-ocular pressure less than or equal to 22 mmHg. RESULTS: A total of 5658 records were examined with 48 papers identified. The sensitivity and specificity of portable instruments or smartphone technologies to detect glaucomatous changes ranged from 58.3% to 93.8% and from 82.4% to 96.8%, respectively. The overall effect size for various glaucoma interventions was: 0.39 (95% confidence interval (CI) 0.27-0.54, I2 = 64.85, p = 0.036) for laser trabeculoplasty; 0.56 (95% CI 0.23-0.84, I2 = 85.74, p = 0.001) for drainage implant devices; 0.66 (95% CI 0.61-0.71, I2 = 0.00, p = 0.402) for medical management; and 0.73 (95% CI 0.65-0.80, I2 = 93.25, p = 0.000) for all other non-drainage tube surgical interventions, including trabeculectomy surgery and the use of anti-metabolites. The mean annual cost of anti-glaucoma drugs across SSA was USD 394, with a mean direct non-medication cost per year of USD 54, and a mean surgical cost per year of USD 283. CONCLUSIONS: While effective glaucoma control interventions exist, their widespread use and diffusion across SSA remain challenging principally due to low per capita income levels and high glaucoma treatment costs.