Paired-eye comparison of medical therapies for glaucoma.

OBJECTIVE: To evaluate efficacy and patient preference retrospectively among intraocular pressure (IOP)-lowering prostamide and prostaglandin medications in a real-world clinical setting. METHODS: Chart review of patients with uncontrolled glaucoma or ocular hypertension seen at a private practice clinic (n = 55) who received bimatoprost 0.03% once daily in one eye and either travoprost 0.004% or latanoprost 0.005% once daily in the fellow eye. IOP was evaluated at the initial visit and at a follow-up visit scheduled 4-6 weeks later. At the follow-up visit, each patient discussed the clinical results with their physician, chose which medication they preferred to continue using, and were queried regarding the reason for their choice. This paired-eye comparison method is used routinely in clinical practice to assess clinical response and involve patients in decisions regarding treatment. Change in mean IOP from baseline and patient medication choice were the outcome measures. RESULTS: Bimatoprost-treated eyes (n = 52) had a mean IOP reduction of 2.7 mmHg and travoprost-treated eyes (n = 47) had an average decrease of 1.7 mmHg (P = 0.230). Bimatoprost significantly reduced mean IOP (from 19.8 mmHg at baseline to 17.1 mmHg at follow-up, P < 0.0001), as did travoprost (from 19.4 mmHg at baseline to 17.7 mmHg at follow-up, P = 0.009). Latanoprost-treated eyes were excluded from the efficacy analysis due to small sample size (n = 5). For continued therapy, patients chose bimatoprost over travoprost by a factor of 2.4 to 1. Of the 15 patients who gave a reason for their choice, 80% said their decision was based primarily on IOP change. CONCLUSIONS: Bimatoprost and travoprost were efficacious in reducing IOP among patients with uncontrolled glaucoma and ocular hypertension. Patients preferred bimatoprost over travoprost when trialed in fellow eyes.

Assessing quality of life in patients with glaucoma using the Glaucoma Quality of Life-15 (GQL-15) questionnaire.

PURPOSE: To measure and compare quality of life in patients with and without glaucoma using the Glaucoma Quality of Life-15 Questionnaire, and to determine the association between glaucoma-related quality of life and clinical indices of glaucoma. PATIENTS AND METHODS: Using a prospective, cross-sectional study, we collected demographic information via interviews and administered the questionnaire to assess glaucoma-related quality of life in 121 patients with glaucoma and 31 subjects without glaucoma. Visual function was measured objectively by clinical examination. Group differences and the association between questionnaire scores and clinical indices were evaluated using nonparametric analysis of variance and correlation coefficients, respectively. The relationship between the likelihood of reporting vision-related dysfunction and glaucoma severity was examined using logistic regression. RESULTS: Patients with glaucoma had significantly poorer glaucoma-related quality of life than controls (P<0.001). Summary scores differed significantly among patients with mild, moderate, and severe glaucoma demonstrating a trend of poorer quality of life with increasing disease severity. Activities involving glare and dark adaptation were most problematic for all, but patients with glaucoma felt significantly more compromised in central and near vision, peripheral vision, and outdoor mobility (all P<0.001). Glaucoma-related quality of life scores correlated moderately and significantly with visual acuity, disease severity, and visual field measurements, but only severe glaucoma was a significant predictor of self-perceived deficits in glaucoma-related quality of life (P=0.038). CONCLUSIONS: The Glaucoma Quality of Life-15 Questionnaire correlated well with objective measures of visual function and discriminated between quality of life in patients with glaucoma and subjects without glaucoma.

The prevalence of glaucomatous risk factors in patients from a managed care setting: a pilot evaluation.

OBJECTIVE: To report percentage of patients who present with glaucomatous risk factors (RFs) and determine average cumulative 5-year glaucoma progression risk in a subset of ocular hypertensive patients using the Ocular Hypertension Study (OHTS) predictive risk scoring system. STUDY DESIGN: A retrospective chart review of patients treated at a large ophthalmology clinic for International Classification of Diseases, Ninth Revision glaucoma-related diagnoses. METHODS: Medical records were screened for demographic, clinical, and ocular RFs. Data were collected on ocular attributes, and descriptive, cross-tabulation, and regression statistics were applied to depict prevalence and potential influence of RFs. For the ocular hypertension subset, the OHTS risk scoring system calculated average cumulative 5-year risk of glaucoma conversion. RESULTS: With 1189 eligible medical records available, univariate analyses demonstrated significant associations between older age and mean deviation (MD), vertical cup-to-disc ratio (CDR), intraocular pressure, and central corneal thickness (CCT). The presence of diabetes mellitus had a protective effect. Regression analyses identified age, mean CCT, and CDR as significant predictors of MD, whereas CCT was the strongest predictor of vertical CDR. Mean composite OHTS score was 9.7, signifying a 15% cumulative 5-year risk for developing glaucoma. CONCLUSIONS: Known RFs were present in approximately one third of patients. Although analyses confirmed the predictive value of these RFs, existing models may not account for several important RFs or may rely on ocular metrics that might not be routinely or practically assessed in clinical practice. Additional studies are required to incorporate these considerations into future predictive models to enhance their clinical application and the interpretation of risk estimates.

Direct costs of blindness experienced by patients enrolled in managed care.

PURPOSE: To evaluate total and condition-related charges incurred by blind patients in a managed care population in the United States and compare total charges with those of a matched nonblind cohort. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients with blindness (N = 10 796) and a 1:1 matched cohort of nonblind patients were selected from a managed care claims database. All study subjects were required to be > or =18 years old at diagnosis (blind patients) or enrollment (nonblind patients) and to have had > or =1 years of continuous follow-up. METHODS: Total and pharmacy-related direct medical charges in the first year of follow-up were calculated for both blind and nonblind cohorts. Among blind patients, condition-related charges, charge per treated person, and charge breakdown by age group were calculated. For patients with follow-up extending past 1 year, total charges (both cohorts) and condition-related charges (blind cohort only) were assessed and annualized. Mean and median charges were assessed for blind and nonblind patients within each stratum of matched covariates; a multivariate linear regression assessed the statistical significance of the difference in charges between the 2 cohorts. MAIN OUTCOME MEASURES: Total health care charges in the first year of follow-up and condition-related health care charges in the first year of follow-up for blind patients. RESULTS: For the blind population (mean age, 52 years [standard deviation (SD), 17.5]), the total mean and median health care charges per person in the first year were $20,677 (SD, $48,835) and $6854, respectively. Total mean and median health care charges per nonblind patient in the first year were $13,321 (SD, $40,059) and $3778, respectively. Condition-related charges among blind patients were substantially lower than total charges, with mean and median charges per person of $4565 (SD, $17,472) and $371, respectively. After adjusting for covariates, blind patients had significantly higher total health care charges in the first year of follow-up than nonblind patients (P<0.0001). Costs of the blind did not differ substantially from costs of the normally sighted in subsequent years of follow-up. CONCLUSION: This study demonstrates the substantial direct cost burden of blindness during the first year of follow-up in a managed care population.

Health care charges for patients with ocular hypertension or primary open-angle glaucoma.

OBJECTIVES: To determine the total and condition-related direct health care charges of patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG) and identify factors that affect these charges. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients with OH (n = 36 767) and POAG (n = 72 412) with > or =1 year of continuous enrollment during calendar years 1998 through 2005 in a nationally representative, multimanaged health plan database (PharMetrics). METHODS: First year total health care and condition-related charges were calculated. Subsequently multivariate linear regression models determined the impact of ophthalmic condition (OH or POAG), age, index year, gender, geographic region, payer mix, product type, treatment with glaucoma medication, ocular comorbidities, and systemic comorbidities on these charges. MAIN OUTCOME MEASURES: Per-person per year first-year total health care and ocular condition-related charges in United States dollars, adjusted for multiple covariates. RESULTS: Patients with POAG had significantly higher adjusted total and condition-related health care charges during the first year of follow-up than patients with OH in multivariable analysis ($2070 vs. $1990, P<0.0001 and $556 vs. $322 P<0.0001, respectively). Females and older patients had higher total health care charges compared with males and younger patients ($586 or 28.3% more; P<0.0001 and $27 per year or 0.8% per year more; P<0.0001, respectively). However, neither gender nor age were strong determinants of condition-related charges (P = 0.13 and P = 0.052, respectively). Index year, region, payer, and product types significantly dictated both total and disease-related charges. Patients with ocular comorbid conditions, including cataracts, cataract surgery, diabetic retinopathy, and blindness, had significantly higher total and condition-related health care charges than patients without these conditions (P<0.0001). CONCLUSION: Total and condition-related health care charges are considerable for patients with OH and POAG. These data identify several factors that dictate these charges.

Refill rates and budget impact of glaucoma lipid therapy: a retrospective database analysis.

BACKGROUND AND OBJECTIVE: Drugs in the lipid class of glaucoma medications, including bimatoprost, travoprost and latanoprost, are effective at lowering intraocular pressure. In addition to clinical efficacy, the budget impact of long-term therapy with each medication is important for patients, physicians and managed-care decision makers to differentiate between the products and make informed decisions regarding the choice of therapy. This study aimed to determine the average number of days between refills for latanoprost, travoprost and bimatoprost, and to estimate the potential effect of differences in refill rates on pharmacy budgets. METHODS: In this retrospective database analysis of pharmacy records, the dispensing patterns of patients with glaucoma lipid therapies were obtained. Patients with a pharmacy prescription for the 2.5 mL bottle of latanoprost, travoprost or bimatoprost between September 2002 and December 2002, and receiving continuous treatment defined as having at least one prescription for the same lipid agent and bottle size 1 year later between September 2003 and December 2003, were included in this study. The main outcome measures were mean number of days between refills, mean number of refills, cost per patient per year (based on the average wholesale price [AWP]), and annual refill cost differences between cohorts. RESULTS: The mean number of days between refills was 46.74 days, 53.65 days and 51.98 days for latanoprost, travoprost and bimatoprost, respectively (p < 0.0001, ANOVA). The mean number of refills per year was 7.1, 6.2 and 6.4 for latanoprost, travoprost and bimatoprost, respectively. Based on this and the AWP, the average cost per patient per year was $US435.16 for latanoprost, $US385.58 for travoprost and $US397.44 for bimatoprost. The cost savings per year if the population of patients using latanoprost (n = 79,820) used bimatoprost or travoprost instead would be approximately $US3.0-$US3.9 million. CONCLUSION: A statistically significant difference in mean days between refills was found among the three studied drugs. Latanoprost presented the highest annual cost followed by bimatoprost and travoprost.

A gap analysis approach to assess patient persistence with glaucoma medication.

PURPOSE: To develop an alternative method for analysis of patient persistence with prescribed medications using the prostaglandin class of intraocular pressure (IOP)-lowering drugs as a model. DESIGN: A retrospective study of prescription refill patterns. METHODS: Patients with a pharmacy claim for a 2.5 ml bottle of latanoprost, travoprost, or bimatoprost between September 1, 2002 and December 31, 2002 were identified from a retail pharmacy database and were followed up for 12 months. Three separate analyses defined gaps in therapy as spans in excess of 45, 60, or 120 days without a refill for the same medication. Patients were categorized by the number of gaps in therapy and the cumulative length of gaps. A Kaplan-Meier analysis was conducted using a 120-day allowable refill period. RESULTS: For refill periods of 45, 60, and 120 days, 10.6%, 28.6%, and 77.5% of patients, respectively, had no gaps in therapy, and 32.6%, 53.4%, and 86.5%, respectively, had 30 days or fewer off therapy annually. According to the 45-day threshold analysis, 50.7% of patients had three or more gaps vs 18.5% in the 60-day analysis and none in the 120-day analysis. The Kaplan-Meier curve shows 88.6% and 76.1% of patients were persistent for 120 days and one year, respectively. CONCLUSIONS: Compared with Kaplan-Meier survival curves, the gap analysis approach may better parallel clinical experience with patient persistence, in which patients stop and restart medications for a variety of reasons over time. This method also may help to identify avenues for investigation of lack of persistency among many patients.

Real-world utilization patterns of cyclosporine ophthalmic emulsion 0.05% within managed care.

BACKGROUND: Cyclosporine 0.05% ophthalmic emulsion (Restasis) is a treatment for dry eye disease. OBJECTIVES: To examine patients' cyclosporine 0.05% utilization patterns by analyzing prescription fill data. METHODS: A retrospective analysis with a large de-identified longitudinal patient database was conducted. Participants in the study had 1 prescription fill for cyclosporine 0.05% during a 3-month "enrollment" period from January 1 to March 31, 2004, and at least 1 refill within the following 12 months. Continuing patients had at least 1 cyclosporine 0.05% prescription fill, and new patients had none during 12 months prior to the "enrollment" period. Daily, monthly, and annual utilizations were assessed. RESULTS: 38,164 patients met the inclusion criteria. The majority of patients were female (82%), 50 years or older (77%), and new to therapy (59%). The FDA-recommended use is 2 vials daily (2 trays/month, each tray containing 32 vials) to receive the prescribed dosage of 1 drop in each eye twice daily. Prescription refill patterns demonstrated 73% of patients used 1 tray/month; similarly, 80% of the patients used 11 trays or less per year. Daily utilization differed between continuing and new patients. New patients had a bimodal use pattern. Over 30% were using > or = 1.75 vials/day and approximately 55% were using 0.25 to 1.25 vials/day. The majority of continuing patients (approximately 80%), however, used 0.25 to 1.25 vials/day. CONCLUSIONS: Most patients used about 1 vial per day, less than the labeled 2 per day. The cost to managed care for cyclosporine 0.05% ophthalmic emulsion may be less than anticipated. Key words: Cyclosporine 0.05% ophthalmic emulsion, longitudinal patient database, cost, utilization.

The impact of glaucoma coding in a large claims database.

PURPOSE: Coding variation and its impact on identified populations is a major concern in database analyses. We assessed potential differences in demographics and healthcare charges among patients with open-angle glaucoma identified through different International Classification of Diseases, Ninth Revision (ICD-9) coding algorithms. DESIGN: Retrospective database analysis. METHODS: Three glaucoma cohorts were identified based on hierarchical inclusion of patients with >/=2 glaucoma ICD-9 codes (PharMetrics, Inc, Watertown, Massachusetts, USA, 1998 to 2003). Descriptive statistics and healthcare charges were assessed for each cohort. RESULTS: The three cohorts included 64,380, 14,705, and 4,225 unique patients each. Although significant differences in age, gender, region, payer type, product type, and medical comorbidities existed among the three cohorts, these differences had little impact on resource consumption when the cohorts were combined, given the smaller number of patients outside of the primary cohort. CONCLUSIONS: Glaucoma coding variation in administrative data sets has limited impact on analyses of resource consumption among open-angle glaucoma patients.

Cost of patients with primary open-angle glaucoma: a retrospective study of commercial insurance claims data.

PURPOSE: Primary open-angle glaucoma (POAG) poses a large burden on eye care resources in the United States. We evaluated the total health care and POAG-specific charges (both pharmacy and nonpharmacy) incurred by patients with POAG using a longitudinal U.S. commercial insurance claims database to determine the relative magnitude of glaucoma care charges to overall health care charges for those patients with glaucoma. DESIGN: Retrospective cohort design. PARTICIPANTS: Sixty-four thousand three hundred eighty patients with POAG were identified. METHODS: Patients with POAG were selected (International Classification of Diseases, 9th Revision code 365.11 on at least 2 encounters) from a managed care claims database. Total health care and POAG-specific charges were calculated. Component charges (pharmacy and nonpharmacy) also were evaluated and the charge per treated person was calculated. MAIN OUTCOME MEASURE: Health care charges. RESULTS: The mean total health care charges per person in the first year after initial entry into the database with POAG were $13,404 (standard deviation [SD], $33,987), with a median charge of $5403. The mean POAG-specific charge per person was $1570 (SD, $3428), with a median charge of $840. Pharmacy charges were 25% of the POAG-specific charges. The POAG-specific charges in subsequent years after the initial year decreased by 7% per year, whereas the total health care mean charge increased by 39% per year. Patients aged 65 years and older had significantly higher mean charges for both total health care charges ($16,759 vs. $11,651; P<0.0001) and POAG-specific charges ($1624 vs. $1542; P = 0.0049), for an age-related increase of 44% for total charges and 5% for POAG-specific charges. Overall, POAG-specific mean charges represented 12% of total mean charges in the first year and 8% of total overall mean charges in subsequent years. CONCLUSIONS: There is a substantial cost burden associated with POAG in a population with commercial insurance, and most of these charges are not pharmacy related.

Efficiency of instillation methods for prostaglandin medications.

PURPOSE: The aim of this study was to determine the most efficient methods for instillation of prostaglandin analogs. METHODS: Drops were dispensed at room temperature from 2.5-mL bottles of bimatoprost, travoprost, and latanoprost. Two determinations of drop count were each made from bottles held vertically, at a 45-degree angle, and horizontally. The total volumes of medication dispensed from each bottle were measured. RESULTS: The mean number of drops dispensed was 111.0, 105.1, and 76.1 drops for bimatoprost bottles; 81.4, 101.1, and 85.3 drops for travoprost bottles; and 94.3, 88.4, and 67.1 drops for latanoprost bottles, held vertically, at 45 degrees, and horizontally, respectively. The mean volume of medication dispensed per 2.5-mL bottle was 3.17 mL for bimatoprost, 2.54 mL for travoprost, and 3.02 mL for latanoprost. The most efficient instillation methods provided 56 days of bilateral therapy per 2.5-mL bottle for bimatoprost, 51 days for travoprost, and 47 days for latanoprost, with corresponding yearly medication costs of $408 for bimatoprost, $449 for travoprost, and $475 for latanoprost. Yearly savings of $109 to $192 could be achieved by using the most efficient instillation methods, representing 5.6 months of medication saved for patients using bimatoprost, 3.0 months for patients using travoprost, and 4.9 months for patients using latanoprost. CONCLUSIONS: Health care providers are urged to instruct glaucoma patients in the most efficient method of instillation. For bimatoprost and latanoprost, vertical instillation is recommended, with 45 degrees nearly as efficient, and for travoprost, instillation at 45 degrees is recommended.

Improving hypertension care in a large group-model MCO.

The effectiveness of a quality improvement program for hypertension management practices and patient health outcomes in a group-model managed care organization was evaluated. Health-system pharmacists analyzed medical and pharmacy claims data to identify hypertensive patients. Chart review was conducted on a random sample of these patients to validate a hypertension diagnosis and to obtain blood pressure (BP) control rates and prevalence of cardiovascular risk factors and comorbid conditions. The interventions consisted of educating health care providers and recommending appropriate pharmacotherapy for compelling indications. Patient outcomes were compared with baseline hypertension data. After interventions were implemented, medical and pharmacy claims identified 30,721 hypertensive patients and chart reviews were performed on a random sample of 417 patients. Pharmacy claims revealed a total of 193,311 antihypertensive prescriptions. Approximately 47% of all hypertensive patients were managed with monotherapy, while 24% received dual therapy, and 11% were taking three or more antihypertensive medications per day. Of the patients on monotherapy, 93% received an angiotensin-converting-enzyme inhibitor (27.3%), diuretic (26.6%), beta-blocker (23.4%), or calcium channel blocker (15.4%). The overall level of BP control significantly improved from 37.2% at baseline to 49.2% at follow-up (p = 0.0007). BP control in the follow-up evaluation was 22.2% in diabetic patients. For treatment of patients with comorbid disease states, provider practice patterns were evaluated at baseline and follow-up. Improving the quality of hypertension management increased BP control from 37.2% to 49.2%. Continued efforts to improve hypertension management, particularly in patients with concomitant diabetes and in elderly patients with isolated systolic hypertension, are needed.

Determinants of uncontrolled hypertension in an African-American population.

OBJECTIVES: The purpose of this study was to assess blood pressure control and the determinants of uncontrolled blood pressure among African-American hypertensive patients. DESIGN: Baseline clinical data were collected as part of a nationwide hypertension quality improvement initiative. An analysis of determinants of uncontrolled blood pressure was conducted using logistic regression for the following variables: angina, congestive heart failure, coronary artery disease, diabetes, family history of cardiovascular disease or stroke, hyperlipidemia, left ventricular hypertrophy, and tobacco use. SETTING: 10 managed care/advanced physician organizations. PATIENTS: Pharmacy and medical claims covering 1,965,000 lives were reviewed and 292,996 members with a hypertension-related claim were identified between June 1, 1998 and July 1, 2001. A random sample (N = 5,935) was selected for chart review. The present analysis was conducted on the subset of African-American patients (N = 440) included in this sample. RESULTS: Approximately 66% of the African-American patients were female, the mean age was 60.4 years, 47.8% had dyslipidemia, and 31.4% had diabetes. Approximately 64% had uncontrolled hypertension. Patients with diabetes were 3 times more likely to have uncontrolled blood pressure as were patients without diabetes (OR = 2.92; P < .0001). CONCLUSIONS: Blood pressure control in the African-American population is lower than the Healthy People 2010 goal of 50%. African Americans with hypertension and diabetes are at an increased risk for uncontrolled blood pressure. Treating this high-risk population more aggressively may reduce long-term complications and decrease mortality.