Development and Validation of the Eyelash Satisfaction Questionnaire.

BACKGROUND: Patient-reported outcome (PRO) measures have been used to assess treatment benefit in a variety of therapeutic areas and are now becoming increasingly important in aesthetic research. OBJECTIVES: The objective of the current study was to develop and validate a new PRO measure (Eyelash Satisfaction Questionnaire [ESQ]) to assess satisfaction with eyelash prominence. METHODS: The content of the questionnaire (including conceptual framework and questionnaire items) was generated by review of literature, participant interviews, and expert opinion. Cognitive interviews were conducted to pilot test the questionnaire. Psychometric properties of the questionnaire were examined in a combined sample of participants (n = 970) completing Internet- (n = 909) and paper-based (n = 61) versions. Item- and domain-level properties were examined using modern and classical psychometrics. RESULTS: Content-based analysis of qualitative data demonstrated the presence of 3 distinct domains (Length, Fullness, Overall Satisfaction; Confidence, Attractiveness, and Professionalism; and Daily Routine). Initial confirmatory factor analysis (CFA) results of 23 items revealed insufficient model-data fit (comparative fit index [CFI] of 0.86 and a non-normed fit index [NNFI] of 0.82). A revised model using 9 items (3 per domain) achieved appropriate fit (CFI of 0.99 and NNFI of 0.97). Analyses revealed measurement equivalence across the Internet- and paper-based versions. The 3 ESQ domains had strong internal consistency reliability (Cronbach's α [range] = 0.919-0.976) and adequate convergent and discriminant validity. CONCLUSIONS: The ESQ was found to be a reliable and valid PRO measure for assessing satisfaction with eyelash prominence. LEVEL OF EVIDENCE 3: Therapeutic.

Two or more dexamethasone intravitreal implants in treatment-naïve patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a biodegradable, sustained-release implant that releases dexamethasone for up to 6 months. We evaluated the efficacy and safety of DEX implant in the treatment of macular edema secondary to retinal vein occlusion (RVO) in treatment-naïve patients. METHODS: A multicenter, retrospective, open-label chart review study investigated the efficacy and safety of DEX implant treatment in 289 patients with macular edema secondary to branch or central RVO (BRVO, CRVO) who received ≥2 treatments with DEX implant in the study eye. Concomitant adjunctive RVO treatments were permitted. Data collected from the time of the first implant (baseline) to 3-6 months after the last implant included best-corrected visual acuity (BCVA) and central retinal thickness measured with optical coherence tomography. In this subgroup analysis, we evaluated outcomes in patients who had received no previous treatment for RVO complications. RESULTS: Thirty-nine patients were treatment-naïve at the time of their first DEX implant (18 BRVO, 21 CRVO). Before the initial DEX implant, the mean duration of macular edema in treatment-naïve patients was 4.9 months, mean central retinal thickness was 550 µm, and mean Early Treatment Diabetic Retinopathy Study BCVA was 8.5 lines (20/125 Snellen). Treatment-naïve patients received a mean of 2.9 implants, either as monotherapy (n = 12) or with adjunctive RVO treatments (n = 27). The mean interval between implants was 177 days. After the first through sixth implants, mean changes from baseline BCVA ranged from +3.0 - +8.0 lines, and mean decreases from baseline central retinal thickness ranged from 241-459 µm. BCVA improved in both BRVO and CRVO and in both phakic and pseudophakic eyes. Overall, 83.8 % of treatment-naïve patients gained ≥2 lines in BCVA, 70.3 % gained ≥3 lines in BCVA, and 56.4 % achieved central retinal thickness ≤250 µm. The most common adverse event was increased intraocular pressure. Fifteen treatment-naïve patients had intraocular pressure ≥25 mm Hg; none required laser or incisional glaucoma surgery. CONCLUSION: Treatment with 2 or more DEX implants had a favorable safety profile and improved visual acuity and anatomic outcomes when used, either alone or with adjunctive RVO therapy, as initial treatment for RVO-associated macular edema. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 , registered on August 5, 2011.

Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a sustained-release biodegradable implant approved for treatment of macular edema associated with retinal vein occlusion (RVO). The safety and efficacy of treatment of RVO-associated macular edema with sequential DEX implants in clinical practice was evaluated in patients who received DEX implant as monotherapy compared with patients who received DEX implant in combination with other RVO treatments. METHODS: A multicenter, retrospective, open-label chart review study (one study eye/patient) evaluated use of DEX implant and outcomes in 289 patients with branch or central RVO who received at least 2 DEX implant treatments in the study eye. Data were collected from the time of the first implant (baseline) to 3-6 months after the last implant. Subgroup analysis evaluated outcomes in patients receiving only DEX implant during the study versus patients receiving DEX implant plus adjunctive RVO treatments. Endpoints included best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change from baseline. RESULTS: DEX implant was used as monotherapy in 84 (29.1%) patients and in combination with other therapy in 205 (70.9%) patients. Mean number of DEX implant treatments received was 3.1 in the monotherapy group and 3.3 in the combination therapy group (P = 0.344). Mean time between implants was longer in the combination therapy group (177 vs. 151 days, P < 0.001). Mean change from baseline BCVA after the first through sixth DEX implants ranged from +0.6 to +3.4 lines in the monotherapy group and +1.3 to +2.8 lines in the combination therapy group. Mean decrease from baseline CRT ranged from 165 to 230 µm in the monotherapy group and 136 to 175 µm in the combination therapy group. Increased intraocular pressure was more common in the combination therapy group. CONCLUSIONS: Treatment of RVO-associated macular edema with at least 2 sequential DEX implants was safe and effective both when used alone and when combined with other RVO treatments. Improvements in BCVA and CRT were generally similar in the monotherapy and combined therapy groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 .

Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta study).

PURPOSE: To evaluate the efficacy, safety, and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion and central retinal vein occlusion patients receiving ≥ 2 DEX implant treatments. METHODS: Multicenter (26-site), retrospective chart review study. Data were collected from baseline (at first DEX implant) through 3 months to 6 months after last DEX implant. RESULTS: Patients (n = 289) received 2 to 9 (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months. Mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity from baseline through 4 weeks to 20 weeks after final DEX implant was +1.0 line (P < 0.001). Best-corrected visual acuity and central retinal thickness improved significantly from baseline after each of the first 6 DEX implant injections (P ≤ 0.037); 59.7% of branch retinal vein occlusion and 66.7% of central retinal vein occlusion patients achieved ≥ 2-line best-corrected visual acuity improvement. Intraocular pressure increase (≥ 10 mmHg) occurred in 32.6% of patients; 29.1% used intraocular pressure-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery. CONCLUSION: Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

Topical cyclosporine versus emulsion vehicle for the treatment of brittle nails: a randomized controlled pilot study.

BACKGROUND: Limited options are available for the treatment of brittle nail syndrome. OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome. RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit. RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups. LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy. CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.

Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study.

BACKGROUND: Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). OBJECTIVES: The authors assess patient-reported outcomes (PRO) after treatment with bimatoprost for hypotrichosis of the eyelashes. METHODS: In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). RESULTS: By week 16, the bimatoprost group reported significantly greater improvements from baseline on all ESQ items (P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). CONCLUSIONS: The bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults.

Rasch analysis in the development of a simplified version of the National Eye Institute Visual-Function Questionnaire-25 for utility estimation.

PURPOSE: Preference-based health measures value how people feel about the desirability of a health state. Generic measures may not effectively capture the impact of vision loss from ocular diseases. Disease-targeted measures could address this limitation. This study developed a vision-targeted health state classification system based on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). METHODS: Secondary analysis of NEI VFQ-25 data from studies of patients with central (n = 932)- and peripheral-vision loss (n = 2,451) were used to develop a health state classification system. Classical test theory and Rasch analyses were used to identify a smaller set of NEI VFQ-25 items suitable for the central- and peripheral-vision-loss groups. RESULTS: Rasch analysis of the NEI VFQ-25 items using the peripheral vision-loss data indicated that 11 items fit a unidimensional model, while 14 NEI VFQ-25 items fit using the central-vision-loss data. Combining peripheral-vision-loss data and central-vision-loss data resulted in 9 items fitting a unidimensional model. Six items covering near vision, distance vision, social vision, role difficulties, vision dependency, and vision-related mental health were selected for the health-state classification. CONCLUSIONS: The derived health-state classification system covers relevant domains of vision-related functioning and well-being.

Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth.

BACKGROUND: Ocularly applied bimatoprost 0.03% is associated with increased eyelash growth. OBJECTIVE: To assess the safety, efficacy, and subjective experience of using dermal application of bimatoprost 0.03% for the growth of natural eyelashes. METHODS: Prospective, open-label study of subjects who desired longer, thicker (fuller), and darker natural eyelashes. Bimatoprost was applied to the upper lid margin once daily for 12 weeks. Adverse events and intraocular pressure were assessed, and subjects completed health outcomes questionnaires. Eyelash growth and darkening were scored using photographs taken at weeks 1 and 12. RESULTS: All subjects were female (N=28). No serious or unexpected adverse events were reported. The mean change from baseline intraocular pressure was less than 1 mmHg at each time point, but was statistically significant at weeks 1 and 4 (p< or =.047). At week 12, all subjects had noticed significant growth or darkening. Post hoc analysis of photographs corroborated these reports (p<.001). CONCLUSION: Bimatoprost was found safe for eyelid application and was associated with enhanced eyelash growth. All subjects noticed favorable changes in the appearance of their eyelashes.

Comparing adherence and persistence across 6 chronic medication classes.

BACKGROUND: The National Quality Forum recently endorsed the proportion of days covered (PDC)-a measure of medication adherence-as an indicator of quality in drug therapy management. OBJECTIVE: To inform initial efforts to improve the quality of drug therapy management, we compared PDC and persistence among new users of 6 commonly used chronic medication categories. METHODS: A retrospective analysis of pharmacy claims in a database of more than 64 million members enrolled in 100 health plans assessed persistence and adherence to drug therapy in 6 chronic conditions. Patients were included in the analysis if they initiated a prescription drug of interest in any of 6 drug classes-prostaglandin analogs, statins, bisphosphonates, oral antidiabetics, angiotensin II receptor blockers (ARBs), and overactive bladder (OAB) medications-between January 1 and December 31, 2005. The first claim for a drug of interest during this period was considered a patient's index date. Patients were required to have a minimum of 12 months of continuous enrollment both preceding and following their index date. New users of a treatment were identified by excluding patients who filled a prescription for any drug in the same class during the previous 12 months and were followed for a minimum of 12 months. Nonpersistence was defined as discontinuation of the therapy class following an allowed gap between refills-30-, 60-, and 90-day refill gaps were used. Adherence was defined as a continuous measure of the proportion of days covered (PDC) during the 12-month post-index period. Logistic regression analyses predicted (a) nonpersistence during the 12-month post-index period and (b) adherence (PDC) of at least 80%, with drug class as the predictor variable of interest, controlling for demographic variables, insurance and plan type, history of hospitalization, Charlson comorbidity score, copayment for index medication, and number of medications at index. RESULTS: A total of 167,907 patients were identified across 6 cohorts. Using the 60-day gap, 6-month persistence rates were prostaglandin analogs 47%, statins 56%, bisphosphonates 56%, oral antidiabetics 66%, ARBs 63%, and OAB medications 28%. After the first 90 days of therapy, relative persistence was stable across cohorts, and rates declined consistently from 6 months post-index to study end. Logistic regression models showed that oral antidiabetic users had a 59%, 36%, 37%, and 79% decreased risk of nonpersistence in a 12-month follow-up period compared with patients taking prostaglandin analogs, statins, bisphosphonates, or OAB medications, respectively. Risk of nonpersistence decreased with increasing age. Mean (SD) 12-month adherence rates were: prostaglandin analogs 37% (26%), statins 61% (33%), bisphosphonates 60% (34%), oral antidiabetics 72% (32%), ARBs 66% (32%), and OAB medications 35% (32%). Logistic regression indicated that oral antidiabetic use was a significant predictor of adherence (PDC) of at least 80% compared with other therapy classes. Adjusted odds ratios for oral antidiabetics were 17.60 (95% confidence interval [CI] = 15.38-20.14) versus prostaglandin analogs, 2.06 (95% CI = 1.99-2.12) versus statins, 1.92 (95% CI = 1.83-2.02) versus bisphosphonates, 1.29 (95% CI = 1.24-1.34) versus ARBs, and 5.77 (95% CI = 5.38-6.19) versus OAB medications. CONCLUSION: This analysis of adherence (PDC) and persistence across a sample of 6 chronic therapies found variable but uniformly suboptimal medication use. Adherence to prostaglandin eye drops and OAB medications was lower than to cardiovascular, oral antidiabetic, and oral osteoporosis therapies. These findings provide useful baseline information for the development of initiatives to improve the quality of drug therapy management.

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.

Comparative study of the stability of bimatoprost 0.03% and latanoprost 0.005%: a patient-use study.

BACKGROUND: The stability of ophthalmic preparations in multidose containers is influenced by the preservative as well as the stability of the active ingredient. Unstable drugs may require refrigeration to preserve their active ingredient level and they are more likely to degrade over time, therefore becoming more susceptible to degradation based on patient mishandling. The purpose of this study was to determine the degree of molecular degradation that occurs in bimatoprost and latanoprost in a patient-use setting. METHODS: This was an open-label, laboratory evaluation of the relative stability of bimatoprost and latanoprost. Patients presently using bimatoprost (n = 31) or latanoprost (n = 34) were identified at 2 clinical sites in Brazil. Patients were instructed to use and store their drops as usual and return all used medication bottles between day 28 and day 34 after opening. RESULTS: Bimatoprost demonstrated no degradation, but latanoprost degraded at various levels. The mean age of bimatoprost was 43.0 +/- 3.4 days and the mean age of latanoprost was 43.9 +/- 2.8 days (P = .072). The mean percentage of labeled concentration was 103.7% in the bimatoprost bottles and 88.1% in the latanoprost bottles (P < 001). CONCLUSION: This study showed that bimatoprost maintained > or =100% concentration throughout the study period while latanoprost did not.

Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2).

PURPOSE: To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) antagonists in the treatment of macular edema secondary to retinal vein occlusion (RVO) in clinical practice. PATIENTS AND METHODS: A multicenter retrospective study of the medical records of 165 patients (95 branch RVO, 70 central RVO) treated with at least three anti-VEGF injections in the study eye was conducted. Available data collected for at least 6 months after the first injection included Snellen best-corrected visual acuity (BCVA), central retinal thickness (CRT) by time-domain optical coherence tomography (TD-OCT) or spectral-domain optical coherence tomography (SD-OCT), anti-VEGF injections, other treatments/procedures for RVO, and adverse events. RESULTS: At baseline prior to anti-VEGF treatment, mean BCVA was 20/80 Snellen equivalent and mean CRT was 499 µm. Mean number of anti-VEGF injections received was 7.1 during the first year, 5.4 during the second year, and 5.9 during the third year; 51.3% (842/1,641) of injections were ranibizumab, 44.1% (724/1,641) were bevacizumab, and 4.6% (75/1,641) were aflibercept. One in five patients received concomitant focal laser treatment. The percentage of patients achieving both BCVA of 20/40 or better and CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT at the same visit (primary endpoint) was 26.1% (30/115) after the first anti-VEGF injection and ranged from 20.0% (7/35) to 36.7% (11/30) after the first 16 injections. After each anti-VEGF injection from the 1st to the 16th, <60% of patients achieved 20/40 or better BCVA and ≤70% of patients achieved CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT. The most common treatment-related adverse event was blurry or cloudy vision. CONCLUSION: In this real-world study, a mean of five to seven anti-VEGF injections was administered yearly, and the response to anti-VEGF therapy was suboptimal in many patients. Anti-VEGF therapy was well tolerated.

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.

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.

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.

Glaucoma in the United States and europe: predicting costs and surgical rates based upon stage of disease.

PURPOSE: Primary open-angle glaucoma is a significant health-economic burden in both the United States and Europe that is likely to increase. This study compared treatment patterns and cost among patients with primary open-angle glaucoma in these locations. METHODS: Retrospective medical chart reviews were conducted in the United States (1990 to 2002) and Europe (1995 to 2003). A total sample of 151 US charts and 194 European charts was studied, and patients were assigned a baseline intraocular pressure (IOP) and baseline stage, using a 6-stage visual functional glaucoma staging algorithm. Resource utilization and direct costs were assessed by stage of disease using publicly available United States and European costs. Cox Proportional Hazards modeling were used to examine covariates predicting glaucoma surgery. Total cost was predicted, adjusting for covariates using Generalized Linear Models, with baseline stage as the independent variable. RESULTS: Glaucoma surgery requirement was highly associated with baseline disease stage and IOP increase before surgery in the United States and somewhat associated with these factors in Europe. Within both locations, baseline IOP was highly associated with glaucoma surgery requirement. Controlling for covariates, patients at higher baseline stages incurred greater costs in the United States (P=0.0017) and Europe (P=0.0715). Surgery and medication were also highly predictive of increased cost (P<0.0001). Cost of care differed greatly between the European countries, with costs lowest in Italy. CONCLUSIONS: Increases in annual cost were related to higher baseline IOP, higher baseline stage, medication, and surgery. Thus, significant potential savings and reductions in annual healthcare burden are possible if patients are diagnosed and treated at earlier stages of glaucoma.

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.

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1).

PURPOSE: To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) inhibitors as used in clinical practice for the treatment of diabetic macular edema. METHODS: Multicenter (10 sites), retrospective chart review in patients (n=156) who received ≥3 anti-VEGF injections. Data collected for ≥6 months after the first injection included Snellen best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by time-domain or spectral-domain optical coherence tomography (TD-OCT or SD-OCT). RESULTS: Mean number of anti-VEGF injections (627 bevacizumab, 594 ranibizumab, 1 aflibercept) was 5.8 (year 1), 5.0 (year 2), and 3.4 (year 3). Percentage of patients with BCVA of 20/40 or better and CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT at the same visit (primary endpoint) ranged from 16.4% to 38.9% after the first 10 injections; 51.9%-62.3% achieved ≥20/40 BCVA and 26.2%-48.0% met CRT criteria. Therapy was well tolerated with 19 treatment-related adverse events (all ocular) reported. CONCLUSION: Anti-VEGF injections were administered less frequently and were less effective than those in the ranibizumab registration trials. After each of the first 9 injections, <25% of patients achieved both BCVA of 20/40 or better and a dry macula. A substantial proportion of patients are suboptimal responders to anti-VEGF therapy; these patients may be candidates for other therapies, including intravitreal corticosteroid and laser therapy.

A multicenter, retrospective pilot study of resource use and costs associated with severity of disease in glaucoma.

OBJECTIVE: To examine resource consumption and the direct costs of treating glaucoma at different disease severity levels. DESIGN: Observational, retrospective cohort study based on medical record review. PARTICIPANTS: One hundred fifty-one records of patients with primary open-angle or normal-tension glaucoma, glaucoma suspect, or ocular hypertension (age > or =18 years) were randomly selected from 12 sites in the United States and stratified according to severity based on International Classification of Diseases, Ninth Revision, Clinical Modification codes. Patients had to have been followed up for a minimum of 5 years. Patients with concomitant ocular disease likely to affect glaucoma treatment-related resource consumption were excluded. METHODS: Glaucoma severity was assessed and assigned using a 6-stage glaucoma staging system, modified from the Bascom Palmer (Hodapp-Anderson-Parrish) system. Clinical and resource use data were collected from the medical record review. Resource consumption for low-vision care and vision rehabilitation was estimated for patients with end-stage disease based on specialist surveys. For each stage of disease, publicly available economic data were then applied to assign resource valuation and estimate patient-level direct costs from the payer perspective. MAIN OUTCOME MEASURES: Average annual resource use and estimated total annual direct cost of treatment were calculated at the patient level and stratified by stage of disease. Direct costs by specific resource types, including ophthalmology visits, glaucoma surgeries, medications, visual field examinations, and other glaucoma services, were also assessed. RESULTS: Direct ophthalmology-related resource use, including ophthalmology visits, glaucoma surgeries, and medication use, increased as disease severity worsened. Average direct cost of treatment ranged from $623 per patient per year for glaucoma suspects or patients with early-stage disease to $2511 per patient per year for patients with end-stage disease. Medication costs composed the largest proportion of total direct cost for all stages of disease (range, 24%-61%). CONCLUSIONS: The study results suggest that resource use and direct cost of glaucoma management increase with worsening disease severity. Based on these findings, a glaucoma treatment that delays the progression of disease could have the potential to significantly reduce the health economic burden of this chronic disease over many years.