Real-World Outcomes of Selective Laser Trabeculoplasty in the United Kingdom.

PURPOSE: Selective laser trabeculoplasty (SLT) is a common treatment option for managing glaucoma and ocular hypertension. We assessed the real-world effectiveness of SLT and baseline factors associated with treatment success in the United Kingdom. DESIGN: Retrospective observational study of de-identified electronic medical records (Medisoft Glaucoma module [Medisoft Ltd, Leeds, UK]) from 5 UK ophthalmology teaching centers. PARTICIPANTS: Adult patients undergoing their first recorded SLT. For bilateral SLT (same day), analyses included 1 randomly selected eye. METHODS: Patient demographics, procedure details, and clinical outcomes data were extracted. Factors associated with treatment success were assessed using multivariable Cox regression. MAIN OUTCOME MEASURES: Change from baseline in intraocular pressure (IOP) and glaucoma medication use at 12 to 18 and 24 to 36 months post-SLT. A Kaplan-Meier survival analysis was also conducted. Failure of SLT was defined as any further glaucoma procedure post-SLT or any of the following at 2 consecutive visits: IOP >21 mmHg, IOP reduction <20% from baseline, or increase in glaucoma medications from baseline. RESULTS: A total of 831 SLT-treated eyes (mean baseline IOP 22.0 mmHg) of 831 patients were analyzed. At 12 to 18 and 24 to 36 months post-SLT, respectively, significant reductions in IOP (-4.2 [95% confidence interval {CI}, -4.7 to -3.7] and -3.4 [95% CI, -4.1 to -2.7] mmHg; both P < 0.0001) and significant increases in the number of glaucoma medications (0.13 [95% CI, 0.04-0.23], P = 0.007, and 0.20 [95% CI, 0.06-0.33], P = 0.005) were observed. Survival analysis demonstrated treatment success in 70%, 45%, and 27% of eyes at 6, 12, and 24 months post-SLT, respectively. Higher baseline IOP was strongly associated with treatment success (hazard ratio [HR], 0.67 for baseline IOP >21 mmHg vs. ≤21 mmHg, 95% CI, 0.57-0.80; P < 0.001). Selective laser trabeculoplasty success was not significantly associated with age (P = 0.78), baseline visual field mean deviation (P = 1.00), or concurrent use of IOP-lowering medication (P = 0.52). CONCLUSIONS: Most patients initially responded to SLT, but the majority failed within 1 year. Efficacy of SLT was better in patients with higher baseline IOP but did not differ by glaucoma severity or concurrent use of IOP-lowering medication. These findings may help inform which patients are suitable for SLT therapy.

Treatment patterns in diabetic macular edema in Taiwan: a retrospective chart review.

OBJECTIVES: To characterize diabetic macular edema (DME) treatment patterns in Taiwan and examine their impact on health care resource utilization and visual and anatomic outcomes. METHODS: Retrospective, observational cohort study of longitudinal data from medical records of five hospital ophthalmology clinics. Patients with type 2 diabetes and DME who received ≥1 laser treatment or pharmacotherapy (intravitreal/subtenon corticosteroids and/or intravitreal anti-vascular endothelial growth factor [VEGF] agents) between January 2012 and December 2013 (index period) and attended ≥1 follow-up visit after the first treatment during that period were identified (prevalent population, N=431). In addition, a subset that received no anti-VEGFs before 2012 (anti-VEGF-naïve population, N=77) was analyzed. Outcome measures were change in DME treatment distribution between January 2009 and December 2014 and health care resource utilization over up to 3 years from the first DME treatment received in the index period (prevalent population), mean number of anti-VEGF injections and change from baseline in visual acuity and central macular thickness over 12 months (anti-VEGF-naïve population). RESULTS: Between 2009 and 2014, laser treatment use declined, overall use of anti-VEGFs increased, and bevacizumab use decreased proportionately as ranibizumab use increased. Patients receiving corticosteroids and anti-VEGFs in the first 6 months post-index had greater health care resource utilization than those treated with laser, corticosteroids, or anti-VEGF alone (P<0.0001, cross-cohort comparison). Among anti-VEGF-naïve patients, 69% received one to four anti-VEGF injections in the first year post-index. Overall, visual acuity improvement from baseline was minimal at 1 year (0.4 letters, observed data; 0.1 letters, last observation carried forward), and modest central macular thickness reduction (28 µm [last observation carried forward]) was detected. CONCLUSION: In Taiwanese clinics, DME treatment patterns have shifted from use of laser to anti-VEGFs (with higher health care resource utilization); however, few patients receive anti-VEGF injections at the frequency reported in landmark trials, consistent with poorer visual outcomes. Effective alternative treatments with lower treatment burden should be considered.

The Effect of an Educational Intervention on Adherence to Intraocular Pressure-Lowering Medications in a Large Cohort of Older Adults with Glaucoma.

BACKGROUND: Glaucoma is a progressive, irreversible disease that can lead to vision loss and lower quality of life if treatment is not optimized. Effective glaucoma therapies are available to lower intraocular pressure (IOP) and minimize or delay disease progression. Nonetheless, adherence to treatment remains suboptimal for many patients. OBJECTIVE: To identify potentially nonadherent patients and evaluate the effect of patient- and physician-centric educational interventions on adherence by using a validated predictive model of nonadherence to glaucoma medication. METHODS: This prospective, randomized, controlled, and interventional study included Humana Medicare Advantage Prescription Drug plan patients with a glaucoma diagnosis between May and October 2014, ≥ 1 pharmacy claim for glaucoma medication, and ≥ 50% likelihood of nonadherence. Patients and physicians were randomized to cohorts A (no interventions), B (physician intervention), or C (patient and physician interventions). Physicians in cohorts B and C received information on the model, adherence, and patient profiles at baseline and months 3, 6, and 9. Patients in cohort C received educational materials on glaucoma and adherence (same schedule). The primary outcome was the proportion of days covered (PDC) with medication over 12 months. Adherence was defined as PDC ≥ 0.80. RESULTS: Overall, 23,306 patients and 2,955 physicians were eligible. After excluding physicians with < 3 nonadherent patients, each cohort included 200 physicians and 600 patients. Mean PDC was 0.54-0.56 across cohorts. At 12 months, ≥ 90.5% of physicians and ≥ 75.5% of patients remained in the study; mean PDC was 0.53-0.54 across cohorts. No statistically significant between-cohort differences in PDC and adherence were observed. CONCLUSIONS: Intensive educational mailings to patients and their physicians did not improve PDC or adherence in this large population of potentially nonadherent patients with glaucoma. Findings highlight the difficulty of improving adherence in a disease that requires lifelong therapy despite being largely asymptomatic and can inform development of future interventions aimed at improving adherence to glaucoma therapy. DISCLOSURES: This study was sponsored by Allergan plc (Dublin, Ireland). Fiscella and Chandwani are employees of Allergan plc. Caplan, Kamble, Bunniran, and Uribe are employees of Comprehensive Health Insights, a Humana company. The authors did not receive honoraria or other payments for authorship.

Vision Outcomes Following Anti-Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice.

PURPOSE: To determine monitoring and treatment patterns and vision outcomes in real-world patients initiating anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME). DESIGN: Retrospective interventional cohort study. METHODS: Setting: Electronic medical record analysis of Geisinger Health System data. STUDY POPULATION: A total of 110 patients (121 study eyes) initiating intravitreal ranibizumab or bevacizumab for DME during January 2007‒May 2012, with baseline corrected visual acuity of 20/40 to 20/320, and ≥1 ophthalmologist visit during follow-up. MAIN OUTCOME MEASURES: Intravitreal injections per study eye during the first 12 months; corrected visual acuity, change in corrected visual acuity from baseline, proportions of eyes with ≥10 or ≥15 approximate Early Treatment Diabetic Retinopathy Study letter gain/loss at 12 months; number of ophthalmologist visits. RESULTS: Over 12 months, mean number of ophthalmologist visits was 9.2; mean number of intravitreal injections was 3.1 (range, 1-12), with most eyes (68.6%) receiving ≤3 injections. At 12 months, mean corrected visual acuity change was +4.7 letters (mean 56.9 letters at baseline); proportions of eyes gaining ≥10 or ≥15 letters were 31.4% and 24.0%, respectively; proportions of eyes losing ≥10 or ≥15 letters were 10.8% and 8.3%, respectively. Eyes receiving adjunctive laser during the first 6 months (n = 33) showed similar change in corrected visual acuity to non-laser-treated eyes (n = 88) (+3.1 vs +5.3 letters at 12 months). CONCLUSIONS: DME patients receiving anti-VEGF therapy in clinical practice undergo less frequent monitoring and intravitreal injections, and achieve inferior vision outcomes to patients in landmark clinical trials.

Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema.

PURPOSE: To examine the comorbidity profile and update estimates of health care resource utilization for commercially insured, working-age adults with diabetic macular edema (DME) relative to a matched comparison group of diabetic adults without DME. Additional comparisons were made in the subgroup of pseudophakic patients. PATIENTS AND METHODS: A retrospective matched-cohort study of commercially insured diabetic adults aged 18-63 years was conducted using medical and outpatient pharmacy claims (July 1, 2008-June 30, 2013). Outcomes included diabetes-related and ocular comorbidities and health care resource utilization (any health care visit days, outpatient visit days, inpatient visit days, emergency room visits, eye care-related visit days, unique medications) in the 12-month post-index period. RESULTS: All diabetes-related and ocular comorbidities were significantly more prevalent in DME cases versus non-DME controls (P<0.05). A significantly greater proportion of DME cases utilized eye care-related visits compared with non-DME controls (P<0.001). DME cases had almost twice the mean number of total health care visit days compared to non-DME controls (28.6 vs 16.9 days, P<0.001), with a minority of visit days being eye care-related (mean 5.1 vs 1.5 days, P<0.001). Similar trends were observed in pseudophakic cohorts. CONCLUSION: This working-age DME population experienced a mean of 29 health care visit days per year. Eye care-related visit days were a minority of the overall visit burden (mean 5 days) emphasizing the trade-offs DME patients face between managing DME and their overall diabetic disease. Insights into the complex comorbidity profile and health care needs of diabetic patients with DME will better inform treatment decisions and help optimize disease management.

Predictors of Nonadherence to Topical Intraocular Pressure Reduction Medications Among Medicare Members: A Claims-Based Retrospective Cohort Study.

BACKGROUND: Reported adherence rates with ocular hypotensive medications typically range from 51% to 56% over the first year of therapy. As intraocular pressure (IOP) reduction slows the progression of vision loss from glaucoma, early identification of nonadherent members is crucial to effective disease management. OBJECTIVES: To (a) identify member characteristics and other factors related to nonadherence with topical IOP-lowering medications available in administrative claims data and (b) create a predictive model incorporating these variables. METHODS: This retrospective cohort study analyzed data from Humana's administrative claims database. The study cohort included members aged 65-89 years enrolled in a Medicare Advantage Prescription Drug plan (MAPD; medical and pharmacy benefits), with > 1 topical IOP-lowering medication claims between January 2011 and September 2012 and a minimum of 24 months of continuous enrollment-12 months before and 12 months after the initial (index) prescription claim for a topical IOP-lowering medication. Adherence was defined as the proportion of days covered (PDC) with drug supply (calculated from the number of drops per bottle and dose) over the first year after the index prescription. Members with PDC > 0.80 were considered adherent, while members with PDC < 0.80 were considered nonadherent. Multivariable stepwise logistic regression with backward elimination was used to construct a predictive model for the likelihood of nonadherence (PDC < 0.80). The model was developed using 28 input variables*#x2013;10 variables were retained in the final model. RESULTS: 73,256 MAPD members were included in this study; most (69%) of these members were continuing topical IOP-lowering medication users. The proportion of patients adherent (PDC > 0.80) to IOP-lowering medications was 51%. The study sample was split, using a 2:1 ratio, into a development sample (n = 48,840 members) and a validation sample (n=24,416 members). The model performed equally well in the development sample and the validation sample (area under the curve = 0.71 for development and validation sets), making it appear robust in this Medicare population. In the final predictive model, characteristics increasing the likelihood (P < 0.01) of nonadherence to IOP-lowering medication within the MAPD population included index IOP prescription filled through mail order, higher medical costs during the pre-index period, being a new IOP-lowering medication user, and being male. Characteristics that lowered the likelihood of nonadherence included advanced age, higher pharmacy costs during the pre-index period, receiving a low-income subsidy, residing in the South, and a previous diagnosis of open-angle glaucoma or history of glaucoma surgery. CONCLUSIONS: Nonadherence to topical IOP-lowering medication can be predicted with 10 commonly available demographic, clinical, and treatment-related variables generally available in administrative claims data for an MAPD population. Given that this predictive model was constructed using these generally available data, it could potentially be replicated by other health plans for use in predicting nonadherence to topical IOP-lowering medications among MAPD plan members. This predictive model can be used to identify members that are likely to be nonadherent in order to target interventions intended to improve ocular hypotensive medication adherence. DISCLOSURES: Funding for this study was contributed by Allergan. Comprehensive Health Insights was contracted by Allergan to conduct this study. Sheer, Bunniran, and Uribe are employed by Comprehensive Health Insights/Humana and own stock in Humana. Fiscella, Chandwani, and Patel are employed by Allergan. Study concept and design were contributed by Sheer, Fiscella, and Patel, along with Bunniran and Uribe. Sheer and Bunniran took the lead in data collection, and data interpretation was performed by Bunniran and Uribe, along with the other authors. The manuscript was written and revised by Sheer, Bunniran, Chandwani, and Uribe, with assistance from Fiscella and Patel.

Estimates of charges associated with emergency department and hospital inpatient care for opioid abuse-related events.

The economic burden of prescription opioid abuse is substantial; however, no study has estimated the monetary burden of hospital services (emergency department [ED] and inpatient) using a single, nationally representative database. We sought to estimate total and average (adjusted for demographic and clinical factors) charges billed for opioid abuse-related events, and magnitude of difference in charges between ED visits resulting in inpatient admission to the same hospital and treat-and-release ED visits in the United States. We used the 2006, 2007, and 2008 files of the Healthcare Cost and Utilization Project's Nationwide Emergency Departments Sample (HCUP-NEDS) to identify events and charges assigned opioid abuse, dependence, or poisoning ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification) diagnosis codes (304.0X, 304.7X, 305.5X, 965.00, 965.02, 965.09). Using methods to account for the complex sampling design of the NEDS and a log-linked gamma regression model, we estimated national total and mean charges (in 2010 USD). Total charges were $9.8, $9.6, and $9.5 billion for 2006, 2007, and 2008, respectively. Medicaid-covered events had the highest total charges ($3 billion), followed by events covered by Medicare ($2 billion) for each year. The national estimate of adjusted, mean, per-event charges, was $18,891 (95% confidence interval [CI] = $18,167-$19,616). Compared with events covered by private insurance, mean charges for Medicare- and Medicaid-covered events were higher (t = 28.14, P < .001; t = 6.42, P < .001, respectively), whereas self-paid events had significantly lower charges (t = -11.14, P < .001). ED visits resulting in subsequent inpatient admission had approximately 6 times higher charges than treat-and-release visits. This study provides estimates of differences in hospital costs of opioid abuse by insurance status, resulting in a better understanding of the economic burden of opioid abuse on the health care system.

Prescribers and pharmacists requests for prescription monitoring program (PMP) data: does PMP structure matter?

Prescription monitoring programs (PMPs) have been purported to be an effective tool to combat prescription drug abuse. However, utilization rates of PMP data by health care providers (e.g., prescribers and pharmacists) is relatively low. The objectives of the study were to describe (1) PMP utilization (e.g., requested reports) by prescribers, pharmacists, and law enforcement for active state PMPs; (2) PMP utilization by health care providers with and without online access; (3) average annual operational costs for PMPs from 2008 to 2009; and (4) PMP requests based on PMP housing authority (law enforcement vs. non-law enforcement [e.g., board of pharmacy]). This was a cross-sectional study employing a Web-based survey. A 16-item questionnaire was e-mailed to the 33 operational state PMP administrators and responses were collected from January to March 2011. Descriptive statistics were used to describe PMP request rates and annual operating costs. The usable survey response rate was 45.5%. Among all authorized users, prescribers had higher mean (±SD) requests per 100,000 population (2198.2 ± 3218.0) compared with pharmacists' requests (268.9 ± 261.2). Online accessibility resulted in higher request rates per 100,000 population (2996.4 ± 3021.5) compared with mail/fax access (14.6 ± 2.8). On average, PMP annual costs were $12,515 ± $14,911 per 100,000 population. In law enforcement-governed PMPs, health care provider utilization was lower compared with PMPs under health or pharmacy boards. Prescriber request rates were higher than pharmacists and online access for providers (e.g., prescribers and pharmacists) resulted in higher request rates per 100,000 population. More research is needed to determine other factors that may be associated with PMP utilization by prescribers and pharmacists.

Assessing the quality of pharmacoeconomic studies in India: a systematic review.

OBJECTIVE: The aim of the study was to evaluate the quality of pharmacoeconomic studies based in India. METHODS: A literature search was conducted using PubMed, MEDLINE, EconLit, PsycInfo and Google Scholar to identify published work on pharmacoeconomics studies based in India. Articles were included if they were original studies that evaluated pharmaceuticals, were based in India and were conducted between 1990 and 2010. Two reviewers independently reviewed the articles using a subjective 10-point quality scale in addition to the 100-point Quality of Health Economic Studies (QHES) questionnaire. RESULTS: Twenty-nine articles published between 1998 and May 2010 were included in the review. The included articles were published in 23 different journals. Each article was written by an average of five authors. The mean subjective quality score of the 29 articles was 7.8 (standard deviation [SD] = 1.3) and the mean QHES scores for the complete pharmacoeconomic studies (n = 24) was 86 (SD = 6). The majority of authors resided in India (62%) at the time of publication and had a medical background (90%). The quality score was significantly (p ≤ 0.05) related to the country of residence of the primary author (non-India = higher) and the study design (randomized controlled trials = higher). CONCLUSION: Although the overall quality scores were comparable to (e.g. Nigeria) or higher than (e.g. Zimbabwe) similar studies in other developing countries, key features such as an explicit study perspective and the use of sensitivity analyses were missing in about 40% of the articles. The need for economic evaluation of pharmaceuticals is imperative, especially in developing countries such as India as this helps decision makers allocate scarce resources in a justifiable manner.