Joanna Campbell

Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema

Purpose To examine the utilization of bevacizumab and ranibizumab and disease monitoring in patients with branch or central retinal vein occlusion (BRVO/CRVO) or diabetic macular edema (DME) in clinical practice. Patients and methods This retrospective claims analysis included newly diagnosed patients with one or more bevacizumab or ranibizumab injections. Bevacizumab or ranibizumab utilization was assessed by year of first injection: 2008–2010 cohorts (12-month follow-up), January to June 2011 cohort (6-month follow-up). The main outcome measures were mean annual numbers of injections, ophthalmologist visits and optical coherence tomography examinations, and proportion of patients with additional laser or intravitreal triamcinolone (IVTA) use. Results A total of 885 BRVO, 611 CRVO, and 2,733 DME patients treated with bevacizumab were included, with too few ranibizumab-treated patients for meaningful analysis. Across the 2008, 2009, and 2010 cohorts, mean annual numbers of bevacizumab injections increased, but remained low (BRVO 2.5, 3.1, 3.3; CRVO 3.1, 3.1, 3.5; and DME 2.2, 2.5, 3.6, respectively); mean ophthalmologist visits ranged between 4.4 and 6.5, and mean optical coherence tomography examinations ranged between 3.1 and 3.9 across all conditions. A total of 42.0% of BRVO, 16.5% of CRVO, and 57.7% of DME patients received additional laser or IVTA therapy. The number of bevacizumab injections was positively associated with laser use in BRVO (3.3 versus 2.9, P<0.03), and with laser or IVTA use in DME (laser, 3.3 versus 2.7, P<0.03; IVTA, 3.3 versus 3.0, P<0.05). Conclusion During the study period (2008–2011), bevacizumab was the main anti-VEGF therapy used in clinical practice for BRVO, CRVO, and DME. Patients treated with bevacizumab were monitored less frequently and received fewer injections than patients in major clinical trials of ranibizumab.

Patient adherence and persistence with topical ocular hypotensive therapy in real-world practice: a comparison of bimatoprost 0.01% and travoprost Z 0.004% ophthalmic solutions

Background Effective control of intraocular pressure is predicated upon patient compliance with pharmacotherapy. We compared patient adherence and persistence with two new ocular hypotensive formulations, using real-world utilization data. Methods This observational cohort study employed pharmacy claims data from the Source® Lx (Wolters Kluwer Pharma Solutions) database. Patients with an initial (index) prescription for topical bimatoprost 0.01% or travoprost Z (April to June 2011) and no claim for ophthalmic prostaglandin or prostamide analogs within the previous 18 months were identified. Treatment adherence was expressed as proportion of days covered with study medication during the first 365 days after the index prescription. Treatment persistence with study medication was assessed over the first 12 months using Kaplan–Meier survival analyses, allowing a maximum 30-day gap for prescription refill. Treatment status was determined monthly over this period. Results A total of 12,985 patients were assessed for treatment adherence, and 10,470 for treatment persistence. Adherence was better with bimatoprost 0.01% than with travoprost Z (mean proportion of days covered 0.540 versus [vs] 0.486, P<0.001), and more patients showed high adherence (proportion of days covered >0.80) with bimatoprost 0.01% than travoprost Z (29.1% vs 22.3%, P<0.001). Continuous 12-month persistence was higher with bimatoprost 0.01% than with travoprost Z (29.5% vs 24.2%, P<0.001). At month 12, more patients were on treatment with bimatoprost 0.01% than travoprost Z (48.8% vs 45.7%, P<0.01). Similar findings were demonstrated in cohorts of ocular hypotensive treatment-naïve patients, branded latanoprost switchers, and older patients (age ≥65 years), and after inclusion of patient characteristics as covariates. Conclusion For patients with glaucoma or ocular hypertension, bimatoprost 0.01% offers compliance advantages over travoprost Z.

Comorbidity and Health Care Resource Use Among Commercially Insured Non-Elderly Patients With Diabetic Macular Edema.

BACKGROUND AND OBJECTIVE Diabetic macular edema (DME) is a leading cause of blindness for non-elderly adults; however, health care-associated burden data from this population is lacking. The authors describe health care-associated burden in non-elderly patients with DME compared to those with diabetes and no DME. PATIENTS AND METHODS In this retrospective, large-cohort study examines enrollment and health care claims (2007 to 2011) from a national database of insured patients aged 18 to 63 years (mean: 51). Comorbidity and health care utilization differences between patients with DME (n = 24,326) and matched controls with diabetes but no DME (n = 122,710) were analyzed over 1 and 3 years. RESULTS DME patients had significantly more baseline comorbidities, and generally developed them at a higher rate over the study. Health care resource utilization rates were significantly higher in DME patients for every category analyzed. Patients with DME averaged more than 10 health care visits more than those with diabetes but no DME (25.5 vs 14.9; P < .001). CONCLUSION Working-age patients with DME exhibit a complicated comorbidity profile and high associated burden of health care consumption. Considering this burden is critical for managing this complex population.

Comparison of adherence and persistence with bimatoprost 0.01% versus bimatoprost 0.03% topical ophthalmic solutions

Abstract Objective: To compare patient adherence and persistence with bimatoprost 0.01%, a new formulation that offers equivalent intraocular pressure-lowering efficacy to bimatoprost 0.03% and improved tolerability, with that of the original bimatoprost 0.03% formulation. Methods: Pharmacy claims from a longitudinal database of prescription and medical claims for >115 million patients were analyzed. Patients with an initial (index) prescription for bimatoprost 0.01% or 0.03% between April and June 2011, and with no claim for ophthalmic prostaglandin or prostamide analogs during the preceding 18 months, were identified. Treatment adherence was expressed as the proportion of days covered (PDC) with study medication over the first 365 days after the index prescription. Treatment persistence over the first 12 months following the index prescription was assessed using Kaplan–Meier analyses, assuming a 30 day grace period for prescription refill. Treatment status (on/off study medication) was determined monthly for 12 months post-index. Results: In total, 6150 patients were assessed for treatment adherence and 7660 for persistence. Adherence was significantly better with bimatoprost 0.01% than bimatoprost 0.03% (mean PDC 0.540 vs. 0.438; p < 0.001). Significantly more patients had high adherence (PDC > 0.80) with bimatoprost 0.01% than 0.03% (29.1% vs. 17.3%; p < 0.001). Persistence was also significantly better with bimatoprost 0.01%, with 29.5% (95% confidence interval [CI]: 28.3%, 30.8%) versus 18.3% (95% CI: 16.8%, 19.9%) of patients remaining on continuous treatment for 12 months (p < 0.001). At 12 months, significantly more patients were ‘on treatment’ (continuing/restarting treatment) with bimatoprost 0.01% than 0.03% (48.8% vs. 33.9%; p < 0.001). Sensitivity analyses demonstrated similar findings in cohorts of ocular hypotensive treatment-naïve and elderly (≥65 years) patients. Conclusions: Bimatoprost 0.01% offers adherence and persistency advantages over bimatoprost 0.03% in patients requiring ocular hypotensive therapy. Study limitations included the observational design, lack of control for imbalances in patient characteristics, and assumption that prescription refill is synonymous with medication use.

Clinical Monitoring of Patients With Age-Related Macular Degeneration Treated With Intravitreal Bevacizumab or Ranibizumab

BACKGROUND AND OBJECTIVE Patients with neovascular age-related macular degeneration (AMD) require frequent follow-up and regular anti-VEGF injections for optimal outcomes. Although studies suggest that injection frequency is suboptimal in clinical practice, monitoring frequency in this setting is unclear. This study evaluates annual monitoring patterns between 2008 and 2011. PATIENTS AND METHODS This retrospective claims analysis included newly diagnosed neovascular AMD patients with at least one intravitreal bevacizumab or ranibizumab injection (8,811 and 2,877 patients, respectively). Patient monitoring and treatment patterns were assessed at 12-month intervals. RESULTS From 2008 to 2010, the mean number of injections increased. In the 2010 cohort, among bevacizumab- and ranibizumab-treated patients, respectively, less than 23% and less than 40% had at least 10 ophthalmologist visits, and less than 4% and less than 21% had at least 10 optical coherence tomography scans. CONCLUSION Patients with neovascular AMD in clinical settings during 2008 to 2011 were monitored less frequently and received fewer anti-VEGF injections than patients in major clinical trials, which may affect outcomes.