Clinical and Healthcare Resource Use Outcomes between Dual-plane and Prepectoral Techniques in Implant-based Breast Reconstruction: A Multicenter Retrospective Study.

This multicenter, retrospective study compared clinical outcomes and healthcare resource use in patients who underwent dual-plane (DP) or prepectoral (PP) implant-based breast reconstruction (IBR) after mastectomy in the United States. Methods: Medical records were selected for patients at five sites undergoing immediate one-stage direct-to-implant (first hospitalization) or two-stage IBR (first and second hospitalization) using either DP or PP. Inverse probability of treatment weighting was used to adjust for potential confounders. Complications and healthcare resource use were assessed with logistic regression; pain severity was assessed with ordinary least-squares regression. Results: After inverse probability of treatment weighting, data from 255 patients (DP = 130, PP = 125) and 441 breasts (DP = 226, PP = 215) were analyzed. Mean pain severity scores were lower with PP versus DP immediately after IBR for first (P = 0.0002) and second hospitalizations (P = 0.0145), and before discharge for first (P < 0.0001) and second hospitalizations (P = 0.0002). A greater proportion of PP versus DP patients had a shorter hospital length of stay (≤ 23 hours) for first hospitalization (P = 0.0052); proportions were similar for second hospitalization (P = 0.5499). Intravenous narcotics were prescribed less frequently to PP versus DP patients during first (61.1% versus 69.8%, respectively; P = 0.1486) and second (37.5% versus 55.3%, respectively; P = 0.0172) hospitalizations. Complication rates were low in both groups after first hospitalization discharge (DP: 13.6%, PP: 12.5%, P = 0.7225). Conclusion: This retrospective study suggests that the PP technique in IBR may offer benefits related to clinical outcomes and health resource utilization; however, larger studies, including randomized controlled trials, are needed to confirm.

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.

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.

An adherence based cost-consequence model comparing bimatoprost 0.01% to bimatoprost 0.03%.

OBJECTIVES: Estimate the long-term direct medical costs and clinical consequences of improved adherence with bimatoprost 0.01% compared to bimatoprost 0.03% in the treatment of glaucoma. METHODS: A cost-consequence model was constructed from the perspective of a US healthcare payer. The model structure included three adherence levels (high, moderate, low) and four mean deviation (MD) defined health states (mild, moderate, severe glaucoma, blindness) for each adherence level. Clinical efficacy in terms of IOP reduction was obtained from the randomized controlled trial comparing bimatoprost 0.01% with bimatoprost 0.03%. Medication adherence was based on observed 12 month rates from an analysis of a nationally representative pharmacy claims database. Patients with high, moderate and low adherence were assumed to receive 100%, 50% and 0% of the IOP reduction observed in the clinical trial, respectively. Each 1 mmHg reduction in IOP was assumed to result in a 10% reduction in the risk of glaucoma progression. Worse glaucoma severity health states were associated with higher medical resource costs. Outcome measures were total costs, proportion of patients who progress and who become blind, and years of blindness. Deterministic sensitivity analyses were performed on uncertain model parameters. RESULTS: The percentage of patients progressing, becoming blind, and the time spent blind slightly favored bimatoprost 0.01%. Improved adherence with bimatoprost 0.01% led to higher costs in the first 2 years; however, starting in year 3 bimatoprost 0.01% became less costly compared to bimatoprost 0.03% with a total reduction in costs reaching US$3433 over a lifetime time horizon. Deterministic sensitivity analyses demonstrated that results were robust, with the majority of analyses favoring bimatoprost 0.01%. Application of 1 year adherence and efficacy over the long term are limitations. CONCLUSIONS: Modeling the effect of greater medication adherence with bimatoprost 0.01% compared with bimatoprost 0.03% suggests that differences may result in improved economic and patient outcomes.

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

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.

OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial.

BACKGROUND: Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment. OBJECTIVE: Assess disease-specific quality-of-life outcomes and general health-related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics. DESIGN, SETTING, AND PARTICIPANTS: A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk. INTERVENTION: Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the King's Health Questionnaire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model. RESULTS AND LIMITATIONS: OnabotulinumtoxinA treatment at doses≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 (p<0.05). OnabotulinumtoxinA doses≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01-0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated. CONCLUSIONS: A single onabotulinumtoxinA treatment with doses≥100 U resulted in statistically significant and clinically meaningful improvement in HRQOL by week 2 compared with placebo, and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00168454.

Cost-offset analysis: bimatoprost versus other prostaglandin analogues in open-angle glaucoma.

OBJECTIVES: To develop a cost-offset model from a US payer perspective comparing glaucomatous progression and costs among primary open-angle glaucoma (POAG) patients using bimatoprost, latanoprost, or travoprost. STUDY DESIGN: Cost-offset model. METHODS: A Markov cohort model was used to estimate glaucomatous progression for POAG patients over 7 years. The model assumed bimatoprost-treated patients had lower resulting intraocular pressure (IOP) (by 1 mm Hg) for all presenting IOP categories than latanoprost- or travoprost-treated patients. Patients with lower IOP were assumed to have lower probability of progression. Those that progressed were assumed to do so at a rate of -0.6 dB per year. Direct costs associated with mean deviation score categories were applied to each treatment cohort to calculate the expected 7-year costs of treating patients with each prostaglandin analogue (PGA). Literature was used to support assumptions. A budget impact analysis was conducted where all travoprost patients switched to generic latanoprost and where all bimatoprost patients switched to generic latanoprost. The base case market share was 22% bimatoprost, 23% travoprost, and 55% latanoprost. RESULTS: Model results demonstrate that for a managed care plan with 9500 PGA-treated glaucoma patients, exclusive bimatoprost use would prevent progression in 136 additional individuals compared with exclusive travoprost or latanoprost treatment. Model results demonstrate that greater IOP reduction from bimatoprost is associated with increased cost savings compared with latanoprost or travoprost treatments. CONCLUSIONS: Model results demonstrate that greater IOP reduction from bimatoprost could reduce managed care spending.