Evaluating the Relationship Between Visual Acuity and Utilities in Patients With Diabetic Macular Edema Enrolled in Intravitreal Aflibercept Studies

PURPOSE. The purpose of this study was to explore the relationship between visual acuity and utility (health-related quality of life) in diabetic macular edema (DME) using intravitreal aflibercept data. METHODS. The relationship between visual acuity in the best-seeing eye (BSE) and worseseeing eye (WSE) and utility was explored using ordinary least squares (OLS) and randomeffects models adjusted for different covariates (age, age2 , sex, body mass index, smoking status, glycated hemoglobin, diabetes severity, comorbidities, and geographic region). Utility was measured using the EuroQoL-five dimensions questionnaire (EQ-5D) and Visual Functioning Questionnaire-Utility Index (VFQ-UI). For each model, coefficients (R2 ) were reported, and WSE/BSE was expressed as the ratio of coefficients (OLS models). Models were independent of treatment effects, and outcomes from all time points (up to week 100) were included where available. RESULTS. Data from 1320 patients with DME were analyzed. In all models, the association between visual acuity (BSE > WSE) was stronger with VFQ-UI– than EQ-5D–derived utilities. The estimated relationship between VFQ-UI and visual acuity in the BSE and WSE was robust, even with an increasing number of covariates. WSE/BSE coefficient ratios were similar across VFQ-UI OLS models (32%) compared with EQ-5D models (41%–48%). Actual (unadjusted) versus predicted data plots also showed a better fit with VFQ-UI– than EQ-5D–derived utilities. CONCLUSIONS. These analyses show that VFQ-UI was more sensitive than EQ-5D–derived utilities for measuring the impact of visual acuity in the BSE and WSE. Visual acuity in the BSE was a major contributor to utility, but WSE is also important though to a lesser degree as shown by the coefficient ratios. These new data will be useful for health technology assessments in DME, where utilities data are lacking. Keywords: diabetic macular edema, intravitreal aflibercept, utilit

Economic Evaluation of Community-Based Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease

ObjectivesTo analyse the cost effectiveness of community-based case management for patients suffering from chronic obstructive pulmonary disease (COPD).MethodsThe study took place in the third largest municipality in Denmark and was conducted as a randomised controlled trial with 12 months of follow-up. A total of 150 patients with COPD were randomised into two groups receiving usual care and case management in addition to usual care. Case management included among other things self care proficiency, medicine compliance, and care coordination. Outcome measure for the analysis was the incremental cost-effectiveness ratio (ICER) as cost per quality-adjusted life year (QALY) from the perspective of the healthcare sector. Costs were valued in British Pounds (£) at price level 2016. Scenario analyses and probabilistic sensitivity analyses were conducted in order to assess uncertainty of the ICER estimate.ResultsThe intervention resulted in a QALY improvement of 0.0146 (95% CI −0.0216; 0.0585), and a cost increase of £494 (95% CI −1778; 2766) per patient. No statistically significant difference was observed either in costs or effects. The ICER was £33,865 per QALY gained. Scenario analyses confirmed the robustness of the result and revealed slightly lower ICERs of £28,100–£31,340 per QALY.ConclusionsAnalysis revealed that case management led to a positive incremental QALY, but were more costly than usual care. The highly uncertain ICER somewhat exceeds for instance the threshold value used by the National Institute of Health and Care Excellence (NICE). No formally established Danish threshold value exists.Objectives:To analyse the cost effectiveness of community-based case management for patients suffering from chronic obstructive pulmonary disease (COPD).Methods:The study took place in the third largest municipality in Denmark and was conducted as a randomised controlled trial with 12 months of follow-up. A total of 150 patients with COPD were randomised into two groups receiving usual care and case management in addition to usual care. Case management included among other things self care proficiency, medicine compliance, and care coordination. Outcome measure for the analysis was the incremental cost-effectiveness ratio (ICER) as cost per quality-adjusted life year (QALY) from the perspective of the healthcare sector. Costs were valued in British Pounds (£) at price level 2016. Scenario analyses and probabilistic sensitivity analyses were conducted in order to assess uncertainty of the ICER estimate.Results:The intervention resulted in a QALY improvement of 0.0146 (95% CI −0.0216; 0.0585), and a cost increase of £494 (95% CI −1778; 2766) per patient. No statistically significant difference was observed either in costs or effects. The ICER was £33,865 per QALY gained. Scenario analyses confirmed the robustness of the result and revealed slightly lower ICERs of £28,100–£31,340 per QALY.Conclusions:Analysis revealed that case management led to a positive incremental QALY, but were more costly than usual care. The highly uncertain ICER somewhat exceeds for instance the threshold value used by the National Institute of Health and Care Excellence (NICE). No formally established Danish threshold value exists.ClinicalTrials.gov Identifier: NCT01512836.<br/