Dilated Eye Exam Compliance for Persons With Diabetes Mellitus in a Managed Care Setting

Background/Aims: National practice guidelines recommend regular dilated eye examinations for persons with diabetes mellitus (DM). Regular exams can identify the presence of diabetic eye diseases leading to early detection and treatment along with vision preservation. We aimed to: 1) assess compliance with guideline-recommended dilated eye exams among persons with DM, and 2) determine the factors associated with noncompliance. Methods: Kaiser Permanente Southern California members aged ≥ 18 years with DM identified from January 2009 to December 2010 were followed until disenrollment or study end date (December 2013). Dilated eye exams were identified from CPT-4, ICD-9 procedure codes and retinal photographs. Compliance with guidelines over the entire duration of follow-up was the binary outcome of interest. A patient was defined as compliant when having at least one exam in each 12-month period if there was evidence of retinopathy, or at least one exam in each 24-month period if there was no evidence of retinopathy. Multivariate logistic regressions were used to investigate patient demographics and other baseline characteristics associated with noncompliance. Results: Among the 204,073 eligible patients, mean age ± standard deviation was 61 ± 13 years and 48% were female. The median follow up was 4.8 years, and overall, 71.1% of patients were compliant with dilated eye exams, including 27.7% who received an eye exam every year and 4.4% who never received a dilated eye exam. At baseline 13% of patients had retinopathy, while an additional 20% of patients developed retinopathy during follow-up time. Noncompliant patients were more likely to be younger, black, male, smokers, and have a Medicare plan, a lower income, a lower education and a higher specialist co-payment plan. In addition, these patients were less likely to be adherent to antidiabetes medications, on statin medications, take a diabetes education class and have other eye diseases; however, they were more likely to use insulin, have retinopathy, have nephropathy, and have a lower comorbidity index. Discussion: During nearly 5 years of follow-up, 28.9% of person’s with DM were noncompliant with dilated eye exam guidelines. Future research should focus on eye disease outcomes associated with noncompliance and the development of interventions to address modifiable factors associated with noncompliance

Cost-effectiveness of omalizumab for the treatment of moderate-to-severe uncontrolled allergic asthma in the United States

Objective: Uncontrolled asthma is associated with considerable clinical burden and costs to payers and patients. US economic models evaluating biologics using data from clinical trials demonstrate high incremental cost-effectiveness ratios (ICERs), but the cost-effectiveness based on real-world treatment patterns is unknown. This analysis used real-world evidence to assess the cost-effectiveness of adding omalizumab to standard of care (SOC). Methods: A Markov model was applied to track patients’ health states in 2-week cycles, comparing costs and treatment effects of SOC alone versus SOC + omalizumab over a lifetime (US payer perspective). Outcomes included exacerbation events, life years, quality-adjusted life years (QALYs), total costs, and an ICER. Patient characteristics, exacerbations, patient-reported outcomes, and work productivity were derived from the real-world PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab) study. Published literature informed mortality, exacerbation-related disutility, and unit costs. Sensitivity analyses assessed model robustness. Results: Over a lifetime horizon, omalizumab was associated with an increase of 2.0 QALYs at a cost of $US 148,319 in patients with uncontrolled asthma (ICER of$75,319/QALY gained) and a reduction in exacerbations of 6.0 events/patient. Accounting for responder status improved the ICER ($70,505/QALY); incorporating indirect costs further reduced the ICER. One-way and multivariate sensitivity analyses confirmed that the base case outcome was robust to variation in inputs. Conclusions: Based on real-world outcomes, omalizumab may be cost-effective for uncontrolled asthma from the US payer perspective. Including broader evidence on treatment discontinuation, caregiver burden, and oral corticosteroid reduction from real-world studies may better reflect the effects and value of omalizumab for all healthcare stakeholders