Severe Ocular Inflammation Following Ranibizumab or Aflibercept Injections for Age-Related Macular Degeneration: A Retrospective Claims Database Analysis.

PURPOSE: Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents including ranibizumab and aflibercept are used to treat patients with ocular disorders such as neovascular age-related macular degeneration (nAMD); however, the injections are associated with rare instances of severe ocular inflammation. This study compared severe ocular inflammation rates in patients treated with ranibizumab versus aflibercept. METHODS: United States physician-level claims data covering an 18-month period for each therapy were analyzed. The primary analysis compared severe ocular inflammation event rates per 1000 injections. Sensitivity and subgroup analyses evaluated the impact of factors including intraocular surgery, intravitreal antibiotic administration, and previous intravitreal injections. RESULTS: The analysis included 432,794 injection claims (ranibizumab n = 253,647, aflibercept n = 179,147); significantly, more unique severe ocular inflammation events occurred in patients receiving aflibercept than ranibizumab (1.06/1000 injections, 95% confidence interval [CI], 0.91-1.21, vs. 0.64/1000 injections, 95% CI 0.54-0.74; p < 0.0001). Comparable results were observed for analyses of patients who had undergone glaucoma or cataract surgeries, had antibiotic-associated endophthalmitis, had non-antibiotic-associated endophthalmitis, and were non-treatment-naive. In contrast, no significant differences in severe ocular inflammation claims were recorded in treatment-naive patients who had no record of anti-VEGF treatment in the 6 months preceding the index claim. No significant change occurred in the rate of severe ocular inflammation claims over time following ranibizumab treatment. CONCLUSIONS: Severe ocular inflammation was more frequent following intravitreal injection with aflibercept than with ranibizumab during routine clinical use in patients with nAMD. This highlights the importance of real-world, post-approval, observational monitoring of novel medicines, and may aid clinical decision-making, including choice of anti-VEGF agent.

Indirect costs associated with metastatic breast cancer.

OBJECTIVE: To compare the indirect costs of productivity loss between metastatic breast cancer (MBC) and early stage breast cancer (EBC) patients, as well as their respective family members. METHODS: The MarketScan Health and Productivity Management database (2005-2009) was used. Adult BC patients eligible for employee benefits of sick leave and/or short-term disability were identified with ICD-9 codes. Difference in sick leave and short-term disability days was calculated between MBC patients and their propensity score matched EBC cohort and general population (controls) during a 12-month follow-up period. Generalized linear models were used to examine the impact of MBC on indirect costs to patients and their families. RESULTS: A total of 139 MBC, 432 EBC, and 820 controls were eligible for sick leave and 432 MBC, 1552 EBC, and 4682 controls were eligible for short-term disability (not mutually exclusive). After matching, no statistical difference was found in sick leave days and the associated costs between MBC and EBC cohorts. However, MBC patients had significantly higher short-term disability costs than EBC patients and controls (MBC: $6166 ± $9194 vs. EBC: $3690 ± $6673 vs. CONTROLS: $558 ± $2487, both p < 0.001). MBC patients had more sick leave cost than controls ($2383 ± $5539 vs. $1282 ± $2083, p < 0.05). Controlling for covariates, MBC patients incurred 47% more short-term disability costs vs EBC patients (p = 0.009). Older patients (p = 0.002), non-HMO payers (p < 0.05), or patients not receiving chemotherapy during follow-up (p < 0.001) were associated with lower short-term disability costs. MBC patients' families incurred 39.7% (p = 0.06) higher indirect costs compared to EBC patients' families after controlling for key covariates. CONCLUSION: Productivity loss and associated costs in MBC patients are substantially higher than EBC patients or the general population. These findings underscore the economic burden of MBC from a US societal perspective. Various treatment regimens should be evaluated to identify opportunities to reduce the disease burden from the societal perspective.

Randomized trial showed that an "embedded" survey strategy optimized authorization rates compared with two "after survey" strategies in veterans with PTSD.

OBJECTIVES: To test methods to optimize mail survey response and authorization rates (i.e., allowing one's survey to be linked to medical records) when the survey is sensitive and the targeted population has a mental disorder. STUDY DESIGN AND SETTING: Randomized controlled trial of 1,099 veterans treated for posttraumatic stress disorder (PTSD) at a Midwestern Veteran Affairs Medical Center. Subjects were randomized to one of three groups: (1) Health Insurance Portability and Accountability Act (HIPAA) authorization form embedded in the survey (checking "yes" for consent); (2) HIPAA form requiring signature for consent sent after the survey; or (3) HIPAA form requiring a signature and social security number (SSN) for consent sent after the survey. RESULTS: The "embedded" strategy yielded the lowest survey response rate (67.5%) but highest authorization rate (59.1%). Requiring respondents' signatures and SSNs after the survey was returned generated the highest survey response rate (74.2%) but lowest authorization rate (48.7%). However, the response rate difference was not statistically significant. Reported emotional upset was low (1.5%) and primarily directed to the survey, not the HIPAA form. Older age and greater trustfulness were associated with higher authorization rates. CONCLUSION: Even with our most optimized strategy, authorization rates were disappointingly low.

Financial penalties for the unhealthy? Ethical guidelines for holding employees responsible for their health.

As health care costs continue to rise, an increasing number of self-insured employers are using financial rewards or penalties to promote healthy behavior and control costs. These incentive programs have triggered a backlash from those concerned that holding employees responsible for their health, particularly through the use of penalties, violates individual liberties and discriminates against the unhealthy. This paper offers an ethical analysis of employee health incentive programs and presents an argument for a set of conditions under which penalties can be used in an ethical and responsible way to contain health care costs and encourage healthy behavior among employees.

Community pharmacists' awareness of and involvement with medications intended for use in primary and secondary schools.

OBJECTIVE: To observe the degree to which community pharmacists are aware of and involved in issues related to the use of medications in primary and secondary schools and to identify the interventions they use to deal with these issues. DESIGN: Cross-sectional survey. SETTING: Illinois. PARTICIPANTS: 569 licensed pharmacists with community pharmacy experience. INTERVENTIONS: A survey comprising questions about the experiences, attitudes, and behaviors of community pharmacists with regard to medication use in schools was mailed in June 2003. MAIN OUTCOME MEASURES: Descriptive and bivariate statistical analysis of survey items. RESULTS: Almost all respondents reported that they had dispensed medications for use in school; two thirds thought that taking medications at school creates the potential for special problems (e.g., missed dose, social stigma). Of nine interventions that could help minimize these problems, the respondents used a mean of 3.34 interventions. Providing additional labeled containers for use at school was the most common intervention reported. Respondents who thought that medication use in schools caused special problems provided significantly more interventions than those that did not share this concern. CONCLUSION: Pharmacists are aware of and involved in the issues and potential problems created by medication use in schools. While they make use of interventions that are available to all community pharmacists, they could do more to help resolve issues. Additional effort to raise pharmacist awareness about medication use in schools is warranted.