Biomarker Testing for Patients With Advanced/Metastatic Nonsquamous NSCLC in the United States of America, 2015 to 2021.

Introduction: NSCLC is a solid tumor with a growing number of actionable biomarkers that may inform treatment. Current guidelines recommend a broad, panel-based approach be taken to identify actionable markers. This retrospective study used a deidentified electronic health records database in the United States to evaluate utilization of various testing modalities. Methods: Data from all adult patients diagnosed with having advanced/metastatic nonsquamous NSCLC between January 2015 and March 2021 were eligible if there was evidence of systemic therapy within 90 days of diagnosis. Results: Records from a total of 17,513 patients (91.6% from community-based practices) were eligible with 83,064 genomic biomarker tests recorded from 2015 to 2021. The proportion of patients who received biomarker testing by next-generation sequencing (NGS)-based methods ranged from 28.3% in 2015 to 68.1% in 2020. The proportion of biomarker testing methods with inconclusive or unsuccessful results ranged from 3.4% for NGS to 9.7% for fluorescence in situ hybridization. The median time to receive results ranged from 4.0 days for polymerase chain reaction-based tests to 10.0 days for immunohistochemistry- and NGS-based tests. Median time to receive results was 8 days for academic and 9 days for community practices. Conclusions: These real-world data suggest increased adoption of NGS-based testing, yet nearly one-third of all patients with advanced/metastatic nonsquamous NSCLC still did not receive broad-based genomic testing by 2020.

Validation of an International Classification of Disease, 10th revision coding adaptation for the Charlson Comorbidity Index in United States healthcare claims data.

PURPOSE: An International Classification of Disease (ICD-10) Charlson Comorbidity Index (CCI) adaptation had not been previously developed and validated for United States (US) healthcare claims data. Many researchers use the Canadian adaption by Quan et al (2005), not validated in US data. We sought to evaluate the predictive validity of a US ICD-10 CCI adaptation in US claims and compare it with the Canadian standard. METHODS: Diverse patient cohorts (rheumatoid arthritis, hip/knee replacement, lumbar spine surgery, acute myocardial infarction [AMI], stroke, pneumonia) in the IBM® MarketScan® Research Databases were linked with the IBM MarketScan Mortality file. Predictive performance was measured using c-statistics for binary outcomes (1-year and postoperative mortality, in-hospital complications) and root mean square prediction error (RMSE) for continuous outcomes (1-year all-cause medical costs, index hospitalization costs, length of stay [LOS]), after adjusting for age and sex. C-statistics were compared by the method of DeLong and colleagues (1988); RMSEs, by resampling. RESULTS: C-statistics were generally high (≥ ~ 0.8) for mortality but lower for in-hospital complications (~0.6-0.7). RMSEs for costs and hospitalization LOS were relatively large and comparable to standard deviations. Results were similar overall between the US and Canadian adaptations, with relative differences typically <1%. CONCLUSIONS: This US-based coding adaptation and a previously published Canadian adaptation resulted in similar predictive ability for all outcomes evaluated but may have different construct validity (not evaluated in our study). We recommend using adaptations specific to the country of data origin based on good research practice.

Healthcare costs and adherence associated with human regular U-500 versus high-dose U-100 insulin in patients with diabetes.

OBJECTIVE: Describe the characteristics, costs, and adherence of patients receiving human regular U-500 insulin (U-500R) compared with those of patients receiving high-dose (≥150 units/day) U-100 insulin. METHODS: Data from Truven Health MarketScan Research Databases, July 1, 2008, through December 31, 2010, were used. The U-100 cohort received ≥150 units/day of U-100 insulin for ≥31 days during the first 60 days after the index date. The U-500R cohort received ≥2 prescriptions of U-500R after the index date. Analyses were performed on propensity-matched cohorts. The changes in annualized costs were compared between the 2 cohorts using paired t tests. Adherence was assessed by the proportion of days covered (PDC) and compared using a 2-sample t test. Glycemic efficacy data were not available in this database. RESULTS: There were 1,044 U-500R-treated patients (19.1% with type 1 diabetes [T1D]) and 11,520 U-100-treated patients (23.8% with T1D) identified, from which 1,039 matched pairs were obtained. The mean decrease of $1,290 in annual pharmacy costs for the U-500R cohort was significantly different from the mean increase of $2,586 for the U-100 cohort (P<.001; 95% confidence interval, -$4,345 to -$3,422). More U-500R patients experienced hypoglycemia (17.3% vs. 11.8%; P<.001), but the hypoglycemia rate per person and related costs were not significantly different between cohorts. Finally, the mean 12-month PDC was 65.0% for U-500R versus 47.6% for U-100 patients (P<.0001). CONCLUSION: Compared with treatment with ≥150 units/day of U-100 insulin, treatment with U-500R was associated with decreases in pharmacy costs, a higher percentage of patients experiencing hypoglycemia, and greater treatment adherence.

Cost, healthcare resource utilization, and adherence of individuals with diabetes using U-500 or U-100 insulin: a retrospective database analysis.

OBJECTIVE: To describe costs, healthcare resource utilization, and adherence of US patients receiving human regular U-500 insulin (U-500R), compared to patients receiving high-dose (>200 units/day) U-100 insulins (U-100) by subcutaneous injection for the treatment of diabetes. METHODS: A retrospective analysis of data from Thomson Reuters MarketScan Research Databases (7/1/2008 to 12/31/2010). Difference-in-differences analyses were conducted on cost (medical, pharmacy, and overall costs) and on healthcare resource utilization variables (overall, diabetes-related, and non-diabetes-related medical visits). Adherence rates to the index insulins were assessed by proportion of days covered (PDC). RESULTS: Seven hundred and eleven (19%) patients in the U-500R cohort and 1508 (6%) patients in the U-100 cohort met selection criteria. Propensity score matching resulted in 684 matched pairs. Mean change in annualized pharmacy costs was in favor of the U-500R vs the U-100 cohort (-$1258 vs $3345, a difference of -$4603, p < 0.0001). Mean overall cost increase in the U-500R vs the U-100 cohort was also lower ($1999 vs $9104, a difference of -$7105, p = 0.005). The proportion of patients with at least one coded hypoglycemic event during the 12-month post-index period was higher in the U-500R vs the U-100 cohort (17.1% vs 11.7%, p < 0.005), but neither hypoglycemia rate (2.73 vs 2.90 events per person) nor hypoglycemia-specific costs (mean $1669 vs $1543) were significantly different. No significant differences were noted between cohorts for change (post-pre) in any resource utilization category. PDC was greater in the U-500R vs the U-100 cohort (65.2% vs 39.5%, p < 0.0001). LIMITATIONS: Claims data are not as accurate as empirical evaluation by a clinician. Glycemic control data were not available for this analysis. CONCLUSIONS: In patients requiring high-dose insulin, treatment with U-500R vs high-dose U-100 insulins is associated with significant decreases in pharmacy and overall costs, slightly higher hypoglycemia incidence, no difference in hypoglycemia-specific costs or in resource utilization, and better adherence.

Treatment patterns and resource use among patients with comorbid diabetes mellitus and major depressive disorder.

OBJECTIVE: To descriptively analyze patient characteristics, treatment patterns, and medical resource use of individuals with diabetes mellitus (DM) with and without comorbid major depressive disorder (MDD). RESEARCH DESIGN AND METHODS: Using an administrative claims database, commercially insured adults diagnosed with DM were studied over the calendar years 2005 and 2006. Demographic characteristics, comorbid illnesses, medication use, resource utilization, and costs were examined descriptively among patients with DM both with and without comorbid MDD. RESULTS: Patients with DM and MDD were found to have a high resource burden, compared to patients with DM without MDD. Specifically, these patients were found to be more likely to be diagnosed with other comorbid medical conditions, to use multiple medications, and to use more healthcare services such as inpatient visits, emergency admissions, and outpatient visits. Consistent with these findings, costs for these patients were found to be $19,707 per year, compared to $11,237 for patients with DM without comorbid MDD. LIMITATIONS: The study utilizes data from an administrative claims database of insured individuals and hence, results may not be generalizable. Furthermore, the analysis is unable to examine clinical severity or indirect costs. CONCLUSION: Compared to patients with DM and no comorbid MDD, patients with DM and MDD tend to have a larger burden of disease and to use more healthcare resources.