Identifying Measures of Suboptimal Healthcare Interaction (SOHI) to Develop a Claims-Based Model for Predicting Patients with Inflammatory Bowel Disease at Risk for SOHI.

BACKGROUND: Understanding the demographic and clinical characteristics of patients with Inflammatory Bowel Disease (IBD) who are likely to experience poor disease outcomes may allow early interventions that can improve health outcomes. OBJECTIVES: To describe demographic and clinical characteristics of patients with ulcerative colitis (UC) and Crohn's disease (CD) with the presence of at least one Suboptimal Healthcare Interaction (SOHI) event, which can inform the development of a model to predict SOHI in members with IBD based on insurance claims, with the goal of offering these patients some additional intervention. METHODS: We identified commercially insured individuals with IBD between 01 January 2019 and 31 December 2019 using Optum Labs' administrative claims database. The primary cohort was stratified on the presence or absence of ≥ 1 SOHI event (a SOHI-defining data point or characteristic at a specific time point) during the baseline observation period. SOHI was deployed as the basis for the development of a model to predict which individuals with IBD were most likely to continue to have SOHI within a 1-year timeframe (follow-up SOHI) using insurance claims data. All baseline characteristics were analyzed descriptively. Multivariable logistic regression was used to examine the association of follow-up SOHI with baseline characteristics. RESULTS: Of 19,824 individuals, 6872 (34.7%) were found to have follow-up SOHI. Individuals with follow-up SOHI were more likely to have had similar SOHI events in the baseline period than those with non-SOHI. A significantly greater proportion of individuals with SOHI had ≥ 1 claims-based C-reactive protein (CRP) test order and ≥ 1 CRP lab results compared with non-SOHI. Individuals with follow-up SOHI were more likely to incur higher healthcare expenditures and resource utilization as compared with non-SOHI individuals. A few of the most important variables used to predict follow-up SOHI included baseline mesalamine use, count of baseline opioid fills, count of baseline oral corticosteroid fills, baseline extraintestinal manifestations of disease, proxy for baseline SOHI, and index IBD provider specialty. CONCLUSION: Individuals with SOHI are likely to have higher expenditures, higher healthcare resource utilization, uncontrolled disease, and higher CRP lab results as compared with non-SOHI members. Distinguishing SOHI and non-SOHI patients in a dataset could efficiently identify potential cases of poor future IBD outcomes.

We have developed a model for identifying suboptimal healthcare interactions (SOHI) at follow-up and used it to predict the individuals with inflammatory bowel disease (IBD) who are likely to suffer poor healthcare outcomes. Our study showed that the SOHI and non-SOHI cohorts had notable differences in clinical baseline characteristics. Compared with non-SOHI members, individuals with SOHI experienced poor IBD outcomes and incurred higher healthcare resource utilization and costs. Understanding baseline characteristics of patients with SOHI to predict follow-up SOHI can improve health outcomes by early identification of patients with IBD who are likely to experience it. This can help in targeting efforts toward additional care, resulting in greater chances of a well-managed disease.

Racial and ethnic disparity in clinical outcomes among patients with confirmed COVID-19 infection in a large US electronic health record database.

BACKGROUND: Racial and ethnic minority groups have been disproportionately affected by the US coronavirus disease 2019 (COVID-19) pandemic; however, nationwide data on COVID-19 outcomes stratified by race/ethnicity and adjusted for clinical characteristics are sparse. This study analyzed the impacts of race/ethnicity on outcomes among US patients with COVID-19. METHODS: This was a retrospective observational study of patients with a confirmed COVID-19 diagnosis in the electronic health record from 01 February 2020 through 14 September 2020. Index encounter site, hospitalization, and mortality were assessed by race/ethnicity (Hispanic, non-Hispanic Black [Black], non-Hispanic White [White], non-Hispanic Asian [Asian], or Other/unknown). Associations between racial/ethnic categories and study outcomes adjusted for patient characteristics were evaluated using logistic regression. FINDINGS: Among 202,908 patients with confirmed COVID-19, patients from racial/ethnic minority groups were more likely than White patients to be hospitalized on initial presentation (Hispanic: adjusted odds ratio 1·690, 95% CI 1·620-1·763; Black: 1·810, 1·743-1·880; Asian: 1·503, 1·381-1·636) and during follow-up (Hispanic: 1·700, 1·638-1·764; Black: 1·578, 1·526-1·633; Asian: 1·391, 1·288-1·501). Among hospitalized patients, adjusted mortality risk was lower for Black patients (0·881, 0·809-0·959) but higher for Asian patients (1·205, 1·000-1·452). INTERPRETATION: Racial/ethnic minority patients with COVID-19 had more severe disease on initial presentation than White patients. Increased mortality risk was attenuated by hospitalization among Black patients but not Asian patients, indicating that outcome disparities may be mediated by distinct factors for different groups. In addition to enacting policies to facilitate equitable access to COVID-19-related care, further analyses of disaggregated population-level COVID-19 data are needed.

Real-World Trends in Characteristics of Patients with Migraine Newly Initiated on Erenumab in the USA: A Retrospective Analysis.

INTRODUCTION: This retrospective analysis aimed to characterize patients with migraine initiating erenumab and the shifting or trend of patient characteristics over time in a real-world setting. METHODS: Adult patients with at least one erenumab written prescription/administration between May 1, 2018 and September 30, 2019 were identified from the Optum De-identified Electronic Health Record (EHR) database (index date = date of the first erenumab prescription/administration). Patient demographics and characteristics, acute and preventive medications used prior to initiation of erenumab, and the initial prescriber specialty were examined. In addition, the shifting or trends of patient characteristics over time were analyzed among subgroups of patients based on when they initiated erenumab. RESULTS: A total of 14,774 eligible patients who met inclusion and exclusion criteria were included in the analysis. Most patients were female (86.4%), average age 46.3 (standard deviation [SD] = 13.1) years, Caucasian (88.7%), non-Hispanic (91.8%), and commercially insured (59.8%) at the index date. During the 12-month pre-index period, commonly observed selected comorbid conditions included anxiety (30.6%), depression (28.2%), and cardiovascular diseases (26.4%), and the mean (SD) Elixhauser comorbidity score was 1.7 (5.5). The most common provider specialty at erenumab initiation was neurologist/headache specialist (46.5%). Over time, there was a decrease in mean baseline Elixhauser comorbidity score at erenumab initiation, an increase in general practitioners prescribing initial erenumab, and increased utilization in patients with less severe migraine overall (a proxy of the declining trend in chronic migraine and triptan use). CONCLUSION: Early use of erenumab post approval focused on patients with more severe disease and a high comorbidity index rating. Over time, utilization of this preventive medication occurred in a broader population of patients with migraine, with increased use by general practitioners and those outside of headache centers.

Analysis of patient characteristics, health care costs by surgical venue, and opioid utilization for common orthopedic procedures in the United States.

BACKGROUND: Orthopedic surgery can be performed in hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs), as well as in traditional inpatient venues. Patients who undergo orthopedic surgery may be prescribed opioids for the management of postsurgical pain. However, the association between surgery venue, postsurgical opioid use, and health care costs remains unclear. OBJECTIVE: To compare postsurgical opioid use and health care costs associated with 6 different orthopedic surgical procedures performed at inpatient, ASC, and HOPD venues. METHODS: Using the Optum Research Database, this retrospective study analyzed commercial health care claims from adult patients in the United States undergoing specific orthopedic procedures (total knee arthroplasty, partial knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty, rotator cuff repair, and lumbar spinal fusion) between April 1, 2012, and December 31, 2017. The date of the first procedure in that period was the index date; continuous insurance coverage for 12 months before the index date (baseline period) to 6 months following the index date (postsurgical period, which includes the index date) was required. Opioid use and all-cause costs were measured in the postsurgical period. Baseline patient characteristics included demographics, Quan-Charlson Comorbidity Index, and opioid use. Multivariable analysis identified factors influencing postsurgical costs and persistent opioid use (defined as ≥ 1 opioid fill within 3 days after surgery [or discharge for inpatient stay] and ≥1 additional opioid fill during the postsurgical period at least 90 days after the index date). RESULTS: The sample included 126,172 patients (mean age, 58 years; 49% female). Overall, most procedures were performed at inpatient venues (68%), followed by HOPDs (18%) and ASCs (14%); the percentage of procedures performed at ASCs increased from 12% to 17% from 2012 to 2017. Patients whose procedures were performed at ASCs reported the lowest adjusted percentage of persistent opioid use following the procedure (18%) compared with those with procedures performed at HOPDs (24%) or inpatient venues (26%). Adjusted 30-day costs were 14% and 27% lower for patients with procedures in HOPDs and ASCs, respectively, compared with inpatient venues (P < 0.001 for both), and adjusted costs over the first 90 days were similar. CONCLUSIONS: All-cause costs on the day of surgery through 30 days after surgery for these 6 orthopedic procedures were significantly lower in HOPDs and ASCs compared with inpatient venues, even after adjustment for cohort, surgery year, demographic characteristics, baseline Quan-Charlson Comorbidity Index, and any opioid use within 90 days before the procedure. Additionally, patients undergoing orthopedic surgery at ASCs had the lowest adjusted percentage of persistent opioid use compared with those undergoing surgery at HOPDs or inpatient venues. Migration of certain orthopedic procedures from inpatient venues to HOPDs or ASCs may reduce health care costs and decrease the potential for persistent opioid use. DISCLOSURES: This study and editorial support for the preparation of this manuscript was funded by Pacira BioSciences, which contracted with Optum to conduct the study. Cisternas, Korrer, and Wilson are employees of Optum. Waterman was employed with Pacira BioSciences at the time of the study. Portions of this work were presented at AMCP Nexus 2019; October 29-November 1, 2019; National Harbor, MD.

Real-World Outcomes and Value of First-Line Therapy for Metastatic Non-Small Cell Lung Cancer†.

Although physicians rely on clinical trial data to guide cancer treatment decisions, patient characteristics and outcomes often differ between real-world and clinical trial populations. We analyzed retrospective clinical data collected from a prior authorization (PA) tool linked with payer claims data to describe outcomes of first-line treatment for metastatic non-small cell lung cancer among 2,108 patients. Duration of therapy was shorter than observed in clinical trials. Healthcare costs and hospitalizations varied substantially by regimen. PA clinical data linked with administrative claims enable head-to-head comparisons of contemporary cancer treatments used in routine clinical practice, which are not available from clinical trials.

Health Care Use and Costs Among Patients With Nonalcoholic Steatohepatitis With Advanced Fibrosis Using the Fibrosis-4 Score.

Limited evidence exists on the clinical and economic burden of advanced fibrosis in patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) due to the invasiveness of liver biopsies for accurately staging liver disease. The fibrosis-4 (FIB-4) score allows for noninvasive assessment of liver fibrosis by using clinical and laboratory data alone. This study aimed to characterize the comorbidity burden, health care resource use (HCRU), and costs among patients with NAFLD/NASH with FIB-4-defined F3 (bridging fibrosis) and F4 (compensated cirrhosis) fibrosis. Using the Optum Research Database, a retrospective cohort study was conducted among 251,725 commercially insured adult patients with ≥1 NAFLD/NASH diagnosis from January 1, 2008, to August 31, 2016, and laboratory data required to calculate FIB-4 scores. Five criteria using varying FIB-4 score cutoffs were identified based on expert clinical opinion and published literature. Date of the first valid FIB-4 score marked the index date. Mean annual HCRU and costs were calculated during the pre-index and post-index periods. The prevalence of FIB-4-based F3 and F4 fibrosis was 0.40%-2.72% and 1.03%-1.61%, respectively. Almost 50% of patients identified with FIB-4-based F3 or F4 had type 2 diabetes, cardiovascular disease, or renal impairment. Total all-cause health care costs increased significantly from pre-index to post-index for patients with FIB-4-based F3 fibrosis across most criteria (17%-29% increase) and patients with FIB-4-based F4 fibrosis across all criteria (47%-48% increase). Inpatient costs were the primary drivers of this increment. Conclusion: Significant increases in HCRU and costs were observed following FIB-4-based identification of F3 and F4 fibrosis among U.S. adults with NAFLD/NASH. These data suggest the importance of early identification and management of NAFLD/NASH that may halt or reduce the risk of disease progression and limit the underlying burden.

Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR).

AIMS: To characterize a US population of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) using CONTOR, a real-world longitudinal research platform that deterministically linked administrative claims data with patient-reported outcomes data among patients with these conditions. METHODS: Patients with IBS-C or CIC were identified using diagnosis and treatment codes from administrative claims. Potential respondents received a mailed survey followed by 12 monthly online follow-up surveys and 2 mailed diaries. Surveys collected symptom severity, treatment use, quality of life, productivity, and condition/treatment history. Comorbidities and healthcare costs/utilization were captured from claims data. Diaries collected symptoms, treatments, and clinical outcomes at baseline and 12 months. Data were linked to create a patient-centric research platform. RESULTS: Baseline surveys were returned by 2,052 respondents (16.8% response rate) and retention rates throughout the study were high (64.8%-70.8%). Most participants reported burdensome symptoms despite having complex treatment histories that included multiple treatments over many years. More than half (55.3%) were dissatisfied with their treatment regimen; however, a higher proportion of those treated with prescription medications were satisfied. LIMITATIONS: The study sample may have been biased by patients with difficult-to-treat symptoms as a result of prior authorization processes for IBS-C/CIC prescriptions. Results may not be generalizable to uninsured or older populations because all participants had commercial insurance coverage. CONCLUSIONS: By combining administrative claims and patient-reported data over time, CONTOR afforded a deeper understanding of the IBS-C/CIC patient experience than could be achieved with 1 data source alone; for example, participants self-reported burdensome symptoms and treatment dissatisfaction despite making few treatment changes, highlighting an opportunity to improve patient management. This patient-centric approach to understanding real-world experience and management of a chronic condition could be leveraged for other conditions in which the patient experience is not adequately captured by standardized data sources.

Relative vaccine efficacy of high-dose versus standard-dose influenza vaccines in preventing probable influenza in a Medicare Fee-for-Service population.

BACKGROUND: High-dose (HD) influenza vaccine, currently the most commonly used vaccine among US seniors (aged ≥ 65 years), has been shown to be more efficacious than standard-dose (SD) vaccine in multiple randomized trials. This study evaluated the real-world relative vaccine effectiveness (rVE) of HD vs SD over four influenza seasons. METHODS: This study included Medicare Fee-for-Service enrollees who received HD or SD at an outpatient clinic or pharmacy during influenza seasons 2011-2012 through 2014-2015. Probable influenza (an inpatient stay with an influenza diagnosis on the claim, or an outpatient visit with a rapid influenza test/culture followed by an antiviral prescription) was assessed among HD recipients matched 1:1 with SD recipients by location, vaccination date, age, and sex. Fine-Gray subdistribution hazard models with competing risk of death were used to adjust for residual confounding. Analyses were stratified by outpatient vs pharmacy vaccination. RESULTS: Across the four influenza seasons, there were 535,598, 1,017,552, 1,548,164, and 2,420,450 in the pharmacy cohort; and 821,662, 1,151,080, 1,559,488, and 2,421,758 in the outpatient cohort. During peak influenza season, rVEs for 2011-12 through 2014-15 were 21.8% (95% CI: -5.9%, 42.3%), 14.8% (9.3%, 19.9%), 16.9% (9.2%, 23.9%), and 17.2% (14.5%, 19.9%), respectively, in the pharmacy cohort; and 16.5% (-5.9%, 34.2%), 15.1% (10.9%, 19.1%), 10.0% (2.9%, 16.6%), and -0.2% (-3.0%, 2.5%), respectively, in the outpatient cohort. CONCLUSION: HD was consistently associated with better protection against probable influenza. The lower treatment effect observed in the outpatient cohort could reflect provider bias due to physicians triaging HD to frailer patients.

Validation and Assessment of the COPD Treatment Ratio as a Predictor of Severe Exacerbations.

BACKGROUND: Population-based risk assessments are needed to identify individuals who may benefit from chronic obstructive pulmonary disease (COPD) management programs for preventing exacerbations. This study compared the validated COPD treatment ratio (CTR) versus other COPD exacerbation predictors: prior exacerbation and rescue and maintenance medication use. METHODS: A retrospective observational study using medical and pharmacy claims data among Medicare Advantage with Part D beneficiaries with COPD (January 2011-August 2016). Unadjusted and adjusted logistic regression models tested the predictive performance (C-statistic) of potential exacerbation predictors for future severe exacerbations. RESULTS: The unadjusted association between exacerbation predictors and severe exacerbation was examined in 60,776 patients: baseline severe exacerbation had the highest C-statistic (0.668), then number of rescue units dispensed (0.651), CTR (0.619), and number of controller units dispensed (0.562). During the at-risk period, baseline CTR was inversely associated with severe exacerbation (odds ratio, <1.0); other predictors were positively associated with a severe exacerbation (odds ratio, >1.0). Adjusting for age, geographic region, chronic oxygen, and nebulizer use, the severe exacerbation odds were 0.90 (95% confidence interval [CI], 0.89-0.91) lower per 0.10 change in CTR (C-statistic, 0.710). The C-statistic was 0.734 when baseline exacerbation was added to the model. CONCLUSIONS: The CTR is an effective tool for identifying patients diagnosed with COPD who are at increased risk of severe exacerbation. Although CTR does not predict future exacerbation as well as prior severe exacerbation history, it has the advantage of being applicable in predicting future exacerbations in patients without an exacerbation history, or in databases limited to pharmacy claims only. In addition, the significant reduction in risk has been observed with incremental increases in the ratio: the ratio can be monitored to assess COPD health improvements over time.

The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study.

GOALS: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide. BACKGROUND: As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making. MATERIALS AND METHODS: Data were derived from the Chronic Constipation and IBS-C Treatment and Outcomes Real-world Research Platform (CONTOR) study from 2 patient-reported 7-day daily BM diaries to create a dataset of 2922 diaries representing 26,524 BMs for 1806 participants. Binary variables were created for: medication(s) used in the past 24 hours and categorization of BMs as loose or watery stools (LoWS), hard or lumpy stools (HoLS), or intermediate (neither LoWS nor HoLS). The relationship between stool consistency, medication use, and BM satisfaction was analyzed using logistic regression with SEs corrected for repeated observations. RESULTS: BMs characterized as intermediate stools and LoWS were satisfactory more often (61.2% and 51.2%, respectively) than HoLS (19.4%). Participants who reported taking linaclotide rated a similar proportion of BMs as satisfactory when described as LoWS (65.6%) or intermediate (64.1%). Linaclotide use was associated with higher odds of BMs being reported as satisfactory compared with nonlinaclotide use (odds ratio: 1.23, P<0.05). CONCLUSIONS: Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.

Incidence of febrile neutropenia during chemotherapy among patients with nonmyeloid cancer receiving filgrastim vs a filgrastim biosimilar.

BACKGROUND: Filgrastim and other granulocyte colony-stimulating factors are recommended to decrease febrile neutropenia (FN) incidence among patients with nonmyeloid cancers undergoing chemotherapy. Data comparing biosimilar filgrastim-sndz with reference filgrastim (filgrastim-ref) are limited outside of clinical trials in the US. OBJECTIVE: To compare the incidence of FN across chemotherapy cycles 1-6 between patients treated with filgrastim-sndz vs filgrastim-ref. MATERIALS AND METHODS: This was a retrospective claims analysis of patients with nonmyeloid cancer enrolled in commercial or Medicare Advantage plans from March 2015 to June 2016 and receiving filgrastim-sndz or filgrastim-ref during ≥1 completed chemotherapy cycle. Patients undergoing hematopoietic stem cell transplantation, pregnant patients, and those with missing data were excluded. FN was identified using the diagnosis codes for neutropenia + fever, neutropenia + bacterial/fungal infection, and neutropenia + infection + fever. Equivalence testing for FN incidence at the cycle level across chemotherapy cycles 1-6 was conducted for filgrastim-sndz vs filgrastim-ref after adjusting for baseline characteristics using inverse probability of treatment weighting. Results were considered equivalent if the 90% CIs for between-cohort differences were within ±6.0%. RESULTS: The analysis included 3,459 patients (162 filgrastim-sndz and 3,297 filgrastim-ref). Before weighting, the filgrastim-sndz cohort was younger than filgrastim-ref and had a higher proportion of men, a higher proportion with commercial insurance, and lower proportions with granulocyte colony-stimulating factor prophylaxis or metastatic cancer. After weighting, baseline characteristics were similar between cohorts. Adjusted FN incidence was equivalent for filgrastim-sndz vs filgrastim-ref, respectively: neutropenia + fever, 0.81% vs 0.61% (difference [90% CI]=0.20 [-0.57 to 1.56]); neutropenia + infection, 1.21% vs 1.33% (difference [90% CI]=-0.12 [-1.17 to 2.28]); neutropenia + infection + fever, 0.0% vs 0.14% (difference=-0.14; CI not calculated because filgrastim-sndz had 0 events). CONCLUSION: Filgrastim-sndz and filgrastim-ref are statistically equivalent for preventing FN across chemotherapy cycles 1-6 among patients with nonmyeloid cancer.

Clinical Outcomes of Treatment with Filgrastim Versus a Filgrastim Biosimilar and Febrile Neutropenia-Associated Costs Among Patients with Nonmyeloid Cancer Undergoing Chemotherapy.

BACKGROUND: Granulocyte colony-stimulating factors such as filgrastim are used to decrease the incidence of febrile neutropenia (FN) among patients with nonmyeloid cancers undergoing chemotherapy treatment. Although the biosimilar filgrastim-sndz has been approved in the United States since 2015, limited real-world comparisons of filgrastim-sndz versus reference filgrastim (filgrastim-ref) have been conducted. OBJECTIVE: To compare FN incidence and assess overall FN-related health care resource utilization and medical costs among U.S. patients with non-myeloid cancer who received filgrastim-sndz or filgrastim-ref during their first chemotherapy cycle. METHODS: This was a retrospective claims analysis of patients with non-myeloid cancer who were enrolled in commercial or Medicare Advantage insurance plans from March 2015 through June 2016 and received filgrastim-sndz or filgrastim-ref during their first observed chemotherapy cycle. Patients with evidence of hematopoietic stem cell transplantation or pregnancy and those with missing demographic information were excluded. FN was defined on the basis of diagnosis codes for neutropenia and fever (N/F); neutropenia and infection (N/I); and neutropenia, infection, and fever (N/I/F). Cohorts were adjusted for differences in baseline patient characteristics using the inverse probability of treatment weighting (IPTW) method, and equivalence testing was used to compare the proportion of patients who developed FN between weighted cohorts. On the basis of the range of neutropenic fever incidence found in the PIONEER clinical trial, FN incidence was considered equivalent if 90% CIs for between-cohort differences were within ± 6%. Mean FN-related health care resource utilization and total FN-related medical costs were calculated for the overall study population. RESULTS: A total of 3,542 patients were included in the study (172 filgrastim-sndz; 3,370 filgrastim-ref; mean ages 62.1 years and 64.7 years, respectively). After IPTW, there were 162 patients in the filgrastim-sndz cohort and 3,297 in the filgrastim-ref cohort (mean age 64.5 years for both). FN incidence in the weighted filgrastim-sndz versus filgrastim-ref cohorts, respectively, was 1.4% versus 0.9% for N/F, 2.3% versus 1.7% for N/I, and 0.0% versus 0.3% for N/I/F; FN incidence was statistically equivalent between treatment cohorts. Among patients in either treatment cohort who developed FN, the proportion with FN-related inpatient stays during the first chemotherapy cycle ranged from 35.0% for N/I to 70.0% for N/I/F. Mean (SD) FN-related total medical costs across all patients who developed FN were $11,977 ($18,383) for N/F, $8,040 ($14,809) for N/I, and $21,733 ($30,003) for N/I/F, in 2015 U.S. dollars. For all 3 definitions of FN, the largest proportions (73.5%-93.4%) of medical costs were inpatient related. CONCLUSIONS: In this real-world study of patients with nonmyeloid cancers undergoing chemotherapy, the incidence of FN was statistically equivalent between individuals treated with filgrastim-sndz versus filgrastim-ref during their first chemotherapy cycle. FN-related health care resource utilization and medical costs among patients who developed FN were substantial. DISCLOSURES: This work was funded by Sandoz, which participated in the study design, data interpretation, writing and revision of the manuscript, and decision to submit the manuscript for publication. Balu and Campbell are employees of Sandoz, which is the manufacturer of the filgrastim biosimilars Zarzio and Zarxio. DeLeon was an employee of Sandoz at the time this study was conducted. Lal, Brekke, Elliott, and Korrer are employees of Optum, which was contracted by Sandoz to conduct this study.

Adherence, persistence, and discontinuation among Hispanic and African American patients with multiple sclerosis treated with fingolimod or glatiramer acetate.

OBJECTIVE: Few studies have examined compliance to disease-modifying therapies (DMTs) for multiple sclerosis (MS) in minority populations. This study compared adherence, discontinuation, and persistence for fingolimod (FTY) and glatiramer acetate (GA) initiators among Hispanic and African American patients with MS. METHODS: This retrospective claims data study examined Hispanic and African American adults with MS who initiated FTY or GA between September 1, 2010 and June 30, 2014. Outcomes (adherence, discontinuation, and persistence) were analyzed descriptively and with multivariable models, comparing FTY and GA cohorts within racial/ethnic groups. Adherence was assessed using medication possession ratio (MPR) and proportion of days covered (PDC). RESULTS: There were 171 patients in the Hispanic group (62 FTY, 109 GA) and 210 in the African American group (71 FTY, 139 GA). A larger proportion of GA initiators than FTY initiators were treatment-naïve; other baseline characteristics were similar between cohorts. Hispanic FTY initiators had greater mean MPR, PDC, and persistence and less discontinuation than GA initiators. African American FTY initiators had greater mean PDC than GA initiators; other outcomes favored FTY but were not statistically significant. Multivariable analysis results were consistent with the unadjusted results, but differences between treatment cohorts were not statistically significant. CONCLUSIONS: Hispanic and African American patients with MS who initiated FTY had higher adherence than those who initiated GA, similar to the general MS population. These findings suggest that adherence should be considered in DMT selection, and racial/ethnic variations in MS disease course may not be primarily attributable to differences in DMT compliance.

HbA1c Outcomes in Patients Treated With Canagliflozin Versus Sitagliptin in US Health Plans.

PURPOSE: Clinical trial evidence supports greater glycemic control with canagliflozin than with sitagliptin. The objective of this study was to provide real-world evidence comparing outcomes in routine clinical practice among patients initiating each medication. METHODS: With the use of a health care administrative database, patients initiating canagliflozin were compared with patients initiating sitagliptin (first prescription fill as index date). Baseline (6 months before index date) demographic and clinical (eg, comorbidities and diabetes-related complications) characteristics were compared, and propensity score matching was used to control for baseline differences between cohorts. Outcomes included change in glycosylated hemoglobin (HbA1c) and persistence with medication over a 9-month period after index date. FINDINGS: Before matching, the canagliflozin cohort (N = 3993) was younger than the sitagliptin cohort (N = 12,153) and was composed of fewer women and Medicare Advantage enrollees, with lower mean baseline comorbidity scores (all p < 0.001). Before matching, the canagliflozin cohort (valid n = 1482) had a significantly (p < 0.001) higher baseline HbA1c (8.60) than the sitagliptin cohort (valid n = 3697; HbA1c, 8.32). After matching (n = 1472 per cohort), patients were well balanced on baseline characteristics, and HbA1c values were not significantly different (p = 0.634) between the cohorts. Patients initiating canagliflozin had greater reductions in HbA1c than patients in the sitagliptin cohort (-0.93% versus -0.57%, respectively; p = 0.004), with similar mean (median) time from index date to follow-up HbA1c of 185.4 (199.0) and 184.3 (190.5) days, respectively (p = 0.802). Only 29.8% of canagliflozin patients discontinued during follow-up compared with 41.5% of sitagliptin patients (p < 0.001); the average days of persistence on index therapy was longer for canagliflozin patients (152 days) than for sitagliptin patients (139 days; p < 0.001). IMPLICATIONS: In this observational study, patients initiating canagliflozin had greater reduction in HbA1c and longer persistence with medication than did patients who initiated sitagliptin, over a 9-month period. Better understanding of antihyperglycemic treatment, HbA1c results, and differences among patients in demographic/clinical characteristics as well as persistence with treatment will inform optimal diabetes treatment choice in routine practice.

Serum uric acid levels and the risk of flares among gout patients in a US managed care setting.

OBJECTIVE: Serum uric acid (sUA) levels are causally associated with the risk of gout flares. Our aim was to assess the magnitude of the association and time to first flare among patients in a managed care setting. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using administrative claims data from a large US health plan. Patients were required to have evidence of gout based on medical and pharmacy claims between January 2009 and April 2012. The 12 months prior to the index gout claim were used to assess baseline sUA levels; risk of gout flares, stratified by baseline sUA levels, was examined for 2 years post-index. Risk of flare was modeled with Cox proportional hazards; time to first flare was assessed by Kaplan-Meier. RESULTS: We identified 18,008 patients with gout and available baseline SUA levels (mg/dL). The hazard ratios for the risk of gout flares compared with sUA <5.0 were: 1.17 for sUA 5.0 to <6.0; 1.69 for sUA 6.0 to <7.0; 2.16 for sUA 7.0 to <8.0; 2.87 for sUA 8.0 to <9.0; and 3.85 for sUA ≥9.0 (all p < .001 except for sUA 5.0 to <6.0 cohort). The time to first flare was shorter for cohorts with higher baseline sUA levels. CONCLUSION: These findings confirm that higher sUA levels are associated with an increased risk of gout flares in a dose-response manner over 2 years. This data supports the need to treat to sUA target levels as recommended by recent gout care guidelines. Claims-based algorithms were used to identify gout flares; although this would not be expected to influence estimates of risk by sUA level, there may have been over- or under-estimation of the incidence of flares.

Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting.

BACKGROUND: Despite intensive pharmacotherapy, a considerable number of patients with severe asthma have inadequate disease control. Patients with severe asthma who experience exacerbations consume significant health care resources. OBJECTIVE: To assess health care resource utilization and associated costs among patients with persistent severe asthma who experienced exacerbations compared with patients with persistent but nonsevere asthma. METHODS: This retrospective analysis of a national administrative claims database identified patients aged ≥ 12 years who had at least 1 medical claim with an asthma diagnosis in 2012 and had continuous medical and pharmacy coverage under a commercial or Medicare Advantage plan from January 1, 2012, to December 31, 2013. Patients were assigned to 1 of 2 mutually exclusive cohorts-persistent asthma (PA) or severe asthma (SA)-according to an established algorithm based on asthma-related health care resource use and pharmacy claims for controller medication. SA patients were required to meet PA criteria and also have evidence of ≥2 asthma exacerbations in 2012. Asthma-related health care resource utilization and costs were computed from asthma medication use (rescue and controller therapy) and medical claims with an asthma diagnosis in the primary position in 2012 and 2013. Adherence to controller therapy was assessed over 365 days by using the proportion of days covered (PDC), starting with the first claim for controller therapy in 2012. Differences between the PA and SA cohorts were analyzed by t-test for continuous variables and chi-square test for categorical variables. Asthma-related costs in 2013 were also analyzed using a generalized linear model with a gamma distribution and log link, adjusted for patient demographics (age, gender, region, and insurance type) and Quan-Charlson comorbidity score. RESULTS: A total of 65,359 patients were included: 63,597 (97.3%) PA patients and 1,762 SA patients (2.7%). Compared with the PA cohort, the SA cohort was older (mean age = 50.8 years vs. 46.5 years, P < 0.001) and had higher mean comorbidity score (1.47 vs. 1.31, P< 0.001). The mean count of all asthma medications fills was 2.2-fold (2012) and 2.1-fold (2013) higher in the SA cohort, compared with the PA cohort (P< 0.001). Mean PDC for all oral and inhaled controller therapy was also higher in the SA cohort compared with the PA cohort (0.80 vs. 0.65, P< 0.001). SA patients had a significantly greater mean count of asthma-related hospitalizations, emergency room visits, and ambulatory visits in 2012 and 2013 (P< 0.001). Unadjusted mean annual asthma-related costs in the SA versus PA cohorts were $6,496 versus $2,739 (P < 0.001) in 2012 and $5,174 versus $1,775 (P< 0.001) in 2013. Higher asthma-related costs were driven by greater mean annual asthma medication costs in 2012 ($4,545 vs. $1,738, P< 0.001) and 2013 ($4,068 vs. $1,348, P< 0.001). Adjusted mean annual asthma-related costs in 2013 were $3,336 greater (cost ratio=2.878, P< 0.001) in the SA cohort, and adjusted mean annual asthma medication costs were $2,672 higher (cost ratio=2.982, P< 0.001) in the SA cohort. CONCLUSIONS: Patients with SA who experienced 2 or more exacerbations had 2.1-fold greater use of controller medications across both study years and were more adherent to controller therapy than patients with PA. Despite more intensive pharmacotherapy, SA patients incurred 2.9-fold higher adjusted asthma-related costs and 3-fold higher adjusted asthma medication costs than PA patients. Patients with SA consistently demonstrated a higher rate of health care utilization. DISCLOSURES: Funding for this study (HO-14-14443) was provided by GlaxoSmithKline (GSK). All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. Albers, Forshag, and Yancey are employees of GSK and hold stock in GSK. Dalal, Nagar, and Ortega were employees of GSK at the time this research was conducted. Chastek and Korrer are employees of Optum, which received consulting fees from GSK for research related to this study. Study concept and design were contributed by Chastek, Nagar, and Dalal. Korrer took the lead in data collection, along with Chastek, and data interpretation was performed by Chastek, Ortega, Forshag, and Dalal. The manuscript was written by Chastek and Dalal and revised by Albers and Yancy, assisted by the other authors.

Real-world evaluation of glycemic control among patients with type 2 diabetes mellitus treated with canagliflozin versus dipeptidyl peptidase-4 inhibitors.

Objective To evaluate glycemic control among patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin (CANA) vs. dipeptidyl peptidase-4 (DPP-4) inhibitors. Methods Using integrated claims and lab data from a US health plan of commercial and Medicare Advantage enrollees, this matched-control cohort study assessed adult T2DM patients receiving treatment with CANA or DPP-4 inhibitors (1 April 2013-31 December 2013). Cohorts were chosen hierarchically; the first pharmacy claim for CANA was identified as the index date; then the first pharmacy claim for a DPP-4 inhibitor was identified and index date set. Eligible patients had 6 months of continuous health plan enrollment before the index date (baseline) and 9 months after (follow-up) and no evidence of index drug in baseline. Patients were matched 1:1 using propensity score matching. Changes in glycated hemoglobin (HbA1c) and percentages of patients with HbA1c <8% and <7% during the follow-up were evaluated. Results The matched CANA and DPP-4 inhibitor cohorts (53.2% treated with sitagliptin) included 2766 patients each (mean age: 55.7 years). Among patients with baseline and follow-up HbA1c results, mean baseline HbA1c values were similar, 8.62% and 8.57% (p = 0.615) for the CANA (n = 729) and DPP-4 inhibitor (n = 710) cohorts, respectively. Change in HbA1c was greater among patients in the CANA cohort than for those in the DPP-4 inhibitor cohort (-0.92% vs. -0.63%, p < 0.001), and also among the subset of patients with baseline HbA1c ≥7% (-1.07% [n = 624] vs. -0.79% [n = 603], p = 0.004). During follow-up, greater percentages of the CANA cohort relative to the DPP-4 inhibitor cohort achieved HbA1c of <8% (66.0% vs. 58.6%, p = 0.004) and <7% (35.4% vs. 29.9%, p = 0.022). Limitations This study was observational and residual confounding remains a possibility. Conclusions In this real-world study of patients with T2DM, CANA use was associated with greater HbA1c reduction and higher percentages of patients attaining HbA1c goals than those treated with DPP-4 inhibitors.

Flare frequency, healthcare resource utilisation and costs among patients with gout in a managed care setting: a retrospective medical claims-based analysis.

OBJECTIVES: For most gout patients, excruciatingly painful gout attacks are the major clinical burden of the disease. The goal of this study was to assess the association of frequent gout flares with healthcare burden, and to quantify how much lower gout-related costs and resource use are for those with infrequent flares compared to frequent gout flares. DESIGN: Retrospective cohort study. SETTING: Administrative claims data from a large US health plan. PARTICIPANTS: Patients aged 18 years or above, and with evidence of gout based on medical and pharmacy claims between January 2009 and April 2012 were eligible for inclusion. Patient characteristics were assessed during a 12-month baseline period. OUTCOME MEASURES: Frequency of gout flares, healthcare costs and resource utilisation were assessed in the 12 months following the first qualifying gout claim. Generalised linear models were employed to assess the impact of flare frequency on cost outcomes after adjusting for covariates. RESULTS: 102,703 patients with gout met study inclusion criteria; 89,201 had 0-1 gout flares, 9714 had 2 flares, and 3788 had 3+ flares. Average counts of gout-related inpatient stays, emergency room visits and ambulatory visits were higher among patients with 2 or 3+ flares, compared to those with 0-1 flares (all p<0.001). Adjusted annual gout-related costs were $1804, $3014 and $4363 in those with 0-1, 2 and 3+ gout flares, respectively (p<0.001 comparing 0-1 flares to 2 or 3+ flares). CONCLUSIONS: Gout-related costs and resource use were lower for those with infrequent flares, suggesting significant cost benefit to a gout management plan that has a goal of reducing flare frequency.