Healthcare resource utilization and costs in patients with a newly confirmed diagnosis of lupus nephritis in the United States over a 5-year follow-up period.

BACKGROUND: We aimed to describe healthcare resource utilization (HCRU) and healthcare costs in patients with newly confirmed lupus nephritis (LN) in the United States over a 5-year follow-up period. METHODS: This retrospective, longitudinal cohort study (GSK Study 214102) utilized administrative claims data to identify individuals with a newly confirmed diagnosis of LN between August 01, 2011, and July 31, 2018, based on LN-specific International Classification of Diseases diagnosis codes. Index was the date of first LN-related diagnosis code claim. HCRU, healthcare costs, and incidence of systemic lupus erythematosus (SLE) flares were reported annually among eligible patients with at least 5 years continuous enrollment post-index. RESULTS: Of 2,159 patients with a newly confirmed diagnosis of LN meeting inclusion and exclusion criteria, 335 had at least 5 years continuous enrollment post-index. HCRU was greatest in the first year post-LN diagnosis across all categories (inpatient admission, emergency room [ER] visits, ambulatory visits, and pharmacy use), and trended lower, though remained substantial, in the 5-year follow-up period. Among patients with LN and HCRU, the mean (standard deviation [SD]) number of ER visits and inpatient admissions were 3.7 (4.6) and 1.8 (1.5), respectively, in Year 1, which generally remained stable in Years 2-5; the mean (SD) number of ambulatory visits and pharmacy fills were 35.8 (25.1) and 62.9 (43.8), respectively, in Year 1, and remained similar for Years 2-5. Most patients (≥ 91.6%) had ≥ 1 SLE flare in each of the 5 years of follow-up. The proportion of patients who experienced a severe SLE flare was higher in Year 1 (31.6%) than subsequent years (14.3-18.5%). Total costs (medical and pharmacy; mean [SD]) were higher in Year 1 ($44,205 [71,532]) than subsequent years ($29,444 [52,310]-$32,222 [58,216]), driven mainly by inpatient admissions (Year 1: $21,181 [58,886]; subsequent years: $7,406 [23,331]-$9,389 [29,283]). CONCLUSIONS: Patients with a newly confirmed diagnosis of LN have substantial HCRU and healthcare costs, particularly in the year post-diagnosis, largely driven by inpatient costs. This highlights the need for improved disease management to prevent renal damage, improve patient outcomes, and reduce costs among patients with renal involvement.

Development of a natural language processing algorithm to detect chronic cough in electronic health records.

BACKGROUND: Chronic cough (CC) is difficult to identify in electronic health records (EHRs) due to the lack of specific diagnostic codes. We developed a natural language processing (NLP) model to identify cough in free-text provider notes in EHRs from multiple health care providers with the objective of using the model in a rules-based CC algorithm to identify individuals with CC from EHRs and to describe the demographic and clinical characteristics of individuals with CC. METHODS: This was a retrospective observational study of enrollees in Optum's Integrated Clinical + Claims Database. Participants were 18-85 years of age with medical and pharmacy health insurance coverage between January 2016 and March 2017. A labeled reference standard data set was constructed by manually annotating 1000 randomly selected provider notes from the EHRs of enrollees with ≥ 1 cough mention. An NLP model was developed to extract positive or negated cough contexts. NLP, cough diagnosis and medications identified cough encounters. Patients with ≥ 3 encounters spanning at least 56 days within 120 days were defined as having CC. RESULTS: The positive predictive value and sensitivity of the NLP algorithm were 0.96 and 0.68, respectively, for positive cough contexts, and 0.96 and 0.84, respectively, for negated cough contexts. Among the 4818 individuals identified as having CC, 37% were identified using NLP-identified cough mentions in provider notes alone, 16% by diagnosis codes and/or written medication orders, and 47% through a combination of provider notes and diagnosis codes/medications. Chronic cough patients were, on average, 61.0 years and 67.0% were female. The most prevalent comorbidities were respiratory infections (75%) and other lower respiratory disease (82%). CONCLUSIONS: Our EHR-based algorithm integrating NLP methodology with structured fields was able to identify a CC population. Machine learning based approaches can therefore aid in patient selection for future CC research studies.

Diagnostic testing managed by hematopathology specialty and other laboratories: costs and patient diagnostic outcomes.

BACKGROUND: Successful management of patients with hematologic malignancies depends upon accurate and timely diagnosis, which frequently requires integration and interpretation of multiple tests. Our retrospective analysis compared diagnostic uncertainty, resource utilization, and costs for patients with diagnostic bone marrow (BM) tests managed by commercial laboratories. METHODS: Patients with BM biopsies and suspected hematologic cancer/condition were identified from claims (2005-2011) within a large US health plan (coverage ≥6 pre- and ≥3-months post-biopsy). Cohorts defined by laboratories performing BM morphologic assessment/directing testing sequence: Genoptix (GX, specialty hematology-testing laboratory), large commercial laboratories (LL), other laboratories (OL). One-year post-biopsy changes in diagnosis or treatments, tests performed, and diagnostic/treatment medical costs (measured as per-patient-per-month [PPPM]) were examined. RESULTS: The study population included 1,387 GX, 4,162 LL, and 19,115 OL patients with suspected hematologic malignancy/disease and BM morphology assessment. GX had lower diagnostic uncertainty measured between 2 time periods by diagnostic stability (no conditions the same; 6.16% GX, 8.04% LL, 9.73% OL; p < 0.001) and changes (≥1 condition different; 7.88% GX, 11.19% LL, and 14.08% OL; p < 0.001), fewer repeat BM biopsies, and fewer chemotherapy changes (30-days and 60-days post-initiation). One-year PPPM costs adjusted for patient characteristics differences were $8,202 GX, $7,711 LL, and $10,302 OL (p < 0.05); adjusted PPPM costs (excluding testing period) were $6,019 GX, $6,649 LL, and $7,801 OL (p < 0.05). CONCLUSIONS: Our data suggests that a hematopathology specialty laboratory may result in earlier final diagnosis, fewer subsequent diagnosis changes, reduced need for follow-on testing requiring repeat biopsy procedures, and may result in lower downstream healthcare costs. Further evaluations using medical chart abstractions or registries will be valuable.

Machine learning to identify chronic cough from administrative claims data.

Accurate identification of patient populations is an essential component of clinical research, especially for medical conditions such as chronic cough that are inconsistently defined and diagnosed. We aimed to develop and compare machine learning models to identify chronic cough from medical and pharmacy claims data. In this retrospective observational study, we compared 3 machine learning algorithms based on XG Boost, logistic regression, and neural network approaches using a large claims and electronic health record database. Of the 327,423 patients who met the study criteria, 4,818 had chronic cough based on linked claims-electronic health record data. The XG Boost model showed the best performance, achieving a Receiver-Operator Characteristic Area Under the Curve (ROC-AUC) of 0.916. We selected a cutoff that favors a high positive predictive value (PPV) to minimize false positives, resulting in a sensitivity, specificity, PPV, and negative predictive value of 18.0%, 99.6%, 38.7%, and 98.8%, respectively on the held-out testing set (n = 82,262). Logistic regression and neural network models achieved slightly lower ROC-AUCs of 0.907 and 0.838, respectively. The XG Boost and logistic regression models maintained their robust performance in subgroups of individuals with higher rates of chronic cough. Machine learning algorithms are one way of identifying conditions that are not coded in medical records, and can help identify individuals with chronic cough from claims data with a high degree of classification value.

Healthcare Resource Utilization and Associated Costs in Patients With Systemic Lupus Erythematosus Diagnosed With Lupus Nephritis.

BACKGROUND: Lupus nephritis (LN) is among the most severe organ manifestations of systemic lupus erythematosus (SLE), affecting between 31% and 48% of patients, usually within five years of SLE diagnosis. SLE without LN is associated with a high economic burden on the healthcare system, and although data are limited, several studies have shown that SLE with LN could increase this burden.  Aim: We aimed to compare the economic burden of LN versus SLE without LN among patients managed in routine clinical practices in the USA and describe the clinical course of these patients. MATERIALS AND METHODS: This was a retrospective observational study of patients with commercial or Medicare Advantage health insurance. It included 2310 patients with LN and 2310 matched patients who had SLE without LN; each patient was followed for 12 months after diagnosis (the patient's index date). Outcome measures included healthcare resource utilization (HCRU), direct healthcare costs, and SLE clinical manifestations.  Results: In all healthcare settings, the mean (SD) use of all-cause healthcare resources was significantly higher in the LN versus SLE without LN cohort, including the mean number of ambulatory visits (53.9 (55.1) vs 33.0 (26.0)), emergency room visits (2.9 (7.9) vs 1.6 (3.3)), inpatient stays (0.9 (1.5) vs 0.3 (0.8)), and pharmacy fills (65.0 (48.3) vs 51.2 (42.6)) (all p<0.001). Total all-cause costs per patient in the LN cohort were also significantly higher compared with the SLE without LN cohort ($50,975 (86,281) vs $26,262 (52,720), p<0.001), including costs for inpatient stays and outpatient visits. Clinically, a significantly higher proportion of patients with LN experienced moderate or severe SLE flares compared with the SLE without LN cohort (p<0.001), which may explain the difference in HCRU and healthcare costs. CONCLUSION: All-cause HCRU and costs were higher for patients with LN than for matched patients with SLE without LN, highlighting the economic burden associated with LN.

Hemoglobin A1c outcomes and health care resource use in type 2 diabetes mellitus patients treated with combination oral antidiabetic drugs through step therapy and loose-dose and fixed-dose combinations.

PURPOSE: To compare outcomes of type 2 diabetes mellitus (T2DM) patients initiating therapy with FDC vs. those with loose-dose combination (LDC) or step therapy (ST) in a managed care population. DESIGN: A retrospective claims database analysis. METHODOLOGY: Treatment-naive T2DM patients who were continuously enrolled in a health plan during 2006-2009 were studied. Eligible patients were assigned to FDC, LDC, or ST cohorts. Glycated hemoglobin goal attainment (HbA1c < 7%) was assessed using the American Diabetes Association (ADA) treatment guidelines. Health care resources use and costs, including inpatient, emergency room (ER), and ambulatoryvisits, were measured during the 12 months after therapy initiation. All-cause and diabetes-related use and costs were assessed. PRINCIPAL FINDINGS: 21,048 patients met study criteria (FDC n = 8,416, ST n = 8,407, LDC n = 4,225), and 1,926 of these patients had HbA1c results. FDC patients had lower rates of post-index all-cause inpatient stays and ER visits compared with the other cohorts. FDC patients had lower average counts of diabetes-related ambulatory visits (2.7) compared with ST (3.7; p < 0.001) and LDC (3.2; p < 0.001) and significantly lower average post-index all-cause and diabetes-related costs compared with the other cohorts, with average all-cause costs for FDC, ST, and LDC of $8,445, $10,515, and $9,688, respectively, and diabe-tes-related costs of $1,641, $2,099, and $1,900, respectively. FDC patients had higher rates of achieving HbA1c goal (61%) compared to ST (48%; p < 0.001) or LDC (52%; p = 0.015). Differences in outcomes remained following multivariate analyses. CONCLUSION: Treatment with FDC was associated with lower health care resources use and costs and better likelihood of HbA1c goal attainment.

A comparison of small monetary incentives to convert survey non-respondents: a randomized control trial.

BACKGROUND: Maximizing response rates is critically important in order to provide the most generalizable and unbiased research results. High response rates reduce the chance of respondents being systematically different from non-respondents, and thus, reduce the risk of results not truly reflecting the study population. Monetary incentives are often used to improve response rates, but little is known about whether larger incentives improve response rates in those who previously have been unenthusiastic about participating in research. In this study we compared the response rates and cost-effectiveness of a $5 versus $2 monetary incentive accompanying a short survey mailed to patients who did not respond or refused to participate in research study with a face-to-face survey. METHODS: 1,328 non-responders were randomly assigned to receive $5 or $2 and a short, 10-question survey by mail. Reminder postcards were sent to everyone; those not returning the survey were sent a second survey without incentive. Overall response rates, response rates by incentive condition, and odds of responding to the larger incentive were calculated. Total costs (materials, postage, and labor) and incremental cost-effectiveness ratios were also calculated and compared by incentive condition. RESULTS: After the first mailing, the response rate within the $5 group was significantly higher (57.8% vs. 47.7%, p<.001); after the second mailing, the difference narrowed by 80%, resulting in a non-significant difference in cumulative rates between the $5 and $2 groups (67.3% vs. 65.4%, respectively, p=.47). Regardless of incentive or number of contacts, respondents were significantly more likely to be male, white, married, and 50-75 years old. Total costs were higher with the larger versus smaller incentive ($13.77 versus $9.95 per completed survey). CONCLUSIONS: A $5 incentive provides a significantly higher response rate than a $2 incentive if only one survey mailing is used but not if two survey mailings are used.

Characterization of Heavily Treatment-Experienced People With HIV and Impact on Health Care Resource Utilization in US Commercial and Medicare Advantage Health Plans.

BACKGROUND: This retrospective administrative claims study aimed to describe clinical characteristics, health care resource utilization (HCRU), and costs of people with HIV (PWH) in US commercial and Medicare Advantage health plans by antiretroviral treatment (ART) experience and CD4+ cell count. METHODS: Data from the national Optum Research Database between January 1, 2014, and March 31, 2018, for adult PWH continuously enrolled 6 months before and ≥12 months after the first ART identified (follow-up) were summarized by treatment (heavily treatment-experienced [HTE] with limited remaining ART options, treatment-experienced but not HTE [non-HTE], or treatment-naive starting a first antiretroviral regimen) and index CD4+ cell count (<200, 200-500, or >500 cells/mm3). RESULTS: Compared with non-HTE (n=7604) and treatment-naive PWH (n=4357), HTE PWH (n=2297) were older (53.5 vs 48.8 and 42.3 years), were more likely to have HIV-related emergency department visits (22.3% vs 12.4% and 18.6%) and inpatient stays (15.8% vs 7.1% and 10.3%), and had a higher mean (SD) daily pill burden (9.7 [7.7] vs 5.1 [5.9] and 3.6 [5.3] pills/d) and a higher mortality rate (5.9% vs 2.9% and 2.3%) during follow-up (all P<.001). More HTE (21.8%) and treatment-naive PWH (27.0%) had <200 CD4+ cells/mm3 vs non-HTE PWH (8.0%; P<.001). All-cause and HIV-related costs were higher among HTE PWH in all CD4+ cell count strata and treatment-naive PWH with CD4+ cell counts <200 cells/mm3 vs non-HTE PWH in all CD4+ cell count strata. CONCLUSIONS: Improved support and clinical monitoring of HTE PWH are needed to prevent worsening outcomes and increased costs.

Health care resource utilization and disease modifying treatment use in multiple sclerosis patients by age and insurance type.

OBJECTIVE: The objective of this study was to describe and compare health care resource utilization (HCRU) and disease modifying treatment (DMT) use among US adults <65 years with multiple sclerosis (MS), across commercial and Medicare Advantage plans. METHODS: Medical and pharmacy claims data from commercial and Medicare Advantage with Part D (MAPD) plans were extracted for MS patients age 18 - 64 identified between 1 January 2014 and 31 May 2017. Comparisons were made between commercial and MAPD enrollees for all-cause HCRU and DMT use over 1 year, overall and by 5 year age groups. RESULTS: A total of 28,427 MS patients were identified; two-thirds (67%) had commercial coverage. MAPD patients had statistically significantly higher mean counts of all-cause inpatient, emergency room (ER) and ambulatory visits compared to commercial patients. The significant differences were evident in all age groups ≥30 years, except for ER visits in the 40-44 and 60-64 age groups. MAPD patients had statistically significantly lower prevalence of DMT use compared to commercial patients in all age groups starting at ≥35 years. CONCLUSION: MAPD patients had a higher burden of medical HCRU compared to their commercially insured counterparts, most likely due primarily to their more advanced disease state and higher level of MS-related disability. Reasons for lower prevalence of DMT use among MAPD patients may include their more advanced disease state, older age and higher prevalence of comorbid conditions compared with commercially insured patients, as well as more restrictive formularies for MAPD vs. commercial plans. These findings suggest that there may be an opportunity for recently approved DMTs indicated for active secondary progressive MS to fulfill an unmet need for treatment among MS patients <65 years without contraindicated comorbid conditions who are enrolled in MAPD plans. Novel therapies under development to delay progression may help keep MS patients of working age in the work force.

Treatment patterns following initiation of generic glatiramer acetate among patients with multiple sclerosis from two large real-world databases in the United States.

INTRODUCTION: To better understand treatment patterns in US patients with multiple sclerosis (MS) initiating generic glatiramer acetate (GA), this study examined adherence, discontinuation and switching patterns from generic follow-on glatiramer acetate (FOGA) therapy in real-world patient cohorts. METHODS: Retrospective analyses utilized data from two large US databases (administrative claims and linked electronic medical records). Eligible adult MS patients had ≥1 pharmacy claim for FOGA during the identification period; the first FOGA claim was the index date. All analyses were descriptive; proportion of days covered (PDC) was calculated as a measure of adherence to FOGA during the follow-up period. RESULTS: The first cohort consisted of 95 patients, with 93.6% having a branded GA claim for Copaxone during the baseline period. Half these patients (48.4%) had high adherence to FOGA therapy (PDC: 0.8-1.0). Fifty-five patients (57.9%) initially discontinued FOGA with a mean persistence of 112 days. Of those who discontinued, 7.3% had no subsequent disease-modifying therapy (DMT), 30.9% restarted FOGA and 61.8% did not restart FOGA. The second cohort consisted of 1957 patients, with 63.8% having a branded GA claim for Copaxone during the baseline period and 33.5% were treatment naïve. The majority of patients (61.9%) had high adherence to FOGA therapy. A total of 1597 patients (81.6%) initially discontinued FOGA with a mean persistence of 93 days. Of those who discontinued, 55.8% switched to another DMT, 16.7% restarted FOGA and 37.5% had no subsequent DMT. CONCLUSION: Adherence to FOGA therapy was reasonably high across cohorts; however, most patients discontinued their initial FOGA within four months of the index date and most switches from FOGA were to branded GA products.

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.

T1DBase: integration and presentation of complex data for type 1 diabetes research.

T1DBase (http://T1DBase.org) [Smink et al. (2005) Nucleic Acids Res., 33, D544-D549; Burren et al. (2004) Hum. Genomics, 1, 98-109] is a public website and database that supports the type 1 diabetes (T1D) research community. T1DBase provides a consolidated T1D-oriented view of the complex data world that now confronts medical researchers and enables scientists to navigate from information they know to information that is new to them. Overview pages for genes and markers summarize information for these elements. The Gene Dossier summarizes information for a list of genes. GBrowse [Stein et al. (2002) Genome Res., 10, 1599-1610] displays genes and other features in their genomic context, and Cytoscape [Shannon et al. (2003) Genome Res., 13, 2498-2504] shows genes in the context of interacting proteins and genes. The Beta Cell Gene Atlas shows gene expression in beta cells, islets, and related cell types and lines, and the Tissue Expression Viewer shows expression across other tissues. The Microarray Viewer shows expression from more than 20 array experiments. The Beta Cell Gene Expression Bank contains manually curated gene and pathway annotations for genes expressed in beta cells. T1DMart is a query tool for markers and genotypes. PosterPages are 'home pages' about specific topics or datasets. The key challenge, now and in the future, is to provide powerful informatics capabilities to T1D scientists in a form they can use to enhance their research.

Clinical characteristics and medication patterns in patients with COPD prior to initiation of triple therapy with ICS/LAMA/LABA: A retrospective study.

BACKGROUND: This study assessed patient-level characteristics and patterns of medication use in patients with chronic obstructive pulmonary disease (COPD) before initiation of multiple inhaler triple therapy (MITT; long-acting muscarinic antagonist/long-acting ß2-agonist/inhaled corticosteroid [ICS/LAMA/LABA] combination). METHODS: This retrospective study was conducted using the Optum Research Database. Patients enrolled in commercial or Medicare Advantage Prescription Drug plans, with a COPD diagnosis and >1 prescription for a COPD medication between January 2014 and March 2016 were included. The dispensing date for the first pharmacy prescription completing MITT with at least 1 day of overlap was the patient's index date. The 12 months prior to this date were used to assess patient characteristics, exacerbations, eosinophil counts and changes in medication. RESULTS: The study population comprised 13,701 patients. At the index date, most patients were using a LAMA (n = 13,353 [97.5%]) and combination ICS/LABA (n = 13,292 [97.0%]) MITT. Overall, 90.4% of patients used a LABA, LAMA, LAMA/LABA, or ICS/LABA or had a moderate or severe exacerbation at any time during the baseline period, indicating that approximately 10% of patients initiated MITT without prior bronchodilator use or exacerbation history. Over 65% of patients with an eosinophil measurement had a value ≥ 150 cells/µL. CONCLUSION: Overall, it appears that in this patient population, ICS/LAMA/LABA as triple therapy is being initiated after use of a bronchodilator and/or after an exacerbation event, in accordance with accepted treatment recommendations.

Inhaled Corticosteroid-Containing Treatment Escalation and Outcomes for Patients with Asthma in a U.S. Health Care Organization.

BACKGROUND: Asthma is a common disorder that affects approximately 8% of the U.S. POPULATION: Treatment guidelines indicate inhaled corticosteroids (ICS) as the mainstay treatment, yet poor asthma control is common among ICS-treated patients. Treatment escalation (ICS dose increase and other controller therapy add-ons) is used to manage symptoms. Real-world studies of postescalation outcomes may inform treatment decisions. OBJECTIVES: To (a) describe characteristics and treatment patterns among asthma patients who escalated treatment and (b) assess outcomes (exacerbations, uncontrolled asthma, and health care resource utilization [HCRU]) after escalation. METHODS: The study cohort was identified from a large U.S. administrative claims database via ICD-9-CM codes for asthma (493.xx on ≥ 2 dates) and initiation (defining index date) of long-term (> 1 fill) ICS-containing treatment between January 1, 2009, and September 30, 2014. One year of continuous enrollment was required before and after the index date. Escalation was defined as ≥ 1 of the following: ICS dose increase; a switch between ICS, long-acting beta-2 agonists (LABA), or leukotriene modifiers (LTRM) to a different ICS, LABA, or LTRM; or add-on of controller medications (e.g., antibody biologic). Escalation patterns were examined. Rates of exacerbation (defined by inpatient admission, emergency department [ED] visit, or office visit with a pharmacy claim for an oral corticosteroid [OCS] within 7 days) and occurrence of uncontrolled asthma (defined by > 4 fills for a short-acting beta agonist [SABA] in a 1-year period, ≥ 1 OCS fill, or ≥ 1 asthma-related ED visit or inpatient admission) were calculated. Per-patient-per-year (PPPY) HCRU was estimated. RESULTS: Among 35,126 patients (mean [SD] age 38 [16] years) who initiated long-term ICS-containing treatment, 5,044 (14%) patients escalated their index regimens at 136 (105) days post-index (i.e., pre-escalation period). The most frequent changes, alone or in combination, included ICS dose increase (68%) or LABA (27%) or LTRM (25%) add-ons. Before escalation, the exacerbation rate was 1.60 (5.10) PPPY, and 1,108 (22%) patients experienced exacerbation. During the postescalation period of 251.6 (138.9) days, the exacerbation rate was 0.75 (2.9) PPPY, and 1,038 (21%) patients experienced exacerbation. A majority (> 85%) of exacerbations in the periods before and after escalation were associated with an office visit plus an OCS pharmacy claim within 7 days. Uncontrolled asthma was experienced by 41.5% and 41.0% of patients before and after escalation, respectively. Ambulatory care visits were common before (mean [SD] 24.0 [26.7] all-cause and 8.5 [13.4] asthma-related PPPY) and after escalation (19.3 [21.3] all-cause and 4.6 [8.1] asthma-related PPPY). CONCLUSIONS: Among asthma patients who initiated a long-term ICS-containing regimen, approximately 14% escalated therapy within a year of initiation. Yet, 21% of those patients had ≥ 1 exacerbation, and 41% of patients had uncontrolled asthma within 1 year after treatment escalation. The results demonstrate an unmet need among asthma patients who escalated their ICS-containing treatment. DISCLOSURES: This study was sponsored and funded by Boehringer-Ingelheim, which contracted with Optum to conduct the research. The sponsor collaborated with Optum on the preparation, writing, revision, and approval of the manuscript. Bengston, Cao, Hulbert, Wolbeck, Elliott, and Buikema are employees of Optum. Yu and Wang are employed by Boehringer-Ingelheim. Study concept and design were contributed by Bengston, Yu, and Wang. Cao, Hulbert, and Wolbeck collected the data, and data analysis was performed by Bengston, Yu, and Wang. The manuscript was written by Bengston, along with Yu and Wang, and revised by Bengston, Yu, and Wang, along with the other authors.

Aflibercept vs. Ranibizumab: cost-effectiveness of treatment for wet age-related macular degeneration in Sweden.

PURPOSE: Monthly dosing with ranibizumab (RBZ) is needed to achieve maximal visual gains in patients with neovascular ('wet') age-related macular degeneration (wAMD). In Sweden, dosing is performed as needed (RBZ PRN), resulting in suboptimal efficacy. Intravitreal aflibercept (IVT-AFL) every 2 months after three initial monthly doses was clinically equivalent to RBZ monthly dosing (RBZ q4) in wAMD clinical trials. We assessed the cost-effectiveness of IVT-AFL versus RBZ q4 and RBZ PRN in Sweden. METHODS: A Markov model compared IVT-AFL to RBZ q4 or RBZ PRN over 2 years. Health states were based on visual acuity in better-seeing eye; a proportion discontinued treatment monthly or upon visual acuity <20/400. Parameters were estimated from trial data, published literature or expert opinion. Analyses were performed from a societal perspective with a lifetime horizon. The model calculated costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs), discounted 3% annually. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Lifetime cost of IVT-AFL was 578 400 SEK, compared with 565 700 SEK for RBZ PRN and 686 600 SEK for RBZ q4. Compared with RBZ PRN, the ICER of IVT-AFL was 27 000 SEK/QALY gained. RBZ q4 cost 20.4 million SEK/QALY gained versus IVT-AFL. Results were sensitive to IVT-AFL efficacy, but IVT-AFL had a 100% probability of being cost-effective versus both RBZ PRN and RBZ q4 at a willingness-to-pay threshold of 500 000 SEK. CONCLUSION: Results suggest, in Sweden, at parity price level, IVT-AFL is less costly than RBZ q4, while demonstrating similar efficacy; IVT-AFL is cost-effective versus RBZ PRN.

Improving endoscopy completion: effectiveness of an interactive voice response system.

OBJECTIVE: To test whether an interactive voice response (IVR) system phone call was equally effective as a nurse-delivered phone call at educating and preparing patients for flexible sigmoidoscopy (FS) and colonoscopy examinations. STUDY DESIGN: Three-arm randomized controlled trial. METHODS: The trial included patients with upcoming FS or colonoscopy appointments to test the equivalence of an IVR system to nurse-delivered phone calls in reducing appointment nonattendance and inadequate preparation for an examination. Message timing and satisfaction with the intervention were assessed. The 3 study conditions included the following: nurse phone call 7 days before the procedure, IVR system call 7 days before the procedure, and IVR system call 3 days before the procedure. All calls included an appointment reminder, information about preparation for the examination, and encouragement to prepare for and attend the examination. RESULTS: A total of 3610 patients were eligible for the study; of these, 1229 (34%) were scheduled for FS and 2381 (66%) for colonoscopy. There were no statistically significant differences across the 3 study arms in appointment attendance or adherence to preparation instructions. Significantly more patients in IVR conditions reported neutral perceptions about the phone calls, and more patients receiving nurse calls reported very positive perceptions about the phone calls. CONCLUSION: An IVR system call is as effective as a nurse phone call for ensuring that patients attend appointments and are adequately prepared for endoscopy examinations.