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Vaginitis is one of the most common reasons women access health care in the United States. Despite its prevalence and disruptive impact, it is frequently misdiagnosed and untreated, resulting in unnecessary patient discomfort, follow-up visits, and health care costs. This study presents a costs analysis of diagnostic testing technologies to demonstrate the potential of molecular tests to improve the value of care for women with vaginitis. This study tracks health care spending among women diagnosed with vaginitis and finds that nucleic acid amplification tests (NAATs) are cost-effective for the diagnosis of vaginal symptoms. Women who receive a NAAT on the day of their diagnosis have significantly lower 12-month follow-up costs compared to women who receive a direct probe test or those women who are clinically evaluated without the use of a molecular test. However, despite Food and Drug Administration approval, widely available molecular diagnostics have not been incorporated into clinical guidelines, and many payer policies fail to cover these tests. Greater utilization of NAAT for the diagnosis of vaginitis has the potential to improve the care of women seeking treatment for this prevalent condition and facilitate sexually transmitted infection testing without additional visits.

BACKGROUND: Opioid use after surgery is associated with increased health care utilization and costs. Although some studies show that surgical patients may later become persistent opioid users, data on the association between new persistent opioid use after surgery and health care utilization and costs are lacking. OBJECTIVE: To compare health care utilization and costs after major inpatient or METHODS: The IBM MarketScan Research databases were used to identify opioid-naive patients with major inpatient or outpatient surgeries and at least 1 year of continuous enrollment before and after this index surgery. Cohorts were stratified by new persistent opioid utilization status, setting of surgery (inpatient, outpatient), and payer (commercial, Medicare, Medicaid). Patients were considered new persistent opioid users if they had at least 1 opioid claim 4-90 days after index surgery and at least 1 opioid claim 91-180 days after index surgery. Patients with opioid prescription claims between 1 year and 15 days before their index event were excluded. Health care utilization and costs (excluding index surgery) were measured in the 1-year period after surgery. Predicted costs and cost ratios were estimated using multivariable log-linked gamma-family generalized linear models. RESULTS: In the inpatient cohorts, 827,583 commercial, 186,154 Medicare, and 104,734 Medicaid patients were included in the study, and the incidence of new persistent opioid use in these cohorts was 4.1%, 5.6%, and 7.1%, respectively. In the outpatient cohorts, 1,542,565 commercial, 390,876 Medicare, and 94,878 Medicaid patients were selected, with 2.0%, 1.5%, and 6.4% new persistent opioid use, respectively. Across all 3 payers in both surgical settings, patients with new persistent opioid use had a higher comorbidity burden and more use of concomitant medications in the baseline period. In the 1-year period after index surgery, patients with new persistent opioid use had more inpatient admissions, emergency department visits, and ambulance/paramedic service use than patients without persistent use, regardless of payer and setting. Patients with new persistent opioid use had approximately 5 times more opioid prescriptions and also had more nonopioid pharmacy claims than those without persistent use across all cohorts. After covariate adjustment, predicted 1-year total health care costs were significantly higher for patients with new persistent opioid use compared with those without persistent use for all comparisons (commercial inpatient: $29,499 vs. $11,798; Medicare inpatient: $34,455 vs. $21,313; Medicaid inpatient: $14,622 vs. $6,678; commercial outpatient: $18,751 vs. $7,517; Medicare outpatient ($26,411 vs. $13,577; Medicaid outpatient: $12,381 vs. $6,784; all P < 0.001). CONCLUSIONS: New persistent opioid use after major surgery in opioid-naive patients is associated with increased health care utilization and costs in the year after surgery across all surgical settings and payers. DISCLOSURES: Funding for this study was provided by Heron Therapeutics, which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the analysis and interpretation of the data and development of the publication and maintained control over the final content. England and Evans-Shields are employees of Heron Therapeutics. Kong, Lew, Zimmerman, and Henriques are employees of IBM Watson Health, which was compensated by Heron Therapeutics for conducting this research. Brummett is a paid consultant for Heron Therapeutics, Vertex Pharmaceuticals, and Alosa Health and provides expert testimony. He further reports receipt of research funding from MDHHS (Sub K Michigan Open), NIDA (Centralized Pain Opioid Non-Responsiveness R01 DA038261-05), NIH0DHHS-US-16 PAF 07628 (R01 NR017096-05), NIH-DHHS (P50 AR070600-05 CORT), NIH-DHHS-US (K23 DA038718-04), NIH-DHHS-US-16-PAF06270 (R01 HD088712-05), NIH-DHHS-US-17-PAF02680 (R01 DA042859-05), and UM Michigan Genomics Initiative and holds a patent for peripheral perineural dexmedetomidine. Sun reports funding from the National Institute on Drug Abuse (K08DA042314) as well as consulting fees from the Mission Lisa Foundation that are unrelated to this work.

This study describes the baseline characteristics and treatment patterns of US patients hospitalized with a diagnosis of coronavirus disease 2019 (COVID‐19) and pulmonary involvement. Patients hospitalized with pulmonary involvement due to COVID‐19 (first hospitalization) were identified in the IBM Explorys® electronic health records database. Demographics, baseline clinical characteristics, and in‐hospital medications were assessed. For evaluation of in‐hospital medications, results were stratified by race, geographic region, age, and month of admission. Of 6564 hospitalized patients with COVID‐19‐related pulmonary involvement, 50.4% were male, and mean (SD) age was 62.6 (16.4) years; 75.2% and 23.6% of patients were from the South and Midwest, respectively, and 50.2% of patients were African American. Compared with African American patients, a numerically higher proportion of White patients received dexamethasone (19.7% vs. 31.8%, respectively), nonsteroidal anti‐inflammatory drugs (NSAIDs; 27.1% vs. 34.9%), bronchodilators (19.8% vs. 29.5%), and remdesivir (9.3% vs. 21.0%). Numerically higher proportions of White patients than African American patients received select medications in the South but not in the Midwest. Compared with patients in the South, a numerically higher proportion of patients in the Midwest received dexamethasone (20.1% vs. 34.5%, respectively), NSAIDs (19.6% vs. 55.7%), bronchodilators (15.9% vs. 41.3%), and remdesivir (10.6% vs. 23.1%). Inpatient use of hydroxychloroquine decreased over time, whereas the use of dexamethasone and remdesivir increased over time. Among US patients predominantly from the South and Midwest hospitalized with COVID‐19 and pulmonary involvement, differences were seen in medication use between different races, geographic regions, and months of hospitalization., Research Highlights In this retrospective, electronic health records study, including US patients hospitalized with COVID‐19 and pulmonary involvement, a numerically higher proportion of patients in the Midwest received dexamethasone, nonsteroidal anti‐inflammatory drugs, bronchodilators, and remdesivir than patients in the South. Analysis of select medication use by the US region showed that, in the South, numerically higher proportions of White patients than African American patients received multiple select medications, including dexamethasone and remdesivir; however, in the Midwest, select medication use was generally comparable among White and African American patients. These study results demonstrating differences in rates of medication use between different geographic regions, in addition to differences in the race within some regions and among different age groups, warrant further study.

Non-small cell lung cancer (NSCLC) with brain metastases (BM) is difficult to treat and associated with poor survival. This study assessed the impact of BM on healthcare-related utilization and costs (HRUC) among patients receiving epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).Adults newly-diagnosed with metastatic NSCLC, initiating first-/second-generation EGFR-TKI treatment, with BM or no BM (NBM), were identified retrospectively from IBM MarketScan healthcare claims databases (2013-2017). HRUC were measured during the variable-length follow-up period. Generalized linear models assessed the impact of BM on total healthcare costs, standardized to 2017 US$.Overall, 222 BM and 280 NBM patients were included, with a mean duration of follow-up of 14 months. Adjusted NSCLC-related and all-cause costs over average follow-up were 1.2 times higher among BM patients (Δ$5,640 and Δ$6,366, respectively;NSCLC-related HRUC, especially those attributable to radiation treatment, were higher among patients with BM. Future research should compare the potential for CNS-active EGFR-TKIs vs first-/second-generation EGFR-TKIs combined with radiotherapy to reduce HRUC.

Introduction Coronavirus disease 2019 (COVID-19) can present as a range of symptoms, from mild to critical; lower pulmonary involvement, including pneumonia, is often associated with severe and critical cases. Understanding the baseline characteristics of patients hospitalized with COVID-19 illness is essential for effectively targeting clinical care and allocating resources. This study aimed to describe baseline demographics and clinical characteristics of US patients hospitalized with COVID-19 and pulmonary involvement. Methods US patients with COVID-19 and pulmonary involvement during an inpatient admission from December 1, 2019, to May 20, 2020, were identified using the IBM Explorys® electronic health records database. Baseline (up to 12 months prior to first COVID-19 hospitalization) demographics and clinical characteristics and preadmission (14 days to 1 day prior to admission) pulmonary diagnoses were assessed. Patients were stratified by sex, age, race, and geographic region. Results Overall, 3471 US patients hospitalized with COVID-19 and pulmonary involvement were included. The mean (SD) age was 63.5 (16.3) years; 51.2% of patients were female, 55.0% African American, 81.6% from the South, and 16.8% from the Midwest. The most common comorbidities included hypertension (27.7%), diabetes (17.3%), hyperlipidemia (16.3%), and obesity (9.7%). Cough (27.3%) and dyspnea (15.2%) were the most common preadmission pulmonary symptoms. African American patients were younger (mean [SD], 62.5 [15.4] vs. 67.8 [6.2]) with higher mean (SD) body mass index (33.66 [9.46] vs. 30.42 [7.86]) and prevalence of diabetes (19.8% vs. 16.7%) and lower prevalence of chronic obstructive pulmonary disease (5.6% vs. 8.2%) and smoking/tobacco use (28.1% vs. 37.2%) than White patients. Conclusions Among US patients primarily from the South and Midwest hospitalized with COVID-19 and pulmonary involvement, the most common comorbidities were hypertension, diabetes, hyperlipidemia, and obesity. Differences observed between African American and White patients should be considered in the context of the complex factors underlying racial disparities in COVID-19. Electronic supplementary material The online version of this article (10.1007/s12325-020-01510-y) contains supplementary material, which is available to authorized users.

Objective The aim of this study is to compare outpatient respiratory syncytial virus (RSV) immunoprophylaxis (IP) use and relative RSV hospitalization (RSVH) rates for infants Study Design Infants were identified in the MarketScan Commercial and Multi-State Medicaid databases. Outpatient RSV IP receipt and relative Results Outpatient RSV IP receipt by infants Conclusion The 2014 policy change was associated with a decrease in RSV IP use and an increase in RSVH risk among otherwise healthy infants

Objective To quantify the healthcare expenditures associated with potential oral glucocorticoid (OGC)-related adverse events (AEs) in patients with giant cell arteritis (GCA). Methods Patients with GCA and ≥ 1 OGC prescription fill between 2009 and 2014 were identified from the MarketScan Commercial and Medicare Supplemental claims databases. Patients were stratified into four groups based on cumulative OGC dose (> 0 to ≤ 2607 mg, > 2607 to ≤ 4800 mg, > 4800 to ≤ 7200 mg, and > 7200 mg) during the 1-year follow-up period; incidence of potential AEs and AE-related direct healthcare costs in USD were assessed. Association between the log of cumulative OGC dose and AE-related direct healthcare costs was evaluated, adjusting for baseline characteristics. Results Of 1602 patients with GCA included, 69% were women; the mean age was 73 years. The mean cumulative OGC dose was 5806 mg during the 1-year follow-up; most exposure occurred in the first 6 months. The proportion of patients with potential OGC-related AEs was 36.5% overall and increased as cumulative dose increased (30.7%-45.3% across dose groups). Unadjusted mean AE-related costs for patients with an AE was USD $12,818. In the multivariable model including all patients, increasing OGC dose was associated with increasing AE-related healthcare costs (cost ratio, 1.38 [95% CI, 1.16-1.64] per 1-unit increase in log of cumulative OGC dose [P 0 to ≤ 2607 mg, USD $5176 ($3009) for > 2607 to ≤ 4800 mg, USD $5576 ($3633) for > 4800 to ≤ 7200 mg, and USD $6609 ($4447) for > 7200 mg. Conclusion In patients with GCA, OGC-related AEs increased with increasing cumulative OGC dose, resulting in increased healthcare costs. These results highlight the need for efficacious therapies that reduce the exposure to and potential risks associated with OGCs.

Objective In 2014, the American Academy of Pediatrics (AAP) changed its policy on the use of respiratory syncytial virus immunoprophylaxis (RSV-IP) so that RSV-IP was no longer recommended for use among infants without other medical conditions born >29 weeks gestational age (wGA). This study examines 10-year trends in RSV-IP and RSV hospitalizations among term infants and preterm infants born at 29 to 34 wGA, including the 5 RSV seasons before and 5 RSV seasons after the AAP guidance change. Study Design A retrospective observational cohort study of a convenience sample of infants less than 6 months of age during RSV season (November–March) born between July 1, 2008, and June 30, 2019, who were born at 29 to 34 wGA (preterm) or >37 wGA (term) in the IBM MarketScan Commercial and Multi-State Medicaid databases. We excluded infants with medical conditions that would independently qualify them for RSV-IP. We identified RSV-IP utilization along with RSV and all-cause bronchiolitis hospitalizations during each RSV season. A difference-in-difference model was used to determine if there was a significant change in the relative rate of RSV hospitalizations following the 2014 policy change. Results There were 53,535 commercially insured and 85,099 Medicaid-insured qualifying preterm infants and 1,111,670 commercially insured and 1,492,943 Medicaid-insured qualifying term infants. Following the 2014 policy change, RSV-IP utilization decreased for all infants, while hospitalization rates tended to increase for preterm infants. Rate ratios comparing preterm to term infants also increased. The relative rate for RSV hospitalization for infants born at 29 to 34 wGA increased significantly for both commercially and Medicaid-insured infants (1.95, 95% CI: 1.67–2.27, p Conclusion We found that the previously identified increase in RSV hospitalization rates among infants born at 29 to 34 wGA persisted for at least 5 years following the policy change. Key Points

Introduction Oral glucocorticoids (GC) have been the mainstay of treatment for giant cell arteritis (GCA). We estimated the risk and dose–effect relationship of potential GC-related adverse events (AEs) in patients with GCA. Methods This retrospective, observational cohort study utilized data from the IBM Explorys Electronic Health Records database from 2008 through 2016. Inclusion criteria included the presence of at least two GCA diagnostic codes in subjects aged 50 or older along with supporting laboratory [C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)], prescription data on oral GCs, and at least 12 months of follow-up before and after the first oral GC prescription for GCA (index date). Potential AEs captured on the basis of new diagnoses, prescriptions, and laboratory tests were assessed during the 12 months post-index date. Results were descriptively summarized across cohorts according to quartiles (Q) of mean daily GC dose measured over the first 6 months of follow-up (Q1, ≥ 1.00 to ≤ 13.75 mg; Q2, > 13.75 to ≤ 25.00 mg; Q3, > 25.00 to ≤ 40.00 mg; Q4, > 40.00 mg). Results We identified 785 eligible patients with GCA. The mean (SD) age of the cohort was 76 (9) years and 70% were female. The mean oral GC dose during the first 6 months post-index was 28.9 mg/day. A dose–effect response was observed from Q1 to Q4 in the following potential GC-related AEs: newly diagnosed type 2 diabetes/HbA1c > 7.5% (range 7.5–24.5%), blood glucose ≥ 200 mg/dL (range 7.5–15%), serious infection (range 16.8–24.8%), cataracts (range 12.0–21.7%), gastrointestinal bleed/ulcer (range 6.0–11.8%), and increase in BMI ≥ 5 units (range 4.1–6.4). Conclusions In patients with GCA, potential GC-related AEs increased with higher daily oral GC doses. This highlights the need for effective therapies that reduce GC exposure and toxicity. Funding Genentech, Inc.

Aims: To examine healthcare resource utilization (HRU) and costs within 12 months after hospitalization for respiratory syncytial virus (RSVH) or unspecified bronchiolitis (UBH) in infants. Materials and methods: Infants born July 1, 2009–June 30, 2015 were identified in the MarketScan Medicaid and Commercial databases and were assigned to one of three cohorts: RSVH (with/without UBH), UBH, or comparator (no RSVH or UBH). Each infant was identified as pre-term (5 groups) or term (2 groups) based on weeks gestational age (wGA). Index dates were the first admission dates for RSVH or UBH infants and were randomly assigned to comparator infants based on time from birth to index in the RSVH cohort. HRU, all-cause costs, and incremental cost differences between hospitalized and comparator infants were assessed over 12 months post-index with and without the index hospitalization. Results were propensity score weighted to balance pre-index characteristics across hospitalization cohorts. Results: This study identified 15,872 RSVH infants, 6,081 UBH infants, and 986,087 comparator infants in the Medicaid population and 5,755 RSVH infants, 1,888 UBH infants, and 696,302 comparator infants in the commercial population. HRU in follow-up was greater for RSVH and UBH infants relative to comparator infants in both populations, including hospitalizations (commercial: 7.4%, 11.0%, 1.7%; Medicaid: 12.3%, 15.3%, 3.2%) and emergency department visits (commercial: 33.0%, 33.3%, 17.2%; Medicaid: 65.8%, 68.5%, 51.4%). HRU was highest among RSVH and UBH infants born at Limitations: RSV/UB may be miscoded in claims data. Conclusions: Infants hospitalized for RSV or UB largely had greater subsequent HRU and costs in the first year after index hospitalization than comparator infants. Absolute and incremental follow-up costs relative to comparator infants were highest among infants

The treatment of postsurgical pain with prescription opioids has been associated with persistent opioid use and increased health care utilization and costs.To compare the health care burden between opioid-naive adult patients who were prescribed opioids after a major surgery and opioidnaive adult patients who were not prescribed opioids.Administrative claims data from the IBM Watson Health MarketScan Research Databases for 2010-2016 were used. Opioid-naive adult patients who underwent major inpatient or outpatient surgery and who had at least 1 year of continuous enrollment before and after the index surgery date were eligible for inclusion. Cohorts were defined based on an opioid pharmacy claim between 7 days before index surgery and 1 year after index surgery (opioid use during surgery and inpatient use were not available). To ensure an opioid-naive population, patients with opioid claims between 365 and 8 days before surgery were excluded. Acute medical outcomes, opioid utilization, health care utilization, and costs were measured during the post-index period (index surgery hospitalization and day of index outpatient surgery not included). Predicted costs were estimated from multivariable log-linked gamma-generalized linear models.The final sample consisted of 1,174,905 opioid-naive patients with an inpatient surgery (73% commercial, 20% Medicare, 7% Medicaid) and 2,930,216 opioid-naive patients with an outpatient surgery (74% commercial, 23% Medicare, and 3% Medicaid). Opioid use after discharge was common among all 3 payer types but was less common among Medicare patients (63% inpatient/43% outpatient) than patients with commercial (80% inpatient/75% outpatient) or Medicaid insurance (86% inpatient/81% outpatient). Across all 3 payers, opioid users were younger, were more likely to be female, and had a higher preoperative comorbidity burden than nonopioid users. In unadjusted analyses, opioid users tended to have more hospitalizations, emergency department visits, and pharmacy claims. Adjusted predicted 1-year post-period total health care costs were significantly higher (Filling an outpatient opioid prescription (vs. no opioid prescription) in the 1 year after inpatient or outpatient surgery was associated with increased health care utilization and costs across all payers.Funding for this study was provided by Heron Therapeutics, which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Brummett is a paid consultant for Heron Therapeutics and Recro Pharma and reports receipt of research funding from MDHHS (Sub K Michigan Open), NIDA (Centralized Pain Opioid Non-Responsiveness R01 DA038261-05), NIH0DHHS-US-16 PAF 07628 (R01 NR017096-05), NIH-DHHS (P50 AR070600-05 CORT), NIH-DHHS-US (K23 DA038718-04), NIH-DHHS-US-16-PAF06270 (R01 HD088712-05), NIH-DHHS-US-17-PAF02680 (R01 DA042859-05), and UM Michigan Genomics Initiative and holding a patent for peripheral perineural dexmedetomidine. Oderda is a paid consultant for Heron Therapeutics. Pawasauskas is a paid consultant to Heron Therapeutics and Mallinckrodt Pharmaceuticals. England and Evans-Shields are employees of Heron Therapeutics. Kong, Lew, Zimmerman, and Henriques are employees of IBM Watson Health, which was compensated by Heron Therapeutics for conducting this research. Portions of this work were presented as a poster at the AMCP Managed Care and Specialty Pharmacy Annual Meeting 2019; March 25-28, 2019; San Diego, CA.

The number of people living with HIV (PLWH) ≥65 years is increasing in the United States. By 2035, the proportion of PLWH in this age group is projected to be 27%. As PLWH live longer, they face age-related comorbidities. We compared non-HIV disease and medication burden among PLWH (n = 2359) and HIV-negative individuals (n = 2,010,513) ≥65 years using MarketScan(®) Medicare Supplemental health insurance claims from 2009 to 2015. Outcomes were common diagnoses and medication classes, prevalence of non-HIV conditions, number of non-HIV conditions, and daily non-antiretroviral therapy (ART) medications over a 1-year period. We examined age-standardized prevalence rates and prevalence ratios (PRs) and fit multivariable generalized linear models, stratified by sex. PLWH were younger (mean 71 vs. 76 years) and a larger proportion were men (81% vs. 45%). The most common diagnoses among both cohorts were hypertension and dyslipidemia. Most non-HIV conditions were more prevalent among PLWH. The largest absolute difference was in anemia (29.6 cases per 100 people vs.11.7) and the largest relative difference was in hepatitis C (PR = 22.0). Unadjusted mean number of non-HIV conditions and daily non-ART medications were higher for PLWH (4.61 conditions and 3.79 medications) than HIV-negative individuals (3.94 and 3.41). In models, PLWH had significantly more non-HIV conditions than HIV-negative individuals [ratios: men = 1.272, (95% confidence interval, 1.233–1.312); women = 1.326 (1.245–1.413)]. Among those with >0 daily non-ART medications, men with HIV had significantly more non-ART medications than HIV-negative men [ratio = 1.178 (1.133–1.226)]. The disease burden associated with aging is substantially higher among PLWH, who may require additional services to effectively manage HIV and comorbid conditions.

To measure the effect of thyroidectomy difficulty on intraoperative neuromonitoring false loss of signal (LOS) and to compare intraoperative endotracheal tube-based neuromonitoring (ETNM) and Checkpoint palpation-based direct stimulation (pDS) signals with postoperative laryngoscopy. We hypothesized that pDS has higher a positive predictive value for postdissection confirmation of recurrent laryngeal nerve function than ETNM and that this difference is accentuated with increasing thyroidectomy difficulty.Prospective single-arm cross-sectional study comparing ETNM and pDS for patients undergoing hemi-, total, or completion thyroidectomy from July 2018 to March 2020.Single-surgeon series at a tertiary care hospital.Percentage concordance and positive and negative predictive values were measured. Each thyroidectomy was assigned a validated thyroidectomy difficulty score, and recorded recurrent laryngeal nerve signals were compared with postoperative vocal fold mobility.Percentage concordance was 90.09%. Positive and negative predictive values were 0.19 (95% CI, 0.09-0.31) and 1.0 for ETNM and 0.59 (95% CI, 0.35-0.82) and 1.0 for pDS. The difference in positive predictive value was significant (0.40 [95% CI, 0.33-0.47],ETNM was subject to high rates of postdissection false LOS that increased with thyroidectomy difficulty score. pDS is a reliable alternative that has higher positive predictive value than ETNM, particularly in more challenging cases such as those with posteriorly fixed thyroid cancers and fibrotic glands.2.

Palivizumab is the only licensed respiratory syncytial virus (RSV) immunoprophylaxis (IP) available to prevent severe RSV disease in high-risk pediatric populations, including infants born at 29–34 weeks’ gestational age (wGA). In 2014, the American Academy of Pediatrics (AAP) stopped recommending RSV IP use for otherwise healthy 29–34 wGA infants and stated that 29–34 wGA infants and term infants have similar RSV hospitalization (RSVH) rates. This study aimed to compare RSV IP use and RSVH rates in 29–34 wGA infants and term infants during the 3 RSV seasons before and after the 2014 AAP policy change. RSV IP use in otherwise healthy infants 29–30, 31–32, and 33–34 wGA was estimated from pharmacy or outpatient medical claims for palivizumab. RSVH rates in the first 6 months of life were calculated per 100 infant-seasons. RSVH rate ratios were used to compare preterm infants and term infants before and after the policy change. Across infant cohorts (29–34 wGA) and chronologic age groups (

Introduction: Coronavirus disease 2019 (COVID-19) can present as a range of symptoms, from mild to critical; lower pulmonary involvement, including pneumonia, is often associated with severe and critical cases. Understanding the baseline characteristics of patients hospitalized with COVID-19 illness is essential for effectively targeting clinical care and allocating resources. This study aimed to describe baseline demographics and clinical characteristics of US patients hospitalized with COVID-19 and pulmonary involvement.Methods: US patients with COVID-19 and pulmonary involvement during an inpatient admission from December 1, 2019, to May 20, 2020, were identified using the IBM Explorys® electronic health records database. Baseline (up to 12 months prior to first COVID-19 hospitalization) demographics and clinical characteristics, and preadmission (14 days to 1 day prior to admission) pulmonary diagnoses were assessed. Patients were stratified by sex, age, race, and geographic region.Results: Overall, 3471 US patients hospitalized with COVID-19 and pulmonary involvement were included. The mean (SD) age was 63.5 (16.3) years; 51.2% of patients were female, 55.0% African American, 81.6% from the South, and 16.8% from the Midwest. The most common comorbidities included hypertension (27.7%), diabetes (17.3%), hyperlipidemia (16.3%), and obesity (9.7%). Cough (27.3%) and dyspnea (15.2%) were the most common preadmission pulmonary symptoms. African American patients were younger (mean [SD], 62.5 [15.4] vs 67.8 [6.2]) with higher mean (SD) body mass index (33.66 [9.46] vs 30.42 [7.86]) and prevalence of diabetes (19.8% vs 16.7%) and lower prevalence of chronic obstructive pulmonary disease (5.6% vs 8.2%) and smoking/tobacco use (28.1% vs 37.2%) than White patients.Conclusions: Among US patients primarily from the South and Midwest hospitalized with COVID-19 and pulmonary involvement, the most common comorbidities were hypertension, diabetes, hyperlipidemia, and obesity. Differences observed between African American and White patients should be considered in context of the complex factors underlying racial disparities in COVID-19.

Background Pirfenidone and nintedanib are antifibrotic therapies which slow disease progression in idiopathic pulmonary fibrosis (IPF), an irreversible, progressive lung disease with poor prognosis. We compared adherence, persistence, and healthcare costs between patients initiating one of the two therapies. Methods We used the IBM Watson Health Commercial and Medicare Supplemental claims databases to select patients with IPF with ≥1 pharmacy claim for pirfenidone or nintedanib between 10/1/2014 and 6/30/2018. Adherence (proportion of days covered ≥0.80) and persistence (time to a gap of ≥60 days without medication or switch to the other antifibrotic medication) based on the days’ supply and service date fields on claims were measured over a variable-length follow-up period. Healthcare costs, all-cause and respiratory-related, were measured over the persistent period and a fixed 12-month follow-up period. Inverse probability of treatment weights were applied to models comparing adherence, persistence, and costs between the two cohorts. Results Overall, 799 pirfenidone patients and 656 nintedanib patients were identified. Similar proportions of patients were adherent in both cohorts (pirfenidone = 49% vs. nintedanib = 51%) and there was no significant difference in the odds of being adherent after weighting (odds ratio = 1.1, p = 0.513). The proportions of patients who discontinued/switched were also similar (pirfenidone = 41% vs. nintedanib 43%); however, in a weighted model, the hazards of discontinuation/switching was lower for the pirfenidone cohort (hazard ratio = 0.8, p = 0.032). While patients were persistent on therapy, weighted all-cause healthcare costs were comparable (pirfenidone = $11,272 vs. nintedanib = $11,987 per-patient per-month; p = 0.115), but weighted respiratory-related costs were significantly lower for the pirfenidone cohort ($9015 vs. $10,167 per-patient per-month, p < 0.001). Weighted annual total all-cause and respiratory-related healthcare costs were comparable between cohorts over the fixed 12-month follow-up period, but the pirfenidone cohort had significantly lower weighted annual mean antifibrotic drug costs than the nintedanib cohort ($68,850 vs. $77,033, p = 0.007). Conclusions Pirfenidone use was associated with longer time to discontinuation/switch, lower antifibrotic drug costs, and lower respiratory-related total costs compared to nintedanib use.

Objective.Interstitial lung disease (ILD) is commonly associated with rheumatoid arthritis (RA) and can have significant morbidity and mortality. The objective of this study was to calculate the prevalence, incidence, healthcare costs, and mortality of RA-related ILD (RA-ILD) in the United States.Methods.This retrospective cohort analysis used the Truven Health MarketScan Commercial and Medicare Supplemental health insurance databases from 2003 to 2014 and the Social Security Administration death database. Patients with RA-ILD were selected based on diagnoses on medical claims. Outcomes were 1-year prevalence and incidence of RA-ILD among the general enrollee population, all-cause and respiratory-related healthcare costs (2014 US$), and all-cause survival for a subset of newly diagnosed patients with vital status information. This analysis was descriptive. No statistical testing was conducted.Results.Prevalence of RA-ILD ranged from 3.2 to 6.0 cases per 100,000 people across the 10-year period and incidence ranged from 2.7 to 3.8 cases per 100,000 people. There were 750 incident patients with 5 years of followup data. Over that time, 72% had an inpatient admission and 76% had an emergency room visit. Mean total 5-year costs were US$173,405 per patient (SD $158,837). Annual per-patient costs were highest in years 1 and 5. At 5 years after first diagnosis in the data, 35.9% of patients had died.Conclusion.Prevalence of RA-ILD increased over time. For patients who could be followed over a 5-year period, healthcare use and costs were somewhat stable over time, but were substantial. RA-ILD is associated with decreased survival.

Objective The objective of this study was to compare risk for respiratory syncytial virus (RSV) hospitalizations (RSVH) for preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after 2014 guidance changes for immunoprophylaxis (IP), using data from the 2012 to 2016 RSV seasons. Study Design Using commercial and Medicaid claims databases, infants born between July 1, 2011 and June 30, 2016 were categorized as preterm or term. RSVH during the RSV season (November–March) were identified for infants aged Results In all seasons, preterm infants had higher RSVH rates than term infants. Seasonal RRs prior to the guidance change for preterm wGA categories versus term infants ranged from 1.6 to 3.4. After the guidance change, the seasonal RRs ranged from 2.6 to 5.6. In 2014 to 2016, the risk associated with prematurity of 29 to 34 wGA versus term was significantly higher than in 2012 to 2014 (P Conclusion In infants aged

To compare healthcare utilization and costs between patients with type 2 diabetes (T2D) treated with exenatide (Bydureon) once weekly (EQW) and patients treated with insulin glargine (IG).Using the MarketScan Commercial and Medicare Supplemental databases, we conducted a retrospective cohort study of adult US patients with claim with a diagnosis of T2D, initiating EQW or IG from February 1, 2012 to June 30, 2014 (first claim = index date). All-cause and diabetes-related utilization and costs were measured during the 12 months after the index date. EQW patients were matched 1:1 to IG patients, using propensity scores. Logistic and ordinary least-squares regression models were fit to model differences between the matched cohorts.There were 7749 EQW patients matched to 7749 IG patients. EQW patients had significantly (P .05) lower odds of all-cause inpatient (IP) admissions (odds ratio = 0.737 [95% confidence interval, 0.661, 0.822]), diabetes-related IP admissions (0.720 [95% confidence interval, 0.635, 0.815]) and diabetes-related IP admissions or emergency room visits (0.778 [95% confidence interval, 0.713, 0.847]). EQW patients had significantly (P .05) lower all-cause (cost difference = -113 USD [95% confidence interval, -120 USD, -106 USD]) and diabetes-related (-806 USD [95% confidence interval, -871 USD, -746 USD]) medical costs, and had significantly (P .05) higher all-cause total costs (ie, medical plus pharmacy) (3228 USD [95% confidence interval, 3110 USD, 3367 USD]), diabetes-related total costs (1951 USD [95% confidence interval, 1873 USD, 2036 USD]), all-cause pharmacy costs (2792 USD [95% confidence interval, 2700 USD, 2928 USD]) and diabetes-related pharmacy costs (1923 USD [95% confidence interval, 1890 USD, 1957 USD]) than those of IG patients.Among adults with T2D, EQW initiators had lower odds of IP admission and lower medical costs in the 12 months after initiation than IG initiators. Higher total costs in EQW patients were driven by greater pharmacy costs.

To compare healthcare costs of adults with type 2 diabetes (T2D) after initiation of saxagliptin or linagliptin, two antidiabetic medications in the dipeptidyl peptidase-4 inhibitor medication class.Patients with T2D who were at least 18 years old and initiated saxagliptin or linagliptin (index date) between 1 June 2011 and 30 June 2014 were identified in the MarketScan Commercial and Medicare Supplemental Databases. All-cause healthcare costs and diabetes-related costs (T2D diagnosis on a medical claim and/or an antidiabetic medication claim) were measured in the 1 year follow-up period. Saxagliptin and linagliptin initiators were matched using propensity score methods. Cost ratios (CRs) and predicted costs were estimated from generalized linear models and recycled predictions.There were 34,560 saxagliptin initiators and 18,175 linagliptin initiators identified (mean ages 57 and 59; 55% and 56% male, respectively). Before matching, saxagliptin initiators had significantly lower all-cause total healthcare costs than linagliptin initiators (mean = $15,335 [SD $28,923] vs. mean = $20,069 [SD $48,541], p .001) and significantly lower diabetes-related total healthcare costs (mean = $6109 [SD $13,851] vs. mean = $7393 [SD $26,041], p .001). In matched analyses (n = 16,069 per cohort), saxagliptin initiators had lower all-cause follow-up costs than linagliptin initiators (CR = 0.953, 95% CI = 0.932-0.974, p .001; predicted costs = $17,211 vs. $18,068). There was no significant difference in diabetes-related total costs after matching; however, diabetes-related medical costs were significantly lower for saxagliptin initiators (CR = 0.959, 95% CI = 0.927-0.993, p = 0.017; predicted costs = $3989 vs. $4159).Adult patients with T2D initiating treatment with saxagliptin had lower total all-cause healthcare costs and diabetes-related medical costs over 1 year compared with patients initiating treatment with linagliptin.

Individuals with Down syndrome (DS) experience various comorbidities in excess of the prevalence seen among the non-DS population. However, the extent of the excess burden of comorbidities specifically within commercially and publicly insured DS populations aged21 years is not currently known.To (a) describe the most common diagnoses among individuals with DS who have either commercial or Medicaid insurance and (b) compare the prevalence of those diagnoses between DS cases and non-DS controls.This was a longitudinal, retrospective study using health care claims of commercially insured and Medicaid-insured individuals in the Truven Health MarketScan Databases from 2008 to 2015. Individuals aged2, 2-5, 6-11, and 12-20 years with a DS diagnosis (cases; commercial: n = 15,948; Medicaid: n = 11,958) were matched to individuals without DS (controls; commercial: n = 47,844; Medicaid: n = 35,874) using a 1:3 ratio. The annual number of diagnoses was compared between cases and controls within age groups using t-tests, and the prevalence of the most common diagnoses was compared using chi-square tests.Cases in all age groups in both databases had more diagnoses annually than controls (mean =9-17 per year vs. 4-10 per year, P0.001), and the number of diagnoses decreased with age for cases and controls. Among the most common case diagnoses were upper respiratory infections (28.9%-59.1% vs. 19.5%-52.9%); suppurative otitis media (25.1%-56.8% vs. 8.7%-51.2%); nutrition/metabolic/developmental symptoms (37.9%-50.4% vs. 7.7%-10.6%); delays in development (22.8%-52.8% vs. 4.1%-10.9%); and general symptoms (35.1%-47.2% vs. 22.1%-37.2%), and the prevalence of each was greater among cases versus controls in all age groups in both databases (P0.001). The most common diagnoses among controls included some of the same as among cases, as well as acute pharyngitis (18.7%-31.8% vs. 19.2%-30.5%); allergic rhinitis (19.9%-24.3% vs. 15.3%-20.7%); viral/chlamydial infections (24.2%-26.6% vs. 17.7%-23.5%); and joint disorders (11.6% vs. 16.6%), and most were significantly more prevalent among cases (P0.05).Commercially insured and Medicaid-insured individuals aged21 years with DS experience a greater number and prevalence of concomitant diagnoses compared with non-DS individuals. Awareness of these common diagnoses could help facilitate the optimal care of these individuals by the pediatric health care community.This study was sponsored and funded by Genentech. Truven Health Analytics, an IBM Company, receives payment from Genentech to conduct research, including the research for this study. Truven Health Analytics also receives payment from other pharmaceutical companies to conduct research. Kong and Evans are employed by Truven Health Analytics. Csoboth is employed by Genentech. Brixner reports fees paid to the University of Utah by Truven Health Analytics on her behalf for work related to this study. Hurley reports fees from Genentech for work on this study and for work outside of this study. At the time of this study, Visootsak was employed by F. Hoffman-LaRoche Pharmaceuticals, parent company of Genentech. All authors, including those affiliated with the study sponsor, were involved in the design of the study, interpretation of the data, writing of the manuscript, and the decision to submit the manuscript for publication. Study concept and design were contributed by Kong, Hurley, and Brixner, along with Evans. Kong and Evans collected the data, and data interpretation was performed by Csoboth, Visootsak, Brixner, and Hurley, with assistance from Kong. The manuscript was written by Evans, Kong, Hurley, and Brixner and revised by Kong, Hurley, Evans, and Brixner, with assistance from Csoboth and Visootsak.

Objectives Recommendations for polysomnography (PSG) in pediatric sleep disordered breathing (SDB) vary between the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and the American Academy of Pediatrics (AAP). We determined the rates of preoperative PSG in children without risk factors outlined in the AAO-HNS Clinical Practice Guidelines and described the postoperative course of those patients following T&A. Methods Patients aged 3–17 undergoing T&A for SDB or OSA who did not have an indication for preoperative PSG were included. We conducted retrospective review to describe the rate, type, and timing of respiratory complications for patients with and without PSG following T&A, and discuss cases where disposition was changed due to PSG results. Results 1135 patients without risk factors underwent T&A for SDB or OSA. 196 (17%) had a preoperative PSG, of whom 85 (43.3%) had AHI >10 and 38 (24.8%) had an O2 nadir Conclusion PSG in children without risk factors results in admission of otherwise healthy patients following T&A who would have otherwise undergone ambulatory surgery. PSG alone in pediatric patients with no AAO-HNS risk factors should not influence postoperative disposition. These patients should be monitored for 3 h post-T&A and discharged in the absence of complications. Evidence level 2b

Objective To quantify the healthcare expenditures associated with potential oral glucocorticoid (OGC)-related adverse events (AEs) in patients with giant cell arteritis (GCA). Methods Patients with GCA and ≥ 1 OGC prescription fill between 2009 and 2014 were identified from the MarketScan Commercial and Medicare Supplemental claims databases. Patients were stratified into four groups based on cumulative OGC dose (> 0 to ≤ 2607 mg, > 2607 to ≤ 4800 mg, > 4800 to ≤ 7200 mg, and > 7200 mg) during the 1-year follow-up period; incidence of potential AEs and AE-related direct healthcare costs in USD were assessed. Association between the log of cumulative OGC dose and AE-related direct healthcare costs was evaluated, adjusting for baseline characteristics. Results Of 1602 patients with GCA included, 69% were women; the mean age was 73 years. The mean cumulative OGC dose was 5806 mg during the 1-year follow-up; most exposure occurred in the first 6 months. The proportion of patients with potential OGC-related AEs was 36.5% overall and increased as cumulative dose increased (30.7%–45.3% across dose groups). Unadjusted mean AE-related costs for patients with an AE was USD $12,818. In the multivariable model including all patients, increasing OGC dose was associated with increasing AE-related healthcare costs (cost ratio, 1.38 [95% CI, 1.16–1.64] per 1-unit increase in log of cumulative OGC dose [P < 0.001]). Mean (median)-predicted AE costs for the dose groups were USD $4389 ($2749) for > 0 to ≤ 2607 mg, USD $5176 ($3009) for > 2607 to ≤ 4800 mg, USD $5576 ($3633) for > 4800 to ≤ 7200 mg, and USD $6609 ($4447) for > 7200 mg. Conclusion In patients with GCA, OGC-related AEs increased with increasing cumulative OGC dose, resulting in increased healthcare costs. These results highlight the need for efficacious therapies that reduce the exposure to and potential risks associated with OGCs.

Background Oral glucocorticoids (OGC) have been the mainstay of treatment for giant cell arteritis (GCA). However, OGCs are associated with several adverse events (AEs). Objectives To estimate the risk of potential OGC-related AEs in patients with GCA. Methods This retrospective, observational cohort study utilized the 2008-2017 IBM Explorys Electronic Health Records database which includes lab values. Inclusion criteria included age ≥ 50 years with ≥ 2 GCA diagnoses ≥ 7 days apart, 1 OGC prescription within 6 months of the first GCA diagnosis (index date = date of first OGC prescription) followed by a second OGC prescription, no other autoimmune disease requiring high-dose OGCs, no exposure to anti-tumor necrosis factor or anti-interleukin-6 therapies, ≥ 1 C-reactive protein (CRP)/erythrocyte sedimentation rate (ESR) lab test and 12 months of data available pre- and post-index. Potential AEs assessed during the 12 months post-index were descriptively summarized across cohorts of patients based on quartiles (Q) of mean daily dose of OGCs measured over 6 months post-index among this patient sample (Q1: ≥ 1.00 to ≤ 13.75 mg; Q2: > 13.75 to ≤ 25.00 mg; Q3: > 25.00 to ≤ 40.00 mg; Q4: > 40.00 mg). Potential AEs included type 2 diabetes (T2D) diagnosis, hemoglobin A1c (HbA1c), blood glucose level, serious infections, cataracts, gastrointestinal bleeding or ulcer and increases in body mass index (BMI). Actual OGC use by patient could not be confirmed and is a limitation of this study. Results Mean age of the 785 eligible patients was 76 years (SD 9); 70% were female. Mean Deyo Charlson Comorbidity Index score at baseline was 1.57 (SD 2.01). The most common baseline comorbid conditions were cerebrovascular disease, diabetes, chronic pulmonary disease, and renal disease. Mean daily OGC dose was 28.9 mg during the first 6 months post-index. Mean (SD) CRP and ESR during the 12-month follow-up was 5.1 (13.6) and 26.5 (20.7), respectively. The proportion of patients with newly diagnosed T2D or with HbA1c ≥ 7.5 during the 12-month follow-up ranged from 7.5% to 24.5% from OGC daily dose Q1 to Q4 cohorts. The proportion of patients with glucose ≥ 200 mg/dL ranged from 7.5% to 15.0% from Q1 to Q4. Serious infections ranged from 16.8% to 24.8% from Q1 to Q4 and cataract ranged from 12.0% to 21.7% from Q1 to Q4. The proportions of patients with gastrointestinal bleed/ulcer ranged from 6.0% in Q1 to 11.8% in Q4. An increase in BMI of 5 ranged from 4.1% to 6.4% from Q1 to Q4. Conclusion In patients with GCA, potential OGC-related AEs increased with increased daily OGC dose. This highlights the need for effective therapies that reduce the exposure and potential risk of OGCs. Acknowledgement This work was supported by funding from Genentech, Inc Disclosure of Interests Jennie H. Best Shareholder of: Genentech, Employee of: Genentech, Amanda M. Kong Employee of: IBM Watson Health, Oth Tran Employee of: IBM Watson Health, Margaret Michalska Employee of: Genentech, Inc.

Hypersensitivity pneumonitis is a complex lung disease resulting from repeated inhalation of a variety of antigens. Limited data exist regarding its epidemiology.To describe the trends in the annual incidence and prevalence of hypersensitivity pneumonitis in the United States.We developed novel claims-based coding algorithms to identify hypersensitivity pneumonitis, chronic hypersensitivity pneumonitis, and fibrotic hypersensitivity pneumonitis cases using the 2004 to 2013 MarketScan Commercial and Medicare Supplemental healthcare claims databases. Algorithm validity and reliability were assessed with clinical data from National Jewish Health. We calculated yearly cumulative incidence and prevalence overall and by age. For the subgroup with vital status, Kaplan-Meier methods were used to analyze survival stratified by evidence of fibrosis.We identified 7,498 cases that met our hypersensitivity pneumonitis definition over the 10-year study period, including 3,902 with chronic hypersensitivity pneumonitis and 1,852 with fibrotic hypersensitivity pneumonitis. On the basis of the clinical-radiological adjudication of the validation sample, 38 cases (95%) were confirmed as hypersensitivity pneumonitis. The mean age was 52 years, and 58% were women. The 1-year prevalence rates for hypersensitivity pneumonitis ranged from 1.67 to 2.71 per 100,000 persons, and 1-year cumulative incidence rates ranged from 1.28 to 1.94 per 100,000 persons. The prevalence increased with age, ranging from 0.95 per 100,000 among 0- to 9-year-olds to 11.2 per 100,000 among those aged 65 years and older. Between 56 and 68% of hypersensitivity pneumonitis cases in each year were classified as chronic hypersensitivity pneumonitis (prevalence, 0.91-1.70 per 100,000 persons; cumulative incidence, 0.63-1.08 per 100,000 persons). Fewer had fibrotic hypersensitivity pneumonitis (prevalence, 0.41-0.80 per 100,000 persons; cumulative incidence: 0.29-0.43 per 100,000 persons). Most cases (74%) were classified as unspecified hypersensitivity pneumonitis. Older age, male sex, and fibrosis were associated with higher mortality rates in unadjusted analyses.Using U.S. administrative claims-based data, we developed an algorithm with a high sensitivity and specificity for hypersensitivity pneumonitis. Between 2004 and 2013, hypersensitivity pneumonitis was more common among women and those older than 65 years. Most cases were classified as chronic hypersensitivity pneumonitis. Approximately one-fourth met our criteria for fibrotic hypersensitivity pneumonitis, which was associated with a higher mortality rate.

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are two related forms of systemic vasculitis. Patients with these conditions often experience relapses affecting various body systems. Here we describe rates of relapse and review healthcare costs resulting from relapse among patients with GPA/MPA. Two groups of patients with GPA and MPA were selected from the MarketScan claims databases between 2011 and 2013 based on diagnosis codes. Patients were followed for 12 months to identify relapses based on an algorithm of diagnoses in medical and medication claims. Relapses were categorized into one of the following groups: renal relapse, pulmonary relapse, other relapse-associated condition relapse, GPA or MPA utilization relapse, and mixed relapse. The final sample of patients with GPA and MPA consisted of 2707 and 740 patients, respectively. In both groups, approximately one-quarter of patients experienced relapse during the 12-month follow-up period. The mean all-cause healthcare costs in the 4-month period after relapse were $38,313 (SD, $54,120) for patients with GPA and $35,947 (SD, $48,065) for patients with MPA. In both groups, renal relapses were the costliest. Costs during the 4 months immediately following relapses were substantially higher than what could be expected over a 4-month follow-up among patients who did not experience relapse based on 12-month all-cause costs (GPA, $32,005 [SD, $64,570]; MPA, $61,044 [SD, $125,093]). Relapses are common among patients with GPA and MPA, and treatment of relapses can be costly. More effective therapies are needed to prevent relapses. Genentech, Inc.

Objective.Oral glucocorticoid (OGC) use for rheumatoid arthritis (RA) is debated because of the adverse event (AE) profile of OGC. We evaluated the associations between cumulative doses of OGC and potential OGC-related AE, and quantified the associated healthcare expenditures.Methods.Using the MarketScan databases, patients ≥ 18 years old who have RA with continuous enrollment from January 1 to December 31, 2012 (baseline), and from January 1 to December 31, 2013 (evaluation period), were identified. Cumulative OGC dose was measured using prescription claims during the baseline period. Potential OGC-related AE (osteoporosis, fracture, aseptic necrosis of the bone, type 2 diabetes, ulcer/gastrointestinal bleeding, cataract, hospitalization for opportunistic infection, myocardial infarction, or stroke) and AE-related expenditures (2013 US$) were gathered during the evaluation period. Multivariable regression models were fitted to estimate OR of AE and incremental costs for patients with AE.Results.There were 84,357 patients analyzed, of whom 48% used OGC during the baseline period and 26% had an AE during the evaluation period. A cumulative OGC dose > 1800 mg was associated with an increased risk of any AE compared with no OGC exposure (OR 1.19, 99.65% CI 1.09–1.30). Incremental costs per patient with any AE were significantly greater for cumulative OGC dose > 1800 mg compared with no OGC exposure (incremental cost = $3528, 99.65% CI $2402–$4793).Conclusion.Chronic exposure to low to medium doses of OGC was associated with significantly increased risk of potential OGC-related AE in patients with RA, and greater cumulative OGC dose was associated with substantially higher AE-related healthcare expenditures among patients with AE.

Objective This article aims to compare respiratory syncytial virus (RSV) immunoprophylaxis (IP) use and RSV hospitalization rates (RSVH) in preterm and full-term infants without chronic lung disease of prematurity or congenital heart disease before and after the recommendation against RSV IP use in preterm infants born at 29 to 34 weeks' gestational age (wGA). Study Design Infants in commercial and Medicaid claims databases were followed from birth through first year to assess RSV IP and RSVH, as a function of infant's age and wGA. RSV IP was based on pharmacy or outpatient medical claims for palivizumab. RSVH was based on inpatient medical claims with a diagnosis of RSV. Results Commercial and Medicaid infants 29 to 34 wGA represented 2.9 to 3.5% of all births. RSV IP use in infants 29 to 34 wGA decreased 62 to 95% (p Conclusion Following the 2014 RSV IP guidance change, RSV IP use declined and RSVH increased among infants born at 29 to 34 wGA and aged

Introduction Palivizumab is indicated for the prevention of respiratory syncytial virus (RSV) infection in high-risk children. Previous palivizumab utilization studies examined prior authorization claims but did not examine utilization within insured populations as a whole. This study describes outpatient palivizumab utilization trends and characterizes high-risk infants receiving palivizumab within Medicaid- and commercially insured populations. Methods Infants born July 1, 2003 through June 30, 2013 were identified in the MarketScan® Multistate Medicaid and Commercial claims databases. Infants with ≥ 18 months of continuous medical insurance enrollment with pharmacy benefits after birth and evidence of chronic lung disease of prematurity (CLDP), congenital heart disease (CHD), or preterm birth without CLDP or CHD were studied. Palivizumab use and demographic and clinical characteristics were measured in infant subgroups. Outpatient palivizumab utilization rates were calculated for each seasonal year (July–June) and for each infant subgroup. Results In total, 29,350 (2.1%) Medicaid-insured and 9589 (2.5%) commercially insured infants received palivizumab and had CLDP, CHD, or were born at

Objective.Patients with systemic sclerosis (SSc) often develop interstitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). The effect of ILD and PAH on healthcare costs among patients with SSc is not well described. The objective of this analysis was to describe healthcare costs in patients with newly diagnosed SSc and SSc patients newly diagnosed with ILD and/or PAH in the United States.Methods.This retrospective cohort analysis was conducted in the Truven Health MarketScan Commercial and Medicare Supplemental healthcare claims databases from 2003 to 2014. Based on International Classification of Diseases-9-Clinical Modification diagnosis codes on medical claims, patients were classified into 3 groups: incident SSc, SSc with incident ILD (SSc-ILD), and SSc with incident PAH (SSc-PAH). Patients were required to have continuous enrollment for 5 years to measure all-cause healthcare costs. Costs (adjusted to US$) were reported overall and by service type and year following diagnosis. Because of the overlap between groups, statistical comparisons were not conducted.Results.There were 1957 patients with incident SSc, 219 with incident SSc-ILD, and 108 patients with incident SSc-PAH. Average (mean ± SD) all-cause healthcare costs over followup were higher for patients with incident SSc-ILD ($191,107 ± $322,193) or patients with incident SSc-PAH ($254,425 ± $240,497), compared to patients with incident SSc ($101,839 ± $167,155). Average annual costs over the 5-year period ranged from $18,513 to $23,268 for patients with incident SSc, from $31,285 to $55,446 for patients with incident SSc-ILD, and from $44,454 to $63,320 for patients with incident SSc-PAH. Costs tended to be the highest in the fifth year of followup.Conclusion.Among patients with SSc, ILD and PAH can result in substantial increases in healthcare costs.

Jennie H Best,1 Amanda M Kong,2 David M Smith,2 Ibrahim Abbass,1 Margaret Michalska1 1Genentech, Inc., South San Francisco, CA, USA; 2IBM Watson Health, Cambridge, MA, USACorrespondence: Jennie H BestGenentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USATel +1 858 361-4937Email best.jennie@gene.comObjective: To quantify the healthcare expenditures associated with potential oral glucocorticoid (OGC)-related adverse events (AEs) in patients with giant cell arteritis (GCA).Methods: Patients with GCA and ≥ 1 OGC prescription fill between 2009 and 2014 were identified from the MarketScan Commercial and Medicare Supplemental claims databases. Patients were stratified into four groups based on cumulative OGC dose (> 0 to ≤ 2607 mg, > 2607 to ≤ 4800 mg, > 4800 to ≤ 7200 mg, and > 7200 mg) during the 1-year follow-up period; incidence of potential AEs and AE-related direct healthcare costs in USD were assessed. Association between the log of cumulative OGC dose and AE-related direct healthcare costs was evaluated, adjusting for baseline characteristics.Results: Of 1602 patients with GCA included, 69% were women; the mean age was 73 years. The mean cumulative OGC dose was 5806 mg during the 1-year follow-up; most exposure occurred in the first 6 months. The proportion of patients with potential OGC-related AEs was 36.5% overall and increased as cumulative dose increased (30.7%–45.3% across dose groups). Unadjusted mean AE-related costs for patients with an AE was USD $12,818. In the multivariable model including all patients, increasing OGC dose was associated with increasing AE-related healthcare costs (cost ratio, 1.38 [95% CI, 1.16–1.64] per 1-unit increase in log of cumulative OGC dose [P < 0.001]). Mean (median)-predicted AE costs for the dose groups were USD $4389 ($2749) for > 0 to ≤ 2607 mg, USD $5176 ($3009) for > 2607 to ≤ 4800 mg, USD $5576 ($3633) for > 4800 to ≤ 7200 mg, and USD $6609 ($4447) for > 7200 mg.Conclusion: In patients with GCA, OGC-related AEs increased with increasing cumulative OGC dose, resulting in increased healthcare costs. These results highlight the need for efficacious therapies that reduce the exposure to and potential risks associated with OGCs.Keywords: giant cell arteritis, glucocorticoid, adverse events, healthcare expenditures