Obesity and metabolic syndrome in patients with heart failure with preserved ejection fraction: a cross-sectional analysis of the Veradigm Cardiology Registry.

BACKGROUND: The proportion of heart failure patients with preserved ejection fraction has been rising over the past decades and has coincided with increases in the prevalence of obesity and metabolic syndrome. The relationship between these interconnected comorbidities and heart failure with preserved ejection fraction (HFpEF) is still poorly understood. This study characterized obesity and metabolic syndrome among real-world patients with HFpEF. METHODS: We identified adults with heart failure in the Veradigm Cardiology Registry, previously the PINNACLE Registry, with a left ventricular ejection fraction measurement ≥ 50% between 01/01/2016 and 12/31/2019. Patients were stratified by obesity diagnosis and presence of metabolic syndrome (≥ 3 of the following: diabetes, hypertension, hyperlipidemia, and obesity). We captured baseline demographic and clinical characteristics and used multivariable logistic regression to examine the odds of having cardiac (atrial fibrillation, coronary artery disease, coronary artery bypass surgery, myocardial infarction, and stroke/transient ischemic attack) and non-cardiac (chronic kidney disease, chronic liver disease, and peripheral artery disease) comorbidities of interest. The models adjusted for age and sex, and the main covariates of interest were obesity and metabolic burden score (0-3 based on the presence of diabetes, hypertension, and hyperlipidemia). The models were run with and without an obesity*metabolic burden score interaction term. RESULTS: This study included 264,571 patients with HFpEF, of whom 55.7% had obesity, 52.5% had metabolic syndrome, 42.5% had both, and 34.3% had neither. After adjusting for age, sex, and burden of other metabolic syndrome-associated diagnoses, patients with HFpEF with obesity had lower odds of a diagnosis of other evaluated comorbidities relative to patients without obesity. The presence of metabolic syndrome in HFpEF appears to increase comorbidity burden as each additional metabolic syndrome-associated diagnosis was associated with higher odds of assessed comorbidities except atrial fibrillation. CONCLUSION: Obesity was common among patients with HFpEF and not always co-occurring with metabolic syndrome. Multivariable analysis suggested that patients with obesity may develop HFpEF in the absence of other driving factors such as cardiovascular disease or metabolic syndrome.

Relative Effectiveness of the MF59®-Adjuvanted Influenza Vaccine Versus High-Dose and Non-Adjuvanted Influenza Vaccines in Preventing Cardiorespiratory Hospitalizations During the 2019-2020 US Influenza Season.

BACKGROUND: Adults ≥ 65 years of age have suboptimal influenza vaccination responses compared to younger adults due to age-related immunosenescence. Two vaccines were specifically developed to enhance protection: MF59-adjuvanted trivalent influenza vaccine (aIIV3) and high-dose egg-based trivalent influenza vaccine (HD-IIV3e). METHODS: In a retrospective cohort study conducted using US electronic medical records linked to claims data during the 2019-2020 influenza season, we compared the relative vaccine effectiveness (rVE) of aIIV3 with HD-IIV3e and a standard-dose non-adjuvanted egg-based quadrivalent inactivated influenza vaccine (IIV4e) for the prevention of cardiorespiratory hospitalizations, including influenza hospitalizations. We evaluated outcomes in the "any" diagnosis position and the "admitting" position on the claim. A doubly robust methodology using inverse probability of treatment weighting and logistic regression was used to adjust for covariate imbalance. rVE was calculated as 100 * (1 - ORadjusted). RESULTS: The study included 4,299,594 adults ≥ 65 years of age who received aIIV3, HD-IIV3e, or IIV4e. Overall, aIIV3 was associated with lower proportions of cardiorespiratory hospitalizations with diagnoses in any position compared to HD-IIV3e (rVE = 3.9% [95% CI, 2.7-5.0]) or IIV4e (9.0% [95% CI, 7.7-10.4]). Specifically, aIIV3 was more effective compared with HD-IIV3e and IIV4e in preventing influenza hospitalizations (HD-IIV3e: 9.7% [95% CI, 1.9-17.0]; IIV4e: 25.3% [95% CI, 17.7-32.2]). Consistent trends were observed for admitting diagnoses. CONCLUSION: Relative to both HD-IIV3e and IIV4e, aIIV3 provided improved protection from cardiorespiratory or influenza hospitalizations.

Comparison of COVID-19 and Influenza-Related Outcomes in the United States during Fall-Winter 2022-2023: A Cross-Sectional Retrospective Study.

Influenza and COVID-19 contribute significantly to the infectious disease burden during the respiratory season, but their relative burden remains unknown. This study characterizes the frequency and severity of medically attended COVID-19 and influenza during the peak of the 2022-2023 influenza season in the pediatric, adult, and older adult populations and characterizes the prevalence of underlying conditions among patients hospitalized with COVID-19. This cross-sectional analysis included individuals in the Veradigm EHR Database linked to Komodo claims data with a medical encounter between 1 October 2022 and 31 March 2023 (study period). Patients with medical encounters were identified with a diagnosis of COVID-19 or influenza during the study period and stratified based on the highest level of care received with that diagnosis. Among 23,526,196 individuals, there were more COVID-19-related medical encounters than influenza-related encounters, overall and by outcome. Hospitalizations with COVID-19 were more common than hospitalizations with influenza overall (incidence ratio = 4.6) and in all age groups. Nearly all adults hospitalized with COVID-19 had at least one underlying medical condition, but 37.1% of 0-5-year-olds and 25.0% of 6-17-year-olds had no underlying medical conditions. COVID-19 was associated greater burden than influenza during the peak of the 2022-2023 influenza season.

A Linked Electronic Medical Record-Claims Analysis of the Clinical and Economic Outcomes of Patients Coded for Erosive Esophagitis in the United States.

INTRODUCTION: Erosive esophagitis (EE) is a severe form of gastroesophageal reflux disease commonly treated with proton pump inhibitors (PPIs). The aim of this retrospective, observational cohort study was to describe the characteristics and healthcare burden of patients with EE. METHODS: We identified adults in the USA with an EE diagnosis between January  1, 2016 and February 28, 2019 in a linked dataset containing electronic health records (EHR) from the Veradigm Network EHR and claims data from Komodo Health. Patients were required to have 1 year of baseline data and 3 years of follow-up data. Patients were stratified by the number of PPI lines of therapy (LOT) during the 4-year study period. We descriptively captured patient characteristics and treatment patterns, along with all-cause and EE-related healthcare utilization and costs. RESULTS: Among the 158,347 qualifying adults with EE, 71,958 (45.4%) had 1 PPI LOT, 14,985 (9.5%) had 2 LOTs, 15,129 (9.6%) had 3+ LOTs, and 56,275 (35.5%) did not fill a PPI prescription. Omeprazole and pantoprazole comprised more than 70% of any LOT, with patients commonly switching between the two. Mean (standard deviation) annualized all-cause and EE-related healthcare costs in the follow-up period were $16,853 ($70,507) and $523 ($3659), respectively. Both all-cause and EE-related healthcare costs increased with LOTs. CONCLUSIONS: Patients with EE are commonly treated with prescription PPIs; however, 19.0% of patients cycled through multiple PPIs. Higher PPI use was associated with a higher comorbidity burden and higher healthcare costs compared to 0 PPI use.

The incremental cost of non-alcoholic steatohepatitis and type 2 diabetes in the United States using real-world data.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) and type 2 diabetes (T2D) are both linked to substantial healthcare costs and are often co-occurring. We aim to quantify the incremental cost of NASH and T2D using real-world data. METHODS: Adults (≥18 years old) with ≥2 diagnosis codes for NASH and/or ≥2 diagnosis codes for T2D between 1/1/2016 and 12/31/2021 and ≥24 months of continuous claims enrollment (study period) were identified in electronic health records or claims in the Veradigm Integrated Dataset. Patients were stratified into 3 cohorts: NASH-only, T2D-only, and NASH + T2D. We calculated annualized costs for the 24-month study period and fit a generalized linear model (excluding the most expensive 1%) that controlled for disease cohort, age, sex, and modified Charlson comorbidity index to estimate the per year all-cause healthcare costs and incremental cost of adding T2D to a NASH diagnosis (or vice versa). RESULTS: We identified 23,111 patients diagnosed with NASH-only, 3,548,786 patients with T2D-only, and 30,339 patients with NASH + T2D. The model-predicted mean costs per year were $7,668 for patients with NASH-only, $11,226 for patients with T2D-only, and $16,812 for patients with NASH + T2D. The incremental increase in costs per year of adding T2D to NASH was 63% (+$4,846), and the incremental increase in costs per year of adding NASH to T2D was 42% (+$4,692). CONCLUSIONS: Both NASH and T2D contribute to the high healthcare costs among patients with a dual diagnosis. Results from our analysis indicate that NASH comprises a high portion of total healthcare costs among patients with NASH and T2D.

Healthcare costs among patients with newly diagnosed helicobacter pylori infection in the United States: a linked claims-EHR study.

AIMS: The study objectives were to 1) characterize the cost drivers of patients with Helicobacter pylori (HP) and 2) estimate HP-related cost savings following lab-confirmed HP eradication with US guideline-recommended treatment compared to failed eradication. METHODS: We identified adults newly diagnosed with HP between 1/1/2016-12/31/2019 in the Veradigm Electronic Health Record Database linked to claims data (earliest HP diagnosis = index date). For the overall costs analysis, we required patients to have data available for ≥12 months before and after the index date. Then, we used multivariable modeling to assess the marginal effects of comorbidities on all cause-healthcare costs in the 12 months following HP diagnosis. For the eradication savings analysis, we identified patients with ≥1 HP eradication regimen, a subsequent HP lab test result, and ≥1 year of data after the test result. Then we used multivariable modeling to estimate HP-related cost while adjusting for eradication status, demographics, post-testing HP-related clinical variables, and the interactions between eradication status and each HP-related clinical variable. RESULTS: The overall cost analysis included 60,593 patients with HP (mean age 54.2 years, 65.5% female). Mean (SD) 12-month unadjusted all-cause costs were $23,693 ($78,089). Rare comorbidities demonstrated the highest marginal effect. The marginal effects of gastric cancer and PUD were $15,705 and $7,323, respectively. In the eradication savings analysis, 1,835 (80.0%) of the 2295 patients had lab test-confirmed HP eradication. Compared to failed eradication, there were significant one-year cost savings among patients with successful HP eradication and select conditions: $1,770 for PUD, $518 for atrophic gastritis, $494 for functional dyspepsia, and $352 for gastritis. CONCLUSIONS: The healthcare costs of patients with HP are partially confounded by their burden of high-cost comorbidities. In the subset of patients with available results, confirmed vs. failed eradication of HP was associated with short-term cost offsets among those with specific to HP-related sequelae.

Helicobacter pylori (HP) is a common infection. We aimed to better understand healthcare costs for people infected with HP. Specifically, we were interested in 1) investigating whether complications from HP were causing high costs. 2) whether successful eradication of HP would lead to lower healthcare costs. We captured data on adults diagnosed with HP between 2016 and 2019. The data used in this study came from medical records and insurance bills. In the first part of the study, we found that patients with HP often have other health issues, and these other health issues were driving high healthcare costs. The majority of cost savings associated with HP eradication accrue from the prevention of potential complications of long-term infection, such as peptic ulcer disease and, rarely, gastric cancer.

Relative Effectiveness of the Cell-Based Quadrivalent Influenza Vaccine in Preventing Cardiorespiratory Hospitalizations in Adults Aged 18-64 Years During the 2019-2020 US Influenza Season.

Background: The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) has advantages over egg-based quadrivalent inactivated influenza vaccine (IIV4e), as production using cell-derived candidate viruses eliminates the opportunity for egg adaptation. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus IIV4e in preventing cardiorespiratory hospitalizations during the 2019-2020 US influenza season. Methods: We conducted a retrospective cohort study using electronic medical records linked to claims data of US individuals aged 18-64 years. We assessed rVE against cardiorespiratory hospitalizations and against subcategories of this outcome, including influenza, pneumonia, myocardial infarction and ischemic stroke, and respiratory hospitalizations. We used a doubly robust inverse probability of treatment weighting and logistic regression model to obtain odds ratios (ORs; odds of outcome among IIV4c recipients/odds of outcome among IIV4e recipients) adjusted for age, sex, race, ethnicity, geographic region, vaccination week, health status, frailty, and healthcare resource utilization. rVE was calculated as 100(1 - ORadjusted). Results: In total, 1 491 097 individuals (25.2%) received IIV4c, and 4 414 758 (74.8%) received IIV4e. IIV4c was associated with lower odds of cardiorespiratory (rVE, 2.5% [95% confidence interval, 0.9%-4.1%]), respiratory (3.7% [1.5%-5.8%]), and influenza (9.3% [0.4%-17.3%]) hospitalizations among adults 18-64 years of age. No difference was observed for the other outcomes. Conclusions: This real-world study conducted for the 2019-2020 season demonstrated that vaccination with IIV4c was associated with fewer cardiorespiratory, respiratory, and influenza hospitalizations compared with IIV4e.

Long COVID Incidence in a Large US Ambulatory Electronic Health Record System.

Estimates of the prevalence of long-term symptoms of coronavirus disease 2019 (COVID-19), referred to as long COVID, vary widely. This retrospective cohort study describes the incidence of long COVID symptoms 12-20 weeks postdiagnosis in a US ambulatory care setting and identifies potential risk factors. We identified patients with and without a diagnosis of or positive test for COVID-19 between January 1, 2020, and March 13, 2022, in the Veradigm (Veradigm LLC, Chicago, Illinois) electronic health record database. We captured data on patient demographic characteristics, clinical characteristics, and COVID-19 comorbidity in the 12-month baseline period. We compared long COVID symptoms between matched cases and controls 12-20 weeks after the index date (COVID-19 diagnosis date (cases) or median visit date (controls)). Multivariable logistic regression was used to examine associations between baseline COVID-19 comorbid conditions and long COVID symptoms. Among 916,894 patients with COVID-19, 14.8% had at least 1 long COVID symptom in the 12-20 weeks postindex as compared with 2.9% of patients without documented COVID-19. Commonly reported symptoms were joint stiffness (4.5%), cough (3.0%), and fatigue (2.7%). Among patients with COVID-19, the adjusted odds of long COVID symptoms were significantly higher among patients with a baseline COVID-19 comorbid condition (odds ratio = 1.91, 95% confidence interval: 1.88, 1.95). In particular, prior diagnosis of cognitive disorder, transient ischemic attack, hypertension, or obesity was associated with higher odds of long COVID symptoms.

Healthcare resource utilization and costs of care in the United States for patients with non-alcoholic steatohepatitis.

AIMS: This retrospective, observational cohort study aimed to determine the burden of comorbidities, hospitalization, and healthcare costs among patients with non-alcoholic steatohepatitis (NASH) in the United States stratified by fibrosis-4 (FIB-4) or body mass index (BMI). METHODS: Adults with NASH were identified in the Veradigm Health Insights Electronic Health Record Database and linked Komodo claims data. The index date was the earliest coded NASH diagnosis between 1 January 2016 and 31 December 2020 with valid FIB-4 and ≥6 months of database activity and continuous enrollment pre- and post-index. We excluded patients with viral hepatitis, alcohol-use disorder, or alcoholic liver disease. Patients were stratified by FIB-4: FIB-4 ≤ 0.95, 0.95 < FIB-4 ≤ 2.67, 2.67 < FIB-4 ≤ 4.12, FIB-4 > 4.12) or BMI (BMI <25, 25 ≤ BMI ≤30, BMI > 30). Multivariate analysis was used to assess the relationship of FIB-4 with costs and hospitalizations. RESULTS: Among 6,743 qualifying patients, index FIB-4 was ≤0.95 for 2,345 patents, 0.95-2.67 for 3,289 patients, 2.67-4.12 for 571 patients, and >4.12 for 538 patients (mean age 55.8 years; 62.9% female). Mean age, comorbidity burden, cardiovascular disease risk, and healthcare utilization increased with increasing FIB-4. Mean ± SD annual costs increased from $16,744±$53,810 to $34,667±$67,691 between the lowest and highest FIB-4 cohorts and were higher among patients with BMI <25 ($24,568±$81,250) than BMI >30 ($21,542±$61,490). A one-unit increase in FIB-4 at index was associated with a 3.4% (95%CI: 1.7%-5.2%) increase in mean total annual cost and an 11.6% (95%CI: 8.0%-15.3%) increased likelihood of hospitalization. CONCLUSIONS: A higher FIB-4 was associated with increased healthcare costs and risk of hospitalization in adults with NASH; however, even patients with FIB-4 ≤ 0.95 presented a significant burden.

Diagnosis and treatment patterns among patients with newly diagnosed Helicobacter pylori infection in the United States 2016-2019.

Approximately 36% of the United States (US) population is infected with Helicobacter pylori (HP), a known major risk factor for peptic ulcer disease and gastric cancer. HP eradication reduces the rate of complications; however, the benefits are undermined by rising rates of HP eradication treatment failure. This real-world observational cohort analysis aims to describe HP diagnostic and treatment patterns among insured patients in the US. Using diagnoses, lab results, and treatment patterns, we identified adults (18+) with new diagnoses of HP in the Veradigm Health Insights EHR Database linked to Komodo claims data (1/1/2016-12/31/2019). Patients were required to have ≥ 12 months of data pre-/post-index. We captured patient characteristics, HP-related diagnostic testing, and the use of US guideline-recommended HP eradication regimens. HP eradication rates following first-line eradication treatment were measured among patients with available lab results. Overall, 31.8% of the 60,593 included patients did not receive guideline-recommended treatment. Among the 68.2% (41,340) with first-line treatment, 80.2% received clarithromycin-based triple therapy, and 6.6% received bismuth quadruple therapy. Of the 4569 patients with a repeated course of eradication therapy, 53.4% received the same regimen as their first-line, the majority (90.7%) of whom received two rounds of clarithromycin-based triple therapy. Among the 2455 patients with results of HP non-serology testing following first-line treatment, the 180-day eradication rate was 80.2% overall, with differences based on treatments and demographics. This study highlights gaps between guideline-recommended HP management and real-world patterns, underscoring the need to improve HP testing, treatment, and follow-up practices.

Relative Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines in Adults During the 2019-2020 Influenza Season in the United States.

Background: Mutations occurring during egg-based influenza vaccine production may affect vaccine effectiveness. The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) demonstrated improved protection relative to egg-based vaccines in prior seasons. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus standard-dose egg-based quadrivalent inactivated influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRMEs) in the 2019-2020 US influenza season. Methods: This retrospective cohort study was conducted using a dataset linking electronic medical records with medical and pharmacy claims data among individuals ≥18 years vaccinated with IIV4c or IIV4e during 2019-2020. A doubly robust inverse probability of treatment weighting model was used to obtain odds ratios (ORs) adjusted for age, sex, race, ethnicity, region, vaccination week, health status, frailty, and baseline healthcare resource utilization. rVE was calculated by (1 - OR) × 100. An exploratory analysis evaluated IRMEs in inpatient and outpatient settings separately. Results: The final study cohort included 1 499 215 IIV4c and 4 126 263 IIV4e recipients ≥18 years of age. Fewer IRMEs were reported in individuals with recorded IIV4c versus IIV4e. The rVE for IIV4c versus IIIV4e for any IRME was 9.5% (95% confidence interval [CI], 7.9%-11.1%). Inpatient and outpatient rVEs were 5.7% (95% CI, 2.1%-9.2%) and 11.4% (95% CI, 9.5%-13.3%), respectively. In age subgroup analyses, rVEs favored IIV4c except in adults aged ≥65 years. Conclusions: Adults vaccinated with IIV4c had a lower risk of IRMEs versus IIV4e recipients in the 2019-2020 US influenza season. These results support IIV4c as a potentially more effective public health measure against influenza than egg-based vaccines.

Annual costs among patients with major depressive disorder and the impact of key clinical events.

BACKGROUND: The economic burden of major depressive disorder (MDD) is substantial and increasing; however, the impact of key clinical events (eg, hospitalization, suicide attempt/ideation, and treatment changes) on health care resource use and costs are less established. OBJECTIVE: To evaluate the health care utilization and costs among patients with MDD, particularly for those with key clinical events. METHODS: In this retrospective analysis, administrative health care claims from the IBM MarketScan Commercial Claims and Encounters Database were used to identify adults with a new diagnosis of MDD (January 1, 2009, to December 31, 2017). Patients with 12 months or more of continuous health care coverage before and after the initial medical claim with an MDD diagnosis (index date) and 1 or more pharmacy claims for an antidepressant within 60 days of any qualifying medical claim were included. The effect of post-index date key clinical events (eg, treatment changes, moderate to severe MDD, MDD-related emergency department [ED] visits, MDD-related hospitalizations, suicide attempt/ideation, severe mental health disorder, use of brain stimulation therapies) on all-cause total costs was assessed. Actual allcause costs were summarized descriptively and reported per patient per year (PPPY). Multivariable analyses compared differences in all-cause costs during follow-up, depending on whether patients experienced a key clinical event. RESULTS: A total of 455,082 patients met eligibility criteria. The average age was 41 years and 64% of patients were female. Mean (SD) all-cause PPPY costs during the follow-up period were $10,074 ($25,694). The most common key clinical events were treatment changes, moderate to severe MDD diagnosis, and MDD-related ED visits. The majority of patients (90.1%) experienced at least 1 treatment change, which was most commonly treatment discontinuation. Generally, mean costs for up to 90 days following an event were higher than those preceding the event. In multivariable analyses, patients with any key clinical events had 51% higher PPPY allcause health care costs compared with those who did not have any key clinical events. Compared with patients without key clinical events, follow-up costs were more than 2 times higher among patients with severe mental health disorder, MDD-related hospitalization, and suicide attempt/ideation. The most impactful key clinical event was treatment with electroconvulsive therapy, vagal nerve stimulation, or transcranial magnetic stimulation, in which patients incurred 4.3 times higher follow-up costs than those who did not receive one of these treatments. CONCLUSIONS: Key clinical events exacerbate health care resource use and costs among patients with MDD. Effective therapeutic regimens initiated optimally in the course of treatment may mitigate costly clinical events associated with MDD. DISCLOSURES: This study was sponsored by Allergan plc (prior to its acquisition by AbbVie). The sponsor was involved in the study design, data collection, data analysis, manuscript preparation, and publication decisions. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Dr Cutler is a consultant for AbbVie, Acadia Pharmaceuticals, Akili Interactive, Alfasigma, Alkermes, Allergan (now AbbVie), Avanir, BioXcel Therapeutics, BlackThorn Therapeutics, Intra-Cellular Therapies, Ironshore, Janssen, Karuna Therapeutics, Lundbeck, Neurocrine Biosciences, Noven, Otsuka, Sage Therapeutics, Sunovion, Supernus Pharmaceuticals, Takeda, Teva and Tris Pharma; has received speaker/promotional honoraria from AbbVie, Acadia Pharmaceuticals, Alfasigma, Alkermes, Allergan, Avanir, Intra-Cellular Therapies, Ironshore, Janssen, Lundbeck, Neurocrine Biosciences, Noven, Otsuka, Sunovion, Takeda, Teva, and Tris Pharma; and has received research grants from Aevi Genomics, Akili Interactive, Alkermes, Allergan (now AbbVie), Arbor Pharmaceuticals, Biohaven, Ironshore, KemPharm, Lilly, Lundbeck, Neos Therapeutics, Novartis, Otsuka, Purdue Canada, Sunovion, Supernus Pharmaceuticals, Takeda and Tris Pharma. Drs Keyloun and Gillard are AbbVie employees and may hold stock. Dr Higa was an employee of AbbVie at the time of the study and may hold stock. Ms Park is an employee of Merative, formerly IBM Watson Health, which received funding from Allergan (prior to its acquisition by AbbVie) to conduct this analysis. Dr Bonafede was an employee of IBM Watson Health, now Merative, which received funding from Allergan (prior to its acquisition by AbbVie) to conduct this analysis. Dr Jain has served as a consultant to Addrenex, Allergan (now AbbVie), Avanir, Janssen, Lilly, Lundbeck, Merck, Neos Therapeutics, Neurocrine Biosciences, Otsuka, Pamlab, Pfizer, Shionogi, Shire, Sunovion, Supernus, Takeda, and Teva; has been a paid speaker for Addrenex, Alkermes, Allergan (now AbbVie), Lilly, Lundbeck, Merck, Neos Therapeutics, Otsuka, Pamlab, Pfizer, Rhodes, Shionogi, Shire, Sunovion, Takeda, and Tris Pharmaceuticals; has received research support from Allergan (now AbbVie), AstraZeneca, Lilly, Lundbeck, Otsuka, Pfizer, Shire, and Takeda; and has served on the advisory boards for Addrenex, Alkermes, Avanir, Forum, Janssen, Lilly, Lundbeck, Merck, Neos Therapeutics, Neurocrine Biosciences, Otsuka, Pamlab, Pfizer, Shionogi, Shire, Sunovion, Supernus, Takeda, and Teva.

Relative Effectiveness of Cell-based Versus Egg-based Quadrivalent Influenza Vaccines in Children and Adolescents in the United States During the 2019-2020 Influenza Season.

BACKGROUND: Egg-based influenza vaccine production can lead to the accumulation of mutations that affect antigenicity. The mammalian cell-based inactivated quadrivalent influenza vaccine (IIV4c) may improve effectiveness compared with egg-based vaccines. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus egg-based inactivated quadrivalent influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRME) among children and adolescents during the 2019-2020 US influenza season. METHODS: This retrospective cohort study used a dataset linking primary and specialty care electronic medical records with medical and pharmacy claims data from US residents 4 through 17 years of age vaccinated with IIV4c or IIV4e during the 2019-2020 influenza season. Odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, region, index week, health status and two proxy variables for healthcare accessibility and use. Adjusted rVE was estimated by (1-OR adjusted )*100, and an exploratory analysis evaluated IRMEs separately for outpatient and inpatient settings. RESULTS: The final study cohort included 60,480 (IIV4c) and 1,240,990 (IIV4e) vaccine recipients. Fewer IRMEs were reported in subjects vaccinated with IIV4c than IIV4e. The rVE for IIV4c versus IIV4e was 12.2% [95% confidence interval (CI): 7.5-16.6] for any IRME and 14.3% (9.3-19.0) for outpatient IRMEs. Inpatient IRMEs were much less frequent, and effectiveness estimates were around the null. CONCLUSIONS: Fewer IRMEs occurred in pediatric subjects vaccinated with IIV4c versus IIV4e. These results support the greater effectiveness of IIV4c over IIV4e in this population during the 2019-2020 US influenza season.

Real-world disease-modifying therapy pathways from administrative claims data in patients with multiple sclerosis.

BACKGROUND: Over a dozen disease-modifying therapies (DMTs) have been approved for treatment of multiple sclerosis (MS). Treatment guidelines focus on when to initiate, change, and discontinue treatment but provide little guidance on how to select or sequence DMTs. This study assessed sequencing patterns of DMTs in patients with newly diagnosed MS. METHODS: Adults newly diagnosed with MS in the United States were identified from January 2007 to October 2017 using IBM MarketScan database. Patients had ≥12 months of continuous enrollment prior to diagnosis and ≥ 2 years of follow-up. Treatment pathways consisting of up to 3 DMT courses were reported, and each treatment course ended with discontinuation, switch, or end of follow-up. RESULTS: In total, 14,627 MS patients were treated with DMTs and had ≥2 years of follow-up. More than 400 DMT treatment pathways were observed. Glatiramer acetate was the most common DMT; 40% of patients initiated this treatment. Among these, 51.3% had 2 DMT courses during follow-up and 26.5% had 3 DMT courses. Approximately 70% of patients switched or discontinued their initial DMT, and rates of switch and discontinuation differed by initial DMT. Injectable DMTs were used most commonly over the study period (87.5% as first course to 66.6% as third course). Oral DMTs were more common as second or third treatment courses (29.9% and 31.8%, respectively). CONCLUSIONS: A wide variety in treatment patterns were observed among patients newly diagnosed with MS. Further examination of DMT prescribing practices is needed to understand the reasons behind treatment discontinuation and treatment cycling.

Treatment Patterns During Major Depressive Episodes Among Patients with Major Depressive Disorder: A Retrospective Database Analysis.

BACKGROUND: Major depressive disorder, a highly prevalent mental health condition, can be challenging to treat. OBJECTIVE: We aimed to characterize treatment patterns within and across multiple major depressive episodes in patients receiving treatment for major depressive disorder. METHODS: Adults with newly diagnosed major depressive disorder and one or more major depressive episodes were identified using the IBM® MarketScan® Commercial database. Eligible patients had 12 months of continuous enrollment before and after diagnosis. Lines of therapy were periods of continuous treatment with one or more antidepressant claims. Antidepressant, atypical antipsychotic, or mood stabilizer regimens as monotherapy or adjunctive therapy were characterized by lines of therapy and major depressive episodes. Descriptive analyses were performed. RESULTS: A total of 455,082 patients were included in the analysis. The majority of treatment regimens were monotherapy, which decreased with subsequent lines of therapy, while adjunctive treatments increased with subsequent lines of therapy. There were 1860 unique adjunctive regimens identified. Of the 40,315 patients (9%) who received adjunctive therapy, 8024 (20%; 2% of all patients) received atypical antipsychotic-adjunctive regimens. Only 19% of patients treated with atypical antipsychotic-adjunctive therapy discontinued treatment versus 42% of monotherapy-treated patients. On average, patients who received an adjunctive atypical antipsychotic received it as their third line of therapy and approximately 400 days after the initial antidepressant treatment. CONCLUSIONS: In this study, many patients continued monotherapy major depressive disorder regimens and experienced multiple treatment changes. Few patients were treated with adjunctive therapy. These results suggest underutilization of potentially effective treatments, which represents an opportunity to optimize the treatment of patients with major depressive disorder.

Relative Effectiveness of MF59 Adjuvanted Trivalent Influenza Vaccine vs Nonadjuvanted Vaccines During the 2019-2020 Influenza Season.

Background: Age-related immunosenescence may impair the immune response to vaccination in older adults. Adjuvanted influenza vaccines are designed to overcome immune senescence in older adults. This study estimated the relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) vs egg-derived quadrivalent inactivated influenza vaccine (IIV4e) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) in preventing influenza-related medical encounters in the 2019-2020 US season. Methods: This retrospective cohort study used electronic medical records linked to pharmacy and medical claims data. The study population included adults age ≥65 years with a record of aIIV3, IIV4e, or HD-IIV3 vaccination. A doubly robust inverse probability of treatment weighting model was used to derive adjusted odds ratios (ORs). rVE was calculated by (1 - ORadjusted)*100 and was determined overall and separately for age subgroups. An exploratory analysis evaluated the outcome separately in inpatient and outpatient settings. Results: Subjects received aIIV3 (n = 936 508), IIV3e (n = 651 034), and HD-IIV3 (n = 1 813 819), and influenza-related medical encounters were recorded in 0.5%, 0.9%, and 0.7% of each cohort, respectively. Overall, the rVE of aIIV3 was 27.5% (95% CI, 24.4% to 30.5%) vs IIV4e and 13.9% (95% CI, 10.7% to 17.0%) vs HD-IIV3. aIIV3 had a more favorable rVE in inpatient and outpatient settings. Findings remained consistent across age subgroups and during alternative seasonal dates. Conclusions: Adults age ≥65 years vaccinated with aIIV3 had fewer influenza-related medical encounters compared with IIV4e or HD-IIV3 during the 2019-2020 US influenza season.

Healthcare utilization and cost of cancer-related care prior to allogeneic hematopoietic cell transplantation for hematologic malignancies in the US: a retrospective real-world analysis.

BACKGROUND: Hematopoietic cell transplantation (HCT) is a potentially curative therapy as well as a costly procedure. Published studies have examined the cost of HCT in the US and the complications that follow but little is known about the cancer-related healthcare costs and resource utilization prior to the procedure and none of the studies have examined the variability in cost based on the type of hematologic malignancy involved. The aim of this study was to estimate mean cancer-related costs and resources incurred before the HCT is performed from the time the hematologic malignancy first develops. METHODS: The IBM® MarketScan® Research Databases were used to identify adult patients ≥18 years of age with commercial or Medicare supplemental insurance who had undergone allogeneic HCT for hematologic malignancies from January 1, 2008 to December 31, 2017. Healthcare utilization and costs were assessed during the 6 months prior to diagnosis (pre-diagnostic period) and the follow-up period from diagnosis just prior to the HCT (pre-HCT period). Multivariable regression models were constructed to estimate total all-cause costs and cancer-related costs as well as healthcare utilization by type in each time period. RESULTS: A total of 2663 commercially insured patients and 266 with Medicare supplemental insurance were included in the study population. The mean-adjusted incremental cancer-related costs for commercially insured patients was $399,011 in the overall observation period including the pre-diagnostic and pre-HCT periods combined, 9% of which was incurred in the pre-diagnostic period. The corresponding mean-adjusted incremental cancer-related costs for Medicare supplemental patients was $195,575 for the same time period but the patterns of healthcare utilization were similar to the commercially insured population. Inpatient care accounted for approximately one-half the cost in both patient populations. By type of hematologic malignancy, costs were lowest for myeloproliferative disorders ($211,561) and highest for acute lymphocytic leukemia ($462,072) in the commercially insured population. CONCLUSION: This study demonstrates that overall patients with hematologic malignancies requiring HCT have considerable cancer-related healthcare resource utilization and costs leading up to HCT compared to the period of time prior to developing cancer.

The direct and indirect costs of adult atopic dermatitis.

BACKGROUND: Atopic dermatitis is considered a childhood illness, and the direct and indirect health care burden of atopic dermatitis in adults is not fully understood. OBJECTIVE: To measure the direct and indirect costs of atopic dermatitis among adults in 2018. METHODS: This retrospective cohort study compared commercial and Medicare-insured adults with atopic dermatitis in 2018 with directly matched (1:3) adults without atopic dermatitis. Atopic dermatitis prevalence was reported. Health care utilization, direct health care costs, and work loss data were compared between cohorts. This analysis was repeated for adults with atopic dermatitis in 2016 and 2017. RESULTS: 31,164 adults with atopic dermatitis in 2018 were identified and directly matched (1:3) to controls. Adults with atopic dermatitis had greater utilization of outpatient services, outpatient pharmacy services, and short-term disability benefits than controls. Unadjusted annual health care costs in 2018 were $4,979 higher for adults with atopic dermatitis ($14,603) than for the matched controls ($9,624), driven by outpatient services and pharmacy. Findings were supported by analyses of adults from 2016 and 2017 and multivariable analyses. One limitation of this study was that patients with mild cases of atopic dermatitis may not seek medical treatment and may be underrepresented in the study cohort. CONCLUSIONS: The direct health care and indirect (short-term disability) health care costs of atopic dermatitis present a significant health care burden among the adult population. DISCLOSURES: This study was funded by Eli Lilly and Company. Employees of Eli Lilly were involved in the planning, execution, and interpretation of the study. Pierce is employed by Eli Lilly and Company. Boytsov and Goldblum were employed by Eli Lilly and Company Health at the time this research was conducted. Manjelievskaia and Brouillette are employed by IBM Watson Health, which received funding from Eli Lilly and Company to conduct this study. Bonafede and Onyekwere were employed at IBM Watson Health at the time this research was conducted.

Healthcare resource utilization and costs among children with cystic fibrosis in the United States.

BACKGROUND: Adverse health impacts of cystic fibrosis (CF) can be present in children before respiratory complications are observed. Children with CF show progressive health decline, with increasing lung function decline in adolescence. This study aims to quantify the healthcare resource utilization (HCRU) and costs attributable to CF by comparing children with CF with the general pediatric population. METHODS: This retrospective, cross-sectional, observational study compared HCRU and costs among children with CF in the US with demographically similar children without CF (comparison group) over a 12-month period using administrative claims data spanning 2010-2017. Analyses were conducted by insurance type (commercially insured [COM] and Medicaid insured [MED]) and stratified by age (<2 years, 2 to <6 years, 6 to <12 years, and 12-17 years). RESULTS: Children with CF (2831 COM and 1896 MED) were matched to children in the comparison group (8493 COM and 5688 MED). Higher prevalence of comorbidities was seen in children with CF versus the comparison group across all ages. Across all ages, HCRU attributable to CF was substantial (higher hospitalization rates, more outpatient and emergency room visits, and greater use of prescription medications), and there were higher associated costs (all p values < .05), in COM and MED populations. HCRU and costs attributable to CF were highest for children aged 12-17 years. CONCLUSIONS: Substantial HCRU and costs are evident among children with CF across all ages, starting as young as infancy, with highest HCRU and costs among adolescents. Effective treatments from an early age are needed for children with CF.