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Ray, Markqayne, Elyse Swallow, Kavita Gandhi, Christopher Carley, Vanja Sikirica, Travis Wang, Nicolae Done, James Signorovitch, and Arash Mostaghimi. "Chronic Myeloid Leukemia: Part I—Real-World Treatment Patterns, Healthcare Resource Utilization, and Associated Costs in Later Lines of Therapy in the United States." Journal of Health Economics and Outcomes Research 9, no. 2 (July 29, 2022): 11–18. http://dx.doi.org/10.36469/jheor.2022.36229.
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Background: Alopecia areata (AA) is an autoimmune disease of hair loss affecting people of all ages. Alopecia totalis (AT) and universalis (AU) involve scalp and total body hair loss, respectively. AA significantly affects quality of life, but evidence on the economic burden in adolescents is limited. Objectives: To assess healthcare resource utilization (HCRU) and all-cause direct healthcare costs, including out-of-pocket (OOP) costs, of US adolescents with AA. Methods: IBM MarketScan® Commercial and Medicare databases were used to identify patients aged 12-17 years with ≥2 claims with AA/AT/AU diagnosis (prevalent cases), from October 1, 2015, to March 31, 2018, enrolled for ≥12 months before and after the first AA diagnosis (index). Patients were matched 1:3 to non-AA controls on index year, demographics, plan type, and Charlson Comorbidity Index. Per patient per year HCRU and costs were compared post-index. Results: Patients comprised 130 AT/AU adolescents and 1105 non-AT/AU adolescents (53.8% female; mean age, 14.6 years). Post-index, AT/AU vs controls had more outpatient (14.5 vs 7.1) and dermatologist (3.6 vs 0.3) visits, higher mean plan costs ($9397 vs $2267), including medical ($7480 vs $1780) and pharmacy ($1918 vs $487) costs, and higher OOP costs ($2081 vs $751) (all P<.001). The non-AT/AU cohort vs controls had more outpatient (11.6 vs 8.0) and dermatologist (3.4 vs 0.4) visits, higher mean plan costs ($7587 vs $4496), and higher OOP costs ($1579 vs $805) (all P<.001). Discussion: This large-sample, real-world analysis found that adolescents with prevalent AA had significantly higher HCRU and all-cause costs than matched controls. The greater burden was driven by more frequent outpatient visits, and higher payer medical and pharmacy costs in comparison with controls. Oral corticosteroid use was higher among patients with AT/AU; topical and injectable corticosteroid use was higher for non-AT/AU. Although the data preclude the identification of AA-attributable costs, the matched-control design allows an estimation of incremental all-cause costs associated with AA. Conclusions: Adolescents with AA incurred substantial incremental healthcare costs, with greater costs incurred among those with AT/AU. Study findings suggest that AA incurs costs as a medical condition with a high burden on adolescent patients and health plans.
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Stovall, R., E. Kersey, J. LI, R. Baker, C. Anastasiou, A. Palmowski, G. Schmajuk, L. S. Gensler, and J. Yazdany. "POS0665 INCIDENCE RATE AND FACTORS ASSOCIATED WITH FRACTURES AMONG ADULTS WITH ANKYLOSING SPONDYLITIS IN THE UNITED STATES." Annals of the Rheumatic Diseases 82, Suppl 1 (May 30, 2023): 612–13. http://dx.doi.org/10.1136/annrheumdis-2023-eular.1161.
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BackgroundAdults with ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis, are at a significantly increased risk of fracture relative to the general population. While some studies have evaluated the risk of fracture in AS, we do not have European or U.S. population-level studies assessing different fracture types performed within the last three decades.ObjectivesWe evaluated the incidence rate and factors associated with fractures among those with AS using linked data from the national U.S. Rheumatology Informatics System for Effectiveness (RISE) registry and Medicare claims.MethodsData were derived from RISE, a large, national electronic health record-based registry, which was linked to Medicare claims from 2016-2018. Patients were required to have at least two visits for AS with a rheumatology provider, ≥ 30 days apart, prior to the baseline period of the study and at least one Medicare claim. One year of baseline characteristics was collected from both RISE and Medicare claims. Subjects were considered to have a historical fracture (vs. an incident fracture) if a fracture occurred prior to the index date. Patients were followed over time for incident fractures after the index date. Fractures were defined by ICD codes. We examined all fractures, including those of the vertebrae, sternum/ribs, shoulder/clavicle/upper arm/elbow, distal forearm/wrist/hand, pelvis/hip/femur, knee/lower leg, and ankle/foot. First, we calculated the combined incidence of fracture and incidence by fracture type. Second, logistic regression models were constructed to identify factors associated with fracture, including age, sex, race or ethnic group, national area deprivation index, dual-eligibility for Medicare (healthcare for adults aged 65+ and some people with certain conditions/disabilities) and Medicaid (healthcare for those with limited income and resources), Charlson comorbidity index, body mass index, smoking status, osteoporosis diagnosis, historical fracture (fracture prior to index date), and use of glucocorticoids and opioids.ResultsWe identified 1,426 adults with AS in RISE who were also observable in Medicare. The mean (SD) age was 69.4 years (9.8), 44.3% were female, and 77.3% were non-Hispanic White. Fractures occurred in 197 AS adults (Table 1). The overall incidence rate of fractures among adults with AS was 76.7 (95% CI 66.4-88.6) per 1,000 person-years. The most common fracture was vertebral with an incidence rate of 23.9 per 1,000 person-years (95% CI 18.6-30.7), followed by distal forearm/wrist/hand with an incidence rate of 17.4 per 1,000 person-years (95% CI 13.0-23.4). Age 85+ (OR 3.64, 95% CI 1.79-7.40), historical fracture (OR 5.18, 95% CI 3.40-7.89), and use of opioid drugs (OR 2.20, 95% CI 1.52-3.19) conferred increased odds of fracture; sex did not (Figure 1).ConclusionIn this large U.S. sample of older adults with AS, vertebral fractures were the most common followed by distal forearm/wrist/hand fractures. Those who were older, had a historical fracture and used opioids had higher odds of fracture. Men and women were equally likely to have a fracture. Since chronic opioid use was associated with fracture in AS, this high-risk population should be considered for interventions to mitigate risk.Table 1.Incidence rate of fractures by type.First FractureN (%)Incidence Rate per 1,000 person-years95% CIAny Fracture197/1,42676.766.4-88.6By Fracture Type*Vertebral61 (25.7)23.918.6-30.7Distal forearm/wrist/hand45 (19.0)17.413.0-23.4Ankle/foot33 (14.0)12.89.1-18.0Pelvis/hip/femur29 (12.2)11.27.8-16.1Sternum/ribs25 (10.5)9.66.5-14.3Shoulder/clavicle/upper arm/elbow24 (10.1)9.36.2-13.8Knee/lower leg20 (8.4)7.75.0-11.9*Subject’s first fracture within a category were included in the counts by fracture type. Subjects can appear in more than one fracture type category if another fracture occurred in a different location. Data displays 237 unique fractures in 197 participants.Figure 1.Model adjusted for all variables shown in the Figure 1.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsRachael Stovall: None declared, Emma Kersey: None declared, Jing Li: None declared, Rahaf Baker: None declared, Christine Anastasiou: None declared, Andriko Palmowski: None declared, Gabriela Schmajuk: None declared, Lianne S. Gensler Consultant of: AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: Novartis and UCB Pharma, Jinoos Yazdany Consultant of: Astra Zeneca, Pfizer, Aurinia, Grant/research support from: Astra Zeneca, BMS Foundation, Gilead and Aurinia.
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Schlesinger, N., N. L. Edwards, S. Clark, and P. Lipsky. "AB1173 RHEUMATOLOGIST CARE IS ASSOCIATED WITH FEWER EMERGENCY ROOM VISITS BY PERSONS WITH GOUT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1877.1–1877. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2340.
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Background:Gout is one of the most common inflammatory arthropathies. By searching a large administrative data base (Symphony Integrated Dataverse), we found that persons with acute gout see a rheumatologist infrequently, whereas less than 50% of advanced gout patients are seen by a rheumatologist. Notably, however, gout patients seen by rheumatologists have more frequent urate measurements and are prescribed urate lowering therapy more frequently. This study sought to determine whether involvement of a rheumatologist in gout care had a positive impact on health outcomesObjectives:To determine whether involvement of a rheumatologist had a positive impact on health outcomes of patients with gout.Methods:We carried out a retrospective analysis to identify persons with gout over an approximately 3-year period from October 2015 to December 2018. This study used data from the Truven Marketscan®database, an administrative database covering over 190 million patients across the United States and based on fully adjudicated and paid insurance claims. Patients were identified as having gout if they were >18 years of age and had at least two medical claims for the diagnosis of gout on different days, separated by at least 3 months. Patients with acute gout were identified by ICD-10 code M10.*, chronic nontophaceous gout (M1A.***0), tophaceous gout (M1A.***1) and uncontrolled gout (M10.*, M1A.*), the latter manifested by three gout codes (any) in the primary diagnosis position and three urate measurements within the same calendar year. Particular attention was placed on Emergency Room (ER) visits by individuals in each category and by individuals who had been evaluated by a rheumatologist.Results:We identified 284,877 gout patients. The median age was 59.2 years and 79.0% were male. Of the 230,998 persons coded as acute gout, 10.7% were seen by a rheumatologist, whereas 26.9% of the 32,942 coded as chronic nontophaceous gout, 47.2% of the 7,723 coded as tophaceous gout and 43.6% of the13,514 coded as uncontrolled gout were seen by a rheumatologist. In each gout category, the frequency of ER visits was significantly reduced in persons who had been seen by a rheumatologist (Table 1). In acute gout, the frequencies of ER visits in those with and without rheumatologist care were 5.6% vs 6.6% (p<0.001), respectively. In chronic nontophaceous gout it was 5.5% vs 6.7% (p=0.001); in tophaceous gout it was 10.3% vs 14.7% (p<0.001); and in uncontrolled gout it was 12.8% vs 19.0%, respectively. If the frequencies of rheumatologist-associated gout patient ER visits were applied to all gout subjects, there would have been 3,088 less ER visits in this cohort of gout patients.Table 1.Rheumatology BreakdownEmergency Room VisitsPopulationOverall NW/ RheumatologyPatients%With Gout ER Visit (%)p-value (comparing %)ER Visits* Per PatientAcute Gout230,698Yes24,63810.68%1373 (5.57%)<0.0011.47No206,06089.32%13632 (6.62%)1.53Non-Tophaceous Chronic32,942Yes8,86326.90%486 (5.48%)<0.0011.95No24,07973.10%1601 (6.65%)2.39Tophaceous Chronic7,723Yes3,64847.24%376 (10.31%)<0.0012.78No4,07552.76%597 (14.65%)2.89Uncontrolled13,514Yes5,88643.55%753 (12.79%)<0.0012.06No7,62856.45%1452 (19.04%)2.56* ER Visits are only included in this analysis if the primary diagnosis code on the claim is a gout code (M10.X, M1A.X)Conclusion:There appears to be a positive impact of rheumatologist involvement in the care of gout patients, manifested by a significant decrease in the frequency of ER visits. Considering the inconvenience and cost of ER visits, rheumatologist care may have a significant impact on the well-being of gout patients and on the overall cost of their care.Disclosure of Interests:Naomi Schlesinger Grant/research support from: Pfizer, Amgen, Consultant of: Novartis, Horizon Therapeutics, Selecta Biosciences, Olatec, IFM Therapeutics, Mallinckrodt Pharmaceuticals, N. Lawrence Edwards Consultant of: Horizon Therapeutics, Takeda Pharmaceuticals US, Aclaris Therapeutics, Atom Biosciences, Sanders Clark: None declared, Peter Lipsky Consultant of: Horizon Therapeutics
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Houtchens, Maria K., Natalie C. Edwards, Gary Schneider, Kevin Stern, and Amy L. Phillips. "Pregnancy rates and outcomes in women with and without MS in the United States." Neurology 91, no. 17 (September 28, 2018): e1559-e1569. http://dx.doi.org/10.1212/wnl.0000000000006384.
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ObjectiveTo compare pregnancy prevalence and complications in women with and without multiple sclerosis (MS).MethodsThis retrospective US administrative claims study used data from January 1, 2006, to June 30, 2015. All data for women with MS were included. A nationally representative 5% random sample from approximately 58 million women without MS was used to compute the dataset. Annual pregnancy rates, identified via diagnosis/procedure codes and adjusted for covariates, were estimated via logistic regression. Claims for pregnancy and labor/delivery complications were compared using propensity score matching.ResultsFrom 2006 to 2014, the adjusted proportion of women with MS and pregnancy increased from 7.91% to 9.47%; the adjusted proportion without MS and with pregnancy decreased from 8.83% to 7.75%. The difference in linear trend (0.17% increase and 0.15% decrease in per-annum pregnancy rates) was significant (t statistic = 7.8; p < 0.0001). After matching (n = 2,115 per group), a higher proportion of women with MS than without had claims for premature labor (31.4% vs 27.4%; p = 0.005), infection (13.3% vs 10.9%; p = 0.016), cardiovascular disease (3.0% vs 1.9%; p = 0.028), anemia/acquired coagulation disorders (2.5% vs 1.3%; p = 0.007), neurologic complications (1.6% vs 0.6%; p = 0.005), sexually transmitted diseases (0.4% vs 0.1%; p = 0.045), acquired fetal damage (27.8% vs 23.5%; p = 0.002), and congenital fetal malformations (13.2% vs 10.3%; p = 0.004).ConclusionsPregnancy rates in this population of women with MS have been increasing. High rates of claims for several peripartum complications were observed in women with and those without MS. Claims data provide knowledge of interactions patients have with the health care system and are valuable initial exploratory analyses.
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Goyal, Ravi K., Keith L. Davis, Isabelle Cote, Nadjat Mounedji, and James A. Kaye. "Increased Incidence of Thromboembolic Event Rates in Patients Diagnosed with Polycythemia Vera: Results from an Observational Cohort Study." Blood 124, no. 21 (December 6, 2014): 4840. http://dx.doi.org/10.1182/blood.v124.21.4840.4840.
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Abstract Background: Polycythemia vera (PV) is a rare hematologic neoplasm with significant morbidities. Blood hyperviscosity reflected by elevated hematocrit (HCT) levels is believed to contribute to most disease symptoms and complications including thrombotic events (TE), which are among the most serious clinical manifestations of PV. Concurrent with ongoing Phase III trials in PV, this study assesses treatment patterns, TE event rates, and direct costs associated with PV in real-world practice settings. Preliminary results on incidence of TE events in a privately insured US population are presented here. Methods: Data for this retrospective observational study were taken from the MarketScan database containing medical and drug utilization data for ~40 million unique individuals enrolled in employer-sponsored private health insurance plans in the United States. Patients with at least two claims of a PV diagnosis (International Classification of Diseases, 9th Clinical Modification [ICD-9-CM] code 238.4) at least 30 days apart, between July 1, 2008 and December 31, 2011, were selected for study inclusion. Using propensity score (PS) methods, we identified a non-PV control group matched with PV cases on demographics and comorbidities. PS matching is frequently used in observational studies to achieve balance on observed covariates between cases and controls. Incident TE events were identified using ICD-9 diagnosis codes and were assessed from the index date (first PV diagnosis) until the earliest of plan disenrollment or end of the database. Both fatal and nonfatal events were included, although a distinction could not be ascertained in these data. The TE event rate was defined as the number of unique patients with a new TE occurrence (i.e., incident cases) per 1000 person-years (PYs) of observation time. Unadjusted TE event rates and incident rate ratios (RR) expressing the increased frequency of events in PV cases relative to controls were estimated for overall (i.e., any), cerebral, arterial, and venous TE events. Kaplan-Meyer (KM) analyses were performed to estimate time to event for each of the event categories listed above. Results: The cohort comprised 8,124 PV patients with mean age of 51 years; 71% of patients were male. Table 1 describes the quality of balance between cases and matched controls for selected variables that differed significantly before PS matching. As shown in Figure 1, TE event rates were significantly higher among PV cases compared to matched controls (overall: 14.3 vs. 4.9/1000 PYs [RR 2.90 (95% CI: 2.28-3.68)], cerebral: 3.5 vs. 1.3/1000 PYs [RR 2.66 (95% CI: 1.66-4.24)], arterial: 6.9 vs. 2.4/1000 PYs [RR 3.16 (95% CI: 2.05-4.87)], and venous: 4.7 vs. 1.5/1000 PYs [RR 2.94 (95% CI: 2.08-4.15)]). KM analyses showed that event probabilities over time were significantly higher among PV cases (Figure 2). Due to high censoring in both the groups, median time to TE event could not be calculated. However, among those with an event, median time to event was shorter (but not statistically significant) among PV cases compared to controls for overall (7.0 vs. 9.7 months [P=0.0817]), cerebral (8.5 vs. 13.1 months [P=0.0634]), and arterial (9.2 vs. 14.7 months [P=0.0768]), but slightly higher for venous (5.3 vs. 4.8 months [P=0.5583]). Conclusion: Patients with PV have significantly higher rate of TE events compared with matched controls. This rate may be higher in patients with HCT > 45%. Further analyses in this ongoing study will assess patient level predictors of cardiovascular and TE events and their impact on overall economic burden of PV. Table 1. Comparison of Baseline Characteristics between PV Cases and Matched Controls PV Cases (n=8124) Control (n=8124) P-value ‡ Percent Age Group (years) <18 1.7 1.7 0.24 18 - 44 19.9 19.0 45 - 59 58.4 59.9 60 - 64 20.1 19.4 Gender Male 71.5 71.2 0.65 Geographic region North Central 20.6 20.9 0.48 North East 16.5 16.7 South 40.8 41.1 West 19.2 18.1 Unknown 3.0 3.2 Year of diagnosis 2008 17.3 17.6 0.16 2009 27.7 29.0 2010 27.5 27.2 2011 27.5 26.2 Charlson comorbidity index (CCI) score (mean [SD]) 0.8 (1.4) 0.7 (1.4) 0.00 Note: Other covariates in the PS estimation include payer type, plan type, employment status, and relationship to employee. ‡ P-values based on McNemar's test for categorical variables and Wilcoxon Signed Rank Sum test for continuous variables. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Goyal: Novartis Pharmaceuticals Corp: Employee of RTI Health Solutions, which received research funding for this work. Other. Davis:Novartis Pharmaceuticals Corporation: Research Funding. Mounedji:Novartis Pharma: Employment. Kaye:Novartis Pharmaceuticals Corp: Employee of RTI Health Solutions, which received research funding for this work. Other.
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Ranavaya, Mohammed I., and James B. Talmage. "Impairment and Disability Compensation Systems in the United States." Guides Newsletter 4, no. 6 (November 1, 1999): 1–13. http://dx.doi.org/10.1001/amaguidesnewsletters.1999.novdec01.
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Abstract Although several states use the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides) when they evaluate individuals with impairments and disabilities, various disability systems exist in the United States. Disability and compensation systems have arisen to ensure that disadvantaged members of society with a medically determinable impairment, which may lead to a disability, have recourse to compensation from various sources, including state and federal workers’ compensation laws, veterans’ benefits, social welfare programs, and legal avenues. Each of these has differing definitions of disability, entitlement, benefits, procedures of claims application, adjudication, and the roles and relative weights assigned to medical vs administrative deliberations. Workers’ compensation statutes were enacted because of inadequacies of recovery from claims for injured workers under common law. Workers’ compensation is a no-fault system adopted to resolve the dilemmas of tort claims by providing automatic coverage to employees injured during the course of employment; in exchange for coverage, employees forego the right to sue the employer except for wanton neglect. Other workers’ compensation programs in the United States include the Federal Employees Compensation Act; the Federal Employers Liability Act (railroads); the Jones Act (Merchant Marine Act); the Longshore and Harbor Workers’ Compensation Act; the Department of Veterans Affairs; Social Security; and private, long-term disability insurance.
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ZELNER, J. L., C. MULLER, and J. J. FEIGENBAUM. "Racial inequality in the annual risk of Tuberculosis infection in the United States, 1910–1933." Epidemiology and Infection 145, no. 9 (April 24, 2017): 1797–804. http://dx.doi.org/10.1017/s0950268817000802.
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SUMMARYTuberculosis (TB) mortality rates in the USA fell rapidly from 1910 to 1933. However, during this period, racial disparities in TB mortality in the nation's expanding cities grew. Because of long delays between infection and disease, TB mortality is a poor indicator of short-term changes in transmission. We estimated the annual risk of TB infection (ARTI) in 11 large US cities to understand whether rising inequality in mortality reflected rising inequality in ARTI using city-level TB mortality data compiled by the US Department of Commerce from 1910 to 1933. We estimated ARTI for African-Americans and whites using pediatric extrapulmonary TB mortality data for African-Americans and whites in our panel of cities. We also estimated age-adjusted pulmonary TB mortality rates for these cities. We find that the ratio of ARTI for African-Americans vs. whites increased from 2·1 (95% CI = 1·7, 2·4) in 1910 to 4·2 (95% CI = 3·4, 5·2) in 1933. This change mirrored the increasing inequality in age-adjusted pulmonary TB mortality during this period. These findings may reflect the combined effects of migration, inequality in access to care, increasing population density, and racial residential segregation in northern cities during this period.
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Buckner, Tyler W., Iryna Bocharova, Kaitlin Hagan, Arielle G. Bensimon, Hongbo Yang, Eric Q. Wu, Eileen K. Sawyer, and Nanxin Li. "Health care resource utilization and cost burden of hemophilia B in the United States." Blood Advances 5, no. 7 (April 8, 2021): 1954–62. http://dx.doi.org/10.1182/bloodadvances.2020003424.
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Abstract Hemophilia B is a rare congenital blood disorder characterized by factor IX deficiency. Clinical profiles of hemophilia B range from mild to severe forms of the disease. The objective of this study was to characterize the economic burden associated with differing clinical profiles of hemophilia B from a US health system perspective. Using the IBM MarketScan database (June 2011-February 2019), a claims-based algorithm was developed to identify 4 distinct profiles (mild, moderate, moderate-severe, and severe) in adult males with hemophilia B based on the frequency of hemorrhage events and factor IX replacement claims. Mean annual health care resource use (HRU) and costs were statistically compared between patients with hemophilia B (N = 454) and 1:1 demographic-matched controls (N = 454), both overall and with stratification by clinical profile. Compared with matched controls, patients with hemophilia B had a significantly higher comorbidity burden (Charlson Comorbidity Index, mean ± standard deviation [SD]: 0.9 ± 1.7 vs 0.3 ± 0.9, P < .001). Across all clinical profiles, patients with hemophilia B had significantly higher HRU vs matched controls (mean ± SD: 0.3 ± 0.6 vs 0.1 ± 0.3 inpatient admissions; 0.6 ± 1.2 vs 0.2 ± 0.6 emergency department visits; 17.7 ± 22.9 vs 8.0 ± 11.0 outpatient visits; all P < .001). Annual total health care costs per patient among patients with hemophilia B were more than 25-fold higher vs matched controls (mean ± SD: $201 635 ± $411 530 vs $7879 ± $29 040, respectively, P < .001). Annual total health care costs per patient increased with increasing severity (mean ± SD: mild, $80 811 ± $284 313; moderate, $137 455 ± $222 021; moderate-severe, $251 619 ± $576 886; severe, $632 088 ± $501 270). The findings of this study highlight the substantial burden of illness associated with hemophilia B.
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Vekeman, Francis, Marjolaine Gauthier-Loiselle, Elizabeth Faust, Patrick Lefebvre, Raquel Lahoz, Mei Sheng Duh, and Patricia Sacco. "Patient and Caregiver Burden Associated With Fragile X Syndrome in the United States." American Journal on Intellectual and Developmental Disabilities 120, no. 5 (September 1, 2015): 444–59. http://dx.doi.org/10.1352/1944-7558-120.5.444.
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Abstract This study evaluated the incremental healthcare costs associated with Fragile X syndrome (FXS) for patients and their caregivers. Using administrative healthcare claims data (1999-2012), subjects with ≥ 1 FXS diagnosis (ICD-9-CM: 759.83) were matched 1:5 with non-FXS controls using high-dimensional propensity scores. Costs and resource utilization were examined. Among employees, payment for disability leave and absenteeism were also examined. We identified 590 FXS and 2,950 non-FXS individuals along with 647 and 2,611 caregivers, respectively. FXS patients and their caregivers experienced higher all-cause direct costs compared to control cohorts (total[SD]: $14,677[46,752] vs. $6,103[26,081]; $5,259[19,360] vs. $2,120[6,425], respectively, p < 0.05). Employed FXS patients and caregivers had higher indirect costs compared to their controls (total[SD]: $4,477[5,161] vs. $1,751[2,556]; $2,641[4,238] vs. $1,211[1,936], respectively, p < 0.05).
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Birnbaum, H., R. Ben-Hamadi, D. Kelley, M. Hsieh, B. Seal, P. Cremieux, and P. Greenberg. "Assessing the Relationship Between Compliance with Antidepressant Therapy and Costs Among Employees in the United States." European Psychiatry 24, S1 (January 2009): 1. http://dx.doi.org/10.1016/s0924-9338(09)70731-x.
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Objective:Assess effects of antidepressant compliance on healthcare and workplace costs.Methods:Using workplace survey data for 2 large employers’ healthcare claims (2004-2006), patient selection criteria considered depression diagnosis and antidepressant claims history. Employed respondents working in the past month were categorized by Medication Possession Ratio into compliance groups by quartiles; bottom/top quartiles were defined as compliant/non-compliant. Direct (medical/drug) costs were measured as insurer payments to providers; indirect (absenteeism/presenteeism) costs were based on one-month recall of workplace performance (hours worked/missed, self-rated performance), estimated as (hours missed x self-reported hourly income). Annualized, inflation-adjusted (2006) costs were compared between compliant/non-compliant groups using multivariate models controlling for baseline characteristics. Analyses were conducted for all patients and a subsample of diagnosed depression patients.Results:Among all patients (n=1,224), medical costs were numerically lower for compliant vs. non-compliant patients ($4,857 vs. $5,926, p=0.221); drug costs were significantly higher for compliant patients ($2,329 vs. $1,570, p=0.001). Indirect costs were not statistically different between compliant/non-compliant patients ($22,278 vs. $20,714, p=0.237). Among the depression subgroup (N=488), medical costs were numerically lower for compliant vs. non-compliant patients ($5,005 vs. $7,630, p=0.152) while drug costs were numerically higher for compliant patients ($2,550 vs. $1,829, p=0.153). Absenteeism costs were 30% lower for compliant patients ($7,725 vs. $11,040, p=0.038); presenteeism costs were not significantly different ($19,079 vs. $17,457, p=0.441).Conclusions:Absenteeism costs decrease significantly with compliance among depressed patients as do medical costs (not significantly). Further research is warranted regarding reason for poor antidepressant compliance and influence of compliance on costs.
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Biddle, Matthew D., Ryan P. Brown, Charles A. Doswell, and David R. Legates. "Regional Differences in the Human Toll from Tornadoes: A New Look at an Old Idea." Weather, Climate, and Society 12, no. 4 (October 2020): 815–25. http://dx.doi.org/10.1175/wcas-d-19-0051.1.
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AbstractPreviously published claims of large regional (northern vs southern states) differences in risks of fatality associated with tornadoes in the United States are reexamined. This new study extends earlier claims to include 1) data from a much longer time frame, 2) injuries as well as fatalities, and 3) more precise estimates of meteorological features of tornado events (specifically, a precise calculation of daytime vs nighttime and pathlength). The current study also includes formal mediation analyses involving variables that might explain regional differences. Results indicate that significant increases in the risk of fatality and injury do occur in southern states as compared with northern states. Mediation models show that these regional differences remain significant when meteorological factors of nocturnal occurrence and pathlength are included. Thus, these meteorological factors cannot explain regional differences in risk of fatality and injury, a failure that is unlikely to reflect a lack of data or a lack of precision in the measurement of potential mediators.
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Sahay, Sandeep, Yuen Tsang, Megan Flynn, Peter Agron, and Robert Dufour. "Burden of pulmonary hypertension in patients with portal hypertension in the United States: a retrospective database study." Pulmonary Circulation 10, no. 4 (October 2020): 204589402096291. http://dx.doi.org/10.1177/2045894020962917.
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Patients with portal hypertension may develop pulmonary hypertension. The economic implications of these comorbidities have not been systematically assessed. We compared healthcare resource utilization and costs in the United States between patients with co-existing portal hypertension and pulmonary hypertension (pulmonary hypertension cohort) and a matched cohort of portal hypertension patients without pulmonary hypertension (control cohort). In this retrospective analysis, adult pulmonary hypertension and control patients were identified from the Optum® Clinformatics® Data Mart database between 1 July 2014 and 30 June 2018. All patients had ≥2 claims with diagnosis codes for portal hypertension; pulmonary hypertension patients had ≥2 claims with diagnosis codes for pulmonary hypertension; controls could not have pulmonary hypertension diagnoses or any claims for pulmonary arterial hypertension-specific medications. Controls were matched to pulmonary hypertension patients by age, sex, Charlson comorbidity index score, and liver diseases. We assessed 12-month healthcare resource utilization and costs. Each cohort included 146 patients. During follow-up, pulmonary hypertension cohort patients were more likely than controls to experience a hospitalization (51% vs. 32%, P = 0.0014) and an emergency room visit (55% vs. 41%, P = 0.026). The average annual total cost was higher in pulmonary hypertension patients than for matched controls ($119,912 vs. $81,839, P < 0.0001). After covariate adjustment, costs for pulmonary hypertension cohort patients were 1.47 times higher than those for controls ( P = 0.0197). These findings suggest that patients with portal hypertension and co-existing pulmonary hypertension are at a greater risk for hospitalization and incur higher mean annual total costs than portal hypertension patients without pulmonary hypertension.
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Khorana, Alok A., Mehul Dalal, Jay Lin, and Gregory Clayton Connolly. "Health care costs associated with venous thromboembolism in select high-risk ambulatory solid tumor patients in the United States." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 6059. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.6059.
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6059 Background: Venous thromboembolism (VTE) is an increasingly common complication of cancer and its treatment, including chemotherapy. VTE has significant clinical consequences, including mortality. However, contemporary data on the healthcare costs of cancer-associated VTE are limited. We examined the real-world economic burden of VTE in ambulatory patients initiating chemotherapy for select common high-risk solid tumors. Methods: Healthcare claims data (2004-2009) from the IMS/PharMetrics Patient-Centric database were collected for propensity score-matched adult cancer (lung, colorectal, pancreas, stomach, bladder and ovary) patients with VTE (n=912) and without VTE (n=2,736) after initiating chemotherapy. Healthcare resource utilization (inpatient, outpatient medical, and outpatient prescription drug claims) and costs were compared between the two cohorts during 12 months’ follow-up after the index VTE event. Incremental costs of VTE were adjusted for demographic and clinical covariates. Results: Cancer patients with VTE had ~3-times as many all-cause hospitalizations (mean 1.38 vs. 0.55 per patient) and days in hospital (10.2 vs. 3.4 per patient), and more outpatient claims (331 vs. 206 per patient) than matched cancer patients without VTE (all P<0.0001). Cancer patients with VTE incurred significantly higher overall (all-cause) inpatient costs (mean $21,299 vs. $7,459 per patient), outpatient costs (mean $53,660 vs. $34,232 per patient) and total healthcare costs (mean $74,959 vs. $41,691 per patient) than cancer patients without VTE (all P<0.0001). Total VTE-related healthcare costs were (mean) $9,247 per VTE patient over 12 months. Adjusted incremental all-cause healthcare costs of VTE were (mean) $30,538 per patient across the selected tumors, ranging from $11,946 per patient for gastric cancer to $38,983 per patient for pancreatic cancer. Conclusions: VTE results in significant inpatient and outpatient resource utilization, and increased all-cause (in addition to VTE-related) healthcare costs. Measures to prevent outpatient cancer-associated VTE may reduce healthcare utilization and costs in high-risk cancer patients.
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Farrar, Mallory, Robert Farber, Ginny P. Sen, Charles Yonan, and Jean Lin Chan. "Real-World Evidence of Clinical Outcomes in Patients With Assumed Classic Congenital Adrenal Hyperplasia in the United States." Journal of the Endocrine Society 5, Supplement_1 (May 1, 2021): A93—A94. http://dx.doi.org/10.1210/jendso/bvab048.187.
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Abstract Background: Classic congenital adrenal hyperplasia (CAH) is an autosomal recessive disorder, usually due to a deficiency in the 21-hydroxylase enzyme, that results in impaired cortisol synthesis and excess androgen production. Patients with classic CAH experience both disease-related features from excess androgens and treatment-related complications from the chronic, supraphysiologic use of glucocorticoids (GCs) often required for androgen control. This study was conducted to evaluate the demographics and clinical characteristics of adult and pediatric patients in the United States (US) with assumed classic CAH based on International Classification of Diseases (ICD) codes, GC prescriptions, and medical claims. Methods: Analyses were based on longitudinal patient-level data from the Decision Resources Group Real World Evidence repository, which links medical claims, prescription claims, and electronic health records from >300 million US patients. Data were analyzed for patients aged ≥18 years (adult) and <18 years (pediatric) with assumed classic CAH based on ICD 9/10 codes associated with “adrenogenital disorders” and whose proportion of days covered with a GC in 2018–2019 was >75%. These patients were matched 1:3 with a control cohort based on age, gender, geographic region, and insurance type. Both assumed CAH and control cohorts had continuous coverage with at least 1 medical claim and 1 pharmacy claim in each year, 2018–2019. Results: Of 1,111 patients with assumed classic CAH, 778 were ≥18 years old (65% female; mean age [±SD], 43±17 years) and 333 were <18 years old (51% female; mean age [±SD], 11±4.7 years). Both adult and pediatric patients with assumed classic CAH were more likely than matched controls (adult N=2334; pediatric N=999) to experience events that could be related to chronic GC use, including infection (adult: 49.9% vs 37.3% [control]; pediatric: 49.5% vs 40.0%), weight gain (adult: 5.9% vs 2.5%; pediatric: 9.0% vs 2.6%), and moon face (adult: 44.0% vs 0.1%; pediatric: 37.8% vs 0.1%); all P<0.01 vs control. Adult patients were more likely than matched controls to experience acne (6.0% vs 3.6%), hirsutism (8.1% [47/508] vs 5.5% [84/1524]), and infertility (1.7% vs 0.4%); all P<0.01. Pediatric patients were more likely to experience pubertal development issues (10.5% vs 1.8%), acne (8.4% vs 5.1%), and advanced bone age (1.2% vs 0.1%); all P<0.05. Conclusions: Compared to matched controls, both adult and pediatric patients with assumed classic CAH had significantly more disease-related comorbidities and potential GC treatment-related conditions, indicating the challenges with current GC treatments. This study was limited by the assumed nature of classic CAH due to lack of a specific ICD code, but the combination of chronic GC use (>75% days) with the diagnosis code most likely used in these patients (adrenogenital disorder) supports the validity of this analysis.
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Patterson, Brandon J., Chi-Chang Chen, Catherine B. McGuiness, Lisa I. Glasser, Kainan Sun, and Philip O. Buck. "17. Assessment of Recombinant Zoster Vaccine Second Dose Completion in the United States." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S31. http://dx.doi.org/10.1093/ofid/ofaa439.062.
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Abstract Background Recombinant Zoster Vaccine (RZV) was licensed in the United States (US) in October 2017 for the prevention of herpes zoster in adults ≥ 50 years of age (YOA). The vaccine is administered in a two-dose sequence with a 2- to 6-month interval; however, the Center for Disease Control & Prevention has advised against restarting a series after the prescribed window. This study describes an assessment of 2nd dose completion and compliance of RZV in the US. Methods Primary analysis was conducted on a cohort ≥ 50 YOA who received an initial RZV dose between October 2017 and September 2018 as indicated in the IQVIA longitudinal prescription claims or medical claims databases. Subjects were required to have ≥ 1 year of observable time post initial dose. A sensitivity analysis was conducted using all eligible subjects regardless of observable time post initial dose. Endpoints of analyses were monthly and cumulative 2nd dose label-compliant proportions at 6 months and completers by 12-month intervals and time to completion from initial RZV vaccine administration with stratifications by age, sex, claim source and payer type. Results The primary sample included 1,225,088 subjects, while the sensitivity analysis included 7,097,441 (Table 1). Overall, 2nd RZV dose completion was 70.4% within 6 months and 81.8% within 12 months. Minimal variation for 12-month completion was demonstrated across age (77.2–84.5%), sex (81.7–81.9%), and Commercial vs. Medicare (80.9–83.0%). However, larger variations were seen across claim sources and other payer type, with medical claims (64.9%), Medicaid patients (72.8%) and Cash patients (74.7%) having lower rates at 12 months (Table 2). Overall, the average time to completion was around 4 months regardless of stratification except by claims source, with medical claims taking 5 months on average to complete. The sensitivity analysis of the variable follow-up cohort demonstrated findings consistent with that of the primary sample. Conclusion Assessment of RZV suggests high levels of completion across age, sex, payer type and claim sources. More effort is needed to understand barriers to completion rates in Medicaid patients and settings where vaccination claims are processed outside of the vaccine recipient’s pharmacy benefit. Disclosures Brandon J. Patterson, PharmD, PhD, GSK (Employee, Shareholder) Chi-Chang Chen, PhD, MSPharm, GSK (Research Grant or Support) Catherine B. McGuiness, MA, MS, GSK (Research Grant or Support)Pfizer (Shareholder) Lisa I. Glasser, MD, GSK (Employee, Shareholder) Kainan Sun, MS, PhD, GSK (Research Grant or Support) Philip O. Buck, PhD, MPH, ORCID: 0000-0002-3898-3669, GSK (Employee, Shareholder)
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Prilutskiy, V. V. "AMERICAN-MEXICAN BORDER CONFLICTS IN THE 1870–1910S." Vestnik Bryanskogo gosudarstvennogo universiteta 03, no. 07 (September 27, 2021): 139–47. http://dx.doi.org/10.22281/2413-9912-2021-05-03-139-147.
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The article analyzes the border conflicts between Mexico and the United States at the turn of the XIXth and XXth centuries. American-Mexican relations were an important factor in the development of the regional subsystem of international relations in the Western Hemisphere. Historically, Mexico and the United States have had a complicated relationship. Mexico in the late XIXth – early XXth centuries was a secondary peripheral state, which was mainly agrarian in nature. There were both phases of acute confrontation (almost the entire XIXth century and the beginning of the XXth century), as well as periods of good neighborliness, relatively good, friendly, stable relationships and constructive cooperation. In relations with the United States at that time, it remained rather not a subject, but an object of influence. The extreme American expansionists proposed in the middle of the XIXth century to capture all of Mexico. In response to the aggressive aspirations of America, the Mexican radicals put forward their territorial claims to the neighboring country. They hoped to regain the vast northern region, that was lost during the wars of 1835-1848, which included Upper California, New Mexico, Utah, Arizona and Texas (which was called the "New Philippines" during the era of Spanish colonization). There are two stages of confrontation between the two countries: the 1870s – 1890s and the 1910s – 1920s. The most serious exacerbations on the border occurred in 1876, 1877, 1891-1893, 1896, 1906 and 1910-1919. Both government troops and irregular (militias, partisans, rebels) formations took part in the regional armed conflict. As a result, the situation stabilized for almost a century.
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Herzog, Mackenzie M., Stephen W. Marshall, Jennifer L. Lund, Virginia Pate, and Jeffrey T. Spang. "Cost of Outpatient Arthroscopic Anterior Cruciate Ligament Reconstruction Among Commercially Insured Patients in the United States, 2005-2013." Orthopaedic Journal of Sports Medicine 5, no. 1 (January 1, 2017): 232596711668477. http://dx.doi.org/10.1177/2325967116684776.
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Background: Despite the significance of anterior cruciate ligament (ACL) injuries, these conditions have been under-researched from a population-level perspective. It is important to determine the economic effect of these injuries in order to document the public health burden in the United States. Purpose: To describe the cost of outpatient arthroscopic ACL reconstruction and health care utilization among commercially insured beneficiaries in the United States. Study Design: Economic and decision analysis; Level of evidence, 3. Methods: The study used the Truven Health Analytics MarketScan Commercial Claims and Encounters database, an administrative claims database that contains a large sample (approximately 148 million) of privately insured individuals aged <65 years and enrolled in employer-sponsored plans. All claims with Current Procedural Terminology (CPT) code 29888 (arthroscopically aided ACL reconstruction or augmentation) from 2005 to 2013 were included. “Immediate procedure” cost was computed assuming a 3-day window of care centered on date of surgery. “Total health care utilization” cost was computed using a 9-month window of care (3 months preoperative and 6 months postoperative). Results: There were 229,446 outpatient arthroscopic ACL reconstructions performed over the 9-year study period. Median immediate procedure cost was $9399.49. Median total health care utilization cost was $13,403.38. Patients who underwent concomitant collateral ligament (medial [MCL], lateral [LCL]) repair or reconstruction had the highest costs for both immediate procedure ($12,473.24) and health care utilization ($17,006.34). For patients who had more than 1 reconstruction captured in the database, total health care utilization costs were higher for the second procedure than the first procedure ($16,238.43 vs $15,000.36), despite the fact that immediate procedure costs were lower for second procedures ($8685.73 vs $9445.26). Conclusion: These results provide a foundation for understanding the public health burden of ACL injuries in the United States. Our findings suggest that further research on the prevention and treatment of ACL injuries is necessary to reduce this burden.
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Pocoski, Jennifer, Brittny Rule, Augustina Ogbonnaya, Lois Lamerato, Michael Eaddy, Orsolya Lunacsek, and Thomas J. Humphries. "Cardiovascular Comorbidities in a United States Patient Population with Hemophilia a: A Comprehensive Chart Review." Blood 128, no. 22 (December 2, 2016): 4966. http://dx.doi.org/10.1182/blood.v128.22.4966.4966.
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Abstract Introduction: Two previous retrospective claims database analyses (Pocoski J, et al. Haemophilia. 2014;20(4):472-478 and Humphries TJ, et al. Am J Hematol. 2016;91(5):E298-299) reported increased prevalence and earlier onset of cardiovascular (CV) comorbidities in patients with vs without hemophilia A (HEM A). Because of many known limitations of claims databases, a comprehensive chart review at a large integrated delivery network was conducted to assess differential CV comorbidities. Aim: This study was designed to confirm the previous findings on CV risk factors and associated diseases in 2 large claims databases of male patients with HEM A in the United States. Methods: This was a retrospective chart review study conducted at the Henry Ford Health System in patients diagnosed with HEM A (n=74) and matched Control patients (3:1) without a diagnosis of HEM A (Control, n=222). Baseline demographics, bleeding events, treatment parameters, co-existing diseases, hemophilia-associated events, and the prevalence of 12 CV risk factors and associated diseases were compared between the HEM A and Control cohorts. P values generated from a chi-square test for categorical variables and a t test for continuous variables were reported. To address the small sample size, statistical differences between the cohorts were also assessed using absolute standardized difference (SDiff), where a value ≥0.10 was considered statistically meaningful. Results: The Control cohort was well matched to the HEM A group by age, race, healthcare payer, and study year. As expected, the prevalence of hepatitis B and C, hepatocellular carcinoma, and HIV/AIDS was much higher in the HEM A cohort. Gastrointestinal, intracranial, muscle, and joint bleeds occurred only in HEM A patients. Bleeds of various types were recorded in 35 HEM A patients vs 1 in the Control group. HEM A was severe in 52.7% of patients, moderate and mild in 10.8% each, and unknown in 25.7%. The prevalence of hypertension, diabetes, obesity, hyperlipidemia, coronary artery disease, heart failure, stroke, venous and arterial thrombosis, ventricular arrhythmias, atrial fibrillation, and chronic renal disease was numerically higher in the Control cohort, but differences were statistically significant (P≤0.05) for diabetes and hyperlipidemia only. Statistical significance using SDiff was not reached for venous and arterial thrombosis and atrial fibrillation. Conclusions:The results of this retrospective chart review did not confirm diffuse statistically significant differences in CV comorbidities and their earlier onset in HEM A vs Controls. Reasons for the lack of confirmation are not clear but may include differences in methodology and patient populations among the studies. The Control group in this current study may have a greater medical burden than in the published studies. Our current results suggest numerically higher comorbidities in Controls for most variables. The conclusions of this study are limited by the small sample size of the hemophilia cohort and a potential selection bias associated with identification of the Control cohort. Disclosures Pocoski: Bayer: Employment. Rule:Bayer: Employment. Ogbonnaya:Takeda: Research Funding. Lamerato:Amgen, Inc.: Research Funding. Lunacsek:Bayer: Research Funding. Humphries:Bayer: Employment.
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Daniel-Robin, Thomas, Pradeep Kumar, Bernard Benichou, and Jean-Philippe Combal. "Characteristics of patients with Wilson disease in the United States: An insurance claims database study." World Journal of Hepatology 16, no. 5 (May 27, 2024): 791–99. http://dx.doi.org/10.4254/wjh.v16.i5.791.
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BACKGROUND Wilson disease (WD) is a progressive, potentially fatal degenerative disease affecting the liver and central nervous system. Given its low prevalence, collecting data on large cohorts of patients with WD is challenging. Comprehensive insurance claims databases provide powerful tools to collect retrospective data on large numbers of patients with rare diseases. AIM To describe patients with WD in the United States, their treatment and clinical outcome, using a large insurance claims database. METHODS This retrospective, longitudinal study was performed in the Clarivate Real-World Data Product database. All patients with ≥ 2 claims associated with an International Classification of Diseases 10 (ICD-10) diagnostic code for WD (E83.01) between 2016 and 2021 were included and followed until death or study end. Patients were divided into two groups by whether or not they were documented to have received a specific treatment for WD. Clinical manifestations, hospitalisations, liver transplantation and death were documented. RESULTS Overall, 5376 patients with an ICD-10 diagnostic code for WD were identified. The mean age at inclusion was 41.2 years and 52.0% were men. A specific WD treatment was documented for 885 patients (15.1%), although the number of patients taking zinc salts may be underestimated due to over the counter purchase. At inclusion, the mean age of patients with a documented treatment was 36.6 ± 17.8 years vs 42.2 ± 19.6 years in those without a documented treatment. During follow-up, 273 patients (5.1%) died. Compared with the American general population, the standardised mortality ratio was 2.19. The proportion of patients with a documented WD-specific treatment who died during follow-up was 4.0% and the mean age at death 52.7 years. CONCLUSION Patients treated for WD in the United States had an excess early mortality compared with the American population. These findings indicate that there is a significant unmet need for effective treatment for WD in the United States.
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Boikos, Constantina, Ian McGovern, Justin R. Ortiz, Joan Puig-Barberà, Eve Versage, and Mendel Haag. "Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States." Vaccines 10, no. 9 (September 2, 2022): 1456. http://dx.doi.org/10.3390/vaccines10091456.
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Traditional influenza vaccines may be less immunogenic in adults ≥65 years of age due to immunosenescence. Two influenza vaccines—MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose influenza vaccine (HD-IIV3)—were developed to overcome this problem. We summarize estimates of the relative vaccine effectiveness (rVE) of aIIV3 vs. HD-IIV3 and aIIV3 vs. standard, egg-based quadrivalent influenza vaccines (IIV4e) during the 2017–2018, 2018–2019, and 2019–2020 US influenza seasons using the same underlying electronic medical record and linked claims dataset for all three seasons. The primary outcome was influenza-related medical encounters (IRMEs), defined by diagnostic codes specific to influenza (ICD J09*-J11*). rVE was estimated using propensity score methods adjusting for demographics and health status. rVE estimates demonstrated consistent benefit for aIIV3 over IIV4e in the overall and at-risk populations. Relative to HD-IIV3, aIIV3 provided improved benefit in the overall study population and comparable benefit in the at-risk population across each season.
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Hui, Shirley, David Bernstein, Vinod P. Balachandran, and Henry J. Henk. "Trends in pancreatic cancer chemotherapy treatment in the United States from 2008 through 2016." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e15734-e15734. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e15734.
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e15734 Background: Pancreatic cancer is the third leading cause of cancer death in the United States. 55% of patients present with advanced disease at diagnosis and are treated with chemotherapy, with gemcitabine and 5FU-backbone based therapies both demonstrating efficacy. However, data on the adoption of these of therapies in academic and non-academic centers is scarce. The goal of this study is to examine the aggregate adoption of these therapeutic regimens in widespread clinical practice from 2008 through 2016 using health plan claims data. Methods: Privately insured and Medicare patients with advanced pancreatic cancer treated with chemotherapy from 2008 through 2016 were identified from the OptumLabs Data Warehouse. First-line treatment regimen and duration were correlated with age, sex, race, Charlson Comorbidiy Index (CCI) score, and opioid use measured by morphine milligram equivalents (MME) (as a proxy for pain) in the 6 months prior to starting chemotherapy. Disease status was classified as advanced, adjuvant or neo-adjuvant. Results: For 14,301 patients treated with chemotherapy primarily, the use of monotherapy has significantly decreased from 73% to 27% (p < 0.001) between 2008 and 2016, while combination therapy using two antineoplastic agents (20% to 41%; p < 0.001) and three or more agents (6% to 32%; p < 0.001) increased. Since 2013, patients receiving combination therapy vs. monotherapy are significantly younger (mean 66 vs. 70; p < 0.001), have higher CCI (6.3 vs. 6.1; p = 0.002), and have similar daily opioid dose prior to chemotherapy (5.2 vs. 3.8 MMEs; p = 0.086). Duration on first-line regimen was greater in patients receiving combined therapy, compared to those on gemcitabine monotherapy (median 130 vs. 119 days; p < 0.001) after adjusting for CCI, disease status, and demographics. Conclusions: The use of combined therapy for the treatment of pancreatic cancer has increased over time, with patients on combined therapy appearing to be younger. [Table: see text]
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Kuczmarski, Thomas M., Tim Jaung, Claire E. Mancuso, Lizabeth Roemer, Gregory A. Abel, and Oreofe O. Odejide. "Pre-Diagnostic and Cancer-Associated Depression and Anxiety Among Patients with Hematologic Malignancies in the United States." Blood 136, Supplement 1 (November 5, 2020): 38. http://dx.doi.org/10.1182/blood-2020-140151.
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Background: Little is known about mental health disorders among patients with hematologic malignancies. As depression and anxiety substantially impair the quality of life of patients with cancer, the Institute of Medicine recommends diagnosis and management of these disorders as an integral part of cancer care (Cancer Care for the Whole Patient, IOM, 2008). Moreover, it has been suggested that non-White patients are less likely to disclose depression and anxiety to physicians due to concerns about stigma, and that physicians also inadequately screen this population (Bell, Annals FM, 2011). We aimed to characterize the prevalence and sociodemographic predictors of pre-diagnostic and cancer-associated (CA) depression and anxiety among patients with hematologic malignancies in the United States. Methods: We conducted a retrospective analysis using the Surveillance Epidemiology and End Results (SEER)-Medicare database. Patients ≥ 67 years old diagnosed with a hematologic malignancy (lymphoma, myeloma, leukemia, or myelodysplastic syndromes) between 2000 and 2015 who died prior to December 31, 2016 were eligible for inclusion. We examined prevalence of pre-diagnostic depression or anxiety, defined as having at least one inpatient or two outpatient Medicare claims for depression or anxiety starting from 24 months to 1 month prior to their blood cancer diagnosis. We also examined prevalence of CA-depression or anxiety, defined as at least one inpatient or two outpatient claims for these conditions between 1 month prior to and 3 months after their blood cancer diagnosis. CA-depression or anxiety were mutually exclusive with pre-diagnostic depression or anxiety respectively. We performed univariable analysis to determine sociodemographic and clinical covariates of CA-depression or CA-anxiety. Next, we fit multivariable logistic regression models to characterize factors independently associated with these two outcomes, adjusting for potential confounders: blood cancer type, age, sex, race, marital status, income, education, comorbidity regardless of univariable significance, and additional variables with p<0.05 in univariable analysis. Results: A total of 64,018 patients were eligible, of which 53.4% had lymphoma, 18.6% myeloma, 18.0% leukemia, and 10.0% myelodysplastic syndromes. Most patients were White (89.6%) and 51.0% were female. Of the entire cohort, 10.6% had pre-diagnostic depression, 4.4% had CA-depression, 7.4% had pre-diagnostic anxiety, and 2.8% had CA-anxiety. Overall, 20.7% of the cohort met our claims-based definition of at least one of these four mental health disorders. In univariable analysis, patients with CA-depression were more likely to have pre-diagnostic anxiety (10.7% vs. 7.3%, p<0.001), have a high comorbidity score (37.5% vs. 31.8%, p<0.001), be female (56.7% vs. 50.6%, p<0.001), and be unmarried (55.3% vs. 52.0%, p=0.001) versus patients without CA-depression. They were also less likely to be non-White (8.8% vs. 10.5%, p=0.005). All associations except marital status remained significant in multivariable analysis (Table 1). In univariable analysis, patients with CA-anxiety were more likely to have pre-diagnostic depression (18.9% vs. 10.4%, p<0.001) and be female (63.2% vs. 50.5%, p<0.001); they were also less likely to be non-White (7.7% vs. 10.5%, p<0.001) compared to patients without CA-anxiety. All associations remained significant in multivariable analysis (Table 2). Conclusions: In this large cohort of patients with blood cancers, more than one in five individuals struggled with depression or anxiety either before their blood cancer diagnosis or as a new mental health syndrome during the three months afterward. These data suggest a critical need for systematic mental health screening and management for this patient population. Moreover, the fact that patients with pre-diagnostic anxiety or depression were at increased risk of developing CA-depression or anxiety respectively emphasizes the importance of additional psychosocial support for patients with pre-existing mental disorders. Finally, our finding that non-White patients were significantly less likely to develop CA-depression or anxiety is provocative, and suggests that either non-White patients with hematologic malignancies have a lower incidence of these disorders or that the mental health concerns of this population are less likely to be routinely captured. Disclosures No relevant conflicts of interest to declare.
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Epperla, Narendranath, Melissa Pavilack, Temitope O. Olufade, Richa Bashyal, Jieni Li, Huseyin Yuce, and Leslie Andritsos. "Adverse Events Among Patients with Hairy Cell Leukemia Treated with Purine Nucleoside Analogs in the United States." Blood 132, Supplement 1 (November 29, 2018): 4833. http://dx.doi.org/10.1182/blood-2018-99-115954.
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Abstract Introduction: Purine nucleoside analogs (PNAs) are the recommended first-line treatment in patients with hairy cell leukemia (HCL) owing to their efficacy. However, because of the rarity of this disease, little is known about clinically significant adverse events (AEs) outside of previously performed clinical trials. This retrospective claims-based study of patients treated in the current era of improved supportive care assessed the incidence and prevalence rates of AEs associated with PNA use and healthcare resource utilization (HRU) among patients with HCL enrolled in the Truven MarketScan Commercial Claims and Encounters and the Medicare Supplemental databases. Methods: Adults (≥18 years old) diagnosed with HCL (≥2 medical claims ≥30 days apart) between January 1, 2006 and December 31, 2015 were included in the study. All patients had ≥1 claim for PNA therapy (cladribine or pentostatin ± rituximab) after the HCL diagnosis date and the 1st prescription claim was defined as the index date. Continuous health plan enrollment for ≥6 months pre- (baseline period) and ≥12 months post-index date (follow-up period) was required. Patients treated with a PNA during the baseline period were excluded. Incidence rate was defined as the number of new cases of an AE during the follow-up period divided by the number of patients at risk (patients without any evidence of the adverse event in the 6-month baseline period). Prevalence rate was defined as the number of all AEs (existing cases during the baseline period and new cases during the follow-up period) divided by the total number of patients. Incidence and prevalence rates were calculated as rate per 1000 patient-years at risk. To evaluate the HRU, PNA-treated patients with HCL were categorized based on occurrence of highest AE during the follow-up period. Generalized linear model (GLM) compared HRU during the 12-month follow-up, adjusting for demographic, clinical characteristics, and baseline total healthcare costs. Results: In total, 647 PNA-treated patients with HCL were identified. Mean age (standard deviation) was 57.1 (12.2) years. Most patients were men (81.5%) and resided in the southern USA (32.2%). Over the 12-month follow-up period, 87.2% of the PNA-treated patients developed at least one AE. PNA-related AEs with the highest incidence rate were myelosuppression, anemia, and skin toxicities. The prevalence rate showed a similar trend for PNA-related AEs. Infectious complications including opportunistic infections were seen at a high rate (Table 1). The incidence and prevalence of infectious complications overall were 23.5% and 39.3% (235 and 393 per 1000 patient-years), respectively. Patients who developed myelosuppression had a higher rate of hospitalization compared with those who did not (47.4% vs 12.2%; p<0.0001) and had a longer inpatient length of stay (LOS) (3.4 vs 0.8 [days]; p=0.001). A higher proportion of patients who developed opportunistic infections were hospitalized compared with those who did not (53.7% vs 30.8%; p=0.025) and had a longer inpatient LOS (5.4 vs 2.4 [days]), although this was not statistically significant (p=0.138). Conclusion: This large claims-based dataset of patients with HCL treated with PNAs shows that a substantial proportion of patients developed AEs, including myelosuppression (most frequent) and infectious complications. Because of the nature of the data set, information regarding mortality is not currently available. However, infections due to myelo- and immunosuppression are known to be the most frequent causes of death in this patient population. These findings indicate a need for larger studies evaluating the outcomes of patients with HCL treated with approved therapies to understand better their short- and long-term toxicities, as well as for the development of therapies with lower risks of myelo- and immunosuppression. Disclosures Pavilack: AstraZeneca: Employment. Olufade:AstraZeneca: Equity Ownership; AstraZeneca: Employment. Bashyal:STATinMED: Employment. Li:STATinMED: Employment. Andritsos:HCLF: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy.
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Geynisman, Daniel M., and Ya-Chen T. Shih. "Treatment (tx) patterns and drug (Rx) costs for patients (pts) with metastatic renal cell carcinoma (mRCC) in the United States." Journal of Clinical Oncology 32, no. 4_suppl (February 1, 2014): 457. http://dx.doi.org/10.1200/jco.2014.32.4_suppl.457.
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457 Background: The tx paradigm for mRCC has rapidly morphed from cytokine-based and cytotoxic tx to targeted therapy (TT). Five oral (O) and two intravenous (IV) TTs are approved for mRCC. No consensus exists on the sequence of TT use. This study aimed to examine the evolution of 1st through 3rd line tx patterns since 2004 and their associated costs. Methods: LifeLink Health Plan Claims Database (October 1, 2003-March 31, 2011), a commercial claims database, was used to create a cohort of age ≥ 18 yo, mRCC pts with at least 12 months of continuous enrollment. We examined tx patterns and sequences by year. When evaluating cost, we limited analysis to pts <65 yo because the database does not have information on claims paid by Medicare. We described pt characteristics and tx patterns over time and applied a nonparametric bootstrapping method to compare costs. Results: 1,561 mRCC pts met the inclusion criteria with 71% men and a mean age of 62 yo (SD=11); 39% were from the South; 57% had a modified Charlson comorbidity score of zero. In 2010: 9 unique Rx regimens were used for 1st line tx, 8 for 2nd, 8 for 3rd; most common 1st/2nd/3rd line tx was sunitinib (44%)/temsirolimus (24%)/everolimus=sunitinib (26%); most common sequence was VEGF->mTOR for the 1st switch and VEGF->VEGF->VEGF for 2nd switch. From 2004 to 2011, 1st line cytotoxic tx decreased from 47% to 6%, IFN-α from 47% to 3%, bevacizumab from 33% to 9%. Over time, more pts were able to go from 1st to 2nd line tx (p=0.01) and 2nd to 3rd line tx (p=0.025). Median time to switch (TTS) from 1st to 2nd line was 175 days (SD 103) with a longer TTS if started on O vs. IV tx (188 vs. 143 days) (p<0.001). For 959 pts <65 yo, stratifying by whether the 1st line tx was O or IV, mean total 1st-yr tx cost/pt was $130,962 (IV) vs. $121,676 (O) (P=0.18) and total 1st-yr Rx cost was $36,636 (IV) vs. $54,596 (O) (p<0.001). Also, costs increased by the number of switches, from $108,428 for no switch to $190,976 for > 1 switch. Conclusions: The results support a drastic shift in the tx of mRCC with wide heterogeneity in tx patterns, reflecting a lack of clear guidelines. Over the years, more pts are able to receive more lines of tx, TTS was longer with initial O tx, but 1st-yr Rx costs were lower with initial IV tx.
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Maskin, Carolyn, Arash Mostaghimi, Aster Meche, Markqayne Ray, Kavita Gandhi, David Gruben, and Vanja Sikirica. "Comorbidities, Healthcare Utilization, and Costs Associated With Alopecia Totalis and Alopecia Universalis in the United States." SKIN The Journal of Cutaneous Medicine 6, no. 6 (November 16, 2022): 511–17. http://dx.doi.org/10.25251/skin.6.6.9.
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Background: Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. Extensive forms of AA include alopecia totalis (AT; complete scalp hair loss) or alopecia universalis (AU; complete scalp, face, and body hair loss). Limited information exists about the cost and healthcare burden of AT and AU. Methods: Using a large US administrative healthcare claims database, two mutually exclusive patient cohorts were identified: AA cohort: ≥1 diagnosis of AA; AT/AU cohort: ≥1 diagnosis of AT/AU between January 1 and December 31, 2017. Baseline characteristics measured at first AA diagnosis (index date) and all-cause healthcare utilization and costs identified in the 1-year post-index period were compared between AT/AU and non-AT/AU AA cohorts. Results: 14,340 patients with AA were identified, including 1,224 patients with AT or AU. Compared with patients with non-AT/AU AA (n=13,116), patients with AT/AU were older (mean age 43.1 vs 40.6 years, P<0.0001) and more were female (68.1% vs 62.9%, P<0.0001). More patients with AT/AU had baseline comorbidities (atopic disease [28.3% vs 24.1%], anemia [10.4% vs 7.4%], autoimmune disorders [9.6% vs 5.5%]; P≤0.001 for all). Post-index patients with AT/AU had higher per person per policy year healthcare resource utilization and costs (P≤0.001) and total adjusted annual mean costs (P<0.05). Over 50% more patients with AT/AU received immunosuppressive agents than patients with non-AT/AU AA. Conclusion: Patients with AT/AU had higher rates of comorbidities and greater healthcare resource utilization medical costs than patients with non-AT/AU AA, suggesting that improved insight into the patterns of specific comorbid conditions is needed.
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QUINT, JENNIFER, JUKKA MONTONEN, XINTONG HE, ALBERTO DE LA HOZ, and DAINA ESPOSITO. "EFFECTIVENESS OF COPD MAINTENANCE THERAPY WITH LAMA/LABA VS LAMA/LABA/ICS IN A UNITED STATES CLAIMS DATABASE." Chest 160, no. 4 (October 2021): A1863—A1864. http://dx.doi.org/10.1016/j.chest.2021.07.1664.
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Seal, Brian S., Susan H. Foltz Boklage, and Carl V. Asche. "Treatment and characteristics of patients treated for hepatocellular carcinoma (HCC) by physician types in the United States." Journal of Clinical Oncology 30, no. 4_suppl (February 1, 2012): 375. http://dx.doi.org/10.1200/jco.2012.30.4_suppl.375.
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375 Background: This study provides a description of the characteristics of patients treated for HCC and how they differ in terms of those treated by 1 type of physician vs. those treated by ≥ 2 physicians. Methods: This was a longitudinal, retrospective analysis of claims from the Thomson Reuters MarketScan database for patients treated for incident HCC. The patients were selected based upon those being treated for malignant neoplasm’s of the liver as their primary diagnosis (ICD-9 code 155.00) and they were required to have continuous eligibility around their initial liver cancer incidence data for 6 months prior and ≥ 12 months subsequent to treatment. Excluded were those having evidence of HCC and any other type of tumor in the prior 6 months. The study period was from 01/01/2006 until 06/30/2010. Descriptive analysis was used to draw comparisons between patients seen by 1 vs. ≥ 2 specialists. Results: 967 patients were analyzed, of whom 631were seen by 1 and 336 were seen by ≥2 physicians. The groups were similar except for age (75.8% of 1 physician were aged 45 to 64 years vs. 89.9% ≥ 2 physicians), gender (55.8% males for the 1 vs. 75.3% ≥2 physicians), not having Hepatitis C (75.4% in the 1 vs. 57.4% ≥2 physicians), not having Cirrhosis (70.4% in the 1 vs. 56.3% ≥2 physicians), not having other diseases of the liver (56.6% in the 1 vs. 47.6% ≥2 physicians), not having chemotherapy (92.6% in the 1 vs. 71.4% ≥2 physicians), not having TAE (86.2% in the 1 vs. 60.7% ≥2 physicians), not having ablation (95.3% in the 1 vs. 84.2% ≥2 physicians), and not having resection (93.3% in the 1 vs. 84.2% ≥2 physicians). The top physicians consulted were: Internal Medicine (16.3%); Medical Doctor (16.03%); Gastroenterology (14.37%); Multispecialty Physician Group (13.65%); Oncology/Hematology (13.35%); Family Practice (9.41%); and Surgeon (7.86%). Conclusions: It was found that the HCC patients treated by 1 vs. ≥ 2 physicians were younger, predominantly female [Odds Ratio (OR) of 1.977], less likely to have Hepatitis C (OR of 0.649], and less likely to have ≥ 1 selected treatment (OR of 0.224). The patients were seen by Internal Medicine, General Medical, Multispecialty Groups, and Family Practice more often than Oncologists.
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Khaki, Ali Raza, Yuan Xu, Shasank R. Chennupati, Scott D. Ramsey, Catherine Fedorenko, Veena Shankaran, Andrew J. Cowan, and Winson Y. Cheung. "Intensity of End of Life Care for Hematologic Malignancy Patients in Western Washington, United States and Alberta, Canada." Blood 136, Supplement 1 (November 5, 2020): 21. http://dx.doi.org/10.1182/blood-2020-134825.
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Background: Aggressive care at the end of life (EOL) leads to unnecessary suffering and healthcare costs for patients with cancer. We have previously shown that among patients with solid tumor malignancies, EOL utilization of chemotherapy, intensive care unit (ICU) admissions and >1 emergency department (ED) visits are higher in Washington State vs Alberta (AB). In this study, we use cancer registry and claims data to compare EOL care among patients with hematological malignancies between western Washington (WW) and AB. Methods: Adult patients with hematological malignancies diagnosed between 2007 and 2017 who died before December 31, 2018 were identified from regional population-based cancer registries in WW and AB. Data sources were 1) WW Cancer Surveillance System (a regional SEER registry) with data from 13 counties linked to enrollment files and claims from four regional insurers and 2) Canada National Ambulatory Care Reporting System, Discharge Abstracts Database, and chemotherapy records from AB Health Services. Proportions of patients receiving chemotherapy, ICU admission, or >1 ED visit in the last 30 days of life (DOL) in WW and AB were determined among all patients and those ≥65 years and compared using two sample z-test with two-tailed hypothesis (α=0.006 after Bonferroni correction). Results: 7859 AB and 3767 WW patients met study inclusion criteria. Median age was 76 (IQR 66-83) and 79 (IQR 71-86) for AB and WW, respectively; 78% and 85% were over age 65, 33% and 59% with ≥2 Charlson Comorbidity Score. Cancer distribution was 33% (AB) and 54% (WW) non-Hodgkin lymphoma, 14% (AB) and 20% (WW) myeloma and 27% (AB) and 19% (AB) leukemia. Table 1 shows utilization of chemotherapy, >1 ED visits and ICU admissions in AB and WW for all patients and Table 2 in those ≥65 years. More patients in WW vs AB were treated with chemotherapy (21% WW vs 7% AB) and admitted to ICU (34% WW vs 9% AB) in the last 30 DOL, whereas multiple ED visits were more similar between WW and AB (17% vs 19%, respectively). Similarly, among patients ≥65 years, chemotherapy use and ICU admissions were higher in WW. The same was true for patients in the last 60 and 90 DOL. Conclusions: Similar to what was noted in solid tumor patients, intensity of healthcare use at EOL is greater in WW vs AB for patients with hematological malignancies. However, ≥1 ED visits were similar between populations. Further work is needed to understand drivers of high intensity healthcare use and identify interventions to minimize low value care at EOL. Disclosures Khaki: Merck: Other: share/stockholder; Pfizer: Other: share/stockholder. Ramsey:AstraZeneca: Other: Personal Fees. Cowan:Janssen: Consultancy, Research Funding; Abbvie: Research Funding; Cellectar: Consultancy; Sanofi: Consultancy; Bristol Myers Squibb: Research Funding.
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Parikh, Kejal, Shivani Pandya, Safiya Abouzaid, Onur Baser, Lin Xie, and Manali I. Patel. "Treatment Patterns Among Newly Diagnosed Multiple Myeloma Patients in the United States Veteran Population (2010-2015)." Blood 128, no. 22 (December 2, 2016): 5952. http://dx.doi.org/10.1182/blood.v128.22.5952.5952.
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Abstract Background: Despite a relatively higher incidence in the veteran population, there are few real-world claims-based analyses to describe Multiple Myeloma (MM) treatment patterns among this patient population (Landgren O, Blood, 2006). This study aimed to assess treatment patterns among newly diagnosed MM (ndMM) patients using the US Veteran Health Administration (VHA) data. Methods: This retrospective study identified adult patients with ≥2 claims for MM (ICD-9-CM code: 203.0x) 30 days apart and ≥1 treatment during identification period (1OCT2011-31MAR2015) from the VHA dataset. The initial course of therapy (COT1) date was the index date and included all treatments prescribed within 60 days of this date. Patients were required to have continuous enrollment for 12 months pre- and ≥6 months post-index date unless patients died within 6 months (follow up period), ≥1 full cycle of therapy with a valid COT1 regimen, no evidence of prior MM diagnosis or treatment (including autologous stem cell transplant (ASCT)), and no evidence of ASCT in the follow up period. A subsequent COT (COT2) was defined as the earliest occurrence of: the addition of a new drug or switch in regimen after the first 60 days, restart of a previous regimen after >180-day gap, or a dose increase from maintenance to relapse therapy. Dexamethasone/prednisone[d] which were assumed to be included regardless of whether or not they were observed during the study period did not impact the ongoing COT. Treatment patterns during the follow-up period were initially examined among patients treated with novel (lenalidomide [R] and/or bortezomib [V] with or without chemotherapy agents) and non-novel therapies (≥1 chemotherapy agent, steroid monotherapy) and then compared among those initiating Rd and Vd. Time to next treatment (TTNT) was defined as the duration from initiation of COT1 plus any gaps before COT2. Kaplan Meier and Cox regression analyses were performed to evaluate TTNT and assess the impact of various predictors on TTNT among patients initiating Rd and Vd. Results: Of 1,183 patients that met the inclusion criteria, 55.4% (n=655) were treated with novel therapies and 44.6% (n=528) with non-novel therapies. Among patients treated with novel therapy, the majority initiated Rd (47.8%; n=313) as COT1 followed by Vd (31.2%; n=204), Vd with cyclophosphamide (11.5%; n=75), RVd (6.6%; n=43), Vd with a chemotherapy agent (2.4%; n=16) and Rd with a chemotherapy agent (0.6%; n=4).Rd initiators were significantly older (75.1 vs 70.6 years, p=0.0002) and a higher percentage was white (69.7% vs 47.0%; p<0.0001) than Vd treated patients. While the Charlson Comorbidities Index score did not differ between the two groups (3.6 vs 4.0, p=0.0583), a significantly higher percentage of patients treated with Vd had some comorbidities including hepatitis and renal disease. Among patients with laboratory tests, patients treated initially with Vd had lower hemoglobin (10.8 vs 11.4 g/dl, p=0.0012) and higher serum creatinine (2.3 vs 1.4 mg/dl, p<0.0001) during the pre-index period. The overall average treatment duration in COT1 was significantly longer among patients treated with Rd vs Vd (10.9 vs 7.0 months, p<0.0001). Among patients who were still on active COT1, the mean duration in COT1 was longer among patients treated with Rd than Vd (18.7 vs 13.3 months, p=0.0061). A significantly higher percentage of patients treated with Vd progressed to COT2 (52.5%, vs 26.2% p<0.0001) as compared to Rd. Among patients who progressed to COT2, those treated with Vd had a shorter TTNT compared to Rd (Mean: 9.3 vs 12.8 months, p=0.0049). After adjusting for baseline demographic and clinical factors using Cox regression, TTNT remained significantly shorter for Vd vs those treated with Rd (HR: 2.67, 95% CI: 1.9-3.7, p <0.0001). Conclusion: Slightly over half of MM patients in the US Veteran population were treated with a regimen containing novel therapies; Rd and Vd were the most commonly observed among these. Patients treated initially with Vd had a significantly shorter TTNT compared to those treated with Rd. The difference remained significant after controlling for baseline characteristics including markers for higher disease severity among patients on Vd. Disclosures Parikh: Celgene Corporation: Employment, Equity Ownership, Research Funding. Pandya:Celgene: Research Funding. Abouzaid:Celgene Corporation: Employment, Equity Ownership, Research Funding. Baser:Celgene: Research Funding. Xie:Celgene: Research Funding. Patel:Celgene: Consultancy.
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Heinrich, Kirstin, Birol Emir, Jasmina Ivanova, Jingying Zhou, and Holly Yu. "2376. Incidence of Clostridioides difficile Infection Among United States Medicare Advantage Enrollees." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S819—S820. http://dx.doi.org/10.1093/ofid/ofz360.2054.
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Abstract Background Clostridioides difficile infection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the United States have been characterized previously. The present study aimed to describe the incidence of CDI among Medicare Advantage Enrollees (MAEs), who account for 34% of all Medicare beneficiaries with enrollment increasing annually since 2004. Methods De-identified claims data for this retrospective cohort study were collected from the Optum® Clinformatics® Data Mart and included MAEs aged ≥ 65 years with continuous enrollment for ≥ 1 year before January 1, 2016, followed through death or disenrollment. CDI incidence was defined using the International Classification of Diseases 9th Revision diagnosis code of 008.45 or 10th Revision code of A04.7 (other than admitting diagnosis) or by treatment with nontopical metronidazole, oral vancomycin, or fidaxomicin within 14 days of CDI test. Incident CDI cases were identified from January 1 to December 31, 2016, and required that no CDI occurred within the previous 60 days in 2016. Incidence in 2016 was calculated as CDI cases and CDI patients per 100,000 person-years (PY) of observation time. Results Of 2,542,341 MAEs analyzed, 15,201 patients (0.6%) experienced a total of 18,842 incident CDI episodes. Overall, incidence rates were 762.8 CDI cases and 616.5 CDI patients per 100,000 PY. Incidence increased with age (539.6, 847.3, and 1259.6 cases per 100,000 PY in patients aged 65‒74 years, 75‒84 years, and ≥ 85 years, respectively). Most episodes (50.9%) were community acquired; the remaining 37.7% and 11.4% of episodes were hospital acquired and indeterminate, respectively. CDI patients were more likely than non-CDI patients to be older (mean age, 78.3 vs. 76.1 years, P < 0.0001), be women (64.5% vs. 58.1%, P < 0.0001), or have comorbidities (mean Charlson comorbidity index score, 4.5 vs. 1.8, P < 0.0001). Conclusion CDI incidence rates in the Medicare Advantage population were similar to those reported previously in the Medicare fee-for-service population and nationally among adults aged ≥ 65 years. Data are consistent with a high CDI burden among older US adults. Funding: Pfizer. Disclosures All authors: No reported disclosures.
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Lin, Feng, Raluca Ionescu-Ittu, Irina Pivneva, Willy Wynant, Sherry Shi, Azadeh Shohudi Mojdehi, Eric Wu, Jackie Kwong, and John A. Abraham. "Disability burden in patients with tenosynovial giant cell tumors in the United States from employer perspective." Journal of Clinical Oncology 36, no. 30_suppl (October 20, 2018): 92. http://dx.doi.org/10.1200/jco.2018.36.30_suppl.92.
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92 Background: Tenosynovial giant cell tumor (TGCT) is a rare locally aggressive tumor causing pain, swelling, joint destruction, and limited mobility. This study assessed the disability burden and the associated costs in TGCT patients from an employer’s perspective. Methods: A retrospective analysis was performed using medical and disability claims from the OptumHealth database. Incident patients 18-64 years old with a diagnosis of TGCT (as identified by ICD-9: 727.02, 719.2x; ICD-10: D48.1, D21.x, M12.2) were matched 1:10 to controls without TGCT based on age, gender, index year, and follow-up duration. Patients without earning and disability data were excluded. Days of work loss due to disability claims and absenteeism associated with medical visits were compared using Poisson regression models. Costs were compared using generalized linear models. Results: A total of 1,395 eligible TGCT patients were matched with 13,950 controls without TGCT. Despite similar demographics (36% female, mean age 45-47) and only slightly higher comorbidity burden (mean Charlson Comorbidity Index (CCI): 0.3 versus 0.2), TGCT patients had increased usage of analgesic drugs (44% versus 20%) and MRI tests (37% versus 3%), prior to their diagnosis, compared with controls. During follow-up, TGCT patients were more likely to have disability claims (15.1% vs. 5.6%; p < 0.001), had more disability claim days (9.5 versus 2.0; p < 0.001), medically related absenteeism days (9.9 versus 4.3; p < 0.001), and total days of work loss (19.4 versus 6.3; p < 0.001) per person-year compared with their matched controls. After adjusting for age, gender, index year and CCI score, the average annual indirect cost per person was greater for patients with TGCT than controls ($4,653 versus $1,902; p < 0.001). Conclusions: In addition to the known problems of pain, limitation of mobility, and eventual joint destruction, TGCT patients had substantial indirect costs associated with increased work absenteeism and disability. These findings highlight the unmet need for more effective treatments to reduce not only the medical, but also the economic burden of TGCT.
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Davis, Keith L., Gregory L. Price, Sudeep Karve, Gerhardt M. Pohl, and Richard A. Walgren. "Comorbidity Burden in Elderly Persons with Non-CML Myeloproliferative Neoplasms: Real-World Evidence From a United States Medicare Population." Blood 120, no. 21 (November 16, 2012): 1734. http://dx.doi.org/10.1182/blood.v120.21.1734.1734.
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Abstract Abstract 1734 Background: Non-CML myeloproliferative neoplasms (MPNs), which include essential thrombocythemia (ET), polycythemia vera (PV), myelofibrosis (MF) and MPN not otherwise specified (MPN-NOS), are characterized by activation of JAK2 signaling and abnormal blood cell production. MPN patients, especially those aged ≥65 years (in whom MPN incidence is highest), are at increased risk for cardiovascular and other comorbidities (Vannucchi et al. Blood 2007;110:840-6, Marchioli et al. J Clin Oncol 2005;23:2224-32). However, comorbidity rates in elderly MPN patients as compared with non-MPN controls have not been described in previous literature. MPNs are more prevalent in the elderly and therefore Medicare enrollees are a highly relevant source for US-based epidemiological data for these diseases. Objective: To compare comorbidity rates from four subtypes of elderly MPN patients (ET, PV, MF and MPN-NOS) with matched non-MPN/non-cancer controls. Methods: Retrospective data were taken from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database in the US, which combines clinical information from the SEER cancer registry (MPN reporting has been required since 2001) with medical and pharmacy claims for Medicare enrollees. Patients with a new MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were selected and evaluated for comorbidities from Jan 1, 2008 (index date) through Dec 31, 2008 (follow-up end date). Patients were classified by MPN subtype based on the most recent diagnosis information (ICD-O-3 from the SEER registry or ICD-9-CM from Medicare claims) before the index date. Patients who died before follow-up end, had HMO or discontinuous Medicare enrollment during the follow-up year, had enrollment based on end stage renal disease, or were diagnosed with a non-MPN malignancy before follow-up end were excluded. Comorbidities were defined by ICD-9-CM diagnosis codes comprising the Charlson Comorbidity Index (CCI) (Charlson et al. J Chron Dis 1987;40:373–83; Deyo et al. J Clin Epidemiol 1992;45:613-9) as well as other adverse conditions. Separate non-MPN/non-cancer control groups were selected for each MPN subtype and matched (5:1) on birth year, gender, ethnicity, geography, and reason for Medicare eligibility. The proportion of patients with individual comorbidities and mean CCI during the follow-up year were compared between MPN cases and controls using univariate chi-square tests and t-tests. Results: A total of 1,355 MPN patients (n = 445 ET, 684 PV, 81 MF, 145 MPN-NOS) were identified for inclusion and assigned matching controls. For ET, PV, MF and MPN-NOS cases, respectively, mean [SD] age at index was 75.5 [9.7], 70.8 [11.3], 70.8 [10.4] and 74.1 [8.9] years and % female was 69.0, 43.9, 54.3, and 55.2. Mean [SD] years between first MPN diagnosis and study index date was 3.1 [2.0], 3.4[1.9], 2.7 [2.0], and 3.1 [2.1] for ET, PV, MF and MPN-NOS cases, respectively. Comorbidity rates during the follow-up period for MPN cases and matched controls are shown in the figure. Compared with controls, ET, PV and MPN-NOS cases had significantly (p<0.05) higher rates of serious cardiovascular events and comorbidities during the follow-up year, including myocardial infarction (ET vs. control: 8.1% vs. 4.0%, PV vs. control: 8.6% vs. 4.3%, MPN-NOS vs. control: 9.7% vs. 5.0%), congestive heart failure (CHF) (ET vs. control: 16.4% vs. 12.7%, PV vs. control: 18.4% vs. 10.1%, MPN-NOS vs. control: 22.1% vs. 12.4%), peripheral vascular disease (PVD) (ET vs. control: 20.0% vs. 15.4%, PV vs. control: 19.4% vs. 13.6%, MPN-NOS vs. control: 27.6% vs. 15.7%), and stroke (ET vs. control: 17.8% vs. 13.4%, PV vs. control: 17.8% vs. 13.1%, MPN-NOS vs. control: 22.1% vs. 13.9%). MF cases also had higher rates of CHF, PVD and stroke, but due to small sample size, only congestive heart failure was significant. Other comorbidities were significantly higher in all MPN subtypes, notably thromboembolism, renal disease, moderate-to-severe liver disease, and infections. Conclusions: Medicare enrollees with MPNs generally experienced significantly higher comorbidity rates and overall comorbidity burden (based on mean CCI scores) than matched controls. These findings have implications for both the clinical management of MPN patients as well as for health economic assessments, since a substantial portion of the cost of care for MPNs may reside in treatment of comorbidities not directly coded to MPNs. Disclosures: Davis: Eli Lilly, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Eisai, Sanof-Aventis, Gilead Sciences, MedImmune: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Price:Eli Lilly and Company: Employment, Equity Ownership. Karve:RTI Health Solutions: Consultancy, Research Funding. Pohl:Eli Lilly and Company: Employment, Equity Ownership. Walgren:Eli Lilly and Company: Employment, Equity Ownership.
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Mukhopadhyay, Subhodeep. "Divergent Perspectives: USCIRF vs. Public Opinion on Religious Freedom in India." Praxis International Journal of Social Science and Literature 6, no. 8 (August 25, 2023): 146–58. http://dx.doi.org/10.51879/pijssl/060817.
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The United States Commission on International Religious Freedom (USCIRF), a U.S. government body, has expressed significant concerns about the state of religious freedom in India in recent years. It has particularly highlighted what it alleges to be a decline in religious freedom, especially since the Bharatiya Janata Party (BJP) assumed power in May 2014. The USCIRF’s annual reports claim that Hindu groups routinely orchestrate violence against Muslims, Christians and other minorities, often with the tacit support of the Indian State and its various organs. This paper examines the commission’s claims regarding worsening religious freedom in India, specifically examining the alignment of these claims with public opinion on the matter. A quantitative analysis of 19 years' worth of Google Trends data is conducted to evaluate if public opinion on religious freedom has significantly worsened, since the BJP came to power. The study examines 9 specific dimensions of religious freedom in India. Results show that 8 out of the 9 dimensions display a statistically significant decline in search volumes after mid-2014. In these 8 cases, the average decline in web searches is more than 75%, indicative of a sharp relative decrease in perception of worsening religious situation in India, which is quite contrary to the USCIRF’s allegation of increasing religious intolerance.
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Zettler, Marjorie E., Ethan Basch, and Chadi Nabhan. "Patient-Reported Outcome Labeling for Malignant Hematology Drugs Approved in the United States: 2011-2017." Blood 132, Supplement 1 (November 29, 2018): 2292. http://dx.doi.org/10.1182/blood-2018-99-116404.
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Abstract Introduction: Patient-reported outcomes (PROs), defined as any report on the status of a patient's health condition that comes directly from the patient without interpretation by anyone else, play an increasingly important role in drug development. In 2009 the FDA issued final guidance on using PRO measures to support labeling claims, to incorporate the patient perspective into the drug approval process. The 21st Century Cures Act emphasizes PROs as a differentiating element in the FDA approval process of new drugs, beyond traditional clinical outcome measures. Further, recent data has shown that intervention based on PROs can improve survival in metastatic cancers (Basch et al; 2017). The incorporation of PROs into the labeling of new drugs for malignant hematology disorders has not been studied and is the subject of this investigation. Methods: We reviewed the FDA's Novel New Drug Summaries (2011-2017) to identify drugs approved for malignant hematology indications. Drug approval packages and product labeling were accessed via the Drugs@FDA database and analyzed for PRO endpoints, measures, and labeling claims. Clinical trial designs and published study results were retrieved via the ClinicalTrials.gov website and PubMed. Results: Of 250 novel drugs approved by the FDA between 2011 and 2017, 22 (8.8%) were approved for malignant hematology indications. Interestingly, only 1 had PRO-based claims in their labeling, even though 13 of the 22 drugs (59%) collected PRO data in pivotal trials that led to their approval. Notably, the proportion of malignant hematology trials assessing PROs has increased over time, with 4 of the 5 drugs approved in 2017 for malignant hematology indications evaluating PROs in their development programs, compared with 9 of the 17 drugs approved in the preceding 6 years (80% vs. 53%). PROs evaluated included generic instruments such as the EQ-5D, and disease-specific instruments such as the EORTC QLQ-C30 (see table). Reasons cited for rejection of PRO data inclusion in drug labeling were single arm trial design, excessive missing data, statistical issues, and use of an inappropriate PRO instrument. Conclusions: While the FDA encourages PRO data submission as part of the new drug approval process, and although more than half of all malignant hematology drugs approved in the past 7 years assessed PROs during development, only 1 was able to successfully acquire labeling claims. Whether this is due to lack of PRO expertise on clinical development teams or absence of strong regulatory guidance on how best to implement PROs remains unknown and requires further research. Designing strategies to develop, validate and report PROs effectively is needed to meet regulatory requirements and enhance patients' voices in their own care. Table. Table. Disclosures Nabhan: Cardinal Health: Employment, Equity Ownership.
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Birnbaum, H., R. Kessler, V. Joish, D. Kelley, R. Ben-Hamadi, M. Hsieh, and P. Greenberg. "Healthcare Resource Utilization and Costs of Mild, Moderate, and Severe Depression in the Workforce in the United States." European Psychiatry 24, S1 (January 2009): 1. http://dx.doi.org/10.1016/s0924-9338(09)70847-8.
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Objective:Document the healthcare resource utilization and costs by severity for persons in the workforce with major depressive disorder (MDD).Methods:Using the National Comorbidity Survey-Replication data, workforce respondents (n=4,465) were categorized by clinical severity (not clinically depressed, mild, moderate, severe) using standard scales (CIDI/QIDS-SR). Outcomes measured over 12 months included prevalence of medical services/antidepressant use, average number of visits and days on antidepressants, prevalence of treatment adequacy, and medical/drug costs. Costs represent insurer payments to providers and were estimated by weighting utilization measures by unit costs obtained for similar services used by depressed patients in a U.S. employer claims database for the corresponding period (2000-2001). Outcomes were compared across depression severity groups using multivariate analyses adjusting for demographics.Results:Among the 539 depressed workforce respondents, 13.8% were mildly, 38.5% moderately and 47.7% severely depressed. A significant association existed between severity and prevalence of mental health services usage (19.1%, 27.2%, and 40.3% respectively, p< 0.01) and average number of mental health practitioner visits. The use of antidepressants increased with depression severity (21.1%, 27.3%, and 39.5% respectively, p< 0.01). Similarly, the adequacy of mental health services increased with depression severity (6.2%, 11.8%, and 21.3% respectively, p< 0.05). Average 12-month costs per MDD patient were substantially higher for severe vs. mild (mental health services: $697 vs. $388; general medical services: $138 vs. $53; anti-depressant usage $256 vs. $88).Conclusions:Among workforce respondents, there was a significant association between depression severity and treatment usage and costs, and between treatment adequacy and severity.
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Chen, Yaozhu J., Ajita P. De, Ze Cong, Sanjay K. Aggarwal, and Rolin L. Wade. "Demographic and Comorbidity Characteristics of Newly Diagnosed Multiple Myeloma Patients in the United States: A Real World Data Analysis." Blood 124, no. 21 (December 6, 2014): 1301. http://dx.doi.org/10.1182/blood.v124.21.1301.1301.
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Abstract Background Multiple myeloma (MM) remains an incurable plasma cell neoplasm with >20,000 new cases diagnosed annually in the United States (US). The presentation of MM is diverse and the management is guided by disease- and patient- related factors. Real world evidence regarding disease presentation is sparse for newly diagnosed MM (NDMM) patients. The goal of this study was to describe the baseline demographic and clinical characteristics of NDMM patients by linking multiple large claims databases in the US. Methods A retrospective cohort study was conducted by linking the records between 01/01/2006-12/31/2013 from three longitudinal IMS databases (Medical Claims, Pharmacy Prescriptions, and Hospital Charge Master), to reflect a complete treatment continuum for patients in all ages and by all payer types across healthcare settings. Included patients met the following criteria: ≥2 claims with a diagnosis of MM (ICD-9-CM 203.0x) at least 30 days apart between 01/01/2007-12/31/2012 (first MM diagnosis date = index date); provider stability for at least 6 months before and 3 months after index date; aged 18+ as of index date. NDMM patients were identified as those with no MM diagnosis in the 6 months pre-index. Patient baseline characteristics were assessed using data at index for age, gender, geographic region and payer type; 6-month pre-index plus index day data for Charlson Comorbidity Index (CCI); 6-month pre-index data for 32 comorbidities (e.g., cardiac arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, hypertension, among others); and 5 comorbidity categories (cardiovascular, renal, metabolic, skeletal-related events, and other). Autologous stem cell transplant (ASCT) status was also assessed based on the available follow-up data after initial diagnosis. Patient baseline characteristics were compared between the patients with versus without ASCT after MM diagnosis. Chi-square tests for categorical variables and t-tests for continuous variables (alpha=0.05) were conducted. Results The study cohort of 8,239 NDMM patients had a mean (SD) age of 66.2 (11.3) years at diagnosis, with 56.7% aged 65+; 51.8% were female; and the majority were with commercial (43.3%) or Medicare (42.8%) as payer. Patients with post-index ASCT (n=1,429; 17.3%) were distinctly different from those without (n=6,810; 82.7%): they were younger with a mean (SD) age of 58.1 (8.7) vs. 67.9 (11.1) years, fewer aged 65+, 24.1% vs. 63.5%; fewer female, 47.6% vs. 52.6% (all p<0.001); and the majority (67.5%) of patients who later had ASCT were covered by commercial plans, compared to Medicare as the biggest payer (48.2%) for those who did not have post-index ASCT. NDMM patients had an overall mean (SD) CCI score of 3.1 (1.6). Patients who later received ASCT were healthier than those who did not, with mean (SD) CCI scores of 2.7 (1.4) vs. 3.2 (1.6) (p<0.001). Close to half (47.9%) of all NDMM patients had >1 type of comorbidities at baseline. Figure 1 depicts the baseline comorbidity categories among all NDMM patients as well as the two subsets (with versus without post-index ASCT). Comorbidities were prevalent even before MM diagnosis: 43.9% of patients presented with metabolic comorbidities, 21.4% with cardiovascular diseases, 11.5% with renal conditions, 5.9% with skeletal-related events, and 45.0% with other comorbidities. The patient subset with post-index ASCT had lower comorbidity occurrences compared to those without: 10.5% vs. 23.6% in cardiovascular diseases, 5.9% vs. 12.7% in renal conditions, 32.7% vs. 46.3% in metabolic diseases (all p<0.001), consistent with literature showing that ASCT candidates tend to be younger and have less severe comorbidities. Conclusions This study provided baseline demographic and comorbidity profiles of NDMM patients and showed that the NDMM patient population presented with various comorbidities prior to the first MM diagnosis, suggesting the needs for efficacious, tolerable and safe treatment options for a heterogeneous patient population with complex disease profiles. As expected, patients who had ASCT after initial diagnosis were younger and healthier than those who did not have ASCT. The study findings portray a clearer picture of NDMM patients in the US, and provide clinicians with valuable real world evidence to identify appropriate treatment strategies for these patients. Figure 1 Figure 1. Disclosures Chen: Onyx Pharmaceuticals: Research Funding. De:Onyx Pharmaceuticals: Research Funding. Cong:Onyz Pharmaceuticals: Employment. Aggarwal:Onyx Pharmaceuticals: Employment. Wade:Onyx Pharmaceuticals: Research Funding.
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Near, Aimee, Jenny Tse, Yinong Young-Xu, David K. Hong, and Carolina M. Reyes. "86. Health Resource Burden of Influenza Among the Elderly with Underlying Conditions in the United States." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S174—S175. http://dx.doi.org/10.1093/ofid/ofaa439.396.
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Abstract Background Seasonal influenza poses a substantial clinical and economic burden, despite influenza vaccination efforts. This study evaluates healthcare resource utilization attributable to influenza in elderly populations at increased risk of influenza-related complications. Methods Elderly (≥ 65 years of age) patients (pts) with ≥ 1 influenza diagnosis (Dx) during influenza seasons from October 1, 2014 – March 1, 2019 were identified in the IQVIA PharMetrics® Plus claims database. The earliest influenza Dx was the index date and pts had evidence of pulmonary, cardiovascular, or renal disease before index. Pts had ≥ 12 months continuous enrollment (baseline before index) and ≥ 30 days follow-up after index. Medically-attended influenza cases were identified by primary influenza Dx codes or any influenza Dx with a record of an influenza test within ±14 days. Influenza pts were 1:1 propensity score matched to pts without influenza using baseline demographic and clinical characteristics and baseline healthcare costs. All-cause hospital and emergency department (ED) visits and total healthcare costs during follow-up (30-day and in the index influenza season) were compared in the matched cohorts. Results Baseline characteristics were balanced after matching. Elderly influenza pts had 3 to 7 times higher 30-day hospitalization rates compared to pts without influenza, including pts with congestive heart failure (41% vs. 8%), chronic obstructive pulmonary disease (35% vs. 6%), coronary artery disease (23% vs. 4%), and stage 5/end stage renal disease (ESRD)/dialysis (44% vs. 13%; all p< .05; Figure). Hospital and ED visit rates in the influenza season were 2 to 3 times higher in pts with vs. without influenza; ED visit rates were 49% vs. 23%, 44% vs. 18%, 37% vs. 14%, and 60% vs. 28% for the above cohorts, respectively (all p< .05). Mean total healthcare costs per patient per season were $3,299 to $12,398 higher in pts with vs. without influenza (all p< .05, except myocardial infarction and stage 5/ESRD/dialysis pts). Figure. All-cause 30-day hospitalization rates in matched cohorts of elderly patients with baseline comorbidities with and without influenza Conclusion Hospitalizations, ED visits, and total healthcare costs are elevated in the elderly after evidence of medically-attended influenza, but to varying degrees depending on baseline comorbidities. Continued efforts to reduce influenza burden in high-risk populations are needed. Disclosures Aimee Near, MPH, Employee of IQVIA; IQVIA paid by VIR Bio to complete research project (Consultant) Jenny Tse, MS, Vir Biotechnology, Inc. (Other Financial or Material Support, I am employed by IQVIA which was paid by Vir Biotechnology, Inc. to complete this study.) David K. Hong, MD, Vir Biotechnology (Employee) Carolina M. Reyes, PhD, Vir Biotechnology (Employee, Shareholder)
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Zhou, Mo, Yan Song, Emily Gao, Yohance Whiteside, Emma Billmyer, and James Signorovitch. "863. Pre-Exposure Prophylaxis (PrEP) Prescriptions among Individuals at High Risk for HIV in the United States, 2012-2018." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S523. http://dx.doi.org/10.1093/ofid/ofab466.1058.
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Abstract Background To describe trends in emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) PrEP uptake in 2012-2018 and characterize high risk individuals who use PrEP. Methods The study identified individuals aged ≥ 15 years old with claims suggesting high risk for HIV infection in the IBM MarketScan® Commercial Claims and Multi-state Medicaid Databases. High risk was defined using ICD codes indicating high risk sexual behavior or rectal/repeated bacterial sexually transmitted infection (STI). The index date was defined as the earliest of the first high risk sexual behavior diagnosis, the first rectal bacterial STI diagnosis, or the second non-rectal bacterial STI diagnosis within 12 months. Individuals were considered PrEP users if they had at least one FTC/TDF PrEP prescription within 12 months of index date. Individuals with evidence of HIV prior to or within 30 days after PrEP initiation/index date were excluded. Comorbidities were assessed using a modified Charlson Comorbidity Index that excluded HIV/AIDS. Results FTC/TDF PrEP uptake increased from 0.1% to 7.3% among commercially insured individuals between 2012-2018, and from 0.01% to 0.5% among Medicaid insured individuals between 2012-2017. Individuals ≥ 35 years old had the largest increase in PrEP uptake (0.1% to 13.0%), while those 16-25 years old had the smallest increase (0.03% to 2.3%). The largest proportion of PrEP users across all years were aged 25-34 while the largest proportion of non-PrEP users were aged 18-24. Compared to PrEP users, a larger proportion of PrEP non-users were female (62.9% vs. 1.4%, p < 0.05) and blacks/African American (49.1% vs. 40.3%, p < 0.05). A larger proportion of PrEP users had a risk status of homosexual (46.6% vs. 1.5%, p < 0.05) or bisexual (3.9% vs. 0.8%, p < 0.05) behavior than non-PrEP users. PrEP users also had more comorbidities than non-users among individuals with Medicaid and were less likely to have fee-for-service insurance plans overall (p < 0.05). Table 1. Characteristics of people at high-risk for HIV who do vs. do not use FTC/TDF PrEP measured during the follow-up period Conclusion Despite an increase in FTC/TDF PrEP initiations, uptake was low, especially among young adults, women, heterosexuals and blacks/African Americans. Low initiation rates in these groups may illustrate that FTC/TDF PrEP is not meeting the needs of all high-risk individuals. Disclosures Mo Zhou, PhD, Merck & Co., Inc. (Consultant) Yan Song, PhD, Merck & Co., Inc. (Consultant) Emily Gao, MS, MPH, Merck & Co., Inc. (Consultant) Yohance Whiteside, PhD, MSPH, Merck & Co., Inc. (Employee) Emma Billmyer, BA, Merck & Co., Inc. (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant)
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Dubinsky, M. C., M. Gianfrancesco, G. Gauthier, L. Fallon, G. R. Lichtenstein, N. H. Khan, G. Y. Melmed, et al. "P790 Assessment of steroid use in patients with active ulcerative colitis who initiated a new Janus kinase inhibitor or tumour necrosis factor inhibitor using data from a United States claims database." Journal of Crohn's and Colitis 18, Supplement_1 (January 1, 2024): i1474—i1476. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0920.
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Abstract Background In 2021, the United States (US) FDA issued a label update limiting the use of Janus kinase inhibitors (JAKi) to after tumour necrosis factor inhibitors (TNFi). We examined the rate of steroid use and treatment failure among patients (pts) with ulcerative colitis (UC) initiating a JAKi vs TNFi using data from a US claims database. Methods A database of adjudicated medical and pharmacy claims (IQVIA PharMetrics Plus; 2007–2022) was utilised to select pts with UC starting either a new JAKi/TNFi on/after 30 May 2018. Pts were followed from index date to the end of the study period, event of interest or treatment switch (whichever came first). The study assessed steroid use within 90 days of index date, and also treatment failure over the first 6 months after index date, defined as a composite of any: hospitalisation related to UC/colectomy (inpatient/emergency room)/switch to another advanced treatment (AT)/steroid use ≥90 days after index treatment initiation. Individual components of treatment failure were also analysed. Stabilised inverse probability treatment weights (sIPTW) were calculated using 19 confounders. Cox proportional hazards models with sIPTW were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Additional analyses stratifying by AT-naïve vs AT-experienced pts were conducted. Results In total, 6019 pts were included; 763 initiated a JAKi and 5256 a TNFi. More pts initiating a TNFi had prior use of non-biologic conventional treatments and were on concomitant conventional treatments at index date, compared with pts initiating a JAKi. Prior AT was more prevalent among JAKi- (74.3%) vs TNFi- (15.3%) treated pts; baseline steroid use was generally similar across groups (Table). Overall, there was a significantly lower risk of steroid use within 90 days in pts initiating a JAKi vs a TNFi (HR 0.75 [95% CI 0.65, 0.87]), and among AT-naïve and AT-experienced pts (HR 0.79 [95% CI 0.64, 0.97] and HR 0.69 [95% CI 0.59, 0.82], respectively; Figure a). There was a significantly lower risk of treatment failure with JAKi vs TNFi (HR 0.80 [95% CI 0.68, 0.94]; Figure b). A significantly lower risk of steroid use ≥90 days was found amongst JAKi- vs TNFi-treated pts overall and within AT-naïve and AT-experienced subgroups (Figure b–d). Conclusion In this large US-based claims analysis, pts with UC treated with a JAKi had significantly less steroid use than those treated with a TNFi; this was consistent in AT-naïve and AT-experienced pts. Limitations included confounding of factors uncontrollable in claims data and inherent bias due to approved use of JAKi in the US only in pts with inadequate response to TNFi. Study sponsored by Pfizer. Medical writing support provided by C Duncan, CMC Connect; funded by Pfizer.
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White, Lindsay, Paul Fishman, Anirban Basu, Paul K. Crane, Eric B. Larson, and Norma B. Coe. "Dementia Is Associated With Earlier Mortality for Men and Women in the United States." Gerontology and Geriatric Medicine 6 (January 2020): 233372142094592. http://dx.doi.org/10.1177/2333721420945922.
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Objectives: Sociodemographic trends in the United States may influence future dementia-associated mortality, yet there is little evidence about their potential impact. Our study objective was to estimate the effect of dementia on survival in adults stratified by sex, education, and marital status. Methods: Using survey data from the Health and Retirement Study (HRS) linked to Medicare claims from 1991 to 2012, we identified a retrospective cohort of adults with at least one International Classification of Diseases—ninth revision—Clinical Modification (ICD-9-CM) dementia diagnosis code ( n = 3,714). For each case, we randomly selected up to five comparators, matching on sex, birth year, education, and HRS entry year ( n = 9,531), and assigned comparators the diagnosis date of their matched case. Participants were followed for up to 60 months following diagnosis. We estimated a survival function for the entire study population and then within successive strata defined by sex, education, and marital status. Results: On average, dementia cases were 80.5 years old at diagnosis. Most were female, had less than college-level education, and approximately 40% were married at diagnosis. In multivariate analyses, dementia diagnosis was associated with earlier mortality for women (predicted median survival of 54.5 months vs. 62.5 months; dementia coefficient = −0.13; 95% confidence interval [CI] = [−0.22, −0.04]; p = .003), but even more so among men (predicted median survival of 35.5 months vs. 54.5 months; dementia coefficient = −0.42; 95% CI = [−0.52, −0.31]; p < .001). We found substantial heterogeneity in the relationship between dementia and survival, associated with both education and marital status. Conclusion: Both sex and level of education moderate the relationship between dementia diagnosis and length of survival.
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Bell, Christopher F., Mayank R. Ajmera, and Juliana Meyers. "An evaluation of costs associated with overall organ damage in patients with systemic lupus erythematosus in the United States." Lupus 31, no. 2 (January 21, 2022): 202–11. http://dx.doi.org/10.1177/09612033211073670.
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Introduction Approximately 33–50% of patients with systemic lupus erythematosus (SLE) develop organ damage within 5 years of diagnosis. Real-world studies that capture the healthcare resource utilization (HCRU) and costs associated with SLE-related organ damage are limited. The aim of this study was to evaluate HCRU and costs associated with organ damage in patients with SLE in the USA. Methods This retrospective study (GSK study 208380) used the PharMetrics Plus administrative claims database from 1 January 2008 to 30 June 2019. Patients with SLE and organ damage were identified using International Classification of Diseases (ICD)-9/10 codes derived from the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. The first observed diagnosis of organ damage was designated as the index date. Selection criteria included: ≥18 years of age; ≥1 inpatient or ≥2 outpatient claims for SLE (≥30 days apart before the index date; ICD-9: 710.0 or ICD-10: M32, excluding M32.0); ≥1 inpatient or ≥3 outpatient claims for organ damage within 6 months for the same organ system code; continuous enrollment of 12 months both pre- and post-index date. The proportion of patients with new organ damage, disease severity, SLE flares, SLE-related medication patterns, HCRU and all-cause costs (2018 US$) were assessed 12 months pre- and post-index date. Results Of the 360,803 patients with a diagnosis of SLE, 8952 patients met the inclusion criteria for the presence of new organ damage. Mean (standard deviation (SD)) age was 46.4 (12.2) years and 92% of patients were female. The most common sites of organ damage were neuropsychiatric (22.0%), ocular (12.9%), and cardiovascular (11.4%). Disease severity and proportion of moderate/severe flare episodes significantly increased from pre- to post-index date (p < 0.0001). Overall, SLE-related medication patterns were similar pre- versus post-index date. Inpatient, emergency department and outpatient claims increased from pre- to post-index date and mean (SD) all-cause costs were 71% higher post- versus pre-index date ($26,998 [57,982] vs $15,746 [29,637], respectively). Conclusions: The economic impact associated with organ damage in patients with SLE is profound and reducing or preventing organ damage will be pivotal in alleviating the burden for patients and healthcare providers.
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Sano, Dahlia, Nicholas Liu, Scott Knowles, Joanna P. MacEwan, Shu Wang, Jenifer Wogen, Kristina S. Yu, and Seung Tae Lee. "Brentuximab Vedotin Retreatment in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma or Peripheral T-Cell Lymphoma: A Retrospective United States Claims Analysis." Current Oncology 31, no. 5 (May 2, 2024): 2598–609. http://dx.doi.org/10.3390/curroncol31050195.
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Brentuximab vedotin (BV) monotherapy (BV-M) and combination (BV-C) therapies are safe and effective for classical Hodgkin lymphoma (cHL) and CD30-expressing peripheral T-cell lymphomas (PTCLs). Although the sample sizes have been small (12–29 patients), in clinical studies, response rates of 53–88% have been reported for BV retreatment in patients with an initial BV response. We evaluated the real-world characteristics and treatment patterns of cHL/PTCL patients who received BV and were retreated in the United States. Symphony Health Patient Claims (11/2013–1/2022) were retrospectively analyzed to identify cHL/PTCL patients treated with BV and retreated with BV-M, BV-C, or non-BV therapy. Patient characteristics were described by retreatment, and predictors of BV-M retreatment were identified. Among the cHL and PTCL patients treated with BV (n = 6442 and 2472, respectively), 13% and 12%, respectively, were retreated with BV; the median times from initial BV to BV-M retreatment were 5 and 7 months, respectively; and the numbers of BV-M retreatment doses were 4 and 5, respectively. Among cHL patients, the predictors of BV-M retreatment were age (18–39 vs. ≥60 years), sex (women vs. men), and previous stem cell transplantation (yes vs. no). Among PTCL patients, the only predictor of BV-M retreatment was systemic anaplastic large-cell lymphoma subtype (yes vs. no). Real-world data support clinical study results suggesting earlier BV treatment be considered, as BV retreatment may be an option.
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Werneiwski, Kendall, Ruchika Goel, and Eric A. Gehrie. "Feasibility of Constructing an Interactive Mapping Tool to Visualize Sickle Cell Disease Geographic Distribution and Medical Care Utilization in the United States." Blood 142, Supplement 1 (November 28, 2023): 2304. http://dx.doi.org/10.1182/blood-2023-182079.
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Introduction: It is recognized that many people living with sickle cell disease (SCD) face significant structural obstacles to establishing and maintaining long-term hematology care. For example, some people with SCD care may lose access as a result of a geographic move; others may lose access by aging out of the pediatric care setting. These scenarios could be addressed by providing resources in areas with addressable populations and unmet medical need. However, deploying SCD treatment resources is frustrated by the lack of an established tool that can estimate the number of people living with SCD or gaps in services available in a given geography. We hypothesized that we could build a tool using a combination of publicly available demographic data combined with hospital claims data. Methods: Using CDC estimations for SCD affecting 1 in 365 African American and 1 in 16,300 Hispanic births, we estimated SCD prevalence based on data from the 2021 US Census, segmented by age, race, and county. We added a distinction between rural and urban counties using classification from the Consumer Financial Protection Bureau (CFPB), which designates rural counties as “a county that is neither in a metropolitan statistical area nor in a micropolitan statistical area that is adjacent to a metropolitan statistical area.”. PowerBI was used to generate a heat map to visualize the data at a state and county level, with the ability to filter by patient age and urban vs. rural designation. Finally, using hospital claims data for SCD “with crisis” (i.e., claims referencing ICD10 codes: D5700; D5701; D5702; D57211; D57212; D57219; D57811; D57812; D57819) and SCD “without crisis” (i.e., claims referencing ICD10 codes: D571; D5720; D5740; D5742; D5744; D5780), Pearson correlation was used to determine if an association existed between our estimated SCD prevalence and SCD related hospital claims for claim years 2021, 2022 and partial 2023. Results: Our model estimates a total of 127,297 people living with SCD in the United States, with 97% (123,454) being Black and 3% (3,843) being Hispanic (Table 1). 88% (111,977) were predicted to be under age 65, and 28% (35,675) were predicted to be under age 19. The majority (95%, 120,875) lived in urban counties. Most rural counties with SCD patients are located in the South and Southeast US (Figure 1). There was a strong positive correlation between our predictions of SCD prevalence at the state level and SCD-related hospital claims (coefficient of 0.903217 [95%CI: 0.944-0.836], p<0.001). For claim years 2021, 2022 and 2023 (partial) there were 1.6 claims per 1 SCD patient across the United States. While there were 1.6 claims per patient in urban counties, there were 0.7 claims per 1 patient in rural counties, consistent with a relative lack of access to care in rural areas compared to urban areas. Conclusions: Although not a direct measurement, and possibly overestimating the number of people >age65 living with SCD, our estimate suggests that there may be several thousand more people living with SCD than what is generally believed (100,000 per US CDC). Our estimates are partially validated by our finding that hospital claims data correlate strongly with our estimates of SCD prevalence at the state level. Although only a relatively small population of people living with SCD reside in rural counties, lower utilization of hospital services, as measured by hospital claims data, suggest that rural populations may have an unmet medical need that is particularly striking. Although working with claims data and disease estimates based on census data introduces significant limitations, it is feasible that this type of analysis could help to direct resources to areas with greatest unmet medical need.
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Moon, Rena C., Alen Marijam, Fanny S. Mitrani-Gold, Daniel C. Gibbons, Alex Kartashov, Ning A. Rosenthal, and Ashish V. Joshi. "Treatment patterns, healthcare resource use, and costs associated with uncomplicated urinary tract infection among female patients in the United States." PLOS ONE 17, no. 11 (November 21, 2022): e0277713. http://dx.doi.org/10.1371/journal.pone.0277713.
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Background We evaluated associations between antibiotic prescription and healthcare resource use and costs (Part A), and between antibiotic switching and healthcare resource use, costs, and uncomplicated urinary tract infection recurrence (Part B) in female patients with uncomplicated urinary tract infection in the United States. Methods This retrospective cohort study of linked Optum and Premier Healthcare Database data included female patients ≥12 years old with an uncomplicated urinary tract infection diagnosis (index date), who were prescribed antibiotics during an outpatient/emergency department visit between January 1, 2013 and December 31, 2018. In Part A, patients were stratified by antibiotic prescription appropriateness: appropriate and optimal (compliant with Infectious Diseases Society of America 2011 guidelines for drug class/treatment duration) versus inappropriate/suboptimal (inappropriate drug class/treatment duration per Infectious Diseases Society of America 2011 guidelines, and/or treatment failure). In Part B, patients were stratified by treatment pattern (antibiotic switch vs no antibiotic switch). Healthcare resource use and costs during index episode (within 28 days of index date) and 12-month follow-up were compared. Results Of 5870 patients (mean age 44.5 years), 2762 (47.1%) had inappropriate/suboptimal prescriptions and 567 (9.7%) switched antibiotic. Inappropriate/suboptimal prescriptions were associated with higher healthcare resource use (mean number of ambulatory care and pharmacy claims [both p < 0.001]), and higher total mean cost (inpatient, outpatient/emergency department, ambulatory visits, and pharmacy costs) per patient ($2616) than appropriate and optimal prescriptions ($649; p < 0.001) (Part A). Antibiotic switching was associated with more pharmacy claims and higher total mean costs (p ≤ 0.01), and a higher incidence of recurrent uncomplicated urinary tract infection (18.9%) than no antibiotic switching (14.2%; p < 0.001) (Part B). Conclusions Inappropriate/suboptimal prescriptions and antibiotic switching were associated with high costs, ambulatory care, and pharmacy claims, suggesting a need for improved uncomplicated urinary tract infection prescribing practices in the United States.
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Subramaniam, Divya S., Zidong Zhang, Zachary Timmer, Elisabeth C. DeMarco, Michael P. Poirier, and Leslie J. Hinyard. "Palliative Care and Mental Health among Pancreatic Cancer Patients in the United States: An Examination of Service Utilization and Health Outcomes." Healthcare 12, no. 8 (April 16, 2024): 842. http://dx.doi.org/10.3390/healthcare12080842.
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Introduction: Palliative care (PC) utilization remains low among pancreatic cancer patients. This study explores the association of PC with mental health service and pharmacotherapy utilization among pancreatic cancer patients. Methods: Retrospective analysis was conducted on a sample of patients in the United States with newly diagnosed pancreatic cancer using Electronic Health Record data from Optum’s Integrated Claims-Clinical data set. Subsequent diagnoses of anxiety and depression and PC consultation encounters were determined using ICD-9/10 codes. Adjusted associations of mental health treatments with PC and patient characteristics were quantified using multiple logistic regression. Results: Among newly diagnosed pancreatic cancer patients (n = 4029), those with PC consultations exhibited a higher prevalence of anxiety (33.9% vs. 22.8%) and depression (36.2% vs. 23.2%). Mental health service use and pharmacotherapy varied, with the highest utilization among patients having both anxiety and depression. Treatment pattern was also influenced by age (aOR 1.832 for age <55 vs. 65–70 years). Notably, PC consultations showed no significant effect on the likelihood of documented treatment. Discussion: Our study emphasizes underutilization of PC and MH treatment for pancreatic cancer patients. These findings imply a crucial need for further investigation into palliative care’s role in addressing mental health concerns among pancreatic cancer patients.
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McGovern, Ian, Alina Bogdanov, Katherine Cappell, Sam Whipple, and Mendel Haag. "Influenza Vaccine Uptake in the United States before and during the COVID-19 Pandemic." Vaccines 10, no. 10 (September 26, 2022): 1610. http://dx.doi.org/10.3390/vaccines10101610.
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The COVID-19 pandemic, along with disruptions to routine medical care, brought renewed urgency to public health messaging about the importance of influenza vaccination. This retrospective cohort study used a database of linked claims and electronic medical record data to evaluate clinical and demographic characteristics and influenza vaccination history associated with changes in influenza vaccine uptake following the start of the COVID-19 pandemic. Influenza vaccine uptake was examined in six seasons (2015–2016 through 2020–2021). Individuals were grouped by vaccination history in the five seasons before 2020–2021. Characteristics of 2020–2021 vaccinated vs. unvaccinated individuals were compared, stratified by vaccination history. Overall influenza vaccination uptake was highest in 2020–2021 (35.4%), following a trend of increasing uptake since 2016–2017 (31.4%). Uptake in 2020–2021 was observed in all age groups except ≥65 years, and the increase was particularly notable in individuals <18 years. In the previous five seasons, individuals ≤17 and >65 years, White, and Asian individuals were most likely, while 18-to-49-year-olds and those with fewer comorbidities were least likely, to be consistently vaccinated. Influenza vaccination status in 2020–2021 aligned with vaccination history; few differences in patient characteristics (age, comorbidities, state of residence) were observed when stratified by vaccination history.
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Patel, Ankoor, Clark Zhang, Carlos D. Minacapelli, Kapil Gupta, Carolyn Catalano, You Li, and Vinod K. Rustgi. "Outcomes, Mortality, and Cost Burden of Acute Kidney Injury and Hepatorenal Syndrome in Patients with Cirrhosis." Journal of Gastrointestinal and Liver Diseases 32, no. 1 (March 31, 2023): 39–50. http://dx.doi.org/10.15403/jgld-4618.
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Background and Aims: Cirrhosis is associated with an increased risk of acute kidney injury (AKI) and hepatorenal syndrome (HRS). Healthcare utilization and cost burden of AKI and HRS in cirrhosis is unknown. We aimed to analyze the health care use and cost burden associated with AKI and HRS in patients with cirrhosis in the United States by using real-world claims data.
Methods: We conducted a case-control study using the Truven Health MarketScan Commercial Claims databases from 2007-2017. A total of 34,398 patients with cirrhosis with or without AKI and 4,364 patients with cirrhosis with or without HRS were identified using International Classification of Diseases, Ninth or Tenth Revision, codes and matched 1:1 by sociodemographic characteristics and comorbidities using propensity scores. Total and service-specific were quantified for the 12-months following versus the 12-months before the first date of AKI or HRS diagnosis and over 12-months following a randomly selected date for cirrhosis controls to capture entire disease burdens.
Results: The AKI and HRS group had a higher number of comorbidities and were associated with higher rates of readmission and mortality. The AKI and HRS groups had a significantly higher prevalence of ascites, spontaneous bacterial peritonitis (SBP), encephalopathy, gastrointestinal bleeding, septic shock, pulmonary edema, and respiratory failure. Compared to patients with cirrhosis only, AKI was associated with higher number of claims per person (AKI vs. cirrhosis only, 60.30 vs. 47.09; p<0.0001) and total annual median health care costs (AKI vs. cirrhosis only, $46,150 vs. $26,340; p<0.0001). Compared to patients with cirrhosis only, the HRS cohort was associated with a higher number of claims per person (HRS vs. cirrhosis only, 44.96 vs. 43.50; p<0.0009) and total annual median health care costs (HRS vs. cirrhosis only, $34,912 vs. $23,354; p<0.0001). Inpatient costs were higher than the control cohort for AKI (AKI vs. cirrhosis only, $72,720 vs. $29,111; p<0.0001) and HRS (HRS vs. cirrhosis only, $ 98,246 vs. $27,503; p<0.0001). Compared to the control cohort, AKI and HRS had a higher rate of inpatient admission, mean number of inpatient admissions, and mean total length of stay.
Conclusions: AKI and HRS are associated with higher health care utilization and cost burden compared to cirrhosis alone, highlighting the importance for improved screening and treatment modalities.
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Leung, Jessica, Elizabeth B. Gray, Tara Anderson, Sarah M. Sharkey, and Kathleen L. Dooling. "07. Recombinant Zoster Vaccine (RZV) Second-Dose Completion in Adults Age 50‒64 Years in the United States." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S127. http://dx.doi.org/10.1093/ofid/ofab466.210.
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Abstract Background In 2018, CDC recommended a highly efficacious adjuvanted recombinant zoster vaccine (RZV, Shingrix) as a 2-dose series for prevention of herpes zoster (HZ) for immunocompetent persons age ≥50 years, with the 2nd dose recommended 2–6 months after the 1st dose. Among Medicare beneficiaries, 2-dose series completion 6 months and 12 months post initiation was 78% and 86%, respectively. Here we estimate the proportion of adults age 50–64 years who completed the 2-dose RZV series within 6 or 12 months after receiving their 1st dose, by using two administrative claims databases. Methods We used medical and pharmaceutical claims data from October 2017‒March 2020 IQVIA® PharMetrics Plus and October 2017‒October 2020 IBM® MarketScan® databases. RZV vaccination was defined using Current Procedural Terminology and National Drug Codes. We allowed for sufficient follow-up time by examining 1st doses given at least 6 or 12 months prior to the end of the study period in both databases. Place of administration was available in IQVIA data. Results Among persons age 50‒64 years, in IQVIA and MarketScan, 70% and 68% received their 2nd RZV dose within 6 months, respectively, and 79% and 81% received their 2nd dose within 12 months, respectively. The median age of 1st dose of RZV vaccination was 60 years and ~60% were female [Table 1]. When the 2nd dose was administered within 12 months, the median interval between 1st and 2nd doses was 104 and 98 days in the IQVIA and MarketScan databases, respectively. Characteristics by age, sex, or region were similar in persons who received 1 RZV dose vs. 2 RZV doses [Table 1]. Among those who received only 1 RZV dose with at least 12 months of follow-up time, 55% of vaccinations occurred at ambulatory medical provider offices and 40% at pharmacies; among 2 doses recipients, 33% of vaccinations occurred at provider offices and 62% at pharmacies. Conclusion Among 50‒64-year-olds, 2-dose RZV series completion was ~70% within 6 months and 80% within 12 months of initiation. The findings were similar across two administrative claims databases. Availability of RZV at pharmacies has potentially helped to increase RZV 2nd dose completion rates. Disclosures All Authors: No reported disclosures
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Sacks, Naomi C., Bridget E. Healey, Sajjad Raza, Philip L. Cyr, Gerhard Boerner, and Ajay Sheshadri. "The economic burden of NIPC and BOS following allogeneic HSCT in patients with commercial insurance in the United States." Blood Advances 6, no. 5 (March 4, 2022): 1566–76. http://dx.doi.org/10.1182/bloodadvances.2021004364.
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Abstract Noninfectious pulmonary complications (NIPC) after allogeneic hematopoietic stem cell transplantation (alloHSCT), including bronchiolitis obliterans syndrome (BOS), cause significant morbidity and mortality, but their impact on health care resource utilization (HRU) and costs is unknown. This longitudinal retrospective study quantified the economic burden of NIPC and BOS in alloHSCT patients using commercial claims data from the IQVIA PharMetrics Plus database. Study patients were aged 0 to 64 years and underwent alloHSCT between 1 January 2006 and 30 September 2018, and were observable 12 months before and up to 5 years after index alloHSCT. NIPC patients were identified using International Classification of Disease (ICD) diagnosis codes. Outcomes were mean per patient HRU (inpatient admissions, outpatient office, hospital visits, and prescription medications) and costs paid by insurers in each post-transplant year. Among 2162 alloHSCT patients, 254 developed NIPCs, and 155 were propensity score (PS)-matched to non-NIPC patients. The year following transplantation, NIPC patients had significantly higher inpatient admission rates (3.8 ± 3.2 vs non-NIPC: 2.6 ± 2.4; P < .001) and higher total costs ($567 870 vs $412 400; P = .07), reflecting higher costs for inpatient admissions ($452 475 vs $300 202; P = .06). Among those observable for more years, costs remained higher for NIPC patients, reflecting significantly higher inpatient admission rates in the first 3 years following transplant. Subanalysis of patients with diagnoses likely reflective of BOS were consistent with these findings. AlloHSCT patients who developed NIPC had higher health care resource utilization and incurred higher costs compared with alloHSCT patients who did not develop NIPC following transplant.
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Karve, Sudeep, Gregory L. Price, Keith L. Davis, Gerhardt M. Pohl, and Richard A. Walgren. "Health Care Utilization and Associated Costs in Elderly Persons with Non-CML Myeloproliferative Neoplasms: Real-World Evidence From a United States Medicare Population." Blood 120, no. 21 (November 16, 2012): 4273. http://dx.doi.org/10.1182/blood.v120.21.4273.4273.
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Abstract Abstract 4273 Background: Non-CML myeloproliferative neoplasms (MPNs), which include essential thrombocythemia (ET), polycythemia vera (PV), myelofibrosis (MF) and MPN not otherwise specified (MPN-NOS), are characterized by activation of JAK2 signaling and abnormal blood cell production. Median survival ranges from months to years for MF and up to a decade or more for PV and ET. Some symptomatic treatment options exist, but with the exception of hematopoietic stem cell transplant, none are curative. Although MPN incidence is highest in persons aged ≥65 years, little is known about overall health care utilization and costs in elderly persons with these diseases. MPNs are more prevalent in the elderly and therefore Medicare enrollees are a highly relevant source for US-based resource utilization and cost data for these diseases. Objective: To compare all-cause health care utilization and costs from four subtypes of elderly MPN patients (ET, PV, MF and MPN-NOS) with matched non-MPN/non-cancer controls. Methods: Retrospective data were taken from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database in the US, which combines clinical information from the SEER cancer registry (MPN reporting has been required since 2001) with medical and pharmacy claims for Medicare enrollees. Patients with a new MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were selected and evaluated for all-cause health care utilization and costs from Jan 1, 2008 (index date) through Dec 31, 2008 (follow-up end date). Patients were classified by MPN subtype based on the most recent diagnosis information (ICD-O-3 from the SEER registry or ICD-9-CM from Medicare claims) before the index date. Patients who died before follow-up end, had HMO or discontinuous Medicare enrollment during the follow-up year, had enrollment based on end stage renal disease, or a diagnosis of a non-MPN malignancy before follow-up end were excluded from the study. Separate non-MPN/non-cancer control groups were selected for each MPN subtype and matched (5:1) on birth year, gender, ethnicity, geography, and reason for Medicare eligibility. Per patient health care utilization and costs during the follow-up year were aggregated and stratified by care setting. Costs were adjusted to 2010 US$ and represent amounts reimbursed by Medicare to providers. Costs were compared between MPN cases and controls using univariate t-tests. Results: A total of 1,355 MPN patients (n = 445 ET, 684 PV, 81 MF, 145 MPN-NOS) were identified for study inclusion and assigned matching controls. For ET, PV, MF and MPN-NOS cases, respectively, mean [SD] age at index was 75.5 [9.7], 70.8 [11.3], 70.8 [10.4] and 74.1 [8.9] years and % female was 69.0, 43.9, 54.3, and 55.2. Mean [SD] years between first MPN diagnosis and study index date was 3.1 [2.0], 3.4[1.9], 2.7 [2.0], and 3.1 [2.1] for ET, PV, MF and MPN-NOS cases, respectively. A significantly (p<0.05) higher proportion of MPN cases, regardless of subtype, had ≥1 hospitalization during follow-up vs. controls (ET vs. control: 22% vs. 16%, PV vs. control: 27% vs. 15%, MF vs. control: 31% vs. 12%, MPN-NOS vs. control: 36% vs. 17%). Mean [SD] total days of hospital care were similarly higher in MPN cases (ET vs. control: 2.7 [12.8] vs. 1.6 [6.6], PV vs. control: 2.6 [7.0] vs. 1.7 [9.5], MF vs. control: 2.5 [6.2] vs. 1.2 [5.9], MPN-NOS vs. control: 4.0 [10.0] vs. 2.1 [13.7]), although the PV vs. control difference was not statistically significant. The ER visit rate during follow-up was also significantly (p<0.05) higher in MPN cases (ET vs. control: 34% vs. 24%, PV vs. control: 38% vs. 25%, MF vs. control: 46% vs. 21%, MPN-NOS vs. control: 44% vs. 29%). All-cause costs for MPN cases vs. matched controls are presented in the figure. Mean total costs per patient, driven equally by inpatient and outpatient services, were significantly (p<0.001) higher in MPN cases (ET vs. control: $11,259 vs. $8,897, PV vs. control: $13,337 vs. $8,530, MF vs. control: $20,917 vs. $7,367, MPN-NOS vs. control: $20,174 vs. $9,800). Conclusions: Total health care costs during a given year for elderly patients with MPNs are 1.3 to 3 times higher (depending on subtype) than those of matched controls. These findings may help inform future cost effectiveness evaluations of novel MPN treatments, as well as decision making in the provision of optimal MPN care within a Medicare system in which resources are finite and must be allocated ethically and efficiently. Disclosures: Karve: RTI Health Solutions: Consultancy, Research Funding. Price:Eli Lilly and Company: Employment, Equity Ownership. Davis:Eli Lilly, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Eisai, Sanof-Aventis, Gilead Sciences, MedImmune: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Pohl:Eli Lilly and Company: Employment, Equity Ownership. Walgren:Eli Lilly and Company: Employment, Equity Ownership.