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1
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. 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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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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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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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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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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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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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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Schneider, Robert. "Major College Basketball in the United States: Morality, Amateurism, and Hypocrisies." Physical Culture and Sport. Studies and Research 52, no. 1 (October 1, 2011): 22–32. http://dx.doi.org/10.2478/v10141-011-0011-y.
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Major College Basketball in the United States: Morality, Amateurism, and HypocrisiesThe National Collegiate Athletic Association (NCAA) and member institutions' presentation of major college basketball in the United States as an endeavor of amateurism is contradictory to the realities of college basketball. Discussed are the following amateurism related hypocrisies: a) requiring players to fully engage in formally structured basketball activities as a priority over education, b) expansion of the post season March Madness tournament regardless of the fact that players will miss more classes, c) compensating basketball coaches with salaries contingent on success defined by winning, and d) the athletic scholarship. Literature supports amateurism hypocrisies in major college basketball (Bermuda 2010, Colombo 2010, Sundram 2010). Understanding the effect of NCAA and member institution hypocritical behavior on determining the moral standing of major college basketball is discussed in the context of claims by Grant (1997), that Machiavelli recognized the necessity of political hypocrisy. A utilitarian analysis using Jeremy Bentham's holistic utilitarian approach calling for the agent to "sum up all the values of all the pleasures on the one side, and those of all the pains on the other" (p. 39) to determine the degree of morality, indicates a presence of morality in major college basketball. Under the premise that major college basketball is an extension of core values held by higher education, Aristotle's Golden Mean (Aristotle, 1941) is used to help identify a point of balanced moral perspective concerning sentiments of the sporting community held for the sport. The end goal is to maintain major college basketball's strong level of satisfaction among members of the sporting community, while controlling the false representation of amateurism surrounding it to preserve the moral and structural integrity of major college basketball.
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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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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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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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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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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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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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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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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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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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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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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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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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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.
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Pemmaraju, Naveen, Aaron T. Gerds, Shreekant Parasuraman, Jingbo Yu, Anne Shah, Ann Xi, Shambhavi Kumar, Robyn M. Scherber, and Srdan Verstovsek. "Thrombosis and Risk of Mortality in Newly Diagnosed High-Risk Polycythemia Vera: An Analysis of the Medicare Claims Database in the United States." Blood 136, Supplement 1 (November 5, 2020): 9–10. http://dx.doi.org/10.1182/blood-2020-141370.
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Background Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) associated with an increased risk of thrombotic events (TEs), a major cause of morbidity and mortality. Patients aged ≥60 years and/or with a history of thrombosis are considered to have high-risk PV. There is limited contemporary, real-world evidence exploring the effect of TEs on mortality in patients with PV. The aim of this analysis was to compare the risk of mortality in patients newly diagnosed with high-risk PV who experienced a TE vs those who did not experience a TE. Study Design and Methods All data from the Medicare Fee-for-Service (FFS) claims database (Parts A/B/D) from January 2010-December 2017 were used to identify patients with a PV diagnosis (all high risk based on cohort being ≥65 years of age) with ≥1 inpatient or ≥2 outpatient claims. The index date was the date of the first qualifying PV claim. Patients with a PV diagnosis or use of cytoreductive therapy within 12 months before the index date (pre-index period) were excluded; ≥12-months continuous medical and pharmacy enrollment pre-index dates was required. The study sample was categorized into TE and non-TE groups based on the occurrence of any of the following events during follow-up: deep vein thrombosis, pulmonary embolism, ischemic stroke, acute myocardial infarction, transient ischemic attack, peripheral arterial thrombosis, or superficial thrombophlebitis. TEs were evaluated from the index date to the end of follow-up. Cox regression analyses with time-varying effects were used to assess mortality risk among patients with PV, with post-index TE as a time-dependent variable, stratified by pre-index TE, and adjusting for patient demographic characteristics and comorbid conditions. Results A total of 56,176 Medicare FFS beneficiaries with PV diagnoses met inclusion criteria. The median age was 73 years, 51.9% were men, and 90.7% were white; 10,110 patients (18.0%) had a history of TE before diagnosis (ie, pre-index). In the follow-up period, 20,105 patients (35.8%) had a TE and 36,071 patients (64.2%) did not have a TE. In the comparison between the TE vs non-TE groups, the median (range) age (75.0 [65-104] vs 73.0 [65-106] years, respectively), mean (SD) Charlson comorbidity index score (3.1 [2.6] vs 2.2 [2.3]), and percentage of patients with a history of cardiovascular events (34.1% vs 23.8%), bleeding (13.3% vs 10.4%), or anemia (28.6% vs 23.4%) were higher (Table 1). Among all patients with PV, the median time from diagnosis to first post-index TE was 7.5 months. Among those with pre-index TE (n=10,093), median time from index to first post-index TE was 0.6 months, whereas patients without pre-index TE (n=46,083) had a median time to first post-index TE of 14.2 months. Among all patients with TE during follow-up, the most common TEs were ischemic stroke (47.5%), transient ischemic attack (30.9%), and acute myocardial infarction (30.5%). The risk of mortality was increased for patients who experienced a TE compared with those who did not (hazard ratio [HR; 95% CI], 9.3 [8.4-10.2]; P<0.0001). For patients who experienced a pre-index TE, the risk of mortality was increased for patients who experienced a subsequent TE during follow-up compared with patients who did not (HR [95% CI], 6.7 [5.8-7.8]; P<0.0001). Likewise, for patients who did not experience a pre-index TE, the risk of mortality was increased for patients who experienced a TE during follow-up compared with patients who did not (HR [95% CI], 13.1 [11.4-15.0]; P<0.0001). Conclusions In this real-world study, approximately one-third of patients with newly diagnosed high-risk PV experienced a TE during follow-up and had a 9-fold increased risk of mortality vs those who did not experience a TE. TE risk mitigation remains an important management goal in patients with PV, particularly in those with prior TE. Disclosures Pemmaraju: Samus Therapeutics: Research Funding; Celgene: Honoraria; SagerStrong Foundation: Other: Grant Support; Affymetrix: Other: Grant Support, Research Funding; MustangBio: Honoraria; Blueprint Medicines: Honoraria; LFB Biotechnologies: Honoraria; Plexxikon: Research Funding; Novartis: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; Stemline Therapeutics: Honoraria, Research Funding; Pacylex Pharmaceuticals: Consultancy; Daiichi Sankyo: Research Funding; Incyte Corporation: Honoraria; Roche Diagnostics: Honoraria; Cellectis: Research Funding; DAVA Oncology: Honoraria. Gerds:Sierra Oncology: Research Funding; Celgene: Consultancy, Research Funding; Gilead Sciences: Research Funding; Imago Biosciences: Research Funding; Pfizer: Research Funding; CTI Biopharma: Consultancy, Research Funding; Roche/Genentech: Research Funding; Apexx Oncology: Consultancy; AstraZeneca/MedImmune: Consultancy; Incyte Corporation: Consultancy, Research Funding. Parasuraman:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Yu:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Shah:Avalere Health: Current Employment. Xi:Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation; Avalere Health: Current Employment. Kumar:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Scherber:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Verstovsek:Gilead: Research Funding; Incyte Corporation: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; CTI Biopharma Corp: Research Funding; Promedior: Research Funding; Roche: Research Funding; AstraZeneca: Research Funding; Blueprint Medicines Corp: Research Funding; Genentech: Research Funding; Sierra Oncology: Consultancy, Research Funding; Protagonist Therapeutics: Research Funding; ItalPharma: Research Funding; PharmaEssentia: Research Funding; NS Pharma: Research Funding; Celgene: Consultancy, Research Funding.
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Pelletier, Elise M., Manjiri Pawaskar, Paula J. Smith, Jennie H. Best, and Richard H. Chapman. "Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis." Journal of Medical Economics 15, no. 6 (May 24, 2012): 1039–50. http://dx.doi.org/10.3111/13696998.2012.688903.
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Pearlstein, Kevin Alexander, Laura H. Hendrix, Trevor Joseph Royce, William A. Stokes, and Ronald C. Chen. "Prevalence of cardiovascular disease (CVD) risk factors and receipt of preventive care among prostate cancer (CaP) survivors in the United States." Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013): 185. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.185.
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185 Background: CVD is a major cause of mortality in CaP survivors. Prior claims-based studies have reported underutilization of preventive care in cancer survivors, but most CVD preventive care items are not available in claims data. We directly examined the prevalence of CVD risk factors and receipt of care in patients with these risk factors in two population-based data sources: National Health and Nutrition Examination Survey (NHANES) and National Health Interview Survey (NHIS) – both commonly used to examine patterns of care in the US. Methods: 2,938 (NHANES) and 452 (NHIS) men with CaP diagnosed from 1999 to 2011 were included. Statistical analysis accounted for sampling weight, and was stratifiedby Caucasian (CA) vs. non-CA. Results: CVD risk factors are highly prevalent (Table), and appear more so in non-Caucasian survivors. Further, 32% of survivors reported history of actual CVD (prior stroke, myocardial infarction, angina, or coronary heart disease). Overall, the majority of survivors receive preventive care. 89%of CA and non-CA survivors visited a primary care physician in the past 1 year. Among survivors with hypertension or hyperlipidemia, >80% received blood pressure or cholesterol checks within past 1 year. Rates of tobacco cessation and exercise were lower. Conclusions: CVD and associated risk factors are prevalent in CaP survivors. However, the majority of these survivors visit a primary care physician and receive CVD preventive care. [Table: see text]
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Ungaro, R., B. Chou, J. Mo, L. Ursos, R. Twardowski, N. Candela, and J. F. Colombel. "P326 An exploratory analysis of the impact of COVID-19 on colonoscopy procedures and new biologic treatment initiation among patients with Inflammatory Bowel Disease in the United States." Journal of Crohn's and Colitis 15, Supplement_1 (May 1, 2021): S350—S351. http://dx.doi.org/10.1093/ecco-jcc/jjab076.450.
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Abstract Background Patients with inflammatory bowel disease (IBD) require frequent colonoscopies to optimize disease management and treatment strategies. At the onset of the COVID-19 pandemic, many routine procedures were postponed to reduce the overall burden on healthcare systems. We characterized the impact of COVID-19 on IBD care by conducting an exploratory analysis of real-world US healthcare claims data to identify changes in treatment patterns and the number of colonoscopy procedures performed in patients with IBD during the first wave of the pandemic. Methods De-identified, open-source health insurance claims data, from Jan 2019 to Oct 2020, were obtained from the Symphony Health Integrated Dataverse® for US adults aged 18–80 years with IBD. Four outcome measures were used: number of colonoscopies performed; number of new biologic treatment initiations or treatment switches; number of new biologic treatment initiations or treatment switches in patients who had a colonoscopy within the previous 60 days; and rate of telehealth consultations per 1000 patients per month. Results During Jan–Dec 2019 and Jan–Oct 2020, 1.54 million and 1.29 million patients with IBD, respectively, were included. The bimonthly number of colonoscopies remained stable throughout 2019, with a maximum change of +5.4% in Jul–Aug (N = 49947) vs Jan–Feb 2019 (N = 47399). Colonoscopy use decreased by 4.7% in Jan–Feb 2020 (N = 45167) vs the same period in 2019. In Mar–Apr 2020, colonoscopy numbers decreased by 55.3% (N = 20191) vs Jan–Feb 2020 (Figure 1a); a reduction of 59.4% vs Mar–Apr 2019 (N = 49780). In May–Jun 2020 (−23.8%) and Jul–Aug 2020 (+2.0%) the difference vs Jan–Feb 2020 gradually decreased (Figure 1a). Bimonthly numbers of new treatment initiations or treatment switches in 2019 varied by up to 6.9% vs Jan–Feb 2019. In May–Jun 2020, numbers of new treatment initiations or treatment switches decreased by 17.0% (N = 10072) vs Jan–Feb 2020 (N = 12133) (Figure 1b); a decrease of 19.3% vs May–Jun 2019 (N = 12488). The number of new treatment initiations or treatment switches in patients who had a colonoscopy within the previous 60 days decreased by 42.5% (N = 892) in Mar–Apr 2020 vs Jan–Feb 2020 (N = 1551) (Figure 1c); a decrease of 44.2% vs Mar–Apr 2019 (N = 1599). Telehealth utilization increased in March 2020 and remained higher than in 2019 up to October 2020 (Figure 2). Conclusion Reduction in colonoscopies and subsequent initiation/switching of treatments during the COVID-19 pandemic first wave suggests lost opportunities for therapy optimization that may have an impact on longer-term patient outcomes. Increased utilization of telehealth services may have helped address gaps in routine clinical care.
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Rader, Michael E., Mark Danese, Ze Cong, Marc Halperin, Yi Qian, Carsten Dietrich Goessl, and Karen Chung. "Lifetime cost-effectiveness of denosumab versus zoledronic for prevention of skeletal-related events (SREs) in patients (pts) with castrate-resistant prostate cancer (CRPC) and bone metastases (BM): United States managed care perspective." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e15172-e15172. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e15172.
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e15172 Background: Denosumab (Dmab) is superior to zoledronic acid (ZA) for prevention of SREs in pts with CRPC and BM. As Dmab is not cleared renally, it can be used in pts regardless of renal status or concomitant use of nephrotoxic drugs. Previous economic analyses were limited as the analyses were based on short duration-trial based perspectives and/or did not account for disutility associated with IV vs SC administration of ZA and Dmab, respectively. These analyses assess the lifetime cost-effectiveness of Dmab vs ZA in pts with CRPC and BM from a US managed care perspective, with extensive scenario and sensitivity analyses. Methods: A lifetime Markov model was developed, with efficacy of Dmab vs ZA in SRE prevention from a head-to-head phase 3 trial; clinical practice SRE rate in ZA pts from a large commercial claims database analysis; SRE and mode of administration (IV vs SC) quality adjusted life-year (QALY) decrements estimated using the time trade-off method; and SRE costs estimated from a nationally representative commercial claims database. Drug, drug administration, and renal monitoring costs were also included. Costs and QALYs were discounted at 3% per year. Scenario analyses (including adverse events, drug discontinuation, etc), one-way and multivariate probabilistic sensitivity analyses were conducted. Results: Dmab reduced the number of SREs and increased pts’ QALY vs ZA. In the base case and the scenario analyses, cost per QALY gained was below $50,000, which is commonly considered good value. Cost per SRE avoided was below $9,000. In one-way sensitivity analyses, drug costs and SRE rate were the most influential variables. Probabilistic sensitivity analyses showed the probabilities of Dmab being cost-effective vs ZA were 0.83, 0.94, and 0.98 with willingness-to-pay of $100,000, $150,000 and $200,000 per QALY gained, respectively. Conclusions: Dmab is a cost-effective treatment option in preventing SREs in pts with CRPC and BM compared with ZA from a US managed care perspective. The overall value of Denosumab is based on superior efficacy and more efficient administration.
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Knight, Tyler, Lynell D'Sylva, Brad Moore, and Charles F. Barish. "Burden Of Iron Deficiency Anemia In a Bariatric Surgery Population In The United States." Blood 122, no. 21 (November 15, 2013): 1722. http://dx.doi.org/10.1182/blood.v122.21.1722.1722.
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Abstract Background Estimates show there are approximately 220,000 cases of bariatric surgery performed in the United States (US) each year. Malabsorption of nutrients, including vitamins and minerals following bariatric surgery is common and may lead to iron deficiency anemia (IDA), with some studies showing incidence rates up to 49% of bariatric surgery patients. Objective The purpose of this study was to evaluate the economic, medical resource use (MRU), and clinical outcomes of IDA in adult bariatric surgery patients having commercial insurance coverage, and to further evaluate the treatment of IDA in this population. Methods This study was based on the Truven Health MarketScan® claims databases. Bariatric surgery patients were identified by ICD-9-CM and CPT procedure codes for restrictive, malabsorptive, and combined restrictive/malabsorptive bariatric surgeries; and further classified as an IDA patient if an IDA diagnosis was identified within two years of initial surgery. Intravenous (IV) iron treatment was determined by HCPCS codes. Prescription oral iron treatment was determined by NDC codes. Blood transfusions were determined by CPT and ICD-9-CM procedure codes. Clinical, MRU, and economic outcomes, including hospitalization, bariatric surgery complications, MRU and payer reimbursement for all-cause health services were evaluated over a two-year period following surgery and compared between patients with and without IDA. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using logistic regression, controlling for demographic and clinical characteristics (including post-surgery IDA status, diabetes, cancer, sleep apnea, heart disease, stroke, hypertension, dyslipidemia, gallbladder disease, osteoarthritis, and chronic back pain) on the outcomes of bariatric surgery complications and hospitalization in the post-surgery period. Results A total of 24,382 bariatric surgery patients were analyzed, and 2,845 (11.7%) patients were diagnosed with IDA in the two-year period following surgery (average days to IDA diagnosis = 279 days). Of the patients with IDA, nearly all (98.7%) developed their anemia following surgery. Most IDA patients received a test for iron in the post-index period, but only 9.3% of all IDA patients received IV iron treatement with either iron dextran (3.8%) and iron sucrose (3.4%) being the most common treatments (average days until IV iron treatment = 403 days). Prescription oral iron was found in 4.8% of all IDA patients (average days to oral iron treatment = 477 days). Approximately 9.0% of all IDA patients received a blood transfusion (average days until blood transfusion = 306 days). Average age was 46 years for patients with and without IDA and more females were found in each group (83.8% in patients with IDA, 78.8% in patients without IDA). Clinical characteristics were similar between groups with the exception of heart disease (1.3% patients with IDA vs 0.8% patients without IDA; P = 0.003) and gallbladder disease (0.0% patients with IDA vs 0.2% patients without IDA; P = 0.037). More IDA patients were associated with a bariatric surgery complication than patients without IDA (40.4% vs 27.7%; P < 0.001) with most complications attributable to other and unspecified postsurgical complications: nonabsorption (22.4% vs 16.5%; P < 0.001), digestive system complications (15.6% vs 10.2%; P < 0.001), and gastrojejunal ulcer (7.6% vs 2.0%; P < 0.001). Multivariate results showed IDA patients were more likely to have a bariatric surgical complication as compared to patients without IDA [OR (95 % CI) = 1.372 (1.262, 1.492)]. IDA patients were hospitalized more often than patients without IDA (42.9% vs 20.9%; P < 0.001) and adjusted results showed IDA patients to be more than twice as likely to be hospitalized [OR (95% CI) = 2.574 (2.370, 2.796)]. Total costs were twice as much among IDA patients as compared to those without IDA ($38,025 vs $19,245; P < 0.001) (Figure 1). Conclusions Bariatric surgery patients that develop IDA may be associated with higher complication rates as well as higher MRU and direct medical costs. Although most bariatric surgery patients that develop IDA are tested for their iron, most are not treated with IV iron, oral iron, and most do not receive blood transfusions. Further research is warranted to determine if IDA is a result of bariatric surgery complications or a predictor of increased MRU and costs. Disclosures: Knight: Covance: Consultancy. D'Sylva:American Regent Inc.: Employment. Moore:Covance: Consultancy. Barish:Wake Gastroenterology/Wake Research Associates: Honoraria.
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Mease, P. J., P. Young, D. C. Gruben, L. Fallon, R. Germino, and A. Kavanaugh. "AB0521 EARLY REAL-WORLD EXPERIENCE OF TOFACITINIB FOR PSORIATIC ARTHRITIS: DATA FROM A UNITED STATES HEALTHCARE CLAIMS DATABASE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1286.1–1287. http://dx.doi.org/10.1136/annrheumdis-2021-eular.390.
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Background:Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). It was approved in the United States (US) in December 2017 for use in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).Objectives:This analysis of real-world data assessed demographic and baseline clinical characteristics, as well as treatment persistence/adherence, in patients (pts) with PsA who had newly initiated tofacitinib treatment.Methods:This retrospective cohort study included pts aged ≥18 years in the Truven MarketScan™ US Commercial and Medicare Supplemental Claims and Encounters database with ≥1 tofacitinib claim (first = index) between 14 December 2017–30 April 2019, and PsA diagnoses (≥1 inpatient or ≥2 outpatient [30–365 days apart]) on or within 12 months pre-index. Pts were continuously enrolled for 12 months pre-index and 6 months post-index, with no pre-index claims for tofacitinib. Pt demographic and clinical characteristics on the day of index, history of advanced therapy treatment (≥1 claim for biologic DMARDs or apremilast within 12 months pre-index) and tofacitinib treatment regimen (monotherapy or combination therapy [≥1 claim for conventional synthetic DMARDs or apremilast on or within 90 days post-index]) were recorded. Outcomes at 6 months post-index included tofacitinib persistence (<60-day gap without tofacitinib treatment) and adherence (proportion of days covered ≥80% and medication possession ratio [data not shown]). A sensitivity check was performed by analysing a sub-cohort that excluded pts with a diagnosis of rheumatoid arthritis (RA) on or within 12 months pre-index and within 6 months post-index.Results:Of 17 321 pts receiving tofacitinib, 440 pts met the inclusion criteria for the overall cohort, with 315 pts included in the sub-cohort. In the overall cohort, pts were mostly female, with a mean age of 52.3 years and a mean PsA duration of 738 days (data not shown). Most pts were exposed to ≥1 advanced therapy within 12 months pre-index (mean = 1.1; range = 0–4); most commonly secukinumab (Table 1). Overall, 60.7% of pts received monotherapy and 39.3% of pts received tofacitinib combination therapy post-index; most commonly methotrexate (data not shown). At 6 months post-index, persistence was similar in pts receiving tofacitinib monotherapy vs combination therapy; adherence was slightly lower in pts receiving tofacitinib monotherapy vs combination therapy (Figure 1). Results were similar in the sub-cohort (Table 1, Figure 1).Table 1.History of advanced therapy on or within 12 months pre-index in pts with PsAAll pts(N=440)Pts with no RAa(N=315)Pts exposed to advanced therapy, n (%)b Any advanced therapyc336 (76.4)241 (76.5) Secukinumab113 (25.7)91 (28.9) Adalimumab93 (21.1)58 (18.4) Apremilast81 (18.4)59 (18.7) Etanercept70 (15.9)47 (14.9)Unique advanced therapy prescriptions Mean (SD)1.1 (0.8)1.1 (0.8) Median (IQR)1 (1–2)1 (1–2) Range0–40–4Number of unique advanced therapies, n (%) 0104 (23.6)74 (23.5) 1214 (48.6)153 (48.6) 2100 (22.7)73 (23.2) ≥322 (5.0)15 (4.8)aExcludes pts with a diagnosis of RA on or within 12 months pre-index and within 6 months post-index; bPts with ≥1 claim for biologic DMARDs or apremilast within 12 months pre-index; cOther advanced therapies reported in <10% of all pts were abatacept, certolizumab, golimumab, infliximab, ixekizumab and ustekinumabIQR, interquartile range; N, number of pts per cohort; n, number of pts per category; SD, standard deviationFigure 1Conclusion:This analysis of US-based claims data indicated that pts newly initiated tofacitinib treatment an average of 2 years after PsA diagnosis, with the majority (>60%) of pts receiving tofacitinib as monotherapy. High levels of persistence and adherence to tofacitinib were observed 6 months after treatment initiation. Findings were similar when pts with PsA who also had a diagnosis of RA were excluded. Data were limited in that claims data cannot confirm that pts took the medication for which they filed a claim.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Gemma Turner, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:Philip J Mease Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Pamela Young Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, David C Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lara Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Rebecca Germino Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Arthur Kavanaugh Grant/research support from: Pfizer Inc.
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Mao, Jianbin, Micheal Johnson, Jeffrey Mcpheeters, Girish Prajapati, and Andrew Beyer. "Healthcare Resource Utilization and Costs Associated with Switching First-line Antiretroviral Therapy among HIV-infected Patients in the United States." Open Forum Infectious Diseases 4, suppl_1 (2017): S435—S436. http://dx.doi.org/10.1093/ofid/ofx163.1101.
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Abstract Background Initial antiretroviral therapy (ART) is modified for non-virologic failure reasons in many patients, and the healthcare resource utilization (HRU) and costs associated with these switches in the real world is not well understood. Methods Administrative claims data from the Optum Research and Impact National Benchmark Databases were utilized. Adult patients (≥18 years) with HIV-1 diagnosis code, and claim for an anchor agent of the protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) class in first-line ART between July 1, 2006 and December 31, 2015 were identified (see Figure 1 for addl. criteria). Patients with a claim for an anchor agent (PI or NNRTI) different from that in first-line ART were defined as switchers, with index date as date of first claim for new anchor agent. Switchers were matched to patients who did not switch (non-switchers) at 1:3 ratio using propensity score matching on patient and first-line ART characteristics. For non-switchers, date following corresponding duration of first-line ART in matched switcher was assigned as index date. Per-patient-per-month (PPPM) all-cause HRU and costs (US$) during switch period (±15 days of index date) were compared descriptively. Results 11,302 patients met study criteria. After matching, switcher (1,204) and non-switcher (3,612) groups were comparable on mean age (41.9 vs. 41.7 years), percent male (85.8% vs. 82.6%), percent commercial enrollee (96.0% vs. 95.8%), mean Quan-Charlson comorbidity index score (both 0.4), and mean ART pill burden (both 2.2) with standard difference less than absolute value of 10%. During switch period, switchers had higher mean PPPM ambulatory visits (2.30 vs. 1.26), emergency room visits (0.12 vs. 0.06), inpatient stays (0.04 vs. 0.01), and pharmacy fills (4.52 vs. 3.01) than non-switchers (all P < 0.001). Switchers also incurred greater mean PPPM costs during switch than non-switchers, with an additional $2,261/month total cost, and $1,031/month pharmacy cost (Figure 2). Conclusion The study gives a more complete view of the burden of switching initial ART with pharmacy costs driving this burden. Assuming some patients will switch regardless of the regimen selected, less expensive initial ART could reduce this burden further. Disclosures M. Johnson, Merk & Co: Research Contractor, research funded by Merk; J. Mcpheeters, Merck & Co.: Research Contractor, Sarary from Optum; G. Prajapati, Merck & Co., Inc.: Employee, Salary; A. Beyer, Merck & Co., Inc: Employee and Shareholder, Salary
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Penn, Courtney, Melissa Wong, and Christine S. Walsh. "Cost-effectiveness of various maintenance therapies based on mutation status following first-line treatment of primary epithelial ovarian cancer in the United States." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e19399-e19399. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19399.
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e19399 Background: The recent SOLO1, PRIMA, and PAOLA trials all reported positive efficacy results, making it difficult to determine optimal upfront maintenance therapy for patients with primary, advanced ovarian cancer. We evaluated the cost-effectiveness of the maintenance strategies outlined in these trials for BRCA-positive patients, homologous-recombination deficient patients without a BRCA mutation (HRD-positive), and homologous-recombination proficient (HRD-negative) patients. Methods: Three decision analysis models were developed, one for each mutation status. We evaluated olaparib (SOLO1), olaparib/bevacizumab (PAOLA), bevacizumab alone (PAOLA), and niraparib (PRIMA) maintenance strategies. Base case 1 assessed olaparib vs olaparib/bevacizumab vs bevacizumab vs niraparib vs no maintenance therapy in BRCA-positive patients. Base cases 2 and 3 assessed olaparib/bevacizumab vs bevacizumab vs niraparib vs no maintenance therapy in HRD-positive and HRD-negative patients, respectively. Time horizon was 24 months. Costs, measured in U.S. dollars, were estimated from Medicare claims, wholesale acquisition prices, and previously published sources. Incremental cost-effectiveness ratios (ICERs) were in dollars per progression-free life-year saved (PF-LYS). One-way sensitivity analyses were performed varying drug cost and progression-free survival. Results: Assuming a willingness-to-pay threshold of $100,000/PF-LYS, none of the drug maintenance strategies could be considered cost effective compared with observation. In BRCA-positive patients (base case 1), olaparib monotherapy was the most cost-effective strategy, yielding an ICER of $181,059/PF-LYS. The third-party payer cost per 28-day supply of olaparib would need to be reduced from approximately $17,000 to $9,200 to be considered cost effective compared with observation. In HRD-positive patients (base case 2) and HRD-negative patients (base case 3), bevacizumab monotherapy was the most cost-effective option, with ICERs of $326,491/PF-LYS and $253,937/PF-LYS respectively. Conclusions: At current costs, maintenance therapy for primary ovarian cancer is not cost effective, regardless of mutation status. In BRCA-positive women, lowering the cost of olaparib may make it cost effective compared with observation.
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Ke, Xuehua, Marie-Hélène Lafeuille, Hela Romdhani, Frederic Kinkead, Peter St John Francis, Denise D'Andrea, Charles J. Ryan, and Stephen J. Freedland. "Treatment patterns in men with metastatic castration sensitive prostate cancer (mCSPC) in the United States (US)." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e19131-e19131. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19131.
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e19131 Background: Given recent advances in treatment options for mCSPC, this study assessed US real-world treatment patterns of mCSPC patients over time. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for PC, ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before metastasis). Index (idx) date was the 1st metastasis dx date on or after 1st PC dx and from 2015-2018. Patients were excluded if they had a pre-idx castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-idx or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from idx until CR (i.e., any post-idx CR indicator or initiation of abiraterone acetate [ABI] or docetaxel [DOC] ≥12 mo after post-idx androgen deprivation therapy [ADT] initiation or ≥12 mo post-idx for those with no ADT) or end of data. mCSPC treatment patterns in F/U were assessed overall and in patients with idx years (yrs) in 2015-2016 and in 2017-2018, separately. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: In the 2,825 mCSPC patients identified (age: 75 [9] yrs; F/U: 10.9 [9.0] mo), 43% were in the 2015/16 cohort (age: 75 [9] yrs; F/U: 15.8 [10.2] mo); and 57% were in the 2017/18 cohort (age: 75 [9] yrs; F/U: 7.2 [4.7] mo). The most common first-line (1L) mCSPC therapy was ADT only (Table), but patients in the 2017/18 cohort had fewer ADT only as 1L (43% vs. 52%) and more 1L ABI (10% vs. 4%) compared to the 2015/16 cohort. About 4% (2015/16: 5%; 2017/18: 3%) of patients received second-line (2L) mCSPC therapies, with ABI (74%) and DOC (25%) as the main 2L therapies observed. In patients receiving 2L mCSPC therapies, the 2017/18 cohort had more 2L ABI (81% vs. 68%) and fewer 2L DOC (19% vs. 30%) compared to the 2015/16 cohort. Conclusions: A large proportion of men with mCSPC were untreated/deferred treatment or were treated with ADT only, highlighting unmet needs in this patient group. As additional therapies for mCSPC become available, this trend is expected to improve, as supported by more recent treatment patterns. [Table: see text]
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Adeboyeje, Gboyega, Pooja Shah, Shelby Corman, and Hrishikesh Kale. "Use of BRCA testing among patients diagnosed with pancreatic cancer: Analysis of commercial claims database in the United States." Journal of Clinical Oncology 38, no. 29_suppl (October 10, 2020): 291. http://dx.doi.org/10.1200/jco.2020.38.29_suppl.291.
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291 Background: The role of BRCA testing to guide the course of pancreatic cancer treatment has evolved in the last couple of years. In December 2019, FDA approved the first PARP inhibitor for pancreatic cancer. However, little is known about the use of BRCA testing among pancreatic cancer patients. This study assessed the trend in the prevalence of BRCA testing and predictors of receiving a BRCA test among newly diagnosed pancreatic cancer patients. Methods: The study assessed 2012-2018, Optum Clinformatics Datamart database. Patients newly diagnosed with pancreatic cancer, continuously enrolled in a health plan for ≥6 months before and after diagnosis were included in the study. Claims for BRCA testing were identified after diagnosis using HCPCS, ICD-9/10 procedure, and LOINC codes. The prevalence of BRCA testing was calculated for patients diagnosed in each year from 2012-2017. Multivariable logistic regression was used to assess predictors of BRCA testing controlling for sociodemographic and clinical factors. Results: From a total of 5,339 pancreatic cancer patients included, 293 (5.5%) patients received a BRCA test. The prevalence of BRCA testing increased from 1.2% in 2012 to 7.7% in 2017. Of patients receiving a BRCA test, 198 (67.6%) were tested within 1 year of diagnosis. The median time to receive a BRCA test from diagnosis was 158 days (mean: 269.1 days). Results from logistic regression indicated that younger age at diagnosis (eg.18-44 years versus ≥75 years, odds ratio [OR] = 3.24), diagnosis in recent years (eg. 2017 versus 2012, OR = 6.86), presence of metastasis (OR = 1.86), family history of cancer (OR = 2.26), plan type (point of service versus health maintenance organization, OR = 2.31) and Charlson comorbidity index score (0 vs ≥3, OR = 1.87) significantly (p < 0.05) increased odds for receiving BRCA test. The odds for the BRCA test did not vary statistically significantly by gender (female, OR = 1.25), insurance type (commercial versus Medicare Advantage, OR = 0.90), and census region (eg. Northeast versus West, OR = 1.03). Conclusions: The prevalence of BRCA testing among pancreatic cancer patients was low but increased steadily over time. Several demographic and clinical factors were associated with the use of BRCA testing among pancreatic cancer patients.
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Nadler, Eric S., Kavita Rohidas Sail, Lei Chen, Stephen F. Thompson, and Michael A. Kolodziej. "Retrospective observational study: Bevacizumab (B) use and outcomes among metastatic colorectal cancer (mCRC) patients (pts) receiving care in the outpatient community in the United States." Journal of Clinical Oncology 30, no. 4_suppl (February 1, 2012): 547. http://dx.doi.org/10.1200/jco.2012.30.4_suppl.547.
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547 Background: This study assessed utilization and outcomes of B use in mCRC pts receiving 1st- (1L) and 2nd-line (2L) treatment (Tx) in this setting. Methods: Data were abstracted primarily from US Oncology’s iKnowMed electronic medical record system. Multivariate Cox models were used for overall survival (OS) when testing differences between B and nonbiologic use. mCRC pts initiating 1L or 2L Tx from 1/1/07-6/30/09 were included. Cost of care was derived from outpatient claims data in US Oncology’s Claims Data Warehouse. Results: 1795 pts were identified in 1L setting, 615 in 2L, and 323 in both 1L and 2L; 90% of 1L and 87% of 2L pts received combination Tx. Most received biologics (73% 1L, 65% 2L); among these, most included B (1131/1179 [96%] 1L, 312/345 [90%] 2L). B was commonly combined with FOLFOX (665/1131 [59%]) in 1L and FOLFIRI (135/312 [43%]) in 2L. Results for B use are described as 1L and 2L, respectively. Mean (median) numbers of cycles were 9.1 (7.0) and 7.0 (5.0), and 23% (301/1321) and 34% (120/348) received ≤3 cycles. Mean (median) durations of use were 141 (113) and 108 (75.5) days; average doses across all cycles for B were 5.5 mg/kg and 5.7 mg/kg. Consistent with the literature, 1L B was associated with a 23% reduction in risk of mortality vs nonbiologics (HR=0.77; CI: 0.60-0.98; P=0.036); however, 2L B was not associated with risk of mortality reduction (HR=0.87; CI: 0.62-1.22; P=0.44). With 1L B-containing regimens, median OS was 546.5 days in pts who continued B in 2L (n=269), and 569 days (P=0.11) in pts who did not (n=28); median costs for 2L B vs non-B were $5155 vs $3867 (P=0.068). 1L OS observed in this study was less than 1L OS reported in the BRITE registry (660 days; 95% CI: 21.9-24.4 months [doi: 10.1634/theoncologist.2009-0071]). Conclusions: This study re-examines previously reported observations from the BRITE registry, but evaluates pts treated more recently and in both 1L and 2L settings. Our study did not show a significant survival advantage with prolonged use of B following progression. Further research is needed to confirm these findings. Research and editorial assistance was funded by sanofi-aventis U.S. LLC.
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Altman, Micah. "Traditional Districting Principles: Judicial Myths vs. Reality." Social Science History 22, no. 2 (1998): 159–200. http://dx.doi.org/10.1017/s0145553200023257.
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One person, one vote. With this principle, the Court permanently changed representation in the United States. Equal population requirements changed the face of legislative redistricting in the 1960s, when the Supreme Court applied it to congressional districts in Wesberry v. Sanders, 376 U.S. 1 (1964), and to state legislatures in Reynolds v. Sims, 84 S. Ct. 1362 (1964). Equality in district population was valued not only as instrumental to other goals but also for itself, as Justice Black explained in Wesberry: “As nearly as practicable one man’s vote in a congressional election is to be worth as much as another’s. . . . To say that a vote is worth more in one district than another would . . . run counter to our fundamental ideas of democratic government.”As Justice Brennan made clear, the Court based its decision in large part on a particular understanding of the historical meaning of the Fourteenth Amendment and of article 1, section 2, of the Constitution. And as widely accepted as this principle has come to be, it has been subject to severe historical criticism, criticism that has never been resolved. For example, Berger (1977) claims that malapportionment was historically present and accepted before and during the creation of the Fourteenth Amendment and hence that the equal protection clause could not have implied the equal population principle (from chapter 5): “Certainly there was no disclosure that such intrusion [on apportionment] was contemplated; there is in fact striking evidence that malapportionment was an accepted practice.”
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Malangone-Monaco, Elisabetta, Kathleen Wilson, Helen Varker, Diana Stetsovsky, Lin Shih-Wen, Darren Tayama, and Sarika Ogale. "Title: A real-world study of chemotherapy treatment and costs in metastatic urothelial cancer (mUC) patients in the United States." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e16009-e16009. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e16009.
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e16009 Background: Cisplatin (CIS)-based regimens are recommended for first-line (1L) treatment of mUC. Carboplatin (CAR) serves as an alternative for patients unfit to receive CIS. This study examined treatment patterns and costs for patients treated with CIS, CAR, and other treatment (OT). Methods: This was a retrospective cohort study of 9,436 patients from a U.S. insurance claims database between 1/1/2005-6/30/2015. Adult patients with ≥ 2 diagnosis codes for UC, ≥ 2 diagnosis codes for metastasis (first metastasis = index date), ≥ 6 months of continuous enrollment pre-index and no evidence of cystectomy were included. Results: The population was majority male (74%); with a mean age of 70. Sixty percent of the mUC patients did not receive 1L chemotherapy during the study period. Among the 3,750 who received treatment, 935 (25%) received 1L CIS, 1,505 (40%) received 1L CAR, and the remaining patients received OT. Patients treated with CIS were younger (62 vs. 69 and 68) and healthier (NCI comorbidity score 0.7 vs. 1.1, and 1.0) vs. patients treated with CAR and OT, respectively. Among CAR patients, 87% received it as combination therapy (CT), with GEM being the most common agent used with CAR. Only 16% of OT patients received CT. Per-patient-per-month (PPPM) 1L all-cause healthcare costs were similar across 1L regimens ($16,540 CIS, $15,739 CAR, and $16,443 OT) and 1L mUC-related healthcare costs were $9,043, $6,975 and $6,191 for CIS, CAR, and OT, respectively. Conclusions: In this real-world study, the majority of mUC patients did not receive 1L chemotherapy, and only a small fraction of those treated received CIS. The remaining patients were treated with CAR or OT, often as monotherapy, which tend to have poorer outcomes compared with CIS. Despite CAR and OT treated patients being younger and healthier, their total health care costs were similar to CIS patients. Newer therapies may provide safer and more efficacious treatment alternatives for patients who are not considered a good fit for CIS therapy.
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Pemmaraju, Naveen, Aaron T. Gerds, Jingbo Yu, Shreekant Parasuraman, Anne Shah, Ann Xi, Shambhavi Kumar, Robyn M. Scherber, and Srdan Verstovsek. "Thrombotic Events and Mortality Risk in Patients Newly Diagnosed with Intermediate- to High-Risk Essential Thrombocythemia in the United States." Blood 136, Supplement 1 (November 5, 2020): 21. http://dx.doi.org/10.1182/blood-2020-141333.
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Background Essential thrombocythemia (ET) is a myeloproliferative neoplasm (MPN) associated with an increased risk of thrombotic events (TEs), which represent a substantial cause of mortality in this population. There is limited contemporary, real-world evidence exploring the effect of TEs on mortality in patients with ET. The aim of this analysis was to compare risk of mortality among patients newly diagnosed with intermediate- or high-risk ET who experienced a TE vs those who did not experience a TE. Study Design and Methods All data from the Medicare Fee-for-Service (FFS) claims database (Parts A/B/D) from January 2010-December 2017 were used to identify patients with an ET diagnosis (all intermediate or high risk based on cohort age ≥65 years) with ≥1 inpatient or ≥2 outpatient claims. The index date was the date of the first qualifying ET claim. Patients with an ET diagnosis, use of hydroxyurea, or use of ruxolitinib within 12 months before the index date and patients with a myelofibrosis diagnosis during the study period were excluded. A minimum of 12 months of continuous medical and pharmacy enrollment pre-index was required. The study sample was categorized into TE and non-TE groups based on the occurrence of any of the following events during follow-up: deep vein thrombosis, pulmonary embolism, ischemic stroke, acute myocardial infarction, transient ischemic attack, peripheral arterial thrombosis, or superficial thrombophlebitis. TEs were evaluated from the index date to the end of follow-up. Cox regression analyses with time-varying effects were used to assess mortality risk among patients with ET with post-index TE as a time-dependent variable, stratified by pre-index TE, and adjusting for patient demographic characteristics and comorbid conditions. Results A total of 143,588 Medicare FFS beneficiaries with a diagnosis of ET met the study inclusion criteria; median age was 76.0 years, 68.1% were female, and 84.2% were white. Pre-index TE was reported in 37,284 patients (26.0%). In the follow-up period, 49,497 patients (34.5%) had a TE and 94,091 patients (65.5%) did not have a TE. In the comparison between the TE vs non-TE groups, the median (range) age (77 [65-107] vs 75 [65-110] years, respectively), mean (SD) Charlson comorbidity index score (4.8 [3.5] vs 3.8 [3.5]), and percentage of patients with a history of bleeding (27.0% vs 22.2%), anemia (64.7% vs 55.9%), or a cardiovascular event (45.8% vs 33.5%) were higher (Table 1). The median time from ET diagnosis to first TE in the follow-up period was 2.8 months for all patients, 0.5 months for patients with pre-index TE, and 8.0 months for those without pre-index TE. The most common types of first TE in the follow-up period were ischemic stroke (37.3%), acute myocardial infarction (23.2%), and transient ischemic attack (22.6%). The risk of mortality was increased for patients who experienced a TE compared with those who did not (hazard ratio [HR; 95% CI], 11.2 [10.6-11.8]; P<0.001), including for both those with pre-index TE (HR [95% CI], 9.3 [8.6-10.1]; P<0.001) and those without pre-index TE (HR [95% CI], 15.4 [14.2-16.8]; P<0.001). Conclusions In this contemporary, real-world analysis, approximately one-third of patients with newly diagnosed intermediate- to high-risk ET experienced a TE. Elderly patients with ET who experienced a TE had an approximately 11-fold increased risk of mortality vs those who did not experience a TE, highlighting a continued unmet need in this population. Further efforts are needed to better define and mitigate TE risk in patients with ET, particularly in those with prior TE. Disclosures Pemmaraju: Daiichi Sankyo: Research Funding; Cellectis: Research Funding; Plexxikon: Research Funding; Blueprint Medicines: Honoraria; AbbVie: Honoraria, Research Funding; Samus Therapeutics: Research Funding; Affymetrix: Other: Grant Support, Research Funding; Roche Diagnostics: Honoraria; Stemline Therapeutics: Honoraria, Research Funding; Pacylex Pharmaceuticals: Consultancy; Incyte Corporation: Honoraria; Novartis: Honoraria, Research Funding; LFB Biotechnologies: Honoraria; MustangBio: Honoraria; Celgene: Honoraria; DAVA Oncology: Honoraria; SagerStrong Foundation: Other: Grant Support. Gerds:Gilead Sciences: Research Funding; Incyte Corporation: Consultancy, Research Funding; Roche/Genentech: Research Funding; AstraZeneca/MedImmune: Consultancy; Imago Biosciences: Research Funding; Sierra Oncology: Research Funding; Celgene: Consultancy, Research Funding; Apexx Oncology: Consultancy; CTI Biopharma: Consultancy, Research Funding; Pfizer: Research Funding. Yu:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Parasuraman:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Shah:Avalere Health: Current Employment. Xi:Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation; Avalere Health: Current Employment. Kumar:Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation; Avalere Health: Current Employment. Scherber:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Verstovsek:CTI Biopharma Corp: Research Funding; Protagonist Therapeutics: Research Funding; Roche: Research Funding; Incyte Corporation: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; PharmaEssentia: Research Funding; Sierra Oncology: Consultancy, Research Funding; Blueprint Medicines Corp: Research Funding; Genentech: Research Funding; AstraZeneca: Research Funding; ItalPharma: Research Funding; Promedior: Research Funding; Gilead: Research Funding; Celgene: Consultancy, Research Funding; NS Pharma: Research Funding.
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Tran, Phuong T., Almut G. Winterstein, Xi Wang, Kiyon Rhew, and Patrick J. Antonelli. "Appropriateness of Otic Quinolone Use among Privately Insured US Patients." Otolaryngology–Head and Neck Surgery 162, no. 1 (November 19, 2019): 102–7. http://dx.doi.org/10.1177/0194599819889607.
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Objective Considering emerging safety concerns involving otic quinolones, we assessed the extent of otic quinolone use for questionable indications. Study Design Descriptive cross-sectional study of a national sample of privately insured patients. Setting Outpatient encounters in the United States. Subjects and Methods Children and adults with outpatient pharmacy-dispensing claims for new prescriptions of otic or ophthalmic quinolones in 2017 were identified within the IBM MarketScan Commercial Claims & Encounters and the Medicare Supplemental Database. Each dispensing ≥30 days apart constituted a unique episode. Only claims with supporting ear-related diagnoses on outpatient encounters ±3 days of dispensing were considered. Ophthalmic drops were excluded if eye-related diagnoses were found ±30 days. Prescribing was classified as appropriate, questionable, or undetermined. Results We found 214,897 episodes in 200,270 patients. Adults were twice as likely as children to have otic treatment with questionable indications (6.2% vs 3.0%). Sensitivity analyses with broader time windows to ascertain diagnoses showed similar proportions of questionable use. Otalgia and cerumen impaction constituted 90% of questionable indications. Family physicians (6.8%) and internists (8.0%) had higher percentages of questionable use than other specialties. Conclusion Based on the demonstrated risks of quinolone ear drops, opportunities exist to decrease otic quinolone use, especially in adults.
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Estes, Stephanie J., Ahmed M. Soliman, Marko Zivkovic, Divyan Chopra, and Xuelian Zhu. "The impact of high-risk and chronic opioid use among commercially insured endometriosis patients on health care resource utilization and costs in the United States." Women's Health 16 (January 2020): 174550652096589. http://dx.doi.org/10.1177/1745506520965898.
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Objectives: Evaluate all-cause and endometriosis-related health care resource utilization and costs among newly diagnosed endometriosis patients with high-risk versus low-risk opioid use or patients with chronic versus non-chronic opioid use. Methods: A retrospective analysis of IBM MarketScan® Commercial Claims data from 2009 to 2018 was performed for females aged 18 to 49 with newly diagnosed endometriosis (International Classification of Diseases, Ninth Edition code: 617.xx; International Classification of Diseases, Tenth Edition code: N80.xx). Two sub-cohorts were identified: high-risk (⩾1 day with ⩾90 morphine milligram equivalents per day or ⩾1-day concomitant benzodiazepine use) or chronic opioid utilization (⩾90-day supply prescribed or ⩾10 opioid prescriptions). High-risk or chronic utilization was evaluated during the 12-month assessment period after the index date. Index date was the first opioid prescription within 12 months following endometriosis diagnosis. All outcomes were assessed over 12-month post-assessment period while adjusting for demographic and clinical characteristics. Results: Out of 61,019 patients identified, 18,239 had high-risk opioid use and 5001 chronic opioid use. Health care resource utilization drivers were outpatient visits and pharmacy fills, which were higher among high-risk versus low-risk patients (outpatient visits: 17.49 vs 15.51; pharmacy fills: 19.58 vs 16.88, p < 0.0001). Chronic opioid users had a higher number of outpatient visits (19.53 vs 15.00, p < 0.0001) and pharmacy fills (23.18 vs 16.43, p < 0.0001) compared to non-chronic opioid users. High-risk opioid users had significantly higher all-cause health care costs compared to low-risk opioid users (US$16,377 vs US$13,153; p < 0.0001). Chronic opioid users also had significantly higher all-cause health care costs compared to non-chronic opioid users (US$20,930 vs US$12,272; p < 0.0001). Similar patterns were observed among endometriosis-related HCRU, except pharmacy fills among high-risk and chronic sub-cohorts. Conclusion: This analysis demonstrates significantly higher all-cause and endometriosis-related health care resource utilization and total costs for high-risk opioid users compared to low-risk opioid users among newly diagnosed endometriosis patients over 1 year. Similar trends were observed for comparing chronic opioid users with non-chronic opioid users, except for endometriosis-related pharmacy fills and associated costs.
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Turbeville, Sean, Kevin M. Francis, Ilan Behm, Gretchen R. Chiu, Herman Sanchez, Blake A. Morrison, and Jacob M. Rowe. "Prevalence and Incidence of Acute Myeloid Leukemia May be Higher Than Currently Accepted Estimates Among the ≥65 Year-Old Population in the United States." Blood 124, no. 21 (December 6, 2014): 958. http://dx.doi.org/10.1182/blood.v124.21.958.958.
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Abstract Introduction: Population-based cancer registries, such as the National Cancer Institute Surveillance, Epidemiology and End Results (SEER) program and the North American Association of Central Cancer Registries (NAACCR) are the largest sources of information for cancer epidemiology and statistics. The most recent acute myeloid leukemia incidence estimate from SEER (2011) is 17.5 per 100,000 (N=7,245) among the US ≥65 year-old population; however, recent studies suggest these registries may underreport cancer rates due to reasons including sequencing of diagnoses and inpatient reporting requirements. For cancers such as myelodysplastic syndrome (MDS) and acute and chronic myeloid leukemia (AML & CML), this is concerning as they are more likely to occur after initial diagnosis of other cancers. A recent study independently calculated MDS, AML and CML cases from 2000-2005 using a Medicare claims-based algorithm and concluded that SEER and NAACCR failed to capture a substantial number of cases and the true incidence was 50-75% greater than reported (Cogle, et al., 2012). Updated AML epidemiology statistics outside of SEER and NAACCR have not been published. Objective: To employ a Medicare claims-based algorithm to estimate gender- and age-specific AML incidence and prevalence among the 2012 US Medicare fee-for-service (FFS) population. Methods: A retrospective analysis of claims using 2012 Centers for Medicare and Medicaid Services (CMS) data included an Institutional sample (100%) and random Non-Institutional Carrier samples (5%) which together represented the healthcare utilization of Medicare Part A & B (Medicare FFS) beneficiaries. AML diagnoses were identified using ICD-9 codes and AML treatments identified using HCPCS J Codes and ICD-9 infusion codes. Prevalent AML patients were defined as having ≥2 AML diagnoses associated with medical claims OR 1 AML medical claim and 1 AML treatment. A sub-population of all prevalent AML patients without historical AML diagnoses or treatments during the prior 2 years were identified as new (incident) AML patients.Analyses were computed by gender and two age-cohorts (<65 and ≥65 years old). Patients in the Institutional 100% dataset were considered census and no weighting was required but appropriate weights were used to project the 5% random carrier sample (<9% of AML patients) to the Medicare FFS population. Results: Of 34.2 million Medicare FFS beneficiaries, 15,976 had AML, a prevalence rate of 0.05% (Table). Most were ≥65 years old (N=11,936; 75%) and prevalence did not vary between age groups; however, women ≥65 years old had a significantly lower prevalence than men ≥65 years old (0.03% vs. 0.06%; z=31.2, p<.001) as men were nearly twice as likely to be diagnosed with AML (RR=1.86, 95% CI: 1.78, 1.95). There were no gender differences in incidence among younger patients (18.6 per 100,000 for men vs. 18.4 per 100,000 for women). A high proportion of AML patients were newly diagnosed (N=9,074; 57%). Conclusions : Our AML incidence estimate for the ≥65 year Medicare FFS cohort of 29.0 per 100,000 (N=7,582) is substantially higher than incidence estimate reported by SEER for this age group. As only 70-80% of the ≥65 year-old population is covered under Medicare FFS, the total number of ≥65 incident patients is likely higher than reported by SEER. Registries may be underreporting AML due to methodological differences. Furthermore, the 15,976 prevalent patients in Medicare FFS alone may be much higher than previously known. Claim-based algorithms may provide higher AML estimates than current SEER methodology. Further research should investigate claims data in the remaining ≥65 year-old population covered under Medicare Advantage and a younger, non-Medicare FFS population sample more representative of persons <65 years of age. Table One-year Prevalence and Incidence Rates of AML in the Medicare FFS Population, 2012 Population, N 1-year AML Incident per 100,000, n (%) 1-Year AML Prevalence, n (%) Overall 34,216,076 9,074 (26.5) 15,976 (0.05) <65 years 8,064,566 1,492 (18.5) 4,040 (0.05) ≥65 years 26,151,510 7,582 (29.0) 11,936 (0.05) Male 15,329,040 5,181 (33.8) 8,854 (0.06) Female 18,887,036 3,893 (20.6) 7,121 (0.04) Male, <65 years 4,137,155 770 (18.6) 2,061 (0.05) Male, ≥65 years 11,191,885 4,410 (39.4) 6,793 (0.06) Female, <65 years 3,927,411 722 (18.4) 1,978 (0.05) Female, ≥65 years 14,959,625 3,171 (21.2) 5,143 (0.03) Disclosures Turbeville: Sunesis Pharmaceuticals, Inc.: Employment. Morrison:Sunesis Pharmaceuticals, Inc.: Employment.
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Khalid, Sumaira, Usha Sambamoorthi, and Kim E. Innes. "Non-Cancer Chronic Pain Conditions and Risk for Incident Alzheimer’s Disease and Related Dementias in Community-Dwelling Older Adults: A Population-Based Retrospective Cohort Study of United States Medicare Beneficiaries, 2001–2013." International Journal of Environmental Research and Public Health 17, no. 15 (July 29, 2020): 5454. http://dx.doi.org/10.3390/ijerph17155454.
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Accumulating evidence suggests that certain chronic pain conditions may increase risk for incident Alzheimer’s disease and related dementias (ADRD). Rigorous longitudinal research remains relatively sparse, and the relation of overall chronic pain condition burden to ADRD risk remains little studied, as has the potential mediating role of sleep and mood disorders. In this retrospective cohort study, we investigated the association of common non-cancer chronic pain conditions (NCPC) at baseline to subsequent risk for incident ADRD, and assessed the potential mediating effects of mood and sleep disorders, using baseline and 2-year follow-up data using 11 pooled cohorts (2001–2013) drawn from the U.S. Medicare Current Beneficiaries Survey (MCBS). The study sample comprised 16,934 community-dwelling adults aged ≥65 and ADRD-free at baseline. NCPC included: headache, osteoarthritis, joint pain, back or neck pain, and neuropathic pain, ascertained using claims data; incident ADRD (N = 1149) was identified using claims and survey data. NCPC at baseline remained associated with incident ADRD after adjustment for sociodemographics, lifestyle characteristics, medical history, medications, and other factors (adjusted odds ratio (AOR) for any vs. no NCPC = 1.21, 95% confidence interval (CI) = 1.04–1.40; p = 0.003); the strength and magnitude of this association rose significantly with increasing number of diagnosed NCPCs (AOR for 4+ vs. 0 conditions = 1.91, CI = 1.31–2.80, p-trend < 0.00001). Inclusion of sleep disorders and/or depression/anxiety modestly reduced these risk estimates. Sensitivity analyses yielded similar findings. NCPC was significantly and positively associated with incident ADRD; this association may be partially mediated by mood and sleep disorders. Additional prospective studies with longer-term follow-up are warranted to confirm and extend our findings.
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Mehra, Maneesha, Ravi Potluri, Jianming He, Aleksandra Rizo, Suneel Mundle, and Jacqueline Bussolari. "Transfusion Burden and Outcomes in Patients with Low- or Unspecified-Grade Myelodysplastic Syndromes Treated with Erythropoiesis-Stimulating Agents: Analysis of a United States Commercial Claims Database." Blood 128, no. 22 (December 2, 2016): 5974. http://dx.doi.org/10.1182/blood.v128.22.5974.5974.
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Abstract Introduction: Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic disorders characterized by 1 or more peripheral blood cytopenias.Anemia is the most common cytopenia associated with low-grade MDS (based on the International Prognostic Scoring System). Erythropoiesis-stimulating agents (ESA) are commonly used as frontline treatment of anemia in patients (pts) with low-grade MDS; red blood cell transfusions are also important in supportive care. The present database analysis was conducted to understand the transfusion burden and outcomes among pts in the United States who were diagnosed with low- or unspecified-grade MDS and treated with ESA. Methods: A retrospective analysis of theOptum integrated claims and Electronic Medical Record database ("Optum Database") identified pts aged ≥ 18 years with an index diagnosis of MDS (low-grade, ICD 9 code: 238.72; high-grade, ICD 9 code: 283.73; del(5q), ICD 9 code: 238.74; or unspecified-grade, ICD 9 code: 238.75) between 2006 and 2014 who had 365 days of retrospective data preceding index diagnosis. Pts with baseline acute myeloid leukemia were excluded. Demographics and clinical outcomes were analyzed by descriptive summary. Kaplan-Meier survival analysis was performed to define overall survival (OS) and time to transfusion dependence or transfusion independence. Results: Among the 8,493 pts in the Optum Database who met the inclusion criteria, MDS was categorized as low-grade in 2,136 (25.2%), high-grade in 367 (4.3%), del(5q) in 198 (2.3%), and unspecified-grade in 5,792 (68.2%); median follow-up was 2.3 years. In each MDS category, roughly half of pts were male, and the majority were white and non-Hispanic. Median ages at diagnosis were 75, 74, 74, and 76 years, and 977 (46%), 224 (61%), 83 (42%), and 2,071 (36%) received ≥ 1 treatment in the low-grade, high-grade, del(5q), and unspecified-grade MDS categories, respectively. Frontline therapy with ESA was the mainstay of treatment for pts with low-grade (n = 732; 75%) and unspecified-grade (n = 1,284; 62%) MDS. Average durations of frontline treatment with ESA were 228.1 and 204.5 days in pts with low-grade and unspecified-grade MDS, respectively. Median OS among low- and unspecified-grade MDS pts receiving frontline ESA was 5.4 and 4.6 years, respectively. Of the pts who received frontline ESA, 53 (7.2%) with low-grade and 107 (8.3%) with unspecified-grade MDS were transfusion dependent (≥ 2 transfusions in the 16 weeks prior to treatment initiation). Transfusion dependence in pts receiving frontline ESA was associated with shorter median OS vs transfusion independence (1.7 years vs 5.7 years in low-grade MDS, P < 0.0001; 1.7 years vs 5.2 years in unspecified-grade MDS, P < 0.0001;Figure 1). Among the 160 frontline ESA pts with low-/unspecified-grade MDS who were transfusion dependent, 108 (68%) became transfusion independent (defined as ≥ 60 days without transfusion; 37 of 53 with low-grade MDS; 71 of 107 with unspecified-grade MDS); median time to transfusion independence was 137 and 139 days in pts with low-grade and unspecified-grade MDS, respectively. Most pts with low- or unspecified-grade MDS who received frontline ESA (52% and 51%, respectively) went on to receive second-line treatment, and treatment with ESA was the most common second-line therapy (42% and 40%, respectively). 163 (8.7%) of post-front-line ESA pts were transfusion dependent. Among pts with low-/unspecified-grade MDS who received second-line therapy, median OS was shorter for those who were transfusion dependent after frontline treatment with ESA vs those who were transfusion independent (1.97 years vs 4.5 years, respectively, P < 0.001). 92 (56%) of these transfusion-dependent pts became transfusion independent in a median of 181 days. Conclusions: ESA therapy was the most common treatment approach, both frontline and second-line, for pts with low- or unspecified-grade MDS; however, treatment with ESA did not always eliminate the need for transfusion. Similar to previous reports in pts with low-grade MDS, survival outcomes were substantially worse if pts were transfusion dependent prior to frontline or second-line treatment or became transfusion dependent following frontline treatment. These data indicate the critical importance for treatments to reduce transfusion burden among pts with MDS, in both the frontline and relapsed settings. Disclosures Mehra: Janssen: Employment, Equity Ownership. Potluri:Janssen Research & Development, LLC: Other: Contracted to perform research; SmartAnalyst, Inc.: Employment. He:Janssen Global Services, LLC: Employment, Equity Ownership. Rizo:Janssen Research & Development, LLC: Employment, Equity Ownership. Mundle:Janssen Research & Development, LLC: Employment, Equity Ownership. Bussolari:Janssen Research & Development, LLC: Employment, Equity Ownership.
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Wu, Bingcao, Sophia Li, Ozgur Tunceli, Ji Song, Chris Pericone, Zhijie Ding, Ajay S. Behl, Ayush Srivastava, and Nancy Ann Dawson. "Cost of care for patients with metastatic castration-resistant prostate cancer initiating on docetaxel versus oral targeted therapies in the United States." Journal of Clinical Oncology 36, no. 30_suppl (October 20, 2018): 88. http://dx.doi.org/10.1200/jco.2018.36.30_suppl.88.
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88 Background: Abiraterone acetate + prednisone and enzalutamide are approved oral targeted therapies (OTT) for metastatic castration-resistant prostate cancer (mCRPC) which have significant clinical benefit. However, their impact on healthcare cost relative to docetaxel (DOC) is not well understood. Methods: This retrospective cohort study used combined claims data from Truven MarketScan Commercial and Medicare Supplement Plan databases. Males ≥18 years with ≥1 prostate cancer diagnosis and a subsequent metastasis diagnosis were indexed on the first claim date of DOC or OTT between 1/1/2012 and 12/31/2016. ≥1 claim for an androgen deprivation therapy during the 12-month continuous enrollment period prior to metastasis was required; patients with end stage renal disease or other primary cancer were excluded. All-cause per patient per year (PPPY) costs were estimated in 2016 US dollars. A generalized linear model was used to compare adjusted costs between DOC and OTT cohorts. Results: A total of 1,159 and 200 mCRPC patients initiated on OTT and DOC, respectively. Mean follow up time for both cohorts was 1.2 years. Mean age of OTT patients was 75.1 (Standard Deviation = 10.7) years and mean Quan-Charlson Comorbidity Index (QCI) was 3.2 (1.9). Mean age of DOC patients was 65.9 (9.1) years; mean QCI was 2.9 (1.8). 21% of OTT and 56% of DOC patients were commercially insured. Following treatment initiation, total mean unadjusted all-cause PPPY costs were $144,350 ($80,606) and $137,814 ($84,405) for OTT and DOC cohort, respectively. The primary cost drivers were utilization of treatments indicated for mCRPC, outpatient encounters and inpatient hospitalizations. Total adjusted PPPY costs were higher for OTT than DOC patients ($141,008 vs. $125,318, p = 0.0012), mainly due to higher costs of treatments indicated for mCRPC ($80,443 vs. $55,820, p < .0001). Medical costs (excluding mCRPC treatment) for OTT initiated patients were lower ($54,570 vs. $64,614, p = 0.0128). Conclusions: In a real-world setting, initiation on OTT was associated with higher overall cost of care for mCRPC compared with DOC. However, the cost of medical services was significantly lower when initiated on OTT.