Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.

BACKGROUND AND OBJECTIVE: Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of ibrutinib in the first-line treatment of chronic lymphocytic leukemia in real-world clinical settings. METHODS: MEDLINE, EMBASE, and relevant conference websites were searched for articles published in the USA from 1 January, 2014 to 30 June, 2020. Overall survival, progression-free survival, overall response rate, and time to next treatment were summarized. RESULTS: This analysis included a total of 12 publications representing data from 112 to 2033 patients from community and academic centers, and the multicenter informCLL registry. Patients were predominantly male (60-99%) with a median age range from 62 to 77 years, and included those with high-risk genomic features (del[17p]: 21-33%; del[11q]: 33%; and unmutated immunoglobulin heavy chain variable gene: 59%). Real-world effectiveness with ibrutinib complemented the efficacy demonstrated in randomized clinical trials. Across various studies, the 12-month overall survival rates ranged from 95% to 96%; 18-month overall survival rates were similarly high (91%). Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies. In the studies that reported time to next treatment, 91% and 87% of patients treated with first-line ibrutinib did not initiate new treatment at 12 months and 24 months, respectively. CONCLUSIONS: This systematic literature review confirms the benefit of ibrutinib as a first-line treatment in patients with chronic lymphocytic leukemia in real-world clinical settings and is consistent with results from randomized clinical trials, including in patients with high-risk genomic features.

Treatment patterns and outcomes according to cytogenetic risk stratification in patients with multiple myeloma: a real-world analysis.

A clearer understanding of the prognostic implications of t(11;14) in multiple myeloma (MM) is needed to inform current and future therapeutic options. We utilized real-world data from a US database to examine treatment patterns and outcomes in patients by t(11;14) status compared with high- and standard-risk subgroups across different lines of therapy (LoT). This retrospective, observational cohort study used de-identified patient-level information from adults with MM and first-line treatment initiation between January 2011 and January 2020, followed until February 2020. The high-risk cohort comprised patients with high-risk genetic abnormalities per mSMART criteria (including those with co-occurring t(11;14)). Among 6138 eligible patients, 6137, 3160, and 1654 received first-, second-, and third-line treatments, respectively. Of 645 patients who had t(11;14), 69.1% had t(11;14) alone, while 30.9% had co-occurring high-risk abnormalities. Altogether, 1624 and 2544 patients were classified as high- and standard-risk, respectively. In the absence of biomarker-driven therapy, treatment patterns remain similar across LoT in high-risk, t(11;14)+, and standard-risk subgroups. Across all LoT, patient outcomes in the high-risk subgroup were less favorable than those in the t(11;14)+ and standard-risk subgroups. Thus, there is an opportunity for novel therapeutics targeted to t(11;14) and other defined subgroups to personalize MM therapy and optimize patient outcomes.

Complications and Economic Burden Associated With Obtaining Tissue for Diagnosis and Molecular Analysis in Patients With Non-Small-Cell Lung Cancer in the United States.

PURPOSE: With an increase in biomarker-directed therapies, tissue biopsy to identify targetable genomic and immunologic alterations has become the mainstay of managing patients with non-small-cell lung cancer (NSCLC); however, little is known about the associated economic impact and complication rate. This study assesses the frequency, complications, and costs of diagnostic and postprogression biopsy. METHODS: This retrospective, observational study was conducted using administrative claims data from more than 30 million commercially insured individuals in the United States (2006 to 2014). Data were analyzed for the overall population and by time of biopsy (diagnostic or postprogression biopsy). RESULTS: Of 20,013 eligible patients, 13,411 (67%) received a diagnostic biopsy, whereas only 2,056 (10%) received a postprogression biopsy (mean cost, $9,977 and $16,806, respectively). Complication rates were similar at diagnosis and after progression, on the day of biopsy (10% v 7%, respectively) and within 30 days (63% v 61%, respectively). Mean costs were higher among patients with a complication compared with those without a complication on the day of biopsy (diagnostic biopsy, $12,030 v $6,508, respectively; postprogression biopsy, $22,593 v $7,812, respectively), within 7 days of biopsy (diagnostic biopsy, $13,657 v $7,765, respectively; postprogression biopsy, $23,969 v $8,932, respectively), and within 30 days of biopsy (diagnostic biopsy, $24,968 v $15,988, respectively; postprogression biopsy, $30,293 v $12,494, respectively; P < .001 for all comparisons). CONCLUSION: From 2006 to 2014, postprogression biopsies were not common practice in NSCLC. Complication rates were similar at diagnosis and after progression, with mean costs higher among patients with a complication than those without a complication. With increasing demands for effective novel targeted therapies and safe testing methods, these data may be valuable in determining the budget impact and comparing complication rates with newer, less invasive molecular testing methods, including plasma circulating tumor DNA testing.

The impact of initial antibiotic treatment failure: real-world insights in patients with complicated, health care-associated intra-abdominal infection.

PURPOSE: The RECOMMEND study (NCT02364284; D4280R00005) assessed the clinical management patterns and treatment outcomes associated with initial antibiotic therapy (IAT; antibiotics administered ≤48 hours post-initiation of antibiotic therapy) for health care-associated infections across five countries. PATIENTS AND METHODS: Data were collected from a retrospective chart review of patients aged ≥18 years with health care-associated complicated intra-abdominal infection (cIAI). Potential risk factors for IAT failure were identified using logistic regression analyses. RESULTS: Of 385 patients with complete IAT data, bacterial pathogens were identified in 270 (70.1%), including Gram-negative isolates in 221 (81.9%) and Gram-positive isolates in 92 (34.1%). Multidrug-resistant (MDR) pathogens were identified in 112 patients (41.5% of patients with a pathogen identified). IAT failure rate was 68.3% and in-hospital mortality rate was 40.8%. Multivariate regression analysis demonstrated three factors to be significantly associated with IAT failure: patients admitted/transferred to the intensive care unit during index hospitalization, isolation of an MDR pathogen and previous treatment with ß-lactam antibiotics. CONCLUSION: We reveal the real-world insights into the high rates of IAT failure and mortality observed among patients with cIAI. These data highlight the challenges associated with choosing IAT, the impact of MDR pathogens on IAT outcomes and the importance of tailoring IAT selection to account for local epidemiology and patient history.

The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia.

OBJECTIVES: To assess real-world treatment patterns and clinical outcomes associated with initial antibiotic therapy (IAT, antibiotics received ≤ 48 h post-initiation of antibiotic therapy), including level of IAT failure, and potential risk factors for IAT failure in healthcare-associated infections. METHODS: Data were obtained from medical records of adult patients hospitalized with healthcare-associated pneumonia (HCAP) and nosocomial pneumonia (NP), including ventilator-associated pneumonia, from 1 July 2013 to 30 June 2014 in Brazil, France, Italy, Russia and Spain during the retrospective, observational study, RECOMMEND (NCT02364284; D4280R00005). Potential risk factors for IAT failure were explored using logistic regression analyses. RESULTS: Mean (standard deviation) age and Deyo-Charlson Comorbidity Score were 66.0 (16.2) years and 2.4 (2.4), respectively (N = 451). Most patients (62.5%) received monotherapy. Mean (standard deviation) duration of IAT was 8.8 (7.2) days. Multidrug-resistant (MDR) pathogens were identified in 52.4% of patients with ≥ 1 pathogen isolated (154/294). IAT failure was recorded in 72.5% of patients and was significantly associated with isolation of a MDR pathogen and country using multivariate analyses. CONCLUSIONS: Real-world data demonstrate the burden of HCAP/NP, with high rates of IAT failure. The association of IAT failure with MDR pathogens highlights the urgent need to understand and account for local prevalence of MDR pathogens when selecting IAT for the management of HCAP/NP.

Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer.

Purpose There is a growing demand for BRCA1/ 2 mutation ( BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with > 99% of patients expressing satisfaction with pre- and post- BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with > 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer.

The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection.

OBJECTIVES: RECOMMEND (NCT02364284; D4280R00005) assessed treatment patterns and outcomes associated with initial antibiotic therapy (IAT; antibiotics received <48 h post-initiation of antibiotic therapy) in healthcare-associated infections across five countries. METHODS: Data from medical records of hospitalized patients aged ≥18 years with healthcare-associated complicated urinary tract infections (cUTI) are presented. Univariate and multivariate logistic regression analyses identified potential risk factors associated with IAT failure. RESULTS: Mean (SD) age was 68.7 (17.4) years (n = 408). In patients with microbiological documentation (357/408), Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa were most common (47.1%, 21.6% and 11.8%, respectively); 46.1% of patients had a multidrug resistant (MDR) pathogen isolated. Most patients received monotherapy IAT (72.5%). Mean IAT duration was 7.8 days. IAT failure, in-hospital mortality, and mortality 30-day post-discharge were 54.4%, 35.0% and 37.3%, respectively. IAT failure was associated with age, Deyo-Charlson comorbidity score, country, MDR status and ICU admission in the univariate analysis; and country and age in the multivariate analysis. CONCLUSIONS: This study provides real-world insights into the high rates of IAT failure and morbidity observed in patients with cUTI. Further study is imperative to understand the epidemiology of cUTI, support appropriate IAT selection and management, and reduce the burden of this disease.

Characteristics and treatment patterns among US patients with hairy cell leukemia: a retrospective claims analysis.

AIM: Describe hairy cell leukemia (HCL) treatment patterns using a large, nationally representative US database. PATIENTS & METHODS: Adults newly diagnosed with HCL (1 January 2006 to 30 June 2014) with continuous health plan enrollment ≥180 days pre- and 90 days post-diagnosis were identified from the QuintilesIMS PharMetrics Plus Health Plan Claims Database. Treatment patterns by line of therapy were assessed over the variable follow-up. RESULTS: Among 749 HCL patients (77.4% male; mean age 55.6; mean 32.3 months follow-up), only 37.7% initiated first-line therapy during the available follow-up in a mean of 4.4 months following diagnosis; the majority (75.5%) received cladribine (mean duration 7.3 days). Thirty-eight patients (5.1%) received second-line treatment. CONCLUSION: Over 2.7 years follow-up, more than a third of patients initiated first-line therapy which appeared to provide a long-lasting response.

Ceftaroline fosamil treatment outcomes compared with standard of care among hospitalized patients with complicated skin and soft tissue infections.

AIM: Compare clinical and cost outcomes associated with ceftaroline fosamil with other commonly used antibiotics in complicated skin and soft tissue infections. METHODS: Retrospective analysis of hospital records from 2010 to 2013 in Premier's Perspective comparative database for adults with complicated skin and soft tissue infection treated with intravenous ceftaroline fosamil, vancomycin, daptomycin, linezolid or tigecycline. Length of stay, inpatient costs and mortality were compared between propensity score-matched treatment groups. RESULTS & CONCLUSION: Compared with the other commonly used antibiotics, matched patients in the ceftaroline fosamil treatment group had an equivalent (1%) or lower (compared with linezolid, 2%) in-hospital mortality rate, and significantly lower (p < 0.001) average unadjusted and regression-adjusted length of stay and inpatient costs (savings of $3398.80 compared with daptomycin).

Treatment Patterns, Costs, and Survival among Medicare-Enrolled Elderly Patients Diagnosed with Advanced Stage Gastric Cancer: Analysis of a Linked Population-Based Cancer Registry and Administrative Claims Database.

PURPOSE: To assess real-world treatment patterns, health care utilization, costs, and survival among Medicare enrollees with locally advanced/unresectable or metastatic gastric cancer receiving standard first-line chemotherapy. MATERIALS AND METHODS: This was a retrospective analysis of the Surveillance, Epidemiology, and End Results-Medicare linked database (2000~2009). The inclusion criteria were as follows: (1) first diagnosed with locally advanced/unresectable or metastatic gastric cancer between July 1, 2000 and December 31, 2007 (first diagnosis defined the index date); (2) ≥65 years of age at index; (3) continuously enrolled in Medicare Part A and B from 6 months before index through the end of follow-up, defined by death or the database end date (December 31, 2009), whichever occurred first; and (4) received first-line treatment with fluoropyrimidine and/or a platinum chemo-therapy agent. RESULTS: In total, 2,583 patients met the inclusion criteria. The mean age at index was 74.8±6.0 years. Over 90% of patients died during follow-up, with a median survival of 361 days for the overall post-index period and 167 days for the period after the completion of first-line chemotherapy. The mean total gastric cancer-related cost per patient over the entire post-index follow-up period was United States dollar (USD) 70,808±56,620. Following the completion of first-line chemotherapy, patients receiving further cancer-directed treatment had USD 25,216 additional disease-related costs versus patients receiving supportive care only (P<0.001). CONCLUSIONS: The economic burden of advanced gastric cancer is substantial. Extrapolating based on published incidence estimates and staging distributions, the estimated total disease-related lifetime cost to Medicare for the roughly 22,200 patients expected to be diagnosed with this disease in 2014 approaches USD 300 millions.

Assessment of Outpatient and Inpatient Antibiotic Treatment Patterns and Health Care Costs of Patients with Complicated Urinary Tract Infections.

PURPOSE: The goal of this study was to examine treatment patterns, utilization, and costs for complicated urinary tract infections (UTIs) requiring inpatient/emergency department (ED) and outpatient care. METHODS: This observational study evaluated inpatient/ED-treated and outpatient-treated patients (aged ≥18 years) with complicated UTIs from 2 large US administrative claims databases (HealthCore Integrated Research Environment and Premier Perspective Database). Patient identification depended on treatment setting: outpatients had 2 UTI diagnosis-related office visits and 2 claims for different antibiotics within 30 days, and inpatients had a UTI-related hospitalization/ED visit after 1 UTI diagnosis-related office visit plus 2 claims for different antibiotics within 30 days. The index date for outpatients was the date of the first office visit; for inpatients, it was the date of admission/ED visit. Both cohorts had continuous insurance eligibility. Outcomes were assessed by using univariate and multivariate statistics. FINDINGS: The study sample included 1118 inpatient/ED patients (76.6% female subjects; mean age, 62.4 years) and 41,605 outpatients (85.8% female subjects; mean age, 52.3 years). Mean (SD) pharmacy costs were $2971 ($7650) for inpatient/ED patients and $1882 ($3120) for outpatients during the full treatment period. Index hospitalization/ED averaged $38,422 ($51,161). Mean all-cause 90-day follow-up costs for the inpatient/ED cohort were $34,100 ($71,621) and $11,345 ($34,313) for the outpatient cohort. IMPLICATIONS: Relative to outpatient-treated patients, inpatient/ED-treated patients were older, sicker, had higher costs across treatment periods, and had reduced antibiotic use at a lower rate during the 90-day follow-up. Strategies to avoid preventable inpatient/ED visits may help reduce costs in the management of outpatients with complicated UTIs.

Comparison of demographics, treatment patterns, health care utilization, and costs among elderly patients with extensive-stage small cell and metastatic non-small cell lung cancers.

BACKGROUND: Limited data exist regarding real-world treatment patterns, resource utilization, and costs of extensive-stage small cell lung cancer (esSCLC) among elderly patients in the United States. While abundant data are available on treatment patterns in metastatic non-small cell lung cancer (mNSCLC), to our knowledge no data exist comparing costs and resource use between patients with esSCLC or mNSCLC. METHODS: We retrospectively analyzed administrative claims data (2000-2008) of patients aged ≥65 years from the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database. Patients were selected on the basis of having newly diagnosed esSCLC (n=5,855) or mNSCLC (n=24,090) during 1/1/2000-12/31/2005, and were required to have received cancer-directed therapy. Survival and other measures were compared between esSCLC and mNSCLC patients using Kaplan-Meier log-rank and univariate chi-square and t-tests. Study measures were followed from first diagnosis date of either esSCLC or mNSCLC until the earlier of death or end of the database. RESULTS: Survival between the cohorts did not differ significantly: mean of 10.4 months for esSCLC patients versus 11.1 months for mNSCLC; median survival was 7.4 months versus 5.9 months. A higher percentage of mNSCLC patients (vs. esSCLC) received radiation therapy (75.6% vs. 65.4%; P < 0.001) and surgery (13.6% vs. 7.8%; P < 0.001) during the metastatic disease period. Conversely, a higher percentage of esSCLC patients than mNSCLC patients received chemotherapy (85.5% vs. 60.3%; P < 0.001), red blood-cell transfusion (20.7% vs. 10.9%; P < 0.001), platelet transfusion (5.6% vs. 1.8%; P < 0.001), and growth-factor support (59.0% vs. 39.5%; P < 0.001). esSCLC patients incurred higher lifetime disease-related costs ($44,167 vs. $37,932; P < 0.001) and all-cause costs ($70,549 vs. $67,176; P < 0.001) than mNSCLC patients. CONCLUSIONS: Lifetime total and disease-related costs per patient were high. Increased use of chemotherapy, supportive care therapies (including growth factors), and disease-related hospitalizations were observed in esSCLC patients as compared with mNSCLC patients. Disease-related and all-cause costs for esSCLC also exceeded those of mNSCLC, except for hospice and skilled nursing services. Survival and per-patient costs for both groups underscore the unmet medical need for more effective therapies in patients with esSCLC or mNSCLC.

Prandial insulin versus glucagon-like peptide-1 added to basal insulin: comparative effectiveness in the community practice setting.

BACKGROUND: Real-world data on emerging combination approaches for type 2 diabetes mellitus (T2DM) management are limited. The objective of the current study was to document the characteristics and clinical outcomes of patients with T2DM initiating prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist while on basal insulin. METHODS: This was a retrospective analysis of an electronic medical records database of patients with T2DM managed in a community practice setting in the United States. The main outcome measures were glycated hemoglobin (HbA1c), body weight, hypoglycemia, and health care resource utilization at baseline and at 6-month and 1-year follow-up. RESULTS: A total of 33 810 patients were included in the study: 31 848 on prandial insulin and 1962 on a GLP-1 receptor agonist. At baseline there were significant differences in mean age (60 vs 56 years), mean Charlson Comorbidity Index score (1.1 vs 0.7), mean HbA1c (8.8% vs 8.4%), and mean body weight (99 vs 112 kg) between the prandial insulin and GLP-1 receptor agonist groups, respectively (P < 0.001 for each). After matching for baseline differences, significant and similar changes from baseline were observed between the prandial insulin and the GLP-1 receptor agonist groups during follow-up at the 6 months/1 year post-index date for HbA1c (-0.45/-0.60% vs -0.44/-0.58%, respectively; P = 0.907/0.723 between groups). Body weight changes between the groups were significantly different at 6 months/1 year (+1.7/-1.7 vs -0.9/-3.7 kg; P < 0.001). Hypoglycemia incidence and health care resource utilization were significantly greater in the prandial insulin versus GLP-1 receptor agonist group. CONCLUSIONS: The results of this real-world analysis of patients with T2DM adding a GLP-1 receptor agonist or prandial insulin to basal insulin suggest an association between adding a GLP-1 receptor agonist with similar glycemic control, greater reduction in body weight, lower hypoglycemia incidence, and lower health care utilization compared with adding prandial insulin.

Assessing medication adherence and healthcare utilization and cost patterns among hospital-discharged patients with schizoaffective disorder.

BACKGROUND: Hospital-discharged patients with schizoaffective disorder have a high risk of re-hospitalization. However, limited data exist evaluating critical post-discharge periods during which the risk of re-hospitalization is significant. OBJECTIVE: Among hospital-discharged patients with schizoaffective disorder, we assessed pharmacotherapy adherence and healthcare utilization and costs during sequential 60-day clinical periods before schizoaffective disorder-related hospitalization and post-hospital discharge. METHODS: From the MarketScan(®) Medicaid database (2004-2008), we identified patients (≥18 years) with a schizoaffective disorder-related inpatient admission. Study measures including medication adherence and healthcare utilization and costs were assessed during sequential preadmission and post-discharge periods. We conducted univariate and multivariable regression analyses to compare schizoaffective disorder-related and all-cause healthcare utilization and costs (in 2010 US dollars) between each adjacent 60-day post-discharge periods. No adjustment was made for multiplicity. RESULTS: We identified 1,193 hospital-discharged patients with a mean age of 41 years. The mean medication adherence rate was 46% during the 60-day period prior to index inpatient admission, which improved to 80% during the 60-day post-discharge period. Following hospital discharge, schizoaffective disorder-related healthcare costs were significantly greater during the initial 60-day period compared with the 61- to 120-day post-discharge period (mean US$2,370 vs US$1,765; p < 0.001), with rehospitalization (36%) and pharmacy (40%) accounting for over three-fourths of the initial 60-day period costs. Compared with the initial 60-day post-discharge period, both all-cause and schizoaffective disorder-related costs declined during the 61- to 120-day post-discharge period and remained stable for the remaining post-discharge periods (days 121-365). CONCLUSIONS: We observed considerably lower (46%) adherence during 60 days prior to the inpatient admission; in comparison, adherence for the overall 6-month period was 8% (54%) higher. Our study findings suggest that both short-term (e.g., 60 days) and long-term (e.g., 6-12 months) medication adherence likely are important characteristics to examine among patients with schizoaffective disorder and help provide a more holistic view of patients' adherence patterns. Furthermore, we observed a high rate of rehospitalization and greater healthcare costs during the initial 60-day period post-discharge among patients with schizoaffective disorder. Further research is required to better understand and manage transitional care after discharge (e.g., monitor adherence), which may help reduce the likelihood of rehospitalization and the associated downstream costs.

Burden of acute gastroenteritis, norovirus and rotavirus in a managed care population.

This study assessed and described the episode rate, duration of illness, and health care utilization and costs associated with acute gastroenteritis (AGE), norovirus gastroenteritis (NVGE), and rotavirus gastroenteritis (RVGE) in physician office, emergency department (ED), and inpatient care settings in the United States (US). The retrospective analysis was conducted using an administrative insurance claims database (2006-2011). AGE episode rates were assessed using medical (ICD-9-CM) codes for AGE; whereas a previously published "indirect" method was used in assessing estimated episode rates of NVGE and RVGE. We calculated per-patient, per-episode and total costs incurred in three care settings for the three diseases over five seasons. For each season, we extrapolated the total economic burden associated with the diseases to the US population. The overall AGE episode rate in the physician office care setting declined by 15% during the study period; whereas the AGE episode rate remained stable in the inpatient care setting. AGE-related total costs (inflation-adjusted) per 100 000 plan members increased by 28% during the 2010-2011 season, compared with the 2006-2007 season ($832,849 vs. $1 068 116) primarily due to increase in AGE-related inpatient costs. On average, the duration of illness for NVGE and RVGE was 1 day longer than the duration of illness for AGE (mean: 2 days). Nationally, the average AGE-related estimated total cost was $3.88 billion; NVGE and RVGE each accounted for 7% of this total. The episodes of RVGE among pediatric populations have declined; however, NVGE, RVGE and AGE continue to pose a substantial burden among managed care enrollees. In conclusion, the study further reaffirms that RVGE has continued to decline in pediatric population post-launch of the rotavirus vaccination program and provides RVGE- and NVGE-related costs and utilization estimates which can serve as a resource for researchers and policy makers to conduct cost-effectiveness studies for prevention programs.

Survival patterns in United States (US) medicare enrollees with non-CML myeloproliferative neoplasms (MPN).

PURPOSE: Non-CML myeloproliferative neoplasms (MPN) include essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF). Reported median overall survival (OS) ranges from a few to several years for MF, a decade or more for ET and PV. The study objective was to compare US survival rates of ET, PV, and MF patients with matched non-MPN/non-cancer controls in a nationally representative database. PATIENTS AND METHODS: Data were taken retrospectively from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database. Medicare enrollees with a new SEER MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were eligible. First MPN diagnosis was required at or after Medicare enrollment to allow for continuous follow-up. Non-MPN/non-cancer control groups were selected from Medicare separately for each MPN subtype and demographically matched to cases at a ratio of 5:1. Survival was determined starting from the case diagnosis date using the Kaplan-Meier method. RESULTS: A total of 3,364 MPN patients (n = 1,217 ET; 1,625 PV; 522 MF) met the inclusion criteria and were matched to controls. Mean age was 78.4, 76.1, and 77.4 years for ET, PV, and MF, respectively, and percent female was 63, 50, and 41. Median OS was significantly (p<0.05) lower for MPN cases vs. controls (ET: 68 vs. 101 months; PV: 65 vs. 104; MF: 24 vs. 106). CONCLUSIONS: In the US Medicare population, survival in MF patients was worse than that of patients with ET or PV and significantly worse than matched controls. Survival of patients with ET or PV was substantially inferior to matched controls. These findings have implications for the clinical management of MPN patients and underscore the need for effective therapies in all MPN subtypes.

Smoking and mortality in stroke survivors: can we eliminate the paradox?

BACKGROUND: Many studies have suggested that smoking does not increase mortality in stroke survivors. Index event bias, a sample selection bias, potentially explains this paradoxical finding. Therefore, we compared all-cause, cardiovascular disease (CVD), and cancer mortality by cigarette smoking status among stroke survivors using methods to account for index event bias. METHODS: Among 5797 stroke survivors of 45 years or older who responded to the National Health Interview Survey years 1997-2004, an annual, population-based survey of community-dwelling US adults, linked to the National Death Index, we estimated all-cause, CVD, and cancer mortality by smoking status using Cox proportional regression and propensity score analysis to account for demographic, socioeconomic, and clinical factors. Mean follow-up was 4.5 years. RESULTS: From 1997 to 2004, 18.7% of stroke survivors smoked. There were 1988 deaths in this stroke survivor cohort, with 50% of deaths because of CVD and 15% because of cancer. Current smokers had an increased risk of all-cause mortality (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.14-1.63) and cancer mortality (HR, 3.83; 95% CI, 2.48-5.91) compared with never smokers, after controlling for demographic, socioeconomic, and clinical factors. Current smokers had an increased risk of CVD mortality controlling for age and sex (HR, 1.29; 95% CI, 1.01-1.64), but this risk did not persist after controlling for socioeconomic and clinical factors (HR, 1.15; 95% CI, .88-1.50). CONCLUSIONS: Stroke survivors who smoke have an increased risk of all-cause mortality, which is largely because of cancer mortality. Socioeconomic and clinical factors explain stroke survivors' higher risk of CVD mortality associated with smoking.

Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization.

BACKGROUND: This study aimed to assess antipsychotic adherence patterns and all-cause and schizophrenia-related health care utilization and costs sequentially during critical clinical periods (i.e., before and after schizophrenia-related hospitalization) among Medicaid-enrolled patients experiencing a schizophrenia-related hospitalization. METHODS: All patients aged ≥ 18 years with a schizophrenia-related inpatient admission were identified from the MarketScan Medicaid database (2004-2008). Adherence (proportion of days covered [PDC]) to antipsychotics and schizophrenia-related and all-cause health care utilization and costs were assessed during preadmission (182- to 121-day, 120- to 61-day, and 60- to 0-day periods; overall, 6 months) and postdischarge periods (0- to 60-day, 61- to 120-day, 121- to 180-day, 181- to 240-day, 241- to 300-day, and 301- to 365-day periods; overall, 12 months). Health care utilization and costs (2010 US dollars) were compared between each adjacent 60-day follow-up period after discharge using univariate and multivariable regression analyses. No adjustment was made for multiplicity. RESULTS: Of the 2,541 patients with schizophrenia (mean age: 41.2 years; 57% male; 59% black) who were identified, approximately 89% were "discharged to home self-care." Compared with the 60- to 0-day period before the index inpatient admission, greater mean adherence as measured by PDC was observed during the 0- to 60-day period immediately following discharge (0.46 vs. 0.78, respectively). The mean PDC during the overall 6-month preadmission period was lower than during the 6-month postdischarge period (0.53 vs. 0.69; P < 0.001). Compared with the 0- to 60-day postdischarge period, schizophrenia-related health care costs were significantly lower during the 61- to 120-day postdischarge period (mean: $2,708 vs. $2,102; P < 0.001); the primary cost drivers were rehospitalization (mean: $978 vs. $660; P < 0.001) and pharmacy (mean: $959 vs. $743; P < 0.001). Following the initial 60-day period, both all-cause and schizophrenia-related costs declined and remained stable for the remaining postdischarge periods (days 121-365). CONCLUSIONS: Although long-term (e.g., 365-day) adherence measures are important, estimating adherence over shorter intervals may clarify the course of vulnerability to risk and enable clinicians to better design adherence/risk-related interventions. The greatest risk of rehospitalization and thus greater resource utilization were observed during the initial 60-day postdischarge period. Physicians should consider tailoring management and treatment strategies to help mitigate the economic and humanistic burden for patients with schizophrenia during this period.

Influenza-related health care utilization and productivity losses during seasons with and without a match between the seasonal and vaccine virus B lineage.

OBJECTIVE: To assess and compare direct medical costs (incurred by payers) and indirect productivity losses (incurred by employers) associated with influenza seasons with matched or mismatched circulating and vaccine containing influenza B lineages. METHODS: A retrospective analysis, using two MarketScan databases, for the years 2000-2009. Each influenza season was categorized as matched or mismatched after comparing that season's circulating influenza B lineage and the vaccine influenza B lineage. Patients selected had at least one diagnosis claim for influenza (ICD-9-CM code 487.xx [influenza] or 488.1 [H1N1]) during an influenza season. We assessed the incidence of influenza (overall and influenza B), influenza-related medical utilization and associated costs, and productivity losses for each season. RESULTS: The four matched seasons had lower average influenza incidence (overall incidence per 100,000 plan members: 509; 95% confidence interval [CI]: 505-512) than the five mismatched seasons (748; 95% CI: 745-751). The mismatched seasons had lower influenza B incidence (average incidence per 100,000 plan members: 126; 95% CI: 125-128) than the matched seasons (165; 95% CI: 163-167). The average, per-patient, total influenza-related medical costs in the mismatched seasons ($300.83; range: $245.38-$371.58) were approximately $61.00 higher than in the matched seasons ($239.43; range: $201.49-$264.01). The mismatched seasons had greater average per-patient, influenza-related productivity-loss costs than the matched seasons (mean: $237.31 vs. $175.10). CONCLUSION: CDC data showed that influenza A was the predominant circulating strain during seasons in which the circulating influenza B lineage did not match the vaccine influenza B lineage. This resulted in lower influenza B incidence during the mismatched seasons. However, the average, per-patient, influenza-related direct medical costs and indirect productivity losses were higher during the mismatched seasons. Additional research is required to determine if these higher costs can be attributed to influenza B infections and if the influenza severity varies during mismatched seasons.

Annual all-cause healthcare costs among influenza patients with and without influenza-related complications: analysis of a United States managed care database.

BACKGROUND: Several studies have reported that patients with influenza have a high risk of developing complications such as secondary infections, exacerbation of cardiovascular conditions and asthma. However, limited data exists on the healthcare cost burden for influenza patients with and without influenza-related complications. OBJECTIVE: We compared healthcare utilization and costs among influenza patients with related complications versus patients without complications. METHODS: In this retrospective database analysis (LifeLink database: 1998-2009) of a US managed care database, we selected patients diagnosed with influenza during influenza seasons and categorized them as complicated or uncomplicated based on the presence or absence of a diagnosis for a related complication in the year following their influenza diagnosis. Multivariable regression analyses were conducted to compare all-cause utilization and costs (adjusted to 2009 US dollars) between the two groups. RESULTS: We identified 54,469 patients of which ~65 % had evidence for at least one complication. Patients with complicated influenza had a 1.5-fold higher rate of inpatient utilization compared with uncomplicated cases (p < 0.001). Significantly higher covariate-adjusted predicted mean annual costs were also observed among complicated influenza patients across all care (p-values <0.001 for all comparisons). CONCLUSION: Healthcare costs were twice as high among influenza patients with complications versus those without, with inpatient and outpatient services being the primary cost drivers. Now with the universal recommendation for seasonal influenza vaccination for all individuals ≥6 months of age, improvement in coverage rates may help reduce the healthcare utilization and costs associated with influenza and associated complications.