Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study.

INTRODUCTION: Small cell lung cancer (SCLC) is a subtype of lung cancer, the second most common cancer diagnosis worldwide. Currently, there is little published qualitative research that provides insight into the disease-related symptoms and impacts that are relevant to patients living with SCLC as directly reported by patients themselves. METHODS: This qualitative, cross-sectional, noninterventional, descriptive study included concept elicitation interviews with participants diagnosed with SCLC and the development of a conceptual model of clinical treatment benefit. RESULTS: Concept elicitation interview data from 26 participants with SCLC were used to develop a conceptual model of clinical treatment benefit that organized 28 patient-reported concepts into two domains: disease-related symptoms (organ-specific and systemic) and impacts. Organ-specific symptoms included cough, chest pain, and difficulty breathing. Systemic symptoms included pain, fatigue, appetite loss, and dizziness. Impacts included physical functioning, role functioning, reduced movement, impact on sleep, and weight loss. CONCLUSION: As evidenced by this study, people with SCLC experience considerable and significant symptoms and impacts, including physical and role functioning challenges, that affect their quality of life. This conceptual model will inform the design of a patient-reported outcome (PRO) questionnaire for a future SCLC clinical trial, helping to establish the content validity of the items and questionnaires used in the trial and ensuring that the questionnaires and items selected are appropriately targeted to the population. This conceptual model could also be used to inform future SCLC clinical trials.

Oncology drugs and added benefit: insights from 3 European health technology assessment agencies on the role of efficacy endpoints.

OBJECTIVE: This study aimed to understand the impact of different efficacy endpoints on reimbursement decisions made by health technology assessment (HTA) bodies. MATERIALS AND METHODS: European Medicines Agency (EMA) oncology product marketing authorizations were screened to identify products that completed review by 3 HTA bodies during 2016-2019: United Kingdom's National Institute for Health and Care Excellence, Germany's Gemeinsamer Bundesausschuss, and France's Haute Autorité de Santé. Each decision's endpoint information, including overall survival (OS) and progression-free survival (PFS), was extracted. Each endpoint's influence on added benefits rating (the degree of added benefit as judged by the HTA agency) and full reimbursement (i.e. reimbursed population to label) decisions was tested using bivariate analyses. RESULTS: An increasing trend was observed toward HTA submissions with immature OS data (36.8% and 71.4% in 2016 and 2019, respectively), which was a predictor of limited added benefit (p < .001). Regarding data availability, 63% of submissions provided OS, 2% provided PFS without OS; and 35% provided neither. OS availability significantly influenced added benefit (p < .001) but not full reimbursement (p > .05) decisions, whereas PFS without OS had no significant impact compared with either OS or PFS data for either outcome (p = .99). CONCLUSIONS: The trend toward fewer products filing mature OS data over time suggests sponsors may be increasingly confident achieving reimbursement with surrogate endpoint data, although mature OS data provided the strongest correlation to positive reimbursement decisions. Notably, in some locally advanced settings, OS data maturity will take a long time to obtain. To expedite patient access to new medicines, payers should consider the acceptance of surrogate endpoints predictive of clinical benefit.

Collection of Post-treatment PRO Data in Oncology Clinical Trials.

As patient-reported outcome (PRO) measures are being included more frequently in oncology clinical trials, regulatory and health technology assessment agencies have begun to request long-term, post-treatment PRO data to supplement traditional survival/progression endpoints. These data may be collected as part of cohort extension or registry studies to describe long-term outcomes of study participants after concluding their cancer treatment. While post-treatment PRO data may be expected to satisfy regulatory and payer expectations, significant practical barriers exist for the efficient incorporation of these data into oncology clinical trials, such as subject attrition, protocol deviations, and treatment crossover. The incorporation of post-treatment PRO assessments is a resource-intensive task requiring clear objectives for how the data will be analyzed and interpreted by both sponsors and regulators. Incorporating PRO data collection via electronic modalities (e.g., smartphone, web) may be a less expensive and more feasible option for incorporating long-term follow-up, reducing the frequency of manual study staff follow-up and expensive clinic visits. It is essential to include well-defined estimands for the statistical analysis, as well as to document limitations associated with the long-term follow-up data-collection approach. Analytical techniques will likely rely on descriptive and model-based statistics, and conclusions about treatment differences will likely be limited to preliminary findings of effectiveness (instead of efficacy). Finally, communications with health authorities and regulatory agencies regarding the LTFU study design and analysis should occur as early as possible to ensure that the PRO data to be collected offer an opportunity to properly evaluate the research question(s) of interest.

Treatment and persistence with oral anticoagulants among newly diagnosed patients with non-valvular atrial fibrillation: a retrospective observational study in a US commercially insured and Medicare Advantage population.

OBJECTIVES: With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics. DESIGN: Retrospective observational administrative claims study in the USA. SETTING: Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013. PARTICIPANTS: 45 092 patients with NVAF were included. OUTCOMES: The proportion of OAC-treated patients was stratified by CHADS2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first. RESULTS: Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS2<2: 39.8%; CHADS2=2 or 3: 42.4%; and CHADS2>3: 40.3%: p<0.001). Treated patients were slightly younger (70±12.2 vs 71±14.3 years; p<0.001), more likely male (59.7% vs 52.5%; p<0.001) and had a slightly elevated stroke risk (CHADS2: 2.03±1.3 vs 1.98±1.4; p<0.001) and a lower bleeding risk (HEMORR2HAGES: 2.55±1.8 vs 2.80±1.9; p<0.001) relative to untreated patients. Overall, patients with higher CHADS2 scores had higher HEMORR2HAGES scores. The mean follow-up was 2.25 years (2.25±0.85) and 72.7% of patients discontinued OACs; nearly 25% within 3 months and 55% within 12 months. The mean time to discontinuation was 255±249 days. CONCLUSIONS: The proportion of patients with NVAF who received OAC treatment was lower than previously reported and differed slightly by stroke risk. Patients with an elevated stroke risk had a higher bleeding risk, suggesting that clinicians may incorporate both in the treatment decision.

Comparison of claims vs patient-reported adherence measures and associated outcomes among patients with nonvalvular atrial fibrillation using oral anticoagulant therapy.

OBJECTIVE: To compare oral anticoagulant (OAC) adherence among patients with nonvalvular atrial fibrillation (NVAF) using patient-reported and claims-based measures, and to evaluate the effect of OAC adherence on health care costs and patient satisfaction with OAC therapy. METHODS: This was a hybrid US observational study consisting of a longitudinal cohort survey followed by linkage and analysis of respondents' administrative claims data. Patients with NVAF receiving warfarin, dabigatran, rivaroxaban, or apixaban completed an initial survey and follow-up surveys at 4, 8, and 12 months. Patient-reported adherence was measured at each survey by Morisky Medication Adherence Scale (MMAS-8) and pharmacy claims-determined adherence by the proportion of days covered (PDC) for the 12-month period following the initial survey date; adherence was defined as MMAS-8 score =8 and PDC ≥80%. Patient satisfaction with OAC therapy was assessed by the Duke Anticoagulation Satisfaction Scale (DASS). RESULTS: Overall, 675 patients completed at least the initial survey (warfarin, n=271; dabigatran, n=266; rivaroxaban, n=128; apixaban, n=10). Fewer than half (47.9%) were PDC adherent, 37.2% were MMAS-8 adherent, and 19.4% were adherent by both measures. Total medical costs of PDC-adherent patients were significantly lower vs PDC-nonadherent patients (US$640 vs $993 per-patient per-month, respectively, p<0.05). MMAS-8-adherent patients reported higher treatment satisfaction; total DASS score was significantly lower among MMAS-8-adherent than MMAS-8-nonadherent patients (37.3 vs 42.9, respectively, p<0.001). CONCLUSION: Using claims-based or patient-reported methods to measure OAC adherence may lead to different results when assessing impact on health care costs and satisfaction with anticoagulation medication. These results underscore the importance of considering both claims-based and patient-reported measures when evaluating treatment adherence in real-world settings.

Health Care Resource Utilization and Costs Among Newly Diagnosed and Oral Anticoagulant-Naive Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran or Warfarin in the United States.

BACKGROUND: Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring. OBJECTIVE: To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin. METHODS: This retrospective observational study used data from medical and pharmacy claims extracted from the HealthCore Integrated Research Database representing commercial and Medicare Advantage members. Adults aged > 18 years with a medical diagnosis claim of NVAF were identified between October 1, 2010, and December 31, 2011. The date of first observed OAC prescription claim was the index date. Patients were followed for up to 12 months after the index date. Patients were assigned to the dabigatran or warfarin treatment groups based on their first OAC prescription fills. To reduce potential for selection bias, the cohorts were matched on baseline characteristics using propensity score matching. HCRU was measured and compared between groups on a per-patient-per-month (PPPM) basis for all-cause HCRU, as well as stroke, myocardial infarction, and bleed-specific HCRU. Pharmacy, medical, and total costs were also compared and adjusted to 2012 U.S. dollars. Generalized linear models were conducted to compare all-cause health care costs between cohorts. RESULTS: After propensity score matching, 1,648 patients were included in the analysis (824 each in the dabigatran and warfarin treatment groups). In the post-index period, patients in the dabigatran group had significantly fewer all-cause PPPM physician office visits (mean [SD] 1.29 [± 0.95] vs. 2.02 [± 1.53], P < 0.001) and outpatient visits (mean [SD] 2.17 [± 2.90] vs. 3.52 [± 3.32], P < 0.001) compared with those in the warfarin group. There were no between-group differences in outcomes for the number of stroke, myocardial infarction, or bleeding-related office visits. All-cause medical costs for the dabigatran cohort were lower than the warfarin cohort; however, the difference did not reach statistical significance ($2,696 [SD ± $6,699] vs. $2,893 [± $6,819], P = 0.179). All-cause pharmacy costs were higher in the dabigatran group versus the warfarin group ($455 [± $429] vs. $328 [± $517], P < 0.001). The dabigatran cohort also had significantly higher stroke-related ($32 [± $71] vs. $20 [± $55], P = 0.006) and nonstroke-related pharmacy costs ($423 [± $422] vs. $308 [± $515], P < 0.001). Despite higher pharmacy costs for the dabigatran cohort, both treatment groups had statistically similar all-cause total costs ($3,151 [± $6,744] vs. $3,221 [± $6,869], P = 0.701). CONCLUSIONS: This real-world study showed that among patients newly diagnosed with NVAF who were OAC naive, dabigatran use was associated with significantly less HCRU in terms of physician and outpatient visits but higher pharmaceutical costs in up to 12 months of follow-up. Similar to other real-world studies, this research supports the finding that higher pharmacy costs for dabigatran users was offset by lower medical costs, making total health care costs comparable between dabigatran and warfarin. DISCLOSURES: This work was supported by Boehringer Ingelheim Pharmaceuticals, which is the manufacturer of dabigatran, one of the products included in the analysis of this work. The authors were responsible for all content and editorial decisions. Jain and Tan are employed by HealthCore, a research consultancy which was funded by Boehringer Ingelheim Pharmaceuticals for work on this study. Fu was employed by HealthCore at the time of this study. Lim, Wang, Elder, and Sander are employees of Boehringer Ingelheim Pharmaceuticals. Study concept and design were contributed by Wang, Sander, and Tan, along with Fu and Jain. Fu, Tan, and Jain collected the data, and data interpretation was performed by Lim, Wang, and Sander, along with Jain, Tan, and Fu. The manuscript was written by Jain, Elder, Tan, and Wang, along with Lim and Fu, and revised by Jain, Wang, Elder, and Tan. Some of the results of this study were presented at Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke (QCOR) 2014 Scientific Sessions on June 2-4, 2014, in Baltimore, Maryland.

All-cause mortality and use of antithrombotics within 90 days of discharge in acutely ill medical patients.

Conflicting evidence exists regarding predictors of and antithrombotic benefit on mortality in hospitalised acutely-ill medical patients. We compared mortality risk within 90 days post-discharge among medically ill patients who did and did not receive antithrombotics. This retrospective claims analysis included patients ≥ 40 years with nonsurgical hospitalisation ≥ 2 days between 2005 and 2009 using the HealthCore Integrated Research Database. Antithrombotic use (i.e. anticoagulants and antiplatelets) post-discharge was captured from pharmacy claims. All-cause mortality was determined from Social Security Death Index; cause of death was identified from National Death Index database. Kaplan-Meier survival curves were generated and hazard ratios (HR) for mortality risk were estimated using Cox proportional hazards models. Patients prescribed anticoagulants or antiplatelets post-discharge had lower risk of short-term mortality. For the anticoagulant model, the most significant predictors of mortality were malignant/benign neoplasms (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.5-1.7), liver disease (HR 1.6, 95% CI 1.5-1.7), anticoagulant omission (HR 1.6, 95% CI 1.4-1.8), gastrointestinal or respiratory tract intubations (HR 1.5, 95% CI 1.3-1.7), and blood dyscrasias (HR 1.4, 95% CI 1.4-1.5). For the antiplatelet model, the most significant predictors of mortality were antiplatelet omission (HR 3.7, 95% CI 3.3-4.1), liver disease (HR 1.6, 95% CI 1.4-1.7), malignant/benign neoplasms (HR 1.6, 95% CI 1.5-1.6), gastrointestinal or respiratory tract intubations (HR 1.5, 95% CI 1.3-1.7), and blood dyscrasias (HR 1.4, 95% CI 1.4-1.5). These mortality risk factors may guide future studies assessing potential benefits of antithrombotics in specific subsets of patients.

Cardiovascular-related healthcare resource utilization and costs in patients with hypertension switching from metoprolol to nebivolol.

BACKGROUND: The prevalence of hypertension is increasing in the United States and the associated costs are soaring. Despite the many treatment options, only approximately 50% of Americans with hypertension achieve optimal control. Patients receiving nebivolol, a third-generation beta-blocker, have fewer adverse events and better treatment persistence compared with patients receiving other antihypertensive agents. Little is known about the impact of switching from a second-generation beta-blocker, such as metoprolol, to nebivolol on healthcare resource utilization and costs. OBJECTIVE: To assess the impact of switching patients with hypertension from metoprolol to nebivolol on the associated healthcare resource utilization and cost. METHOD: This retrospective claims-based analysis included 765 adults aged ≥18 years who were diagnosed with hypertension between January 1, 2008, and December 31, 2012. Data were extracted from the HealthCore Integrated Research Database; the study was conducted between July 1, 2007, and June 30, 2013. To be included in the study, patients had to receive metoprolol for ≥6 months before switching from metoprolol to nebivolol (the preperiod), and continue to use nebivolol for an additional 6 months after switching (the postperiod). Patients with compelling indications for metoprolol but not for nebivolol were excluded from the study. The primary outcome measures were healthcare resource utilization and costs for cardiovascular (CV)-related events. The CV-related resource utilization was calculated based on 100 patients per month; the CV-related costs were calculated per patient per month (PPPM) in 2013 US dollars. RESULTS: A total of 765 patients were included in the analysis. Compared with the preperiod, patients switching to nebivolol had significantly fewer CV-related emergency department visits (0.2 [standard deviation (SD), 1.9] vs 0.04 [SD, 0.8], respectively; P = .012) and fewer CV-related outpatient visits (9.2 [SD, 19.9] vs 6.7 [SD, 17.5], respectively; P <.001). The numbers of inpatient visits in the preperiod and postperiod were similar (0.3 [SD, 2.4] vs 0.1 [SD, 1.5], respectively; P = .164). Patients switching to nebivolol also had significantly lower CV-related emergency department costs ($6 [SD, $78] vs $1 [SD, $27] PPPM, respectively; P = .028) and lower CV-related total medical costs ($94 [SD, $526] vs $54 [SD, $266] PPPM, respectively; P = .020). CONCLUSION: This analysis of real-world data suggests that patients with hypertension who switch from the second-generation antihypertensive metoprolol to the third-generation hypertensive nebivolol have significantly lower CV-related healthcare resource utilization (eg, emergency department and outpatient visits) and lower CV-related medical costs.

Association between anticoagulant treatment duration and risk of venous thromboembolism recurrence and bleeding in clinical practice.

INTRODUCTION: This retrospective observational study examined whether anticoagulant treatment duration varies by risks of venous thromboembolism (VTE) recurrence and bleeding. MATERIALS AND METHODS: VTE patients naïve to anticoagulants were identified from the HealthCore Integrated Research Database between 06/01/2007 and 09/30/2011 and categorized into three groups: provoked, cancer-related, and unprovoked VTE. Treatment duration was from initiation to discontinuation of anticoagulation, based on a 60-day gap in prescription fill unless there was an international normalized ratio test every 42 days. Bleeding risk was estimated using RIETE score, and VTE risk categories were based on ACCP guidelines. Kaplan-Meier curves and Cox proportional hazards models were used to evaluate association between VTE recurrence/bleeding and anticoagulation duration. RESULTS: Of 2002 patients identified (52.3% males, mean age 57 ±15 years), 21.4% had provoked, 16.4% had cancer-related, and 62.1% had unprovoked VTE. Average anticoagulant treatment duration was 294 ± 261 days. After adjusting for demographics and clinical characteristics, provoked and cancer-related VTE patients were 32% (95% CI=14-54%, P<0.001) and 35% (95% CI=7-70%, P=0.013) more likely, respectively, to discontinue anticoagulants than unprovoked VTE patients. No differences were observed between provoked and cancer-related VTE patients. Patients with an intermediate/high bleeding risk were 26% (95% CI=14-36%, P<0.001) less likely to discontinue treatment than those with a low bleeding risk. CONCLUSIONS: The observed anticoagulation duration for VTE may not be concordant with guidelines, due to the challenge of counterbalancing risks of VTE recurrence and bleeding. Further studies are needed to explore this.

Characteristics affecting oral anticoagulant therapy choice among patients with non-valvular atrial fibrillation: a retrospective claims analysis.

BACKGROUND: Dabigatran is one of the three newer oral anticoagulants (OACs) recently approved in the United States for stroke prevention in non-valvular atrial fibrillation (NVAF) patients. The objective of this study was to identify patient, healthcare provider, and health plan factors associated with dabigatran versus warfarin use among NVAF patients. METHODS: Administrative claims data from patients with ≥ 2 NVAF medical claims in the HealthCore Integrated Research Database between 10/1/2009 and 10/31/2011 were analyzed. During the study intake period (10/1/2010 - 10/31/2011), dabigatran patients had ≥ 2 dabigatran prescriptions, warfarin patients had ≥ 2 warfarin and no dabigatran prescriptions, and the first oral anticoagulant (OAC) prescription date was the index date. Continuous enrollment for 12 months preceding ("pre-index") and ≥ 6 months following the index date was required. Patients without pre-index warfarin use were assigned to the 'OAC-naïve' subgroup. Separate analyses were performed for 'all-patient' and 'OAC-naïve' cohorts. Multivariable logistic regression (LR) identified factors associated with dabigatran versus warfarin use. RESULTS: Of 20,320 patients (3,019 dabigatran and 17,301 warfarin) who met study criteria, 27% of dabigatran and 13% of warfarin patients were OAC-naïve. Among all-patients, dabigatran patients were younger (mean 67 versus 73 years, p < 0.001), predominantly male (71% versus 61%, p < 0.001), and more frequently had a cardiologist prescriber (51% versus 30%, p < 0.001) than warfarin patients. Warfarin patients had higher pre-index Elixhauser Comorbidity Index (mean: 4.3 versus 4.0, p < 0.001) and higher ATRIA bleeding risk score (mean: 3.0 versus 2.3, p < 0.001). LR results were generally consistent between all- and OAC-naïve patients. Among OAC-naïve patients, strongest factors associated with dabigatran use were prescriber specialty (OR = 3.59, 95% CI 2.68-4.81 for cardiologist; OR = 2.22, 95% CI 1.65-2.97 for other specialist), health plan type (OR = 1.47 95% CI 1.10-1.96 for preferred provider organization), and prior ischemic stroke (OR = 1.42, 95% CI 1.06-1.90). Older age decreased the probability of dabigatran use. CONCLUSIONS: Beside patient characteristics, cardiology specialty of the prescribing physician and health plan type were the strongest factors associated with dabigatran use.

Thromboprophylaxis patterns, risk factors, and outcomes of care in the medically ill patient population.

INTRODUCTION: Medically ill, hospitalized patients are at increased risk for venous thromboembolism (VTE) after discharge. This study aimed to examine thromboprophylaxis patterns, risk factors, and post-discharge outcomes. METHODS: This was a retrospective claims analysis involving administrative claims data and in-patient data abstracted from a sample of hospital charts. Patients aged ≥ 40 years hospitalized for ≥ 2 days for nonsurgical reasons between 2005 and 2009 were included. Hospital chart data were abstracted for a random sample of patients without evidence of anticoagulant use at 30 days post-discharge. The combined data determined whether in-patient thromboprophylaxis (anticoagulant or mechanical prophylaxis) reduces risk of VTE at 90 days post-discharge. Hazard ratios (HR) and odds ratios (OR) were calculated using Cox proportional hazard models and logistic regression. RESULTS: Of 141,628 patients in the claims analysis, 3.9% received anticoagulants (3.6% warfarin). VTE, rehospitalization, and mortality rates were 1.9%, 17.2%, and 6.2%, respectively. The strongest predictors of post-discharge VTE were history of VTE (HR=4.0, 95% confidence interval [CI]: 3.3-4.8), and rehospitalization (HR=3.9, 95% CI: 3.6-4.3). Of 504 medical charts, 209 (41.5%) reported in-patient thromboprophylaxis. There was no statistically significant difference in post-discharge VTE rates between patients who did and did not receive in-patient thromboprophylaxis. All-cause mortality was greater among patients without use of VTE prophylaxis. CONCLUSION: Utilization rates of in-hospital and post-discharge VTE prophylaxis were low. In-hospital VTE prophylaxis did not reduce the risk of post-discharge VTE in the absence of post-discharge anticoagulation. Combined in-patient and post-discharge thromboprophylaxis lowered the odds of short-term, all-cause post-discharge mortality.

A retrospective study of patients' out-of-pocket costs for granulocyte colony-stimulating factors.

OBJECTIVE: With rising healthcare costs, there is an increasing concern with the burden of out-of-pocket costs on cancer patients. This study examined patients' out-of-pocket expenditures for granulocyte colony-stimulating factors, pegfilgrastim and filgrastim, which are given to cancer patients receiving myelosuppressive chemotherapy and have been shown to decrease the incidence of febrile neutropenia. METHODS: Adult patients who received chemotherapy and granulocyte colony-stimulating factors in the outpatient setting in the United States between January 2007 and June 2010 were evaluated using medical and pharmacy claims data from two healthcare data sources, the MarketScan(®) Commercial and Medicare Supplemental Databases and the HealthCore Integrated Research Database(SM). The distribution of out-of-pocket costs for granulocyte colony-stimulating factors per patient and per administration was described for each quarter. Longitudinal analyses of out-of-pocket costs for granulocyte colony-stimulating factors were also performed for patients with continuous health plan eligibility during each calendar year from 2007 to 2009. RESULTS: The pattern of out-of-pocket expenditures for pegfilgrastim and filgrastim was generally consistent between the databases and over time. On average, about 65%-75% of patients had zero quarterly out-of-pocket costs for granulocyte colony-stimulating factors. Across the years, the mean quarterly out-of-pocket costs per patient were $100-$150 and $50-$80 for pegfilgrastim and filgrastim, respectively. The mean quarterly out-of-pocket costs for granulocyte colony-stimulating factors per administration were $40-$70 and $8-$10, respectively. CONCLUSION: In this retrospective analysis of medical and pharmacy claims data, most patients who received chemotherapy and granulocyte colony-stimulating factors in 2007 to 2010 had incurred no quarterly out-of-pocket costs associated with G-CSF use.

Antithrombotic medication use and bleeding risk in medically ill patients after hospitalization.

BACKGROUND: Hospitalized medically ill patients receiving antithrombotic medications experience increased risk of bleeding. We examined antithrombotic use, bleeding rates, and associated risk factors at 30 days post discharge. METHODS: This retrospective database analysis included nonsurgical patients aged ≥40 years hospitalized for ≥2 days during 2005 to 2009. Previously cited, validated International Classification of Diseases, Ninth Revision, Clinical Modification codes for major bleeding were used to define clinically relevant bleeding. RESULTS: Of the 327,578 patients, 9.1% received antithrombotic medications, of which 3.7% were anticoagulants. Rates of major and minor bleeding were 1.8% and 7.1%, respectively. Preindex gastroduodenal ulcer, thromboembolic stroke, blood dyscrasias, liver disease, and rehospitalization were the strongest predictors of major bleeding. Other risk factors included increasing age, male gender, and hospital stay of ≥3 days. CONCLUSIONS: Careful consideration of these demonstrated bleed-associated comorbidities before initiating anticoagulation or combining antithrombotic medications in medically ill patients may improve strategies for prevention of postdischarge thromboembolism.