Association of anemia with worsened activities of daily living and health-related quality of life scores derived from the Minimum Data Set in long-term care residents.

BACKGROUND: Among long-term care (LTC) residents, we explored the association between anemia status and hemoglobin (Hb) level with Activities of Daily Living (ADL) functioning and health-related quality of life (HRQOL). METHODS: Data were derived from the AnalytiCare database, containing laboratory and Minimum Data Set (MDS) reports for 27 LTC facilities in Colorado. Study timeframe was 1/1/07-9/15/08. Patients were selected based on: residence in LTC >90 days, Hb and serum creatinine value within 90 days of the earliest non-admission (index) MDS. From the index MDS, the method of 1) Carpenter et al. [BMC Geriatrics 6:7(2006)] was used to derive a summary measure of ADL performance (the MDS-ADL score) and 2) Wodchis et al. [IJTAHC 19:3(2003)] was used to assign HRQOL scores (MDS items were mapped to the Health Utilities Index Mark 2 (HUI2) scoring function to create the MDS-HSI score). Anemia was defined as Hb <12 g/dL females and <13 g/dL males. Adjusted linear regression was used to evaluate the independent association of anemia and hemoglobin level on MDS-ADL and MDS-HSI scores. RESULTS: 838 residents met all inclusion criteria; 46% of residents were anemic. Mean (SD) MDS-ADL score was 14.9 (7.5) [0-28 scale, where higher score indicates worse functioning]. In the adjusted model, anemia was associated with a significantly worse MDS-ADL score (+1.62 points, P=.001). Residents with Hb levels 10 to <11 g/dL had significantly worse ADL score (+2.06 points, P=.005) than the >13 g/dL reference. The mean MDS-HSI score was 0.431 (0.169) [range, where 0=dead to 1=perfect health]. Compared with non-anemic residents, in this adjusted model, residents with anemia had significantly worse MDS-HSI scores (-0.034 points, P=.005). Residents with hemoglobin levels <10 g/dL had significantly worse MDS-HSI scores (-0.058 points, P=.016) than the >13 g/dL reference. CONCLUSIONS: After adjusting for several covariates, LTC residents with anemia, and many of those with moderate to severe declines in Hb level, had significantly poorer outcomes in both ADL functioning and HRQOL. The association between Hb level and the HRQOL measure of MDS-HSI appears to be largely explained by the mobility domain of the HRQOL measure.

Outcomes of erythropoiesis-stimulating agents in cancer patients with chemotherapy-induced anemia.

PURPOSE: To assess the clinical and economic outcomes among patients with chemotherapy-induced anemia (CIA) treated with United States Food and Drug Administration-approved fixed dosing regimens of erythropoiesis-stimulating agents (ESA). METHODS: Data were employed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) registry to evaluate CIA patients who were initiated on either epoetin alfa (EPO) 40,000 Units (U) or darbepoetin alfa (DARB) 500 micrograms (mcg) between January 1, 2006 and May 8, 2009. Study measurements included ESA treatment dose and dose ratio, changes in hemoglobin (Hb) levels from baseline, and cumulative ESA costs. RESULTS: Five hundred forty patients treated in 44 clinical centers were evaluated, of which 420 were initiated on EPO 40,000 U and 120 were initiated on DARB 500 mcg. Both cohorts had similar baseline characteristics, although EPO patients were less likely than DARB patients to have received iron supplementation before ESA initiation (11.4% EPO vs. 20.0% DARB, p = 0.015). The EPO-to-DARB dose ratio based on cumulative ESA dose was 169:1 (U EPO: mcg DARB). EPO patients showed statistically greater Hb improvement compared to DARB patients, and compared to EPO patients, a greater proportion of DARB patients required a blood transfusion (13.9% EPO vs. 22.5% DARB, p = 0.026). Mean cumulative ESA cost was significantly lower for EPO patients than DARB patients ($4,261 EPO vs. $8,643 DARB, p < 0.0001). CONCLUSIONS: These findings reported that patients with CIA achieved more favorable clinical and economic outcomes if initiated with EPO 40,000 U vs. DARB 500 mcg.

Hematologic outcomes and blood utilization in cancer patients with chemotherapy-induced anemia (CIA) pre- and post-national coverage determination (NCD): results from a multicenter chart review.

PURPOSE: In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. METHODS: Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. RESULTS: Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05-1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15-2.04, p = 0.0034). CONCLUSIONS: Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.

The prevalence and recognition of chronic kidney disease and anemia in long-term care residents.

OBJECTIVE: To evaluate the prevalence of chronic kidney disease (CKD) and anemia in the long-term care facility, the rate of recognition of these conditions, and the specific interventions used to treat anemia. DESIGN: Retrospective cross-sectional analysis. SETTING: Twenty-seven long-term care facilities in Colorado. PATIENTS, PARTICIPANTS: Had > 90-day residency in the long-term care facility; had index serum creatinine and hemoglobin (Hb) values ± 90 days of the earliest (index) Minimum Data Set (MDS). Data were derived from the AnalytiCare(sm) database (January 1, 2007-September 15, 2008) containing laboratory results, MDS reports, and pharmacy fills. Residents with laboratory-defined CKD had estimated glomerular filtration rates < 60 mL/min/1.73 m(2). Those with laboratory-defined anemia had < 12 g/dL Hb females, < 13 g/dL Hb males. MDS reports indicated recognition of CKD and anemia. Prescription records identified anemia-related pharmacotherapy for anemic residents. MAIN OUTCOME MEASUREMENTS: Prevalence rates of laboratory-defined CKD and anemia, recognition rates of anemia and CKD, and rates of use of specific anemia pharmacotherapies. RESULTS: For 838 eligible residents, laboratory findings showed a prevalence rate of 43% for CKD and 46% for anemia. Only 2.8% and 14.6% of residents with laboratory defined CKD had CKD recognized on the index, or any index or postindex MDS, respectively. Anemia recognition rates were 9.6% and 39.9%, respectively. No single anemia prescription therapy class (erythropoiesis stimulating agents, iron, vitamin B(12), or folic acid) was used for more than 10% of all residents with laboratory- or MDS-defined anemia. CONCLUSION: For CKD and anemia, the lack of concordance between laboratory- and MDS-identified disease should alert health care professionals of potential under-recognition within the long-term care facility.

Impact of limiting erythropoiesis-stimulating agent use for chemotherapy-induced anemia on the United States blood supply margin.

BACKGROUND: Recently, the Centers for Medicare and Medicaid Services issued a national coverage determination that limited erythropoiesis-stimulating agents (ESAs) utilization in patients with chemotherapy-induced anemia (CIA). This study evaluated the impact of limiting the use of ESAs for CIA on the US blood supply margin. STUDY DESIGN AND METHODS: A modeling simulation was employed to compare the number of red blood cell (RBC) units transfused in CIA patients treated with ESAs to the number of RBC units that would be transfused if ESAs were limited or discontinued. The excess number of RBC units that would be required with limited ESA treatment was contrasted with the available marginal blood supply from 2004 and 2008. Model inputs were obtained from published literature or empirical evidence when published information was unavailable. RESULTS: The model predicted that up to 18 and 15 percent of the respective 2004 and 2008 marginal US blood supply would be required to cover the incremental demand for blood that would arise from a 25 percent decrease in ESA use. For ESA use reductions of 50 and 75 percent, the model predicted 17 to 21 percent (134,667 units) and 26 to 31 percent (202,001 units) of the 2008 and 2004 marginal US blood supply would be required, respectively. CONCLUSION: This study showed that limiting ESA use in CIA patients would impose considerable pressure on the available blood supply margin given the small margin between usable blood and transfusion demand. The public health consequences of such an outcome should be taken into account when revisions to ESA use are being considered.

Drug utilisation and cost considerations of erythropoiesis stimulating agents in oncology patients receiving chemotherapy: observations from a large managed-care database.

OBJECTIVE: Erythropoiesis stimulating agent (ESA) resource utilisation in cancer chemotherapy patients is of importance to managed-care organisations. To understand current real-world utilisation of ESAs, this study examined epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment patterns (dosing and treatment duration), dose ratio and ESA treatment costs. METHODS: An analysis of medical claims data from January 2006 through to January 2008 was conducted using the PharMetrics Patient-Centric database of over 85 health plans. Patients included in the study were > or =18 years of age, had at least one cancer claim within 90 days prior to ESA treatment initiation, were newly initiated on EPO or DARB, received at least two doses, and were treated with concomitant chemotherapy (at least one chemotherapy claim during ESA treatment). Mean cumulative ESA dose was used to calculate drug cost (based on April 2008 wholesale acquisition cost) and dose ratio (units EPO : microg DARB). RESULTS: A total of 4,111 EPO patients and 6,817 DARB patients met inclusion criteria and formed the study population. EPO-treated patients were slightly older (mean age: EPO 63.6, DARB 61.8, p<0.0001) with a greater proportion of women in the DARB-treated group (EPO 60.9%, DARB 64.1%, p=0.0007). The mean treatment duration was slightly longer in the EPO group (EPO 58.4 days, DARB 55.4 days, p=0.0019). The mean cumulative ESA dose administered was EPO 329,129 units and DARB 1,289 microg, resulting in a dose ratio of 255:1 (units EPO:microg DARB). Mean drug cost per treatment episode was significantly lower in the EPO group by $1,768 (EPO $4,321, DARB $6,089, p<0.0001). After controlling for covariates, the incremental cost associated with DARB treatment remained stable and statistically significant (adjusted cost difference: $1,806 per treatment episode higher for DARB patients than EPO, p<0.0001). CONCLUSIONS: This study of 10,928 oncology patients receiving chemotherapy reported a dose ratio of 255:1 (units EPO:microg DARB) with 29% lower treatment cost in the EPO group. These findings are similar to those previously reported from published clinical trials and real-world utilisation studies.

Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients.

BACKGROUND AND OBJECTIVE: To report the design, methodology, implementation and initial results of the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry, the first US patient registry to collect and report on practice patterns and outcomes associated with erythropoiesis-stimulating therapy (EST) for anaemia management in oncology patients. METHODS: DOSE is a prospective ongoing registry of oncology patients treated with epoetin-alpha or darbepoetin-alpha. Patients from either community or academic centres who meet prespecified entry criteria are eligible for inclusion in the registry. Data collected include patient demographic and clinical characteristics, EST administration, haematological parameters, patient-reported outcomes and medical resource utilization. Patients are followed from EST initiation through to the end of therapy or 16 weeks, whichever is earlier. RESULTS: Initial results from 45 sites for 861 patients (epoetin-alpha, n = 312; darbepoetin-alpha, n = 549) showed that baseline demographic and disease characteristics were similar between the two treatment groups. Administration of EST at both weekly and > or =2-weekly intervals was observed in both groups, with similar numbers of haemoglobin determinations. However, the mean number of office visits was higher in the darbepoetin-alpha group despite more frequent administration of therapy at > or =2-weekly intervals in this group. Mean treatment duration was approximately 8 weeks for both groups. Mean post-baseline haemoglobin levels of 11-12 g/dL were achieved and maintained at all timepoints assessed with epoetin-alpha but not with darbepoetin-alpha. Both groups had similar rates of packed red blood cell transfusions. CONCLUSIONS: The DOSE Registry is a valuable source of data relating to anaemia management, practice patterns and outcomes in oncology patients from the perspective of actual clinical practice. Results from this registry should provide patients, clinicians and healthcare decision makers with a better understanding of the relationship between EST dosage and outcomes in the clinical setting.

Drug administration frequency and provider office visit patterns for oncology patients during treatment with erythropoietic agents: an analysis of four observational studies.

BACKGROUND: Several drug administration regimens of epoetin alfa (EPO) and darbepoetin alfa (DARB) are used for the management of anemia in cancer patients in the clinical practice setting. OBJECTIVE: The purpose of the present analysis was to assess whether drug administration regimens were associated with differences in the number of provider office visits and hemoglobin assessments during treatment with these agents. METHODS: Data from 4 observational studies that examined treatment patterns of EPO and DARE and health care resource utilization were analyzed. These studies, selected based on the availability of office visit and/or hemoglobin determination data during the course of treatment, included a retrospective chart review, 2 retrospective claims analyses, and an ongoing prospective patient registry. The treatment patterns and oncology-related provider visits and/or the frequency of hemoglobin evaluations among the studies were reported. RESULTS: Data from 15,845 cancer patients were included in the analysis. The patient demographic and baseline characteristics were similar across all 4 studies; patients were predominantly women (62%-71%) with a mean age range of 56 to 63 years. Mean treatment duration ranged from 7.1 to 8.4 weeks without significant differences between EPO and DARE in any study. Weekly and extended (at least every 2 weeks [> or =Q2W]) drug administration frequencies were observed in both treatment groups. The most frequent drug administration schedule for EPO was once weekly (53%-75% of patients), and for DARE Q2W (67%-73%). Despite the difference in erythropoietic agent administration frequency, no significant differences were observed between EPO and DARB for either the number of oncology-related provider visits or the number of hemoglobin assessments. CONCLUSIONS: The frequency of oncology-related provider visits and hemoglobin assessments appears to be independent of the EPO and DARB administration frequency. These findings might provide useful information for health care providers and oncology patients in understanding patterns of care during treatment with erythropoietic agents.

Dosing patterns, treatment costs, and frequency of physician visits in adults with cancer receiving erythropoietic agents in managed care organizations.

OBJECTIVE: To investigate the dosing patterns and treatment costs of erythropoietic agents in adult (>or= 18 years of age) cancer patients newly initiated on epoetin alfa (EPO) or darbepoetin alfa (DARB) in managed care organizations. METHODS: An analysis of US medical claims (30 million lives in over 35 health plans) in the period July 1, 2002-February 28, 2005 was conducted. Patients with >or= 1 cancer claim within 90 days prior to initiating EPO or DARB, and who received at least two doses of the same erythropoietic agent, were included in this analysis. Weighted average weekly dosing, cumulative treatment dose, associated drug cost, dosing frequency patterns, and the frequency of outpatient visits were evaluated. The EPO:DARB dose ratio, based on average cumulative treatment doses, was assessed. RESULTS: 5639 EPO and 2166 DARB patients met the inclusion and exclusion criteria. The EPO group was older (EPO 59.1 years; DARB 57.6 years; p < 0.001) with a higher proportion of men (EPO 38.1%; DARB 33.1%; p < 0.001). Variable dosing frequency was observed with similar treatment durations for the two groups (days: EPO 55.6; DARB 57.7; p = 0.122). A dose ratio of 236:1 was observed (average cumulative dose: EPO 252 856 U; DARB 1072 mcg). Average drug cost was significantly higher in the DARB group (drug cost: EPO 3077 dollars; DARB 4674 dollars; p < 0.001). The average number of hematology/oncology outpatient visits per patient (visits: EPO 7.4; DARB 7.3; p = 0.676) and outpatient visits for hemoglobin determination (visits: EPO 6.7; DARB 6.4; p = 0.093) during treatment was similar between the two groups. LIMITATIONS: The results were based on medical claims only. The absence of information on actual injection dates in pharmacy claims prevented their incorporation in the analysis. CONCLUSIONS: Based on the average cumulative doses, the EPO:DARB dose ratio was 236:1 (Units EPO: mcg DARB) with 52% greater drug cost in the DARB group. Despite the variable administration frequency observed between the two agents, the number of hematology/oncology outpatient visits was not different.

Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in predialysis chronic kidney disease patients with anemia.

OBJECTIVE: Few observational studies have evaluated the use of epoetin alfa (EPO) and darbepoetin alfa (DARB) in chronic kidney disease (CKD) patients with anemia. The objective of this study was to investigate dosing patterns, hematologic outcomes, and intervention costs with EPO and DARB in anemic CKD patients treated in an ambulatory care setting. METHODS: This was a multicenter, retrospective, chart review of predialysis CKD patients with anemia treated with EPO or DARB. Charts were sequentially selected from 435 EPO and 432 DARB patients naive to erythropoietic therapy and treated for > or = 24 weeks. Hemoglobin (Hb) levels, dates, and EPO/DARB doses were recorded. Drug costs using 2005 wholesale acquisition costs (WAC) and Federal Supply Schedule (FSS) pricing were based on the mean cumulative drug dose over the 24-week study period. RESULTS: A total of 393 EPO and 396 DARB charts met all criteria with predominantly male subjects (EPO: 94%; DARB: 96%). Mean baseline GFR and Hb levels were similar. Once-weekly and extended dosing (> or = Q2W) was common in both groups. At Weeks 4, 8, and 12 following initiation of therapy, a greater proportion of EPO than DARB patients reached target Hb levels (> or = 11 g/dL) (p < 0.0001); at Week 24, all patients reached target Hb levels. Mean 24-week cumulative doses were EPO 279 336 +/- 68 302 units and DARB 1084 +/- 246 microg. Drug cost was higher for DARB independent of pricing utilized (WAC: EPO = 3400 US dollars, DARB = 4726 US dollars; FSS: EPO = 1528 US dollars, DARB = 2379 US dollars). CONCLUSIONS: Extended dosing (Q2W) was common in EPO- and DARB-treated patients with CKD-related anemia, with EPO-treated patients experiencing a significantly greater hematologic response (at Weeks 4, 8, and 12). In addition, drug cost was 39-56% higher in the DARB group. The male predominance may limit generalizability, warranting further research in other populations.

Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.

OBJECTIVES: To investigate dosing patterns and drug costs of erythropoietic agents and assess the frequency of outpatient nephrologist visits in an elderly population with pre-dialysis chronic kidney disease (pCKD) newly initiated on epoetin alfa (EPO) or darbepoetin alfa (DARB). METHODS: An analysis of medical claims from more than 30 healthcare plans covering all census regions of the US in the period July 2002 through February 2005 was conducted. Patients were included if they were > or = 65 years of age, had at least one claim for CKD within 90 days prior to the initiation of any erythropoietic agent, were newly commenced on either EPO or DARB, and had received at least two treatment doses. If a patient received renal dialysis, data were censored 30 days prior to the first date of dialysis. Patients diagnosed with cancer or those who had undergone chemotherapy were excluded from the analysis. The average dosing interval for both EPO and DARB was calculated and classified as once weekly (qw), every 2 weeks (q2w) or every 3 weeks or less frequently (> or = q3w). Weighted average weekly doses were scaled based on treatment duration. The frequency of outpatient nephrologist visits was analysed. Average weekly treatment costs were calculated and presented using the May 2005 Wholesale Acquisition Costs. RESULTS: A total of 293 EPO and 102 DARB patients met the inclusion criteria. The two groups of patients had similar mean age (74.4 years for EPO vs 74.3 years for DARB) and gender distribution (47.4% female for EPO vs 51.0% for DARB). Extended dosing (every 2 weeks or less frequently: > or = q2w) during treatment was observed in both groups (EPO: qw 49.8%, q2w 31.7%, > or = q3w 18.4%; DARB: qw 19.6%, q2w 52.9%, > or = q3w 27.5%). The average dosing interval between injections was 13.6 days for the EPO group and 17.3 days for the DARB group. The weighted average weekly dose was 12,748 units for EPO and 43.5 microg for DARB. The average weekly erythropoietic treatment cost was significantly greater for DARB compared with EPO (190 US dollars vs 155 US dollars per week [2005 values]; p = 0.028). After controlling for covariates, the cost difference between the two groups was more pronounced and remained statistically significant (adjusted cost difference 41 US dollars/week higher for DARB patients; p = 0.013). The frequency of outpatient nephrologist visits during treatment was similar between the two groups (EPO 3.4 vs DARB 3.0 visits). CONCLUSIONS: Based on this analysis of claims data from more than 30 US healthcare plans, extended dosing (> or = q2w) of EPO and DARB was common in elderly pCKD patients treated with erythropoietic agents, with significantly higher weekly drug costs observed in the DARB group compared with the EPO group. The number of outpatient nephrologist visits was not significantly different between EPO and DARB patients. This study was the first to evaluate the dosing patterns of EPO and DARB in elderly pCKD patients in a large managed care population.

Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial.

INTRODUCTION: A 16-week, open-label, multicentre, randomised trial of weekly epoetin alfa 40 000 units versus biweekly darbepoetin alfa 200microg among 358 patients with solid-tumour cancers and chemotherapy-induced anaemia demonstrated superior haematological outcomes with epoetin alfa. We sought to compare resource use, costs and clinical outcomes between treatment groups and report the results using a cost-consequences framework. METHODS: Pre-specified methods were used to assign costs (US dollars, year 2004-5 values) to medical resources and patient time using a societal perspective. Costs for inpatient care, outpatient care and physician services were based on US Medicare reimbursement rates. Indirect costs assigned to patient time spent receiving study medication were based on the mean hourly wage in the US. In the base-case analysis, the average wholesale price was used to assign costs to medications. Clinical outcomes included all haemoglobin levels and transfusions recorded throughout the trial. Sensitivity analyses were performed to evaluate the impact of different costing methods, cost sources, perspectives and methods to assign haemoglobin values following a blood transfusion. RESULTS: Over a mean follow-up duration of 11.8 weeks, the average cost of study medications and their administration was the single largest component of total costs and was similar between groups (epoetin alfa 5979 US dollars and darbepoetin alfa 5935 US dollars, difference 44 US dollars; 95% CI -590, 692). There were no significant differences in the proportions of patients hospitalised (epoetin alfa 24.6%, darbepoetin alfa 22.0%; p = 0.57). Patients randomised to epoetin alfa experienced more inpatient days, on average, than patients randomised to darbepoetin alfa (2.6 vs 1.6, 95% CI for the difference, 0.07, 2.27). However, with regard to transfusions, patients in the epoetin alfa arm required fewer units of blood than patients in the darbepoetin alfa arm (0.46 vs 0.88, 95% CI for the difference -0.77, -0.08). Mean total costs, comprising costs for study medications and their administration, inpatient care, transfusions, unplanned radiation therapy, haematology and laboratory services, chemotherapy and non-chemotherapy drugs and indirect costs were 14,976 US dollars in the epoetin alfa arm compared with 14,101 US dollars in the darbepoetin alfa arm, a difference of 875 US dollars (95% CI for difference -849, 2607), of which 98% of the difference was attributable to higher inpatient costs in the epoetin alfa arm (2374 US dollars vs 1520 US dollars; 95% CI for difference -33, 1955). Assessments of multiple clinical measures demonstrated improved outcomes with epoetin alfa relative to darbepoetin alfa. CONCLUSION: Most clinical outcome measures suggested greater improvement with epoetin alfa relative to darbepoetin alfa, but most costs for both agents appeared similar. Decision makers must evaluate the differences in costs and efficacy measures that are most relevant from their perspectives.

Retrospective observational study of patients with chemotherapy-related anemia receiving erythropoietic agents.

OBJECTIVE: Epoetin alfa (EPO) and darbepoetin alfa (DARB) are approved for the treatment of chemotherapy-related anemia (CRA) in patients with nonmyeloid malignancies. This study examined dosing and hematologic outcomes with these agents in community oncology clinics. METHODS: Medical charts were abstracted retrospectively for 1005 patients (527 EPO, 478 DARB) with CRA (hemoglobin [Hb] < or = 11 g/dL) who received EPO or DARB at 10 U.S. oncology clinics between January 2002 and March 2003. MAIN OUTCOME MEASURES: Outcome measures included dose and frequency of erythropoietic therapy, change in Hb at 4, 8, and 12 weeks after initiation of therapy, and transfusion of packed red blood cells. RESULTS: Baseline characteristics were generally similar between groups. Most EPO-treated patients received EPO once weekly, but 25% received EPO every 2-3 weeks, with 40,000 U the predominant dose. DARB was usually given every 1-2 weeks in doses ranging from 200-400 mcg/injection. Mean treatment duration was relatively short (< 8 weeks) in both groups, with a similar number of Hb determinations and similar incidence of red blood transfusion between groups. Hb increased from baseline in the EPO and DARB groups at 4 weeks (0.99 vs. 0.69 g/dL, p = 0.003), 8 weeks (1.39 vs. 1.06 g/dL, p = 0.011), and 12 weeks (1.43 vs. 1.11 g/dL, p = 0.055). Early Hb response (> or = 1 g/dL increase by 4 weeks) was more common with EPO than DARB (48% vs. 38%, p = 0.008). CONCLUSIONS: EPO was superior to DARB for early hematologic outcomes in patients with CRA in community oncology clinics. Retrospective data collection and relative inexperience with DARB at the time of the study may limit the generalization of these results. Randomized, controlled trials comparing EPO and DARB are warranted.

Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.

BACKGROUND: With the growing use of oral anticancer medications, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer. OBJECTIVE: To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. METHODS: This study used data from 2 administrative health care claims databases--Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: Symphony Health Solutions' ProMetis Lx (June 2009 to March 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups. RESULTS: 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 AA claim were selected from Dataset 1 and Dataset 2, respectively. The mean (median) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n = 492) in Study Population 1 and 93% (100%; n = 2,449) in Study Population 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n = 488) mg and 10.6 (10.0; n = 2,425) mg in Dataset 1 and 2, respectively. Similar adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without. CONCLUSIONS: Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These findings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice.

Real-World Corticosteroid Utilization Patterns in Patients with Metastatic Castration-Resistant Prostate Cancer in 2 Large US Administrative Claims Databases.

BACKGROUND: Prostate cancer is the most common noncutaneous malignancy in men in the United States. Patients with metastatic castration-resistant prostate cancer (mCRPC) may be treated with secondary hormonal therapy or with chemotherapy, and potentially with concomitant corticosteroids. Corticosteroids can help manage the side effects of chemotherapy and secondary hormonal therapy and ameliorate prostate cancer-related symptoms, although corticosteroids are also associated with adverse effects. With an increasing number of available treatment options for mCRPC, evaluating the real-world concomitant use of corticosteroids in this patient population is important. OBJECTIVE: To evaluate the utilization patterns of corticosteroids for the treatment of patients with mCRPC based on real-world data from 2 large claim databases. METHODS: This retrospective analysis included medical and pharmacy claims from 2 large publicly available healthcare claims databases covering more than 31 million individuals to identify treatment patterns in adult patients with mCRPC. A total of 2593 patients with mCRPC were identified in data set 1 and 626 patients in data set 2 between 2005 and 2011. The appropriate treatment for castration-resistant prostate cancer (CRPC) was defined as chemotherapy, an antiandrogen, an adrenal androgen blocker, or estrogen. The index date was the date of the first CRPC treatment or the first metastasis diagnosis, whichever occurred later. The observation period spanned from the index date to the end of health insurance eligibility. Study end points included population characteristics, the distribution of mCRPC therapies, and corticosteroid utilization patterns. RESULTS: The study population came from the 2 data sets and included 3219 men who were treated for mCRPC. Bone and lymph nodes were the predominant metastatic sites. Bicalutamide was the most common secondary hormonal therapy, and docetaxel was the most common chemotherapy used for these patients. Overall, 73.4% of the patients in data set 1 received concomitant corticosteroids, as did 71.6% of patients in population 2 during the entire period from the index date to the end of eligibility date. In addition, 62.8% and 60.4% of patients, respectively, received concomitant corticosteroids during the secondary hormonal therapy period, and 93.8% and 95.1% of patients, respectively, received concomitant corticosteroids during the chemotherapy period. Similar patterns of corticosteroid use were observed across geographic areas of the United States. CONCLUSION: This study shows consistently similar utilization patterns of corticosteroids in patients with mCRPC in 2 large national databases. Using real-world data to inform concomitant corticosteroid use in the treatment of patients with mCRPC may assist healthcare providers with treatment selection and with sequencing decision. Future research is warranted to investigate evolving treatment options for patients with mCRPC.

Resource utilization before and during infliximab therapy in patients with inflammatory bowel disease.

OBJECTIVE: Although Remicade (infliximab) is costly relative to non-biologic therapy, its impact on healthcare resource utilization and mucosal healing may make it a cost-effective option. This study aimed to compare gastrointestinal (GI)-related healthcare resource utilization and severity of mucosal damage before and during infliximab therapy in Crohn's disease (CD) or ulcerative colitis (UC) patients. METHODS: A retrospective chart review was conducted at 14 gastroenterology practices from across the country, which varied in practice sizes and types. Patients were aged ≥18 years, diagnosed with CD or UC, and had an infliximab index date between January 1, 2005 and September 30, 2007. GI-related utilization 12 months before and 12 months after the index date was compared. Endoscopic disease severity was categorized based on blinded review of abstracted reports. RESULTS: Results from 268 patients indicated significantly lower rates of surgery (29.7% to 9.9%, p < 0.0001, CD; 24.4% to 12.8%, p = 0.042, UC) and colonoscopy (54.4% to 17.6%, p < 0.0001, CD; 50.0% to 22.1%, p = 0.0007, UC) during infliximab therapy. The rates of hospitalizations in UC (15.1% to 3.5%, p = 0.0124) and radiology assessments in CD (23.1% to 10.4%, p = 0.006) also decreased. Based on severity data from 183 procedures, greater proportions of patients had normal or mild ratings during infliximab treatment compared with pre-treatment. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 gastroenterology clinics during the first year of infliximab treatment. In addition, the number of patients with pre-treatment and post-treatment disease severity information was too small to make comparisons among disease severity groups. Further information about the severity of disease and the extent of mucosal healing could be helpful in determining the effect of therapy on resource utilization in future research. CONCLUSIONS: GI-related resource utilization was significantly lower and attenuation of mucosal damage severity was observed during infliximab treatment compared with the pre-treatment period.

Effectiveness of anti-tumor necrosis factor agents in the treatment of rheumatoid arthritis: observational study.

OBJECTIVE: The efficacy of anti-tumor necrosis factor therapies in rheumatoid arthritis has been demonstrated in randomized clinical trials. The purpose of the present study was to evaluate the effectiveness of these agents for the treatment of rheumatoid arthritis in a real-world setting. METHOD: This retrospective chart review included patients from 6 clinics in the United States. Eligibility criteria included age ≥18 years, diagnosis of rheumatoid arthritis, and having been initiated with anti-tumor necrosis factor therapy (ie, adalimumab, etanercept, or infliximab) between January 1, 2002, and November 30, 2004. Patients were assessed for up to 2 years after therapy initiation. Primary outcomes of interest were improvements in 4 effectiveness measures-joint pain, joint swelling, joint stiffness, and fatigue. A total of 496 patients met the study's inclusion criteria: 84 (16.9%) in the adalimumab group, 146 (29.4%) in the etanercept group, and 266 (53.6%) in the infliximab group. RESULTS: Improvement in 1 of the 4 effectiveness measures was documented in 36.8% (n = 25) who received adalimumab, in 47.7% (n = 62) of those who received etanercept, and in 48.7% (n = 115) of patients who received infliximab. The infliximab group was the only cohort to demonstrate significant improvements from baseline in joint pain, joint swelling, and joint stiffness. The adalimumab group had significant improvement in joint pain (P = .004). No significant change in fatigue scores was reached with any of these agents. CONCLUSION: In the real-world setting of patients with rheumatoid arthritis, anti-tumor necrosis factor therapy shows significant improvements in joint pain, joint swelling, and joint stiffness, although there are differences in effectiveness in the 4 measures among the 3 agents assessed in this study.

Healthcare costs associated with nephrology care in pre-dialysis chronic kidney disease patients.

OBJECTIVE: To compare the healthcare costs of pre-dialysis chronic kidney disease (CKD) patients cared for in a nephrology clinic setting versus other care settings. METHODS: An analysis of health claims between 01/2002 and 09/2007 from the Ingenix Impact Database was conducted. Inclusion criteria were ≥ 18 years of age, ≥ 1 ICD-9 claim for CKD, and ≥ 1 estimated glomerular filtration rate (eGFR) value of < 60 mL/min/1.73 m(2). Patients were classified in the nephrology care cohort if they were treated in a nephrology clinic setting at least once during the study period. Univariate and multivariate analyses were conducted to compare average annualized healthcare costs of patients in nephrology care versus other care settings. RESULTS: Among the 20,135 patients identified for analysis, 1,547 patients were cared for in a nephrology clinic setting. Nephrology care was associated with lower healthcare costs with an unadjusted cost savings of $3,049 ($11,303 vs. $14,352, p = 0.0014) and a cost ratio of 0.8:1 relative to other care settings. After adjusting for covariates, nephrology care remained associated with lower costs (adjusted cost savings: $2,742, p = 0.006). LIMITATIONS: Key limitations included potential inaccuracies of claims data, the lack of control for patients' ethnicity in the calculation of eGFR values, and the presence of potential biases due to the observational design of the study. CONCLUSIONS: The current study demonstrated that pre-dialysis CKD patients treated in nephrology clinics were associated with significantly lower healthcare costs compared with patients treated in other healthcare settings.

Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in anemic predialysis chronic kidney disease patients from an observational study.

INTRODUCTION: Epoetin alfa (EPO) and darbepoetin alfa (DARB) are two erythropoietic agents currently available in the United States for the treatment of anemia in patients with pre-dialysis chronic kidney disease (CKD). The goal of this study was to assess and compare EPO- and DARB-treated CKD patients with respect to dosing patterns, hematologic outcomes, and associated costs. MATERIALS AND METHODS: In this multicenter, retrospective chart review, 400 charts of anemic predialysis CKD patients (200 treated with EPO and 200 treated with DARB) were sequentially selected from a large self-insured employer health insurance database. The database included both employees and their dependents. Selection criteria included patients newly initiated on EPO or DARB between July 2002 and December 2003 who had at least 24 weeks of dosing and hematologic laboratory data available. Patients with a diagnosis of malignancy or on dialysis were excluded. Dosing frequency was categorized as once weekly (QW), once every 2 weeks (Q2W), every 3 weeks (Q3W), or every 4 weeks (Q4W). Hemoglobin (Hb) levels and dates/doses of EPO and DARB administrations were recorded. Costs were calculated using 2005 wholesale acquisition costs. RESULTS: Baseline demographics were similar in the EPO and DARB groups with respect to race, sex, renal function, and Hb. Extended dosing (defined as > or =Q2W) was common in both groups. The predominant dosing frequency was Q2W (59.5% of patients) for EPO and Q3W (68.0% of patients) for DARB. Hematologic response (defined as Hb > or = 11 g/dL) was significantly greater in the EPO group at early time points (week 4: EPO 28%, DARB 12%; week 8: EPO 39%, DARB 21%; week 12: EPO 98%, DARB 89%). In both groups, 99% of patients achieved hematologic response by week 24. The mean cumulative dose during the first 12 weeks (initiation phase) was EPO 141,481 +/- 32,426 units and DARB 499 +/- 152 microg. The 24 week mean cumulative dose (initiation and maintenance phase) was EPO 243,715 +/- 39,264 units and DARB 902 +/- 265 microg, corresponding to a drug cost of EPO $2,966 and DARB $3,933 and a dose ratio of 270:1 (units EPO:microg DARB). CONCLUSION: Extended dosing frequency (> or = Q2W) was common in both groups. EPO treatment was associated with a significantly greater hematologic response at early time points (weeks 4, 8, and 12). Erythropoietic agent cost was 33% higher in the DARB group.

Dose and cost comparison of erythropoietic agents in the inpatient hospital setting.

PURPOSE: The inpatient dosing patterns and treatment costs in cancer and predialysis chronic kidney disease (CKD) patients treated with erythropoietic agents from a hospital pharmacy perspective were studied. METHODS: An analysis of electronic inpatient records from the Premier Perspective comparative hospital database was conducted. Study participants were identified through hospitalizations recorded between July 2002 and March 2005 from over 500 hospitals nationwide. Adult patients with an admitting diagnosis of cancer or predialysis CKD and treated with epoetin alfa or darbepoetin alfa during hospitalization were included. Patients who had received renal dialysis or both agents during a hospitalization were excluded. Wholesale acquisition costs from September 2006 were used to calculate drug costs. RESULTS: A total of 25,645 hospitalized patients with cancer (22,873 received epoetin alfa; 2,772 received darbepoetin alfa) and 66,822 hospitalized patients with CKD (60,079 received epoetin alfa; 6,743 received darbepoetin alfa) were identified. The mean cumulative dose per hospitalization resulted in dose ratios of 245:1 and 242:1 (units epoetin alfa:micrograms darbepoetin alfa) for cancer and CKD patients, respectively. On the basis of the cumulative dose per hospitalization, drug costs for darbepoetin alfa-treated patients were approximately 50% higher than drug costs for epoetin alfa-treated patients for both oncology and CKD patients. CONCLUSION: Epoetin alfa was associated with less cost compared with darbepoetin alfa for treating inpatients with cancer or CKD. Further research including the patients' clinical outcomes is necessary to determine the true pharmacoeconomic differences between the two agents.