Units EPO Research Articles

PUK12 Examining the Dosing Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa among Hospital Inpatients with Chronic Kidney Disease Not on Dialysis

To compare retrospective data of erythropoiesis-stimulating agent (ESA) dosing patterns and costs among hospital inpatients with chronic kidney disease (CKD) not on dialysis. Electronic records from the Premier Hospital Database (2006Q1-2011Q1) were used to identify inpatients that had a diagnosis for CKD and had received epoetin alfa (EPO) or darbepoetin alfa (DARB). Exclusion criteria were: <18 years, receipt of renal dialysis, a diagnosis of cancer or myelodysplastic syndrome, receipt of chemotherapy, or receipt of both ESAs. The observation period consisted of the hospital inpatient stay. The dose only ratio (Units EPO: mcg DARB) was calculated using the mean cumulative dose of EPO and DARB. Treatment costs for both ESA groups were determined using cumulative dose and published July 2011 wholesale acquisition costs. A total of 135,432 inpatient stays (EPO: 104,195; DARB: 31,237) were identified. The EPO group was slightly younger than the DARB group (69.5 vs. 70.0 years, respectively; P<0.001), and had a higher proportion of females (52.1% vs. 51.2%, respectively; P=0.022). Length of stay (LOS) was similar with mean LOS of EPO=9.3 vs. DARB=9.2 days, (P=0.084). The mean cumulative dose was EPO 35,355 Units and DARB 128 mcg, which resulted in a dose only ratio (Units EPO: mcg DARB) of 276:1. Corresponding mean ESA treatment costs were higher for DARB than for EPO (EPO: $573 vs. DARB: $718; P<0.001). In this analysis of non-dialysis CKD inpatient records, a dose only ratio (Units EPO: mcg DARB) of 276:1 was observed. Mean ESA treatment costs were found to be approximately 25% higher for the DARB group versus EPO group despite similar length of stay between the groups.

Utilization and cost comparison of erythropoiesis-stimulating agents in inpatient and outpatient hospital settings

Objective:To compare utilization and associated costs of epoetin alfa (EPO) and darbepoetin alfa (DARB), two erythropoiesis-stimulating agents (ESAs), in patients with cancer undergoing chemotherapy and patients with chronic kidney disease (CKD) not on dialysis in inpatient and outpatient hospital settings.Methods:An analysis of medical claims recorded between January 2006 and December 2009 was conducted using the Premier Perspective Comparative Hospital database. Patients included were ≥18 years old with cancer and chemotherapy or with pre-dialysis CKD and with ≥1 claim for EPO or DARB during a hospital inpatient or outpatient treatment episode. Patients treated with both ESAs or who were receiving dialysis were excluded. Mean cumulative drug costs and dose ratios (units EPO: mcg DARB) were calculated using cumulative dose and April 2010 wholesale acquisition costs.Results:Cancer chemotherapy: 13,832 inpatient stays (EPO: 10,454; DARB: 3378) and 5590 outpatient treatment episodes (EPO: 2856; DARB: 2734) were identified. The inpatient and outpatient populations reported ESA dose ratios of 230:1 and 238:1 with DARB cost premiums of 42% (EPO: $948; DARB: $1348) and 38% (EPO: $3358; DARB: $4627), respectively. CKD: 148,746 hospital stays (EPO: 116,017; DARB: 32,729) and 11,012 outpatient treatment episodes (EPO: 6921; DARB 4091) were identified. The inpatient and outpatient populations reported ESA dose ratios of 251:1 and 257:1 with DARB cost premiums of 30% (EPO: $566; DARB: $738) and 27% (EPO: $2077; DARB: $2642), respectively.Limitations:The lack of randomization may have led to confounding by indication. In addition, statistical significance must be interpreted with caution in studies involving large samples.Conclusions:This study of 19,422 patients with cancer receiving chemotherapy and 159,758 patients with pre-dialysis CKD reported ESA dose ratios ranging from 230:1–257:1 (units EPO: mcg DARB) and associated cost premiums of 27–42% for DARB.

PCN35 DOSING PATTERN AND COST COMPARISON OF EPOETIN ALFA AND DARBEPOETIN ALFA IN CHRONIC KIDNEY DISEASE AND CHEMOTHERAPY-INDUCED ANEMIA INPATIENTS

To compare erythropoiesis-stimulating agent (ESA) dosing patterns and costs in inpatients with chronic kidney disease (CKD) not on dialysis or with chemotherapy-induced anemia (CIA). Electronic records from the Premier Perspective Comparative Hospital Database (2006Q1-2009Q4) were analyzed to identify inpatients ≥18 years old treated with epoetin alfa (EPO) or darbepoetin alfa (DARB). Patients receiving renal dialysis or treated with both ESAs were excluded. CKD patients had ≥1 claim for CKD, no claim for cancer, and did not receive chemotherapy. CIA patients had ≥1 claim for cancer, received chemotherapy, and had no claim for CKD. The mean cumulative ESA dose was used to calculate costs, based on April 2010 wholesale acquisition costs (EPO: $15.15/1,000 Units, DARB: $4.96/mcg). A total of 148,746 CKD (EPO: 116,017; DARB: 32,729) and 13,832 CIA (EPO: 10,454; DARB: 3,378) patients were identified. EPO patients were slightly younger than DARB patients in the CKD group (years: 71.0 vs. 71.2; P=.0199) and slightly older in the CIA group (years: 60.7 vs. 59.2; P<.0001). The proportion of females was higher in CKD (EPO 52.3% vs. DARB 51.3%; P=.0018) and similar in CIA (EPO 52.9% vs. DARB 53.8%; P= .3722). The mean length of stay (LOS) was slightly longer for EPO patients (days: CKD: 9.9 vs. 9.7, P=.0006; CIA: 13.4 vs. 12.6; P=.0028). The mean cumulative dose was EPO 37,333 Units and DARB 149 mcg for CKD patients, and EPO 62,605 Units and DARB 272 mcg for CIA patients, yielding dose ratios of 251:1 and 230:1 (Units EPO:mcg DARB), respectively. Corresponding ESA costs were higher for DARB than for EPO in both populations (CKD: $739 vs. $566; CIA: $1,349 vs. $948). This analysis reported dose ratios of 251:1 and 230:1 and a cost premium associated with DARB of 31% and 42% for CKD and CIA inpatients, respectively, despite longer LOS for EPO patients.

PCN32 COMPARISON OF EPOETIN ALFA AND DARBEPOETIN ALFA DOSING PATTERNS AND COSTS IN CHRONIC KIDNEY DISEASE AND CHEMOTHERAPY-INDUCED ANEMIA OUTPATIENTS

To compare erythropoiesis-stimulating agent (ESA) dosing patterns and costs in outpatients with chronic kidney disease (CKD) not on dialysis or with chemotherapy-induced anemia (CIA). Electronic records from the Premier Perspective Comparative Hospital Database (2006Q1-2009Q3) were analyzed to identify outpatients ≥18 years old treated with epoetin alfa (EPO) or darbepoetin alfa (DARB). Patients receiving renal dialysis or treated with both ESAs were excluded. CKD patients had ≥1 claim for CKD, no claim for cancer, and did not receive chemotherapy. CIA patients had ≥1 claim for cancer, received chemotherapy, and had no claim for CKD. The mean cumulative ESA dose was used to calculate costs, based on April 2010 wholesale acquisition costs (EPO: $15.15/1,000 Units, DARB: $4.96/mcg). A total of 11,012 CKD (EPO: 6,921; DARB: 4,091) and 5,590 CIA (EPO: 2,856; DARB: 2,734) outpatients were identified. EPO patients were slightly younger than DARB patients in the CKD group (years: 71.0 vs. 71.6; P=.0341) and of similar age in the CIA group (years: 62.2 vs. 62.7; P=.1316). The proportion of females was higher in CKD (EPO 62.2% vs. DARB 58.8%; P=.0003) and smaller in CIA (EPO 63.4% vs. DARB 67.0%; P=.0047). The mean treatment duration was slightly longer for EPO CKD patients (months: 3.6 vs. 3.4, P=.0004) and similar for CIA patients (months: 2.6 vs. 2.5; P=.1816). The mean cumulative dose was EPO 137,101 Units and DARB 533 mcg in CKD, and EPO 221,652 Units and DARB 933 mcg in CIA, yielding dose ratios of 257:1 and 238:1 (Units EPO:mcg DARB), respectively. Corresponding ESA costs were higher for DARB than for EPO in both populations (CKD: $2,644 vs. $2,077; CIA: $4,627 vs. $3,358). This analysis reported dose ratios of 257:1 and 238:1 in CKD and CIA outpatients, respectively. DARB price premiums of 27% for CKD and 38% for CIA patients were observed.

Estimate of maintenance EPO to darbepoetin alfa dose conversion ratio in a hospital-based dialysis patient population

Background:Epoetin alfa (EPO) and darbepoetin alfa are erythropoiesis-stimulating agents (ESAs) used to treat anemia in patients with chronic kidney disease. EPO and darbepoetin alfa have a non-proportional dose conversion relationship across the dosing spectrum. However, reports comparing the dose relationship between the two ESAs do not adjust for the non-proportional dose relationship or for population differences. Because drug cost is directly related to dosage, appropriate methods to assess the dose relationship between the two ESAs are important to understand the economic implications of converting patient populations from one ESA treatment to another.Objective:To describe dose conversion methods that take into account the non-proportional dose relationship between EPO and darbepoetin alfa, and calculate the dose conversion ratio (DCR) between the two ESAs in a hospital-based dialysis patient population.Methods:This was a retrospective observational study where longitudinal data from medical charts were collected for chronic hemodialysis patients being treated at hospital-based dialysis centers. Mean maintenance DCRs were calculated at the population level for hemodialysis patients converted from EPO to darbepoetin alfa treatment and subsequently maintained on darbepoetin alfa. Two methods were used to determine the DCRs: a regression-based method using ordinary least squares regression, and ratio-based method using an arithmetic mean.Results:The estimated population mean maintenance DCR for the population in this analysis was 320:1 (Units EPO:µg darbepoetin alfa) using the regression-based method, and 350:1 using the ratio-based method. Sensitivity analysis yielded DCRs ranging from 311 to 333:1.Conclusions:The two methods in estimating the DCR presented here provide payers with an empirical way of comparing ESA utilization for pharmacoeconomic evaluation. DCR results may vary according to patient characteristics; however, mean DCRs of greater than 300:1 were obtained in this analysis. Exclusion of other patient-related factors that may influence ESA dose is a possible limitation of the study.

Drug Utilization and Cost for Erythropoiesis-Stimulating Agents in a Long-Term Care Resident Population with Chronic Kidney Disease

To compare drug-utilization patterns and costs in patients with chronic kidney disease (CKD), not on dialysis, yet receiving epoetin alfa (EPO) or darbepoetin alfa (DARB) in a long-term care setting. A retrospective analysis of pharmacy dispensing from January 2007 through March 2009, was conducted using the AnalytiCareSM LTC database. Long-term care. Patients>or=18 years of age, with >or=1 EPO or DARB dose dispensed, were included. Patients dispensed both agents, diagnosed with cancer, receiving chemotherapy, radiation therapy, or renal dialysis, were excluded. Mean cumulative erythropoiesis-stimulating agent (ESA) dose was used to calculate drug cost (using April 2009 wholesale acquisition cost) and dose ratio (Units EPO:mcg DARB). Results were also stratified by payer types. A total of 2,259 patients were identified (EPO 1,640; DARB 619). EPO patients were slightly older (76.1 vs. 74.8 years of age, P=0.021), with similar proportion of women, compared with DARB patients. Mean (SD) cumulative dose was 98,420 (122,381) Units for EPO and 360 (428) mcg for DARB, resulting in a dose ratio of 273:1 (Units EPO:mcg DARB). The corresponding drug cost was 42% higher with DARB than with EPO ($1,734 vs. $1,217, P<0.001). Stratified analysis by payer types yielded similar results (dose ratios: 299:1 and 270:1 [Units EPO:mcg DARB]); cost premiums: 30% and 44% for Medicare Part A/Facility and Medicare Part D/Medicaid groups, respectively. This study of long-term care CKD patients receiving ESAs reported 42% higher drug cost with DARB compared with EPO and a dose ratio of 273:1.

Comparison of epoetin alfa (EPO) and darbepoetin alfa (DARB) utilization in cancer chemotherapy patients treated in a hospital outpatient setting

e17524 Background: With recent changes in erythropoiesis-stimulating agent (ESA) labeling and coverage limitations by the Centers for Medicare and Medicaid Services, it is important to examine the evolution of EPO and DARB real-world utilization in cancer patients receiving chemotherapy in a hospital outpatient setting. Methods: Electronic outpatient records (2006–2007) from &gt;500 hospitals in the Premier Perspective Comparative Hospital Database were analyzed. Subjects were ≥18 years, had ≥1 cancer diagnosis, received chemo during newly initiated ESA therapy, and ≥2 doses during the treatment episode (classified by quarter of ESA initiation). Mean cumulative dose and dose ratio of EPO:DARB were calculated. 2% of patients with extreme doses were excluded. Results: 7,259 outpatient treatment episodes were identified (EPO 3,568;DARB 3,691). EPO patients were slightly younger (years; EPO 62.7;DARB 64.0, p&lt;.0001), had lower proportion of women (EPO 62.2%;DARB 65.4%, p=0.0044), and had slightly longer mean treatment duration (EPO 3.1 months; DARB 2.9 months, p=0.0009) compared to DARB patients. Mean cumulative dose (SD) per treatment episode was EPO 263,582 (210,167) Units and DARB 1,005 (678) mcg, corresponding to a dose ratio of 262:1 (Units EPO: mcg DARB). Over time, mean cumulative dose, mean treatment duration, and dose ratio reflected a downward trend for both groups ( Table ). Conclusions: This analysis reported a mean dose ratio of 262:1 (Units EPO: mcg DARB) in cancer chemotherapy patients from a hospital outpatient setting. Recent changes in ESA prescribing information and coverage appear to have decreased ESA utilization and the EPO: DARB dose ratio over time. [Table: see text] [Table: see text]

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 ≥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 : μg 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 μg, resulting in a dose ratio of 255:1 (units EPO:μg 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:μg 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.

Comparison of Epoetin Alfa and Darbepoetin Alfa Dosing and Costs in an Inpatient Population with Myelodysplastic Syndromes

Background: Prevalent in the majority of patients at diagnosis, anemia associated with myelodysplastic syndromes (MDS) may increase in incidence and severity during the course of the disease. Red blood cell (RBC) transfusion support is often used to manage symptomatic anemia. Epoetin alfa (EPO) and darbepoetin alfa (DARB), two erythropoiesis-stimulating agents (ESAs), are frequently used as supportive care in the treatment of MDS-related anemia to reduce RBC transfusions. To date, limited information on dosing patterns and the associated costs of these agents for MDS patients in the hospital inpatient setting is available. This study examined cumulative ESA dosing and costs in MDS patients treated with ESAs in acute care hospitals.Methods: An analysis of electronic inpatient records from the Premier Perspective Comparative Hospital Database was conducted. The Premier database encompasses detailed inpatient services from patients admitted to more than 500 hospitals nationwide. A retrospective parallel-group design was used to compare two cohorts of MDS patients treated with EPO or DARB during their hospitalization. Study subjects were identified through hospitalization records between 4Q2006 and 1Q2008. Patients were ≥18 years of age, had an admitting diagnosis of MDS (ICD-9 codes: 238.72–238.75), and were treated with EPO or DARB during their hospital stay. Patients were excluded if they had cancer, received renal dialysis, or were treated with both ESAs. To minimize effect of outliers, 2% of patients, based on the upper and lower 1% patients with extreme doses in each group were excluded from the dosing analysis. Mean cumulative dose and July 2008 wholesale acquisition costs (EPO: $13.13/1,000 Units, DARB: $4.722/mcg) were used to calculate ESA costs.Results: A total of 3,312 inpatient stays were identified with a primary or secondary diagnosis of MDS (EPO: 2,719, DARB: 593). Mean age and gender distribution were comparable between groups (age: EPO 77.5 years, DARB 78.0 years; % women: EPO 49.4%, DARB 49.2%, p>.05 for both). Mean hospitalization length of stay was also similar for both groups (EPO: 8.8 days; DARB: 8.9 days; p>.05). The two groups were also comparable in terms of medical history at baseline, including hypertension, diabetes mellitus, cardiovascular disease, congestive heart failure, febrile neutropenia, chronic kidney disease, and sepsis. The mean cumulative dose per inpatient stay was 59,379 ± 66,002 Units for EPO and 230 ± 239 mcg for DARB, corresponding to a dose ratio of 258:1 (Units EPO: mcg DARB). Mean cumulative dose of EPO and DARB remained relatively stable over the period from 4Q2006 to 1Q2008. ESA treatment cost per inpatient stay was significantly lower in the EPO group, compared with DARB (EPO $780 vs. DARB $1,085; P<.0001). Sensitivity analysis including the 2% of outliers in each group corroborated the study findings.Conclusions: The current study, based on recent real-life clinical practice data from an inpatient setting, observed a dose ratio of 258:1 (Units EPO: mcg DARB) in patients with MDS. Based on the cumulative dose administered during hospitalization, EPO was associated with a cost savings of 28% compared to DARB. These results are similar to those observed in MDS patients in the outpatient setting and consistent with reported findings in the chronic kidney disease and oncology populations both in outpatient and inpatient settings.

Drug Utilization and Cost Considerations of Erythropoiesis-Stimulating Agents in Patients with Myelodysplastic Syndromes.

Background: Prevalent in the vast majority of patients at diagnosis, anemia associated with myelodysplastic syndromes (MDS) has historically been treated through red blood cell (RBC) transfusions. More recently, the erythropoiesis-stimulating agents (ESAs), epoetin alfa (EPO) and darbepoetin alfa (DARB), have also been employed for the treatment of MDS-associated anemia. To characterize real-world utilization of ESAs in adult patients with MDS, this retrospective analysis of medical claims examined EPO and DARB dosing patterns, ESA treatment costs, and RBC transfusion use.Methods: An analysis of de-identified medical claims from January 2004–March 2006 using the Integrated Health Care Information Services (IHCIS) national database, which encompasses over 35 health plans, was conducted. Patients included were ≥18 years old, had ≥1 claim for MDS (ICD-9 code: 238.7) prior to ESA therapy, were newly initiated on either EPO or DARB, and received ≥2 doses during the treatment period. Patients with cancer (ICD-9 codes: 140–209) within 180 days prior to ESA treatment initiation were excluded. The study period terminated with either the last ESA treatment dose, end of data availability, initial AML diagnosis, or initial stem cell transplant, whichever occurred first. Dosing frequency was classified into mutually exclusive categories:i.once weekly (QW; ≤9 days),ii.once every two weeks (Q2W; 9.1 to 18 days), andiii.once every three weeks or longer (≥Q3W; >18 days), based on the average dosing interval during treatment.Mean cumulative ESA dose was used to calculate drug cost (based on July 2007 WAC: $12.005/1,000 Units for EPO and $4.576/mcg for DARB) and dose ratio (Units EPO: mcg DARB). RBC transfusions were identified from medical procedure codes, and the proportion of patients transfused during treatment was compared between the two groups.Results: A total of 193 patients, 146 receiving EPO and 47 receiving DARB, formed the study population. Patients receiving EPO were older (69.9 vs. 66.2 years for DARB, p=0.018) with a similar proportion of women (56.2% vs. 51.1%, p=0.541). Extended dosing frequency (defined as every two weeks or greater, ≥Q2W) during treatment was observed in the majority of patients in both groups (EPO: QW 43%, Q2W 35%, ≥Q3W 22%; DARB: QW 15%, Q2W 60%, ≥Q3W 25%). Mean treatment duration was similar for both groups (EPO: 88.3 days; DARB: 87.1 days; p=0.944). The mean cumulative ESA dose administered was 406,685 Units for the EPO group and 1,509 mcg for the DARB group, corresponding to a dose ratio of 270:1 (Units EPO: mcg DARB). Use of concurrent white blood cell growth factors (G-CSF or GM-CSF) was similar (EPO 8.2%, DARB 6.4%, p =0.683). RBC transfusion was administered to 8.9% of EPO patients compared to 8.5% of DARB patients (p=0.934) Cumulative drug cost was lower in the EPO group by $2,022 (EPO $4,882; DARB $6,904; p=0.101) compared to DARB.Conclusion: Based on these data from actual clinical practice, the majority of MDS patients received extended dosing regimens (≥Q2W) of either EPO or DARB. A dose ratio of 270:1 (Units EPO: mcg DARB) between the two agents and 29% lower drug cost in the EPO group was observed. These findings are similar to those previously reported from published real-world ESA drug utilization studies in other therapeutic areas.

Drug Utilization Patterns and Cost Considerations for Erythropoiesis Stimulating Agents in Cancer Chemotherapy Patients in a Managed Care Setting.

Objective and Purpose: To understand current utilization patterns, this study examined real-world dosing and drug costs for erythropoiesis-stimulating agents (ESAs), epoetin alfa (EPO) and darbepoetin alfa (DARB) in cancer patients receiving chemotherapy.Methods: An analysis of ESA utilization in chemotherapy patients using adjudicated medical claims between 2004 and 2006 from seven health plans was conducted. Patients with ≥1 ESA claim, receiving concurrent chemotherapy identified through alphanumeric HCPCS codes, and newly initiated on EPO or DARB (no ESA administration within 90 days prior to initiation), and receiving chemotherapy were included. Those patients who received both EPO and DARB or who had myelodysplastic syndromes or end-stage renal disease were excluded. Treatment duration was defined as time from first to last ESA administration. Mean cumulative ESA dose was used to calculate drug cost (based on 1/2007 wholesale acquisition cost: EPO $12.52/1000 Units; DARB: $4.576/mcg) and dose ratio (Units EPO: mcg DARB).Results: 1,446 EPO and 2,729 DARB patients were included. Mean treatment duration was longer in the DARB-treated group by three days (EPO:49 days; DARB:52 days; p= 0.037). The EPO-treated group reported 5.8 administrations with a mean administered dose of 42,603 Units (median 40,000, interquartile range 40,000–45,714) corresponding to a mean cumulative dose of 247,097 Units. The DARB-treated group reported 5.0 administrations with mean administered dose of 262 mcg (median 250, interquartile range 200–300) corresponding to a mean cumulative dose of 1,310 mcg. Drug costs were $2,901 lower in the EPO group compared to the DARB group (EPO $3,094; DARB $5,995) and utilization reflected a dose ratio of 189:1 (Units EPO: mcg DARB).Conclusions: This observational study of over 4,100 cancer patients receiving chemotherapy found 48% lower drug cost in the EPO group compared to the DARB group. These findings provide greater understanding of current real-world ESA utilization and are consistent with other studies in the cancer chemotherapy population.

Dosing Patterns, Hematologic Outcomes, and Costs of Erythropoietic Agents in Anemic Predialysis Chronic Kidney Disease Patients From an Observational Study

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. 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. 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). 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.

Anemia management with erythropoietic stimulating therapies (ESTs) in patients (pts) with gastrointestinal (GI) malignancies: Results from a prospective observational study

19614 Background: Chemotherapy-induced anemia is a common problem for pts with GI malignancies. To assess dosing patterns and outcomes in GI malignancy pts treated with ESTs (epoetin alfa (EPO) and darbepoetin alfa (DARB), a subset analysis of an ongoing registry was conducted. Methods: Data drawn between1/04 and 10/06 from 41 U.S. oncology clinics from the Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (D.O.S.E.) registry were assessed. Pts were included in this analysis if they were diagnosed with a GI malignancy (colon, rectal, gastric, esophageal, or pancreatic), = 18 years, and received = 2 doses of either EPO or DARB. Outcomes assessed included mean baseline (BL) characteristics, transfusion utilization, hemoglobin (Hb) at Weeks 4, 8, and 12 after initiation of EPO or DARB, and cumulative EST doses with associated cost (based on 9/2006 wholesale acquisition cost). Results: 186 pts (82 EPO, 104 DARB) were identified. BL characteristics were similar between treatment groups: age 64 years, 45% women, and Hb 10.5g/dL. Both groups had a similar treatment duration (7 weeks) and number of Hb determinations (7.6); however, the DARB group had significantly more office visits (EPO 7, DARB 9.8, p=.0006). The proportion of pts transfused from Week 5 to end of study and number of units transfused/pt were similar between both groups. Hb values were similar at Weeks 4 (11.1 g/dL), 8 (11.1 g/dL), and 12 (11.0 g/dL). The mean administered dose per injection was 42,143 Units for EPO and 225 mcg for DARB. Mean cumulative administered dose during the treatment episode was 296,476 Units for EPO and 1,131 mcg for DARB, resulting in a dose ratio of 262:1 (Units EPO:mcg DARB). Overall EST cost was significantly lower in the EPO group compared to the DARB group (EPO $3,608, DARB $5,028, p=.0024). Conclusions: Similar hematological outcomes for EPO- and DARB-treated pts with GI malignancies were observed. Based on observed dosing patterns and cumulative EST utilization from this prospective observational study, EST costs were 28% lower in the EPO group than the DARB group. The observed dose ratio is consistent with previously reported clinical studies. No significant financial relationships to disclose.

CS3 HEALTH CARE EXPENDITURE AND PATIENT SATISFACTION: COST AND QUALITY FROM HEALTH CARE CONSUMERS' PERSPECTIVE

ing an erythropoiesis-stimulating therapy (EST). Patients were included in this analysis if they were >=65 years old and received therapy between October 2005 and October 2006. Patient demographics, comorbid conditions, baseline hemoglobin, CKD status, EST dose, and frequency of administration were collected. Drug cost was based on average weekly dose and September 2006 wholesale acquisition cost (EPO $12.17/1000 Units; DARB $4.446/mcg). RESULTS: 862 patient charts were reviewed; 556 patients met eligibility criteria (EPO: 351; DARB: 205). Patient demographics, comorbid conditions, baseline hemoglobin, and CKD status were similar between groups. Weekly and extended (>= every two weeks [>= Q2W]) dosing patterns were seen in both groups (EPO: QW, 39%; >= Q2W, 61%; DARB: QW, 8%; >= Q2W, 92%). The average weekly dose over the course of the study (EPO: 10,719 units; DARB: 48 mcg) corresponded to a dose ratio of 223 : 1 (Units EPO: mcg DARB) and weekly costs of $130 for EPO and $213 for DARB. CONCLUSION: The doses and 39% lower drug cost in the EPO group observed in this study were similar to those published from earlier time periods. The results reported here should be of assistance to clinicians and formulary decision makers in identifying current realworld dosing and subsequent cost of treatment of these two erythropoietic agents.

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

ABSTRACTObjective: To investigate the dosing patterns and treatment costs of erythropoietic agents in adult (≥ 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 ≥ 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; DARB $4674; 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 and Transfusion Use in Cancer Patients Treated with Erythropoietic Agents: Results of an Observational Study of over 8,000 Patients.

Background: Epoetin alfa (EPO) and darbepoetin alfa (DARB) are FDA approved for the treatment of chemotherapy-related anemia in patients with non-myeloid malignancies. To understand current utilization patterns, this retrospective study examined real-world EPO and DARB treatment patterns (administration frequency, dosing, and treatment duration), frequency of physician visits, and red blood cell (RBC) transfusion use in adult patients with cancer.Methods: An analysis of medical claims from July 2002 through February 2005 using the Integrated Health Care Information services (IHCIS) national database, which encompasses over 35 health plans, was conducted. Patients included in the study were ≥ 18 years old, had ≥ 1 claim for cancer within 90 days prior to treatment initiation, were newly initiated on EPO or DARB, and received ≥ 2 treatment doses. Patient dosing frequency was classified into three mutually exclusive categories: (a) once weekly (QW; ≤ 9 days), (b) once every other week (Q2W; 9.1 to 18 days), and (c) once every three weeks or longer (≥ Q3W; >18 days), based on the average dosing interval during treatment. Dose only ratio (Units EPO: mcg DARB) was calculated using the ratio of cumulative dose of erythropoietic agents. Frequencies of outpatient hematologist and/or oncologist visits were summarized for EPO and DARB patients. RBC transfusions were identified using the medical procedure codes and the proportion of patients transfused was compared between the two groups.Results: 5,796 EPO and 2,226 DARB patients met inclusion criteria. Patients receiving EPO were slightly older (59.1 vs. 57.5 years, P<.001) with a lower proportion of female patients (62% vs. 67%, P<.001), compared to those patients receiving DARB. Variability of administration frequency was observed in both treatment groups (EPO: QW 53%, Q2W 38%, ≥ Q3W 9%; DARB: QW 11%, Q2W 67%, ≥ Q3W 22%). Mean treatment duration was similar for both groups (EPO: 58 days; DARB: 59 days; p=0.339). The mean cumulative dose was 269,811 Units for the EPO group and 1,154 mcg for the DARB group, corresponding to a dose only ratio of 234:1 (Units EPO: mcg DARB). While the majority of patients received fixed dosing of EPO 40,000 Units and DARB 200 mcg, extended dosing intervals (≥ Q2W) observed with both agents resulted in a mean weekly EPO dose of 29,281 Units and mean weekly DARB dose of 114 mcg. Frequencies of outpatient hematologist or oncologist visits during treatment were similar between the two groups (visits: 7.7 for EPO vs. 7.5 for DARB, P=0.462). Finally, RBC transfusion was administered to 6.9% of EPO patients compared to 8.4% of DARB patients (p=0.023).Conclusion: The treatment patterns and dose only ratio from the current study provide greater understanding of the relative effectiveness of these two erythropoietic agents. This observational study of over 8,000 patients shows that the dose only ratio from EPO to DARB is 234:1, frequencies of outpatient hematologist or oncologist visits are similar across the two groups, and transfusion rate is significantly lower in patients treated with EPO, compared to patients treated with DARB. These findings confirm similar results from past research.