RESUMO
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.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Conhecimentos, Atitudes e Prática em Saúde , Adesão à Medicação , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Acetato de Abiraterona , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Androgênios/administração & dosagem , Androstadienos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/provisão & distribuição , Prescrições de Medicamentos , Revisão de Uso de Medicamentos , Humanos , Seguro de Serviços Farmacêuticos , Masculino , Programas de Assistência Gerenciada , Medicare , Pessoa de Meia-Idade , Padrões de Prática Médica , Prednisona/administração & dosagem , Neoplasias de Próstata Resistentes à Castração/patologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
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.
Assuntos
Anemia/tratamento farmacológico , Eritropoetina/análogos & derivados , Hematínicos/uso terapêutico , Idoso , Anemia/induzido quimicamente , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Darbepoetina alfa , Suplementos Nutricionais , Relação Dose-Resposta a Droga , Custos de Medicamentos , Epoetina alfa , Eritropoetina/administração & dosagem , Eritropoetina/economia , Eritropoetina/uso terapêutico , Feminino , Hematínicos/administração & dosagem , Hematínicos/economia , Hemoglobinas/metabolismo , Humanos , Ferro/administração & dosagem , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Sistema de Registros , Resultado do TratamentoRESUMO
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.
Assuntos
Anemia/induzido quimicamente , Transfusão de Sangue/estatística & dados numéricos , Cobertura do Seguro , Neoplasias/tratamento farmacológico , Idoso , Neoplasias da Mama/sangue , Neoplasias da Mama/tratamento farmacológico , Centers for Medicare and Medicaid Services, U.S. , Neoplasias Colorretais/sangue , Neoplasias Colorretais/tratamento farmacológico , Eritropoese/efeitos dos fármacos , Feminino , Hemoglobinas/análise , Humanos , Neoplasias Pulmonares/sangue , Neoplasias Pulmonares/tratamento farmacológico , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Neoplasias/sangue , Estados UnidosRESUMO
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.
Assuntos
Instituições de Assistência Ambulatorial/economia , Gastos em Saúde/estatística & dados numéricos , Falência Renal Crônica/economia , Falência Renal Crônica/terapia , Nefrologia , Idoso , Estudos de Coortes , Comorbidade , Feminino , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Modelos EconômicosRESUMO
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.
Assuntos
Anemia/tratamento farmacológico , Hematínicos/economia , Programas de Assistência Gerenciada/economia , Neoplasias/tratamento farmacológico , Anemia/economia , Anemia/etiologia , Antineoplásicos/efeitos adversos , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Darbepoetina alfa , Custos de Medicamentos , Uso de Medicamentos/economia , Epoetina alfa , Eritropoetina/administração & dosagem , Eritropoetina/análogos & derivados , Eritropoetina/economia , Eritropoetina/uso terapêutico , Feminino , Hematínicos/administração & dosagem , Humanos , Revisão da Utilização de Seguros , Masculino , Programas de Assistência Gerenciada/estatística & dados numéricos , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/economia , Proteínas Recombinantes , Estudos RetrospectivosRESUMO
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.
Assuntos
Anemia/tratamento farmacológico , Eritropoetina/análogos & derivados , Eritropoetina/administração & dosagem , Custos de Cuidados de Saúde , Adulto , Idoso , Estudos de Coortes , Darbepoetina alfa , Epoetina alfa , Eritropoetina/economia , Feminino , Humanos , Pacientes Internados , Nefropatias/complicações , Nefropatias/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Serviço de Farmácia Hospitalar , Proteínas Recombinantes , Estudos RetrospectivosRESUMO
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.
Assuntos
Anemia/tratamento farmacológico , Eritropoetina/análogos & derivados , Eritropoetina/uso terapêutico , Hematínicos/economia , Hematínicos/uso terapêutico , Falência Renal Crônica/complicações , Anemia/etiologia , Darbepoetina alfa , Esquema de Medicação , Epoetina alfa , Eritropoetina/economia , Feminino , Hematínicos/administração & dosagem , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes , Estudos RetrospectivosRESUMO
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.
Assuntos
Anemia/tratamento farmacológico , Eritropoetina/análogos & derivados , Custos de Cuidados de Saúde , Falência Renal Crônica/economia , Programas de Assistência Gerenciada/economia , Idoso , Anemia/economia , Anemia/etiologia , Estudos de Coortes , Darbepoetina alfa , Relação Dose-Resposta a Droga , Custos de Medicamentos , Epoetina alfa , Eritropoetina/administração & dosagem , Eritropoetina/economia , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/tratamento farmacológico , Programas de Assistência Gerenciada/organização & administração , Visita a Consultório Médico/economia , Visita a Consultório Médico/estatística & dados numéricos , Proteínas Recombinantes , Diálise Renal , Estudos RetrospectivosRESUMO
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.
Assuntos
Eritropoetina/análogos & derivados , Eritropoetina/administração & dosagem , Eritropoetina/economia , Programas de Assistência Gerenciada/economia , Adulto , Idoso , Estudos de Coortes , Darbepoetina alfa , Custos de Medicamentos , Tratamento Farmacológico/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Visita a Consultório Médico/estatística & dados numéricos , Pacientes Ambulatoriais , Papel do Médico , Estudos RetrospectivosRESUMO
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.
Assuntos
Anemia Hemolítica/tratamento farmacológico , Eritropoetina/análogos & derivados , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Hemoglobinas/efeitos dos fármacos , Falência Renal Crônica/complicações , Resultado do Tratamento , Anemia Hemolítica/etiologia , Darbepoetina alfa , Progressão da Doença , Relação Dose-Resposta a Droga , Custos de Medicamentos/estatística & dados numéricos , Epoetina alfa , Eritropoetina/economia , Feminino , Hematínicos/economia , Humanos , Falência Renal Crônica/sangue , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes , Diálise Renal , Estudos Retrospectivos , Fatores de TempoRESUMO
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.