Cost-minimization analysis between intravenous iron sucrose and iron sucrose similar in hemodialysis patients.

OBJECTIVES: Intravenous iron and erythropoiesis-stimulating agents are used to manage anemia in chronic hemodialysis patients. The interchangeability between intravenous iron sucrose preparations is still debated. We evaluated how cost and effectiveness were impacted when chronic hemodialysis patients were switched from an original iron sucrose product to an iron sucrose similar preparation. METHODS: A single center sequential observational retrospective study was conducted at a French hospital. The same patients were followed during two 24-week periods (iron sucrose in period P1; and iron sucrose similar in period P2). Anemia-related treatment costs were assessed in P1 and P2 from a hospital perspective. Sensitivity analyses were performed to assess the robustness of the results. RESULTS: Our study included 109 patients (105 analyzed patients and 4 patients with missing data). The mean hemoglobin level was not different between P1 and P2 (p = 0.92). The mean differential cost per patient was + €13.90 (P2 - P1). The factors with the biggest impact on this result were the prices of epoetin alfa and iron sucrose. CONCLUSION: This cost minimization analysis suggests that for chronic hemodialysis patients, iron sucrose and iron sucrose similar have the same efficacy and that using iron sucrose similar was more expensive in 66.7% of iterations.

Time spent on erythropoietin stimulating agents administration in hemodialysis centers in Panama: a time and motion study.

Objectives: There is a lack of data in Panama on the potential differences in total healthcare professional (HCP) time between routine administrations of short-acting erythropoietin simulating agents (ESAs) (i.e. epoetin alfa) and continuous erythropoietin receptor activator (CERA) (i.e. methoxy polyethylene glycol-epoetin beta). This study aimed to quantify the HCP time associated with a single administration of epoetin alfa and CERA for the treatment of anemic patients with chronic kidney disease (CKD) on hemodialysis. Methods: This was a multi-center, cross-sectional study, using a time-and-motion methodology. Costs related to HCP time and consumables usage associated with administration of epoetin alfa and CERA were estimated. Results: Based on 60 administrations of either CERA or epoetin alfa, the estimated savings in mean total active HCP time were 2.34 (95% confidence interval = 1.87-2.81) min (-30%) per administration. When extrapolating to a full year's treatment with intravenous ESA, it would require a total of 20.3 (95% CI = 19.90-20.71) h of HCP time for epoetin alfa vs 1.1 (95% CI = 1.01-1.19) h for CERA per patient per year. Estimated savings in active HCP time per patient per year were 19.20 (95% CI = 19.20-19.21) h (-95%). This, in turn, translates into staff cost efficiency that favors Mircera with an estimated annual saving of $78.24 (95% CI = 78.24-78.28) (-95%) per patient. Conclusions: Data from a real-world setting showed that the adoption of CERA could potentially lead to a reduction in active HCP time. Highlights Few comparative data have explored the costs and potential savings of using long-acting erythropoietin-stimulating agents (ESA) instead of short-acting ESAs to treat anemia in CKD patients on hemodialysis. This time-and-motion study shows that use of CERA reduces total healthcare professional time and could represent a save for an institution in a real-world setting in Panama.

A strategy to reduce inflammation and anemia treatment's related costs in dialysis patients.

This is a post-hoc analysis evaluating erythropoiesis stimulating agents' (ESA) related costs while using an additional ultrafilter (Estorclean PLUS) to produce ultrapure dialysis water located within the fluid pathway after the treatment with reverse osmosis and before the dialysis machine. Twenty-nine patients (19 treated with epoetin alfa and 10 with darboepoetin alfa) were included in the analysis. We showed to gain savings of 210 € per patient (35 € per patient each month) with epoetin alfa during the experimental period of 6 months, compared to the control period and of 545 € per patient (90 € per patient each month) with darboepoetin alfa. Estorclean PLUS had a cost of 600 € (25 € per month per each patient) and was used for 6 months. Intravenous iron therapy with sodium ferrigluconate had a cost of 0,545 €/62,5 mg. In conclusion, during the experimental period with the use of Estorclean, we obtained global savings of 11 € per patient per month with epoetin alfa and 30 € per patient per month with darboepoetin alfa to treat anemia in dialysis patients.

Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia.

PURPOSE: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA. METHODS: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA. RESULTS: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010. CONCLUSION: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.

The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders.

Biosimilars are required to be similar or highly similar in structure to their biologic reference product but are neither expected nor required to contain identical active substances. For example, glycosylated biosimilars approved to date demonstrate quantitative and qualitative structural differences from their reference product and exemplify the latitude of variations permitted for biosimilars. Although differences between a candidate biosimilar and its reference product will be evaluated for differential clinical effects during biosimilarity assessment, it is unlikely that potential differences between any two indirectly related biosimilars will be formally evaluated. Furthermore, biosimilar pathways permit variations in pharmaceutical attributes, clinical development approaches, and regulatory outcomes, resulting in further diversity of attributes among approved biosimilars. Because biosimilars may vary across the ranges of structural and functional acceptance criteria, they should not be treated like multisource, generic drugs.

Estudio de utilización y descripción de costes de eritropoyetina en pacientes hematológicos / A descriptive study of erythropoietin use and cost in hematologic patients

Objetivo: Evaluar la efectividad de la utilización de eritropoyetinaen pacientes hematológicos, analizar el grado de aplicación delas recomendaciones de la ficha técnica española, de la guía publicadapor la Sociedad Americana de Oncología Clínica (ASCO) y laSociedad Americana de Hematología (ASH), así como de las recomendacionesespecíficas para los síndromes mielodisplásicos(SMD), y realizar un análisis de descripción de los costes.Método: Estudio descriptivo y retrospectivo. La selección depacientes se llevó a cabo en la unidad de atención farmacéutica apacientes externos (UFPE) durante un periodo de 3 meses. Elseguimiento se realizó hasta los 9 meses posteriores al periodo deselección.Resultados: Se incluyeron 36 pacientes (37% hombres). Enel grupo de pacientes con mieloma múltiple y linfomas la efectividadfue del 57% y en el grupo de SMD fue del 45-64%(dependiendo del criterio de respuesta eritroide utilizado). Delos 24 pacientes (excluidos los SMD), sólo 4 (17%) se ajustarona los criterios de indicación, adecuación a la respuesta eritroidea las 4 y 8 semanas, y ajuste de la dosis en caso necesario. Lacontinuación de tratamientos con eritropoyetina en todos lospacientes no respondedores ha supuesto entre un 59-69% delgasto de pacientes no respondedores.Conclusiones: Existe un elevado porcentaje de fracaso terapéuticoy de discordancia entre las recomendaciones de utilizaciónde eritropoyetina y la práctica clínica. Esta circunstancia, así comoel elevado impacto económico que ha supuesto, hace indispensableel establecimiento de estrategias de control y seguimiento quecontribuyan a un óptimo empleo de los factores estimulantes de laeritropoyesis

Objective: To assess the effectiveness of erythropoietin use inhematologic patients; to analyze the extent to which recommendationsare applied as provided by Spanish prescribing information,American Society of Clinical Oncology (ASCO) and AmericanSociety of Hematology (ASH) guidelines, as well as specificrecommendations for myelodysplastic syndromes (MDSs), and toperform a descriptive analysis of costs.Method: A descriptive retrospective study. Patient selectionwas performed by Unidad de Atención Farmacéutica aPacientes Externos (UFPE: Pharmaceutical Outpatient CareUnit) during a 3-month period of time. Follow-up was performedto month 9 after selection.Results: Thirty-six patients (37% males) were included. In thegroup of patients with multiple myeloma and lymphomas, effectivenesswas 57%; while in the MDS group it was 45-64%(depending on criteria used to measure erythroid response). Of all24 patients (MDSs excluded) only 4 (17%) met indication criteria –adjustment to erythroid response at 4 and 8 weeks, and dosagetitration when needed. Continued treatment with erythropoietin inall non-responders amounted to 59-69% of total expense for nonresponders.Conclusions: There is a high percentage of therapy failuresand inconsistency between erythropoietin use recommendationsand clinical practice. This circumstance, as well as the high financialimpact it entails, makes it essential that monitoring and follow-up strategies are implemented to contribute to an optimalusage of erythropoiesis stimulating factors

Estudio multicéntrico de darbepoetin alfa en el tratamiento de la anemia secundaria a insuficiencia renal crónica en diálisis / Darbepoietin treatment of anemia secondary to chronic renal failure in dialysis

Este ensayo clínico prospectivo, multicéntrico, de un solo brazo, evaluó el mantenimiento de las concentraciones de hemoglobina (Hb) entre 10-13 g/dL con darbepoetin alfa y la seguridad de este tratamiento, en pacientes con insuficiencia renal crónica (IRC) en diálisis (94% hemodiálisis, 6% diálisis peritoneal, concentración de Hb basal = 11,7 g/dL) tratados hasta el inicio de este estudio con eritropoyetina recombinante humana (r-HuEPO). Se incluyeron 826 pacientes con concentraciones de Hb y dosis de r-HuEPO estables (824 recibieron al menos una dosis de darbepoetin alfa y fueron evaluables para el análisis de seguridad). Los pacientes recibieron darbepoetin alfa durante 24 semanas (20 de titulación más 4 de evaluación). La dosis inicial de darbepoetin alfa se determinó a partir de la dosis previa de r-HuEPO, utilizando la equivalencia en masa peptídica entre ambas moléculas y ajustando a la jeringa precargada más próxima. Se administró darbepoetin alfa 1 × semana (en pacientes en tratamiento previo con r-HuEPO 2-3 × semana) o cada dos semanas (en los pacientes con r-HuEPO 1 × semana). El 86,8% de los pacientes completaron las 24 semanas de estudio. El cambio del tratamiento a menor frecuencia de dosificación no produjo modificaciones clínicamente significativas en la concentración de Hb [los cambios desde la visita basal al período de evaluación consistieron en un descenso de 0,09 (IC 95%, –0,2; –0,0) g/dL, con aumento de 0,19 (IC 95% 0,0; 0,3) g/dL en la vía iv y descenso de 0,22 (IC 95%, –0,3; –0,1) g/dL en la vía sc]. Este mantenimiento de Hb se acompañó de una reducción media de la dosis de darbepoetin alfa de un 9,8% (IC 95%, –12,9; –6,6) [19,7% (IC 95%, -24,9;-14,2) (vía iv) y 4,7% (IC 95%, –8,5; –0,7) (vía sc)]. El tratamiento con darbepoetin alfa fue bien tolerado, no observándose acontecimientos adversos inesperados. En conclusión, la sustitución de cér-HuEPO por darbepoetin alfa en la terapia de la anemia secundaria a IRC en pacientes en diálisis fue eficaz, bien tolerada y disminuyó la frecuencia de administración de dosis en comparación con el tratamiento previo con r-HuEPO. Darbepoetin alfa 1 vez por semana o 1 vez cada 2 semanas mantuvo los niveles de Hb basales a la vez que permitió una reducción de la dosis por ambas vías de administración, siendo mayor en los pacientes tratados por vía iv

This Spanish single-arm, multicenter, prospective clinical trial assessed the maintenance of hemoglobin concentrations (Hb) between 10-13 g/dL with unit doses of darbepoetin alfa and the safety of the treatment in dialysis patients. Eight-hundred twenty-six patients with chronic renal failure (CRF) (94% receiving haemodialysis and 6% receiving peritoneal dialysis) previously maintained on stable recombinant human erythropoietin (r-HuEPO) therapy with stable hemoglobin (Hb) concentrations (mean Hb concentration = 11.7 g/dL) were switched to darbepoetin alfa at a reduced dosing frequency for 24 weeks (a 20-week titration phase plus a 4-week treatment evaluation phase). Subjects receiving r-HuEPO two or three times weekly were switched to darbepoetin alfa once weekly, and those. who were receiving r-HuEPO once weekly were switched to darbepoetin alfa once every two weeks. The initial dose of darbepoetin alfa was determined from the r-HuEPO dose at inclusion into the study using a formula equating the peptide mass of the two molecules and rounding to the nearest available prefilled syringe dose. Overall, 86.8% of patients completed the 24-weeks of study. Changing the treatment from r-HuEPO to darbepoetin alfa and increasing the dose interval did not result in any clinically significant change in the Hb concentration. From baseline to the evaluation phase, the mean Hb fell 0.09 (95% CI, –0.2; –0.0) g/dl, with an increase of 0.19 (95% CI, 0.0;0.3) g/dL iv and a decrease of 0.22 (95% CI, –0.3; –0.1) g/dL sc). This maintenance of the mean Hb concentration was accompanied by a mean 9.8% reduction of the darbepoetin alfa dose (19.7% (95% CI, –24.9;-14.2) iv and 4.7% (95% CI, –8.5; –0.7) sc. Treatment with darbepoetin alfa was well tolerated and no unexpected adverse events were reported. In conclusion, the replacement of previous r-HuEPO treatment by darbepoetin alfa in the therapy of anemia secondary to chronic renal failure in diaiyzed patients was effective, well tolerated, and decreased the frequency of dose administration compared with the previous r-HuEPO treatment. Darbepoetin alfa administered once weekly or once every two weeks maintained the baseline Hb levels whilst allowing dose reduction, which was higher in patients receiving iv darbepoetin alfa