Intravenous ferric carboxymaltose for iron deficiency anemia in dialysis patients: Effect of a new protocol adopted for a hemodialysis limited assistance center.

Iron and erythropoietin deficiencies are determinants of anemia in chronic kidney disease. In hemodialysis (HD) patients, intravenous (IV) iron is associated with a greater hemoglobin (Hb) production and better erythropoietin response but may be associated to hypersensitivity reaction. After the 2013 European Medicines Agency report regarding early detection/management of iron allergic reactions, IV iron administration dramatically reduced in Italian Hemodialysis-Limited-Assistance-Centre (HD-CAL) where a physician is present only once a week. Objective of the study was providing an effective and secure IV iron administration protocol for HD-CAL patients. IV ferric carboxymaltose (FCM) administration was more effective and better tolerated than sodium ferric gluconate for iron deficiency correction and resolution of anemia in 24 patients undergoing HD in our HD-CAL. Six months of FCM IV treatment once a week increased ferritin and Hb compared to sodium ferric gluconate once a week leading to decreased erythropoietin consumption from 24 000 to 15 000 U/patient/week with an erythropoietin annual expense reduction. No blood transfusions, gastrointestinal intolerance or other adverse effects were reported. The FCM IV administration protocol for our HD-CAL patients was safe and no adverse events were reported, resulting in significantly increased ferritin, transferrin saturation, and Hb levels, reduction of erythropoietin requirements, and consequently reduction of erythropoietin expenses.

Iron Support in Erythropoietin Treatment in Myelodysplastic Syndrome Patients Affected by Low-Risk Refractory Anaemia: Real-Life Evidence from an Italian Setting.

Refractory anaemia (RA) among myelodysplastic syndrome (MDS) is associated with a partial functional iron deficit and may require transfusions. In low-risk lymphoma and solid tumour patients, iron support improves erythropoietin (EPO) cost-effectiveness in treating anaemia. The aim of this study is to see if oral sucrosomial iron support improves the cost-effectiveness of EPO treatment in MDS patients affected by low-risk RA. We treated patients with EPO only or with EPO plus oral sucrosomial iron or intravenous (i.v.) iron. The need for transfusions was lowest in the group taking oral iron (p = 0.016) or not receiving supplementation at all (p = 0.022). We compared costs of EPO with i.v. ferric gluconate or oral sucrosomial iron supplementation or no iron supplementation. The oral iron group had fewer side effects, fewer patient medical visits in the out-patient setting, and fewer transfusions; this led to higher savings on direct hospital costs and indirect patient costs (lost days at work) and translated into a 50% abatement of overall expenditures. EPO treatment-related expenditures in MDS-RA patients were lowest with oral sucrosomial iron supplementation (Sideral®), with a longer interval between EPO administration in maintenance treatment, quicker hemoglobin recovery, lower ferritin increase and fewer blood transfusions.

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.

Cost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis.

The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). Unadjusted mean quality-adjusted life-years (QALYs; 95% confidence interval [CI]) at 6 months were 0.027 (0.020-0.034; p < 0.001) higher in the EPO group, with an adjusted QALY increment of 0.014 (0.000-0.028; p = 0.04). Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.

A Retrospective Comparative Study of Different Methods of Blood Management in Total Knee Replacement.

Perioperative blood management is essential to minimize allogeneic blood transfusion in total knee replacement. The effect of preoperative administration of erythropoietin, intraoperative cell saver, tranexamic acid, and restrictive transfusion strategies on allogeneic transfusion is studied in total knee replacement. A retrospective comparative study of 106 patients who underwent total knee replacement in different time periods was performed. Group A (n 1 = 45) underwent restrictive strategies of transfusion between 2009 and 2010. Group B (n 2 = 24) includes patients where erythropoietin of either 10.000 IU or 20.000 IU was given preoperatively. Patients of Group C (n 3 = 21) underwent autologous washed erythrocytes transfusion through a cell saver. Lastly, in Group D (n 4 = 15) tranexamic acid dose of 1 gr IV was given intraoperatively. The preoperative and discharge hemoglobin together with total units of blood transfusion and creatinine levels was studied. Tranexamic acid noted the least units of blood transfusion (mean = 0.82 units/patient, p < 0.001, CI 95%) in contrast to the two regimens of erythropoietin (1.16 units/patient) OrthoPAT (1.43 units/patient) and restrictive strategies (1.92 units/patient). The mean preoperative hemoglobin was 13.37 g/dL with no statistical difference among the groups of patients. The postoperative mean hemoglobin was 10.59 with no statistical difference among the groups of patients too. Additionally, the mean creatinine level was 0.93 mg/dL; however, no statistical difference among the groups of patients was noted. Finally, tranexamic acid seemed to be the most cost-effective regime. In our study, tranexamic acid proved its superiority concerning the postoperative blood transfusion on patients undergoing total knee replacement, in comparison with the other existing methods of perioperative blood management. This is a Level III, retrospective comparative study.

Ultrapure versus standard dialysate: A cost-benefit analysis.

Low-level bacterial and endotoxin contamination of water used to generate dialysate propagates chronic inflammation in patients with a wide-range of potential adverse consequences, including erythropoietin hyporesponsiveness. Advancements in hemodialysis systems now allow for the generation of ultrapure dialysate that has lower bacterial and endotoxin levels than the standard dialysate. The cost associated with ultrapure dialysate is thought to be a major barrier to its widespread adoption. In this report, we conduct a cost-benefit analysis examining the excess cost of generating ultrapure dialysate and the potential cost saving from a lower erythropoietin dose requirement. Our analysis suggests a potential cost saving of approximately $371 to $425 million per year with full adoption of ultrapure dialysate in the United States.

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 effectiveness and safety of preoperative use of erythropoietin in patients scheduled for total hip or knee arthroplasty: A systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Because allogeneic blood transfusion carries a risk of serious complications, erythropoietin (EPO) has been used in patients scheduled for total hip or knee arthroplasty in an effort to reduce the need for allogeneic blood transfusion; however, its efficacy, cost-effectiveness, and safety are still controversial. The purpose of this review was to determine the hematopoiesis-promoting effect and potential complications, as well as the cost-effectiveness, of preoperative use of EPO in patients scheduled for total hip or knee arthroplasty. METHODS: We searched MEDLINE, EMBASE, Cochrane, and ClinicalTrials.gov databases for relevant literature from 2000 to 2015. Risk of bias was assessed for all included studies and data were extracted and analyzed. RESULTS: Preoperative use of EPO was associated with lower exposure to allogeneic blood transfusion (odds ratio = 0.41) and higher hemoglobin concentration after surgery (standardized mean difference = 0.86, P < 0.001). Complications were not generally reported, but there was no significant difference between the group with and without EPO based on given data. Cost-effectiveness was also summarized but was not conclusive. CONCLUSION: Preoperative administration of EPO reduces the requirement for allogeneic blood transfusion and increases hemoglobin level after surgery. The studies of cost-effectiveness were not conclusive. Further studies and guidelines specific to blood management in the perioperative stage of total knee and hip arthroplasty are expected.

Competition Between Biosimilars and Patented Biologics: Learning from European and Japanese Experience.

BACKGROUND: The expiry of patents for costly biologics is creating new momentum on the pharmaceutical market for biosimilars (copies of off-patent biologics) and paving the way for their development. However, little is known about the competitiveness of biosimilars versus their originators and other biologics belonging to the same therapeutic class. OBJECTIVE: The main goal of this study was to analyse the type of competition generated by the first biosimilars commercialised on key global biologic markets and to grasp their economic model. The secondary goal was to distinguish the main factors likely to influence the uptake of biosimilars on national markets. METHODS: To be included in this study, countries had to meet three conditions: the regulatory framework for the development of biosimilars closely resembled that in Europe, biosimilars were marketed in 2014, and the value of the biologics market was >US$3 billion. We analysed granulocyte colony-stimulating factors (GCSFs) and erythropoietins (EPOs) over the period 2007-2014 because these are the two main therapeutic classes that have been 'biosimilarised' and thus have many years of experience available. We assessed market sizes, retail/hospital distribution mixes, incentives for using biosimilars and price discounts for originators versus biosimilars. We conducted a linear regression analysis to assess the relationship between uptakes of biosimilars and the market shares of other biologics. RESULTS: The EU-5 (France, Germany, Italy, Spain and the UK) and Japanese GCSF and EPO markets are highly-country-specific. Uptake of biosimilars seems to depend on retail/hospital distribution mixes and on medical practice. Depending on the therapeutic class and the market sector (retail or hospital), biosimilars may compete with first-generation or second-generation products or both. Some incentives implemented to encourage the use of biosimilars had mixed results. Overall, discounts for biosimilars versus originators are not factors that determine global uptake of biosimilars. CONCLUSION: Unlike generics, there appears to be no unique economic model for biosimilars. Moreover, a new phenomenon occurs with biosimilars: sometimes, they are able to take market shares from subsequent generations of biologics.

Drug Utilization Patterns and Costs of Erythropoiesis-Stimulating Agents in an Outpatient Setting in Greece.

UNLABELLED: Anemia in the elderly is often related to a higher prevalence of chronic diseases such as chronic kidney failure, arthritis, and malignancy. Erythropoiesis-stimulating agents (ESAs) have been used for years to effectively treat anemia and when used appropriately can substantially improve the health status and quality of life of older adults. Following the 2008 recession in Greece, the government introduced ESA price control restrictions, but no prescribing restrictions, in an effort to reduce drug expenditure. OBJECTIVE: ESA prescribing patterns and treatment costs were analyzed to determine inappropriate or appropriate use of these agents and related health care resources in Greece. METHOD: A retrospective register-based drug utilization study was carried out using data from prescriptions dispensed at the public pharmacy of the largest social insurance fund (IKA-ETAM), for patients receiving ESAs over a six-month period. For each patient, demographic data, ESA dosage regimen, treatment indication and cost, prescriber specialty, and prescription origin were recorded. RESULTS: A total of 14,387 prescriptions from 6,074 patients (median age 74 years) were reviewed. A substantial number of patients (13.5%) were treated for off-label indications, for which the average cost per patient per indication was higher. ESA dosage/frequency of administration varied but was in accordance with recommendations. The percentage of patients who received innovator and biosimilar erythropoietin (EPO) was 88% and 12%, respectively. CONCLUSION: For the optimization of ESA utilization and the reduction of treatment costs, strict ESA prescription monitoring, development of registries, and criteria for off-label indications and biosimilar use in naive patients under the umbrella of risk-sharing agreements should be proposed.

[Can we transfer the mechanisms of the generics market to biosimilars?]

Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period. Price competition similar to that found in the generic markets has been established for erythropoietin and filgrastim. The same has not been observed for follitropin alfa and somatropin due to the limited number of competitors and products available at this stage. No definitive conclusions can be drown from the results at this stage. Time will tell whether it will be possible for physicians and individuals with private health insurance to fully leverage the savings potential of biosimilars while safeguarding patient safety.

[Treatment of anemia in Patient Blood Management from an economic perspective]. / Tratamiento de la anemia en el "Patient Blood Management" desde una perspectiva económica.

The liberal use of transfusions is not only a risk for patients but also represents a significant healthcare expenditure. The rational use of allogeneic blood transfusions and the use of transfusion alternatives, such as the optimization of preoperative hemoglobin levels, can offer substantial savings to health departments by reducing the cost of transfusions and the morbidity related to the transfusions.

Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience.

BACKGROUND: Patent expiries on leading biologics are creating new momentum in the market for biosimilars (copies of off-patent biologics), paving the way for their development. However, little is known about the factors influencing the competition between biosimilars and their reference products (REF). OBJECTIVES: The aim of this study was to analyse key global erythropoietin (EPO) markets and factors affecting biosimilar EPO (BIOSIM-EPO) uptakes, and to identify countries where BIOSIM-EPOs have gained significant market shares. METHODS: Inclusion criteria for countries in the study were a biosimilar regulatory framework similar to the EU framework, and biological market value higher than US$2.5 billion. Factors evaluated included EPO market size, EPO retail/hospital distribution mix, national incentives to use biosimilars and BIOSIM-EPO/REF price differences. IMS Health provided EPO consumption in volumes, values, and EPO ex-manufacturer prices from 2007 to 2012. RESULTS: Japan: large-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (6.8 % in 2012). France: large-sized market, dominant retail distribution, no incentives, low BIOSIM-EPO uptake (5.8 %). Spain and Italy: medium-sized market, dominant hospital distribution, no incentives, moderate BIOSIM-EPO uptakes (11.5 and 8.6 %). Germany: small-sized market, dominant retail distribution, presence of incentives, high BIOSIM-EPO uptake (30.4 %). UK: small-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (2.0 %). BIOSIM-EPO/REF price differences play no role at a global level (-10.8 % in Germany and -26.9 % in Japan). CONCLUSIONS: EPO markets have proven to be highly country-specific. EPO market sizes, EPO retail/hospital distribution mixes and BIOSIM-EPO/REF price differences may not be determining factors of BIOSIM-EPO uptakes. Prescription and substitution incentives to use BIOSIM-EPO appear to be determining factors in Germany. The heterogeneity of national EPO markets makes it impossible to outline country profile types with significant BIOSIM-EPO penetrations.

Preoperative erythropoietin alpha reduces postoperative transfusions in THA and TKA but may not be cost-effective.

BACKGROUND: Preoperative erythropoietin alpha (EPO) has been shown to be effective at reducing postoperative blood transfusions in total hip arthroplasty (THA) and total knee arthroplasty (TKA); however, treatment with EPO is associated with additional costs, and it is not known whether these costs can be justified when weighed against the transfusion reductions achieved in patients who receive the drug. QUESTIONS/PURPOSES: The purpose of this study is to investigate (1) efficacy of preoperative EPO in reducing postoperative transfusions in TKA and THA; (2) whether patients treated with EPO have reduced length of stay or a different discharge disposition; and (3) whether EPO use reduces overall blood management costs. METHODS: Patients undergoing primary THA or TKA over a 10-month period with preoperative hemoglobin<13 g/dL were recommended to be treated preoperatively with EPO. During that time, 80 of 286 (28%) patients met that inclusion criterion and the treating team recommended EPO to all of them; of that group, 24 (30%) opted to take EPO and 56 (70%) opted not to. Patients receiving at least one dose of EPO and those not receiving EPO were compared in terms of transfusion frequency, length of stay and discharge disposition, and overall blood management costs. Demographics, preoperative hemoglobin, and operative blood loss for both groups were similar (p>0.05). No transfusion triggers were used; rather, patients with postoperative hemoglobin<10 mg/dL and who were symptomatic despite fluid boluses were transfused. The clinician responsible for transfusing symptomatic patients was blinded to the patient's EPO treatment status. Costs were defined as direct costs paid or incurred by our institution for EPO, allogeneic blood, and variable costs associated with patient care after THA/TKA. A decision-tree cost analysis was performed using the collected clinical data and cost data collected from our institution; the analysis considered total associated blood management cost for an EPO and a non-EPO strategy with sensitivity analysis of key cost variables. RESULTS: The proportion of patients receiving transfusions was lower in patients who received EPO than in patients who did not (0% [zero of 24] versus 41% [23 of 56]; p<0.001). The mean length of inpatient hospital stay (EPO: 3.0±0.4 versus control: 3.3±0.8 days, p=0.77) and discharge disposition also was not different between the groups. The cost analysis demonstrated that the EPO strategy was more costly compared with no EPO (USD 2632 versus USD 2284) and its cost would need to be less than USD 225/dose for this to change. CONCLUSIONS: EPO reduced the need for postoperative transfusions in high-risk patients undergoing THA and TKA; however, it was not found to be cost-effective in our model. Our model could not consider relatively rare complications of blood transfusions, including disease transmission, deep periprosthetic infections, and transfusion reactions, but if surgeons or patients value avoiding these potential but rare factors highly, this could reasonably influence the decision of whether to use EPO despite our findings that it was not cost-effective. LEVEL OF EVIDENCE: Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury.

BACKGROUND: The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes. METHODS: EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled. Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection administered weekly for up to three doses during their ICU admission. The primary outcome measure is the proportion of unfavourable neurological outcomes, comprising death or severe disability, observed at 6 months following randomisation utilizing the Extended Glasgow Outcome Scale. Secondary outcomes, also assessed at 6 months following randomisation, include the probability of an equal or greater Extended Glasgow Outcome Scale level, mortality, the proportions of patients with proximal deep venous thrombosis or with composite thrombotic vascular events, as well as assessment of quality of life and cost-effectiveness. The planned sample size will allow 90% power to detect a reduction from 50% to 36% in unfavourable neurological outcomes at a two-sided alpha of 0.05. DISCUSSION: A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses. Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12609000827235 (22 September 2009). ClinicalTrials.gov: NCT00987454 (29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (18 January 2012).

Efficacy of subcutaneous epoetin-zeta on anemia in renal transplant recipients: a single-center experience.

BACKGROUND: Persistent or "de novo" anemia (plasma hemoglobin<11 g/dL) may complicate the graft outcome in a significant number of renal transplant recipients. We describe a single-center experience with epoetin-zeta (EPO-Z), the biosimilar form for epoetin-alfa. METHODS: Twenty patients were included in the study, 10 in treatment with different erythropoiesis-stimulating agents (ESA) and shifted to EPO-Z (shift group) and 10 who started EPO-Z treatment for anemia (naive group). All the patients had stable renal function and normal values of main inflammation markers and were prospectively followed up for 12 months. Iron supplements were administered during the study, as needed. RESULTS: In the shift group, mean plasma hemoglobin levels>11 g/dL were maintained for the entire 1-year follow-up period, with average EPO-Z doses 3.4% higher than the corresponding doses of previous ESA; in the naive group, the target value was reached between the first and third months and remained stable throughout the study. Mean corpuscular volume did not vary in either group. No change was observed in glomerular filtration rate, nor in proteinuria or in main laboratory data. No drug-related side effect was reported. CONCLUSIONS: EPO-Z may be considered a valid alternative to different ESAs in renal transplant recipients, with an interesting pharmaco-economic profile, considering its lower cost.

[Experiences with price competition of biosimilar drugs in Hungary]. / A biohasonló gyógyszerek árversenyének tapasztalatai Magyarországon.

AIM: The aim of our study is to analyse the biosimilar bids of the Hungarian National Health Insurance Fund Administration in case of colony-stimulating factor and erythropoietin products. DATA AND METHODS: Data derived from the nationwide pharmaceutical database of Hungarian National Health Insurance Fund Administration. We analysed how the number of patients treated by colony-stimulating factor and erythropoietin products changed before (01.07.2011.-30.06.2012.) and after (01.07.2012.-30.06.2013.) the first biosimilar bid performed in March 2012 in Hungary. RESULTS: In the 12 months before biosimilar bid 4167 patients received erythropoietin treatment, while in the first 12 months after the bid 3647 patients, resulting in a 12.5 % decline. In the 12 months before biosimilar bid 13974 patients received colony-stimulating factor treatment, while in the first 12 months after the bid 13352 patients, resulting in a 4.5% decline. CONCLUSIONS: The analyses of the Hungarian price competition bid of biosimilar products showed a minimal decline in the number of patients under treatment by both colony-stimulating factor and erythropoietin products while the health insurance reimbursement of these drugs significantly decreased.

Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries.

AIM: We simulated the budget impact of biosimilar erythropoiesis-stimulating agent (ESA) in EU G5 countries. MATERIALS & METHODS: Three models were built to estimate the number of patients who could be provided with antineoplastic therapy with rituximab, bevacizumab or trastuzumab from cost savings of biosimilar erythropoietin use in a hypothetical panel of 100,000 patients. The associated number of patients needed to convert to biosimilar ESA to provide such treatments was also calculated. RESULTS: Under fixed dosing, the savings from 100% conversion were €110,592,159, translating into an additional 9770 rituximab, 3912 bevacizumab, or 3713 trastuzumab treatments. Under weight-based dosing, the savings from 100% conversion were €146,170,333, corresponding to an additional 12,913 rituximab, 5171 bevacizumab or 4908 trastuzumab treatments. The number of patients needed to convert ranged from four to 51. CONCLUSION: Using biosimilar ESA for supportive cancer care yields significant savings and increases accessibility to primary antineoplastic therapy in a budget neutral way.

Cost savings using a protocol approach to manage anemia in a hemodialysis unit.

BACKGROUND: National guidelines recommend using anemia management protocols to guide treatment. The objective of this study was to determine if an anemia management protocol would improve hemoglobin (Hgb) indices in hemodialysis patients and to measure whether the protocol would reduce the use and cost of darbepoetin alfa (DBO) and intravenous (IV) iron in hemodialysis patients. METHODS: An anemia management protocol was created and implemented for hemodialysis patients at our institution. A retrospective observational review of the use of DBO and IV iron as well as changes in Hgb, transferrin saturation and ferritin in 174 patients was conducted 6 months before and after implementation of the anemia protocol. RESULTS: The number of Hgb measurements in the target range increased from 44.3 to 46.0% (p = 0.48) after protocol implementation. The mean weekly dose of DBO was reduced from 34.56 ± 31.12 to 31.11 ± 28.64 µg post-protocol implementation (p = 0.011), which translated to a cost savings of USD 41,649 over 6 months. The mean monthly IV iron dose also decreased from 139.56 ± 98.83 to 97.65 ± 79.05 mg (p < 0.005), a cost savings of USD 18,594 over the same time period. CONCLUSION: The use of an anemia management protocol resulted in the deprescribing of DBO and iron agents while increasing the number of patients in the target Hgb range, which led to significant cost savings in the treatment of anemia.

Perceived barriers among physicians for stopping non-cost-effective blood-saving measures in total hip and total knee arthroplasties.

BACKGROUND: Despite evidence that the blood-saving measures (BSMs) erythropoietin (EPO) and intra- and postoperative blood salvage are not (cost-)effective in primary elective total hip and knee arthroplasties, they are used frequently in Dutch hospitals. This study aims to assess the impact of barriers associated with the intention of physicians to stop BSMs. STUDY DESIGN AND METHODS: A survey among 400 orthopedic surgeons and 400 anesthesiologists within the Netherlands was performed. Multivariate logistic regression was used to identify barriers associated with intention to stop BSMs. RESULTS: A total of 153 (40%) orthopedic surgeons and 100 (27%) anesthesiologists responded. Of all responders 67% used EPO, perioperative blood salvage, or a combination. After reading the evidence on non-cost-effective BSMs, 50% of respondents intended to stop EPO and 53% to stop perioperative blood salvage. In general, barriers perceived most frequently were lack of attention for blood management (90% of respondents), department priority to prevent transfusions (88%), and patient characteristics such as comorbidity (81%). Barriers significantly associated with intention to stop EPO were lack of interest to save money and the impact of other involved parties. Barriers significantly associated with intention to stop perioperative blood salvage were concerns about patient safety, lack of alternatives, losing experience with the technique, and lack of interest to save money. CONCLUSION: Physicians experience barriers to stop using BSMs, related to their own technical skills, patient safety, current blood management policy, and lack of interest to save money. These barriers should be targeted in strategies to make BSM use cost-effective.