Efficacy and cost effectiveness of intravenous ferric carboxymaltose versus iron sucrose in adult patients with iron deficiency anaemia.

BACKGROUND: Iron deficiency anaemia (IDA) is a major health issues and common type of nutritional deficiency worldwide. For IDA treatment, intravenous (IV) iron is a useful therapy. OBJECTIVE: To determine the efficacy and cost-effectiveness (CE) of intravenous (IV) Ferric Carboxymaltose (FCM) versus IV Iron Sucrose (IS) in treating IDA. DATA SOURCES: Electronic medical record i.e. Cerner® system. TARGET POPULATION: Adults patients with iron deficiency anaemia. TIME HORIZON: A 12-month period (01/01/2018-31/12/2018). PERSPECTIVE: Hamad Medical Corporation (HMC, a public hospital). INTERVENTION: IV Ferric Carboxymaltose versus IV Iron Sucrose. OUTCOME MEASURES: With regard to responses to treatment i.e., efficacy of treatment with FCM & IS in IDA patients, hemoglobin (Hgb), ferritin, and transferrin saturation (TSAT) levels were the primary outcomes. Additionally, the researchers also collected levels of iron, platelet, white blood cell (WBC), red blood cell (RBC), mean corpuscular hemoglobin (MCH), and mean corpuscular volume (MCV). The costs i.e. resources consumed (obtained from NCCCR-HMC) and the CE of FCM versus IS were the secondary outcomes. RESULTS OF BASE-CASE ANALYSIS: There was a significant improvement in Hgb, RBC and MCH levels in the IS group than the FCM group. The overall cost of IS therapy was significantly higher than FCM. The medication cost for FCM was approximately 6.5 times higher than IS, nonetheless, it is cheaper in terms of bed cost and nursing cost. The cost effectiveness (CE) ratio illustrated that FCM and IS were significantly different in terms of Hgb, ferritin and MCH levels. Further, Incremental Cost Effectiveness Ratio (ICER) indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes. RESULTS OF SENSITIVITY ANALYSIS: Not applicable. LIMITATIONS: The study did not consider the clinical or humanistic outcome. CONCLUSIONS: The higher cost of FCM versus IS can be offset by savings in healthcare personnel time and bed space. ICER indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes.

Attitude changes in prescribing intravenous iron supplementation in different settings at a hospital consortium in Italy.

BACKGROUND: Iron deficiency anaemia is a public health problem. In case oral iron treatment is ineffective, poorly tolerated or contraindicated, the intravenous route becomes the first choice. The aim of the study was to evaluate the shift between ferrous gluconate (FG) and ferric carboxymaltose (FCM) usage at our hospitals over the years. We also performed a cost comparison between pre and post-FCM availability periods, taking into account the acquisition costs of both intravenous iron and red blood cell units (PRBC). STUDY DESIGN AND METHODS: The amount and costs of FG and FCM released by hospital Pharmacy Services from 2010 to 2019 were analysed, along with the number of transfused PRBC units in the same timeframe. RESULTS: Overall, the proportion of FCM usage rose from 8.6 % in 2014 to 71.9 % in 2019, as percentage of total intravenous iron released. After exclusion of haemodialysis, where FG is still widely used, the FCM use in the last four years raised from 12.9% to 92.5%. Despite the higher FCM cost, the mean yearly expenditure for intravenous iron plus PRBC units did not differ between pre- and post-FCM eras (2010-2013, € 2,396,876 € versus 2014-2019, € 2,307,875 - p = 0.234), as a result of a net decrease of PRBC usage, namely from 15,083 to 12,654 (-16.1 %), respectively. DISCUSSION: Intravenous iron has a major role in treating iron deficiency anaemia in several settings. Third generation compounds are paving the way to more updated and safer treatments.

Effects of a multifaceted intervention to promote the use of intravenous iron sucrose complex instead of ferric carboxymaltose in patients admitted for more than 24 h.

PURPOSE: Although more practical for use, the impact of ferric carboxymaltose (FCM) on the hospital budget is considerable, and intravenous iron sucrose complex (ISC) represents a cost-saving alternative for the management of iron deficiency anemia in patients during hospitalization. The Drug Committee decided to reserve FCM for day hospitalizations and contraindications to ISC, especially allergy. ISC was available for prescription for all other situations. METHODS: The impact of a multifaceted intervention promoting a switch from FCM to ISC was evaluated using an interrupted time series model with segmented regression analysis. The standardized rate of the dispensing of FCM, ISC, and oral iron by the hospital pharmacy, as well as the rate of the dispensing of packed red blood cells and the number of biological iron status measurements, was analyzed before and after the intervention. RESULTS: There was an immediate decrease in FCM consumption following the intervention, with a reduction of 88% (RR: 0.12 [CI95% 0.10 to 0.15]). Conversely, there was a large increase in ISC use (RR: 5.1 [CI95% 4.4 to 5.9]). We did not observe a prescription shift to packed red blood cells or oral iron after the intervention. The time series analysis showed the frequency of iron status testing to remain stable before and after. The direct savings for intravenous iron for 8 months were 187,417.54 €. CONCLUSION: Our intervention to lower the impact of intravenous iron therapy on the hospital budget was effective.

Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate: a multicentric randomized study.

Iron deficiency anemia is among the most frequent causes of disability. Intravenous iron is the quickest way to correct iron deficiency, bypassing the bottleneck of iron intestinal absorption, the only true mechanism of iron balance regulation in human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. However, the intravenous way of iron administration requires several precautions; as the in-hospital administration requires a resuscitation service, as imposed in Europe by the European Medicine Agency, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal way of absorption, seems to be cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. In this multicentric randomized study, we analyze the cost-effectiveness of intravenous sodium ferrigluconate vs oral Sucrosomial iron in patients with iron deficiency anemia refractory/intolerant to oral iron sulfate without other interfering factors on iron absorption.

Association of Family Income and Risk of Food Insecurity With Iron Status in Young Children.

Importance: Iron deficiency (ID) has the greatest prevalence in early childhood and has been associated with poor developmental outcomes. Previous research examining associations of income and food insecurity (FI) with ID is inconsistent. Objective: To examine the association of family income and family risk of FI with iron status in healthy young children attending primary care. Design, Setting, and Participants: This cross-sectional study included 1245 children aged 12 to 29 months who attended scheduled primary care supervision visits from 2008 to 2018 in Toronto, Canada, and the surrounding area. Exposures: Family income and risk of FI were collected from parent-reported questionnaires. Children whose parents provided an affirmative response to the 1-item FI screen on the Nutrition Screening Tool for Every Toddler or at least 1 item on the 2-item Hunger Vital Sign FI screening tool were categorized as having family risk of FI. Main Outcomes and Measures: Iron deficiency (serum ferritin level <12 ng/mL) and ID anemia (IDA; serum ferritin level <12 ng/mL and hemoglobin level <11.0 g/dL). All models were adjusted for age, sex, birth weight, body mass index z score, C-reactive protein level, maternal education, breastfeeding duration, bottle use, cow's milk intake, and formula feeding in the first year. Results: Of 1245 children (595 [47.8%] girls; median [interquartile range] age, 18.1 [13.3-24.0] months), 131 (10.5%) were from households with a family income of less than CAD $40 000 ($29 534), 77 (6.2%) were from families at risk of FI, 185 (14.9%) had ID, and 58 (5.3%) had IDA. The odds of children with a family income of less than CAD $40 000 having ID and IDA were 3 times higher than those of children in the highest family income group (ID: odds ratio [OR], 3.08; 95% CI, 1.66-5.72; P < .001; IDA: OR, 3.28; 95% CI, 1.22-8.87; P = .02). Being in a family at risk of FI, compared with all other children, was not associated with ID or IDA (ID: OR, 0.43; 95% CI, 0.18-1.02; P = .06; IDA: OR, 0.16; 95% CI, 0.02-1.23; P = .08). Conclusions and Relevance: In this study, low family income was associated with increased risk of ID and IDA in young children. Risk of FI was not a risk factor for ID or IDA. These findings suggest that targeting income security may be more effective than targeting access to food to reduce health inequities in the prevention of iron deficiency.

IRON DEFICIENCY ANEMIA AND ITS RELATIONSHIP WITH SOCIOECONOMIC VULNERABILITY.

OBJECTIVE: To analyze the association of anemia with the socioeconomic vulnerability of preschoolers in public day care centers, in the city of Taubaté, SP, Brazil. METHODS: This is a cross-sectional study with a probabilistic sample that analyzed 363 children assisted in public day care centres in low-income and high-income areas of Taubaté, SP, Brazil. The hemoglobin concentration (Hb), dependent variable, was obtained by digital puncture, considering anemic children with Hb concentration <11.0 g/dL. The independent variables such as socioeconomic and demographic conditions were collected by a semi-structured questionnaire. RESULTS: The prevalence of iron deficiency anemia was 19.3% among preschoolers. Children from day care centers with high socioeconomic vulnerability had lower Hb concentration than those from a non-vulnerable area (p<0.05). CONCLUSIONS: The lower concentration of hemoglobin in preschoolers is associated with the location of day care centers in an area of socioeconomic vulnerability. Children attending these day care centers face adverse family conditions such as low income, working mothers, and mothers with low schooling, though they receive social benefits and monitoring by public health services.

Annual Prevalence, Health Expenditures, and Co-Morbidities Trend of Iron Deficiency Anemia in Korea: National Health Insurance Service Data from 2002 to 2013.

Despite improvements in nutritional status, iron deficiency anemia (IDA) remains a debilitating nutritional problem worldwide. We estimate annual IDA prevalence rates by sex and age and the trends therein in Korea. We also calculate the health expenditures of IDA and its co-morbidities by analyzing claims data in the National Health Information Database from 2002 to 2013. All analyses were performed based on diagnosis codes of IDA (D50, D50.0, D50.8, and D50.9) regardless of whether IDA was the principal or a coexisting disease. Trends in IDA prevalence rates were evaluated by calculating annual percent changes (APCs) in prevalence. The health expenditures of IDA were calculated based on the direct medical costs (outpatient and hospitalization costs, pharmaceutical costs) and direct non-medical costs (travel costs). The overall IDA prevalence in both sexes increased approximately 2.3-fold from 2002 to 2013; the APC was +7.6%. In females, the prevalence of IDA was highest in aged 30-39 and 40-49 years. The APC was highest in those aged <10 years (+18.2%), followed by those aged ≥80 (+14.7%) and 70-79 (+9.8%) years. In males, the prevalence rates were highest in aged <10 years, followed by those aged ≥60 years. The APC was highest in those aged <10 years (+19.1%), followed by those aged ≥80 years (+10.5%). The total health expenditures increased 2.8-fold during 12 years. Diseases of the respiratory or gastrointestinal tract were the most prevalent co-morbidities in both males and females. The annual prevalence of IDA continues to rise in association with adverse health expenditures and co-morbidities in spite of improvements in nutritional status. Most importantly, infants and young children, the elderly, and females aged 30-49 years are at highest risk of IDA. A national, prospective, and well-organized effort to improve iron status and to manage IDA is required.

Iron deficiency in 78 805 people admitted with heart failure across England: a retrospective cohort study.

Objectives: Iron deficiency (ID), with or without anaemia (IDA), is an important comorbidity in people with chronic heart failure (HF), but the prevalence and significance in those admitted with HF is uncertain. We assessed the prevalence of ID or IDA in adults (age ≥21 years) hospitalised with a primary diagnosis of HF, and examined key metrics associated with these secondary diagnoses. Methods: A retrospective cohort study of Hospital Episode Statistics describing all adults admitted to National Health Service (NHS) hospitals across England from April 2015 through March 2016 with primary diagnostic discharge coding as HF, with or without subsidiary coding for ID/IDA. Results: 78 805 adults were admitted to 177 NHS hospitals with primary coding as HF: 26 530 (33.7%) with secondary coding for ID/IDA, and 52 275 (66.3%) without. Proportionately more patients coded ID/IDA were admitted as emergencies (94.8% vs 87.6%; p<0.0001). Tending to be older and female, they required a longer length of stay (15.8 vs 12.2 days; p<0.0001), with higher per capita costs (£3623 vs £2918; p<0.0001), the cumulative excess expenditure being £21.5 million. HF-related (8.2% vs 5.2%; p<0.0001) and all-cause readmission rates (25.8% vs 17.7%; p<0.05) at ≤30 days were greater in those with ID/IDA against those without, and they manifested a small but statistically significant increased inpatient mortality (13.5% v 12.9%; p=0.009). Conclusions: For adults admitted to hospitals in England, principally with acute HF, ID/IDA are significant comorbidities and associated with adverse outcomes, both for affected individuals, and the health economy.

Early intravenous iron administration in the Emergency Department reduces red blood cell unit transfusion, hospitalisation, re-transfusion, length of stay and costs.

BACKGROUND: Moderate to severe iron deficiency anaemia is a common finding in patients admitted to the Emergency Department (ED). According to Patient Blood Management principles, intravenous iron should be the therapy of choice instead of blood transfusion for selected cases affected by chronic iron deficiency anaemia. However, this option is only rarely taken into account by physicians in the ED. As a result, in many circumstances, treatment of iron deficiency anaemia in the ED can differ from that of the Anaemia Clinic. With the aim of reducing inappropriate transfusions, and to implement intravenous iron usage, we shared a specific protocol with the ED. MATERIAL AND METHODS: We reviewed the medical records of all subjects admitted to the ED (n=267, Post-protocol group) with hemoglobin ≤9.0 g/dL and mean corpuscular volume <80 fL in a 13-month period, except if the massive transfusion protocol was activated, and results were compared with an equivalent Pre-protocol historical cohort (n=226). RESULTS: In comparison with the Pre-protocol series, the number of patients transfused did not change, but the appropriateness in terms of transfusion and red blood cell volume transfused improved sharply (87.0 vs 13.3%; p<0.001) with a significant increase in intravenous iron administration (50.2 vs 4.4% of cases; p<0.001). As a positive consequence, both the time spent in the ED by patients who were then directly discharged and costs per subject treated dropped by 37.9% and 59.0%, respectively. Treatment with infusion only in comparison with transfusion only led to a statistically significant Relative Risk reduction in transfusion on the ward and post-discharge transfusion of 55.6% and 44.4%, respectively. DISCUSSION: The implementation of Patient Blood Management principles and early intravenous iron therapy in the Emergency Department have proved to be effective tools to optimise resources both in terms of units transfused and costs.

Iron deficiency anemia and its relationship with socioeconomic vulnerability / Anemia por deficiência de ferro e sua relação com a vulnerabilidade socioeconômica

ABSTRACT Objective: To analyze the association of anemia with the socioeconomic vulnerability of preschoolers in public day care centers, in the city of Taubaté, SP, Brazil. Methods: This is a cross-sectional study with a probabilistic sample that analyzed 363 children assisted in public day care centres in low-income and high-income areas of Taubaté, SP, Brazil. The hemoglobin concentration (Hb), dependent variable, was obtained by digital puncture, considering anemic children with Hb concentration <11.0 g/dL. The independent variables such as socioeconomic and demographic conditions were collected by a semi-structured questionnaire. Results: The prevalence of iron deficiency anemia was 19.3% among preschoolers. Children from day care centers with high socioeconomic vulnerability had lower Hb concentration than those from a non-vulnerable area (p<0.05). Conclusions: The lower concentration of hemoglobin in preschoolers is associated with the location of day care centers in an area of socioeconomic vulnerability. Children attending these day care centers face adverse family conditions such as low income, working mothers, and mothers with low schooling, though they receive social benefits and monitoring by public health services.

RESUMO Objetivo: Analisar a associação da anemia com a vulnerabilidade socioeconômica de pré-escolares de creches públicas da cidade de Taubaté, SP, Brasil. Métodos: Trata-se de um estudo transversal com amostra probabilística que analisou 363 crianças assistidas em creches públicas de regiões de baixa e alta renda de Taubaté. A concentração de hemoglobina (Hb), variável dependente, foi obtida por meio de punção digital, considerando anêmicas as crianças com concentração de Hb<11,0 g/dL. As variáveis independentes como condições socioeconômicas e demográficas foram coletadas por questionário semiestruturado. Resultados: A prevalência de anemia por deficiência de ferro foi de 19,3% entre os pré-escolares. As crianças das creches de elevada vulnerabilidade socioeconômica apresentaram concentração de Hb estatisticamente menor do que aquelas de região não vulnerável (p<0,05). Conclusões: A menor concentração de Hb em pré-escolares está associada à localização das creches em região de vulnerabilidade socioeconômica, uma vez que as crianças que frequentam tais creches enfrentam condições adversas familiares, como baixa renda, mães que trabalham e com baixa escolaridade, embora recebam benefício social e acompanhamento pelos serviços públicos de saúde.

Economic Evaluation of Ferric Carboxymaltose for the Management of Hemodialysis Patients with Iron Deficiency Anemia in Italy.

INTRODUCTION: Patients with chronic kidney disease on hemodialysis (HD) are at high risk of developing both iron deficiency and iron deficiency anemia (IDA). The administration of intravenous iron therefore represents the standard of care for the management of anemia in this patient setting. METHODS: A retrospective cohort of 38 HD patients in Italy was analyzed to assess the clinical and economic implications of switching from intravenous ferric gluconate (FG) to ferric carboxymaltose (FCM) on achievement of adequate hemoglobin (Hb) values and iron balance. The total observational period for each patient was 12 months, 6 months before and 6 months after switching to iron FCM. The pharmacoeconomic analysis considered the hospital perspective and the consumption of iron, blood transfusions and erythropoiesis-stimulating agents (ESAs), including healthcare personnel time. RESULTS: Switching from FG to FCM in dialysis adult patients with IDA allows a cost reduction per patient/month in the range €14-46, considering the use of biosimilar ESA or originator ESA, respectively. The percentage of patients with Hb target values increased from 63% to 82%, considering the entire observation period. In addition, other clinical parameters (ferritin, transferrin saturation, erythropoietin resistance index) improved after switching from FG to FCM. CONCLUSION: FCM in HD patients was shown to provide a favorable efficacy profile over FG, with a lower cost per patient, mainly driven by a consistent reduction of ESA consumption. FUNDING: Vifor Pharma Italia Srl.

Economic burden of symptomatic iron deficiency - a survey among Swiss women.

BACKGROUND: Symptomatic iron deficiency (ID) is a disorder affecting 10-20% of menstruating women. ID is diagnosed by measuring serum ferritin, a protein helping to store iron in the body. A deeper understanding of the association between ID and its societal and economic burden is relevant for patients, physicians, health care decision makers. METHODS: An online household survey was carried out among Swiss women aged 18-50 years suffering from debilitating symptoms due to ID. The data was population-weighted for age and region. The costs of misdiagnosis and the ID-related economic burden (i.e. days of sick leave) from productivity losses on the labor market were determined and extrapolated to the Swiss population. Furthermore, the patient burden was assessed based on quality of life daily measurements. RESULTS: The total sample included 1010 women who received an ID diagnosis with a blood test in the last 2 years (mean age: 33.5 years). Most named symptoms were "being tired or exhausted" (96.4%) and reduced physical energy level (41.0%). In total, 354 (35.0% of the total sample) patients received an initial diagnosis other than ID. Of those, 46.8% were treated prior to the ID diagnosis with a pharmacological medical therapy or psychotherapy. Extrapolating these numbers to the Swiss female population aged 18-50 years, the direct medical costs would be CHF 78 million (assuming an annual ID incidence of ID diagnosis of 9.5%). On average, 28.5% of participants in the work-force had to take sick leave due to ID symptoms within a period of 2 years (mean: 5.2 days, i.e. 2.6 days/year). The estimated annual indirect costs in Switzerland would be CHF 33 million (human capital approach) or CHF 26 million (friction cost method), respectively. Being exhausted and impaired concentration appear to be the most important factors negatively impacting daily living and hence quality of life. CONCLUSION: The societal and economic burden among women due to debilitating symptoms of ID in Switzerland is substantial. Timely, correct diagnosis and treatment of ID may contribute to reducing this burden. Further studies are needed in this area to validate our results.

Cost effectiveness of implementing ESC guidelines for treatment of iron deficiency in heart failure in the Nordic countries.

OBJECTIVES: Guidelines of the European Society of Cardiology (ESC) recommend that ferritin and transferrin saturation should be tested in chronic heart failure (HF) and state that iron treatment with ferric carboxymaltose should be considered in HF patients with iron deficiency to alleviate symptoms and improve exercise tolerance and quality of life. This study evaluates the cost effectiveness of the implementation of this recommendation in four Nordic countries (Denmark, Finland, Norway, and Sweden). DESIGN: We performed a cost-utility analysis comparing ferric carboxymaltose treatment with placebo over a one-year time period in each country. Data on healthcare resource use and health outcomes were taken from the CONFIRM-HF study and combined with country-specific unit costs. Differences in per-patient costs and quality-adjusted life years (QALYs) were calculated. RESULTS: QALYs were higher (increase of 0.050 QALYs per patient) in the iron-treated group compared with placebo. Per-patient costs were lower in all countries (with reductions ranging from €36 to €484). Fewer hospitalizations were one key driver of these results. Another important driver was how well the new routines for iron treatment can be integrated into the current healthcare management of HF. A sensitivity analysis confirmed the results to be robust. CONCLUSIONS: Iron deficiency therapy in HF with ferric carboxymaltose compared with placebo is estimated to both improve health-related quality of life and save healthcare costs in all Nordic countries. A well-organized healthcare management of HF patients can enable the implementation of ESC-recommended treatment of iron deficiency without need for additional resources.

Cost-effectiveness analysis of ferric carboxymaltose in pre-operative haemoglobin optimisation in patients undergoing primary knee arthroplasty.

BACKGROUND: An analytic-decision model was built to estimate the cost-effectiveness of using ferric carboxymaltose for pre-operative haemoglobin optimisation in patients with iron deficiency anaemia undergoing primary knee arthroplasty. MATERIALS AND METHODS: We simulated 20,000 patients who were randomly assigned to the haemoglobin optimisation arm or the non-optimisation control arm in a strict 1:1 ratio. The main outcomes were cost per patient transfusion avoided and red blood cell units spared. The analyses were performed from the hospital perspective with length of stay as the time horizon. RESULTS: In the reference case scenario, pre-operative haemoglobin optimisation led to fewer patients being exposed to allogeneic red blood cell transfusion (2,212 vs 6,595 out of 10,000 patients) and a relevant decrease in the number of red blood cell units transfused (4.342 vs 13.336). The costs of avoiding one patient transfusion and sparing one red blood cell unit were € 831 and € 405, respectively. Increased costs in the optimisation arm were mostly associated with the outpatient day hospital visit (54%) and ferric carboxymaltose treatment (40%). DISCUSSION: In primary knee arthroplasty, pre-operative haemoglobin optimisation with intravenous ferric carboxymaltose is less expensive than other reported patient blood management modalities and must be considered in patients with iron deficiency anaemia.

Reducing micronutrient deficiencies in Pakistani children: are subsidies on fortified complementary foods cost-effective?

OBJECTIVE: To estimate the cost-effectiveness of price subsidies on fortified packaged complementary foods (FPCF) in reducing iodine deficiency, iron-deficiency anaemia and vitamin A deficiency in Pakistani children. DESIGN: The study proceeded in three steps: (i) we determined the current lifetime costs of the three micronutrient deficiencies with a health economic model; (ii) we assessed the price sensitivity of demand for FPCF with a market survey in two Pakistani districts; (iii) we combined the findings of the first two steps with the results of a systematic review on the effectiveness of FPCF in reducing micronutrient deficiencies. The cost-effectiveness was estimated by comparing the net social cost of price subsidies with the disability-adjusted life years (DALY) averted. SETTING: Districts of Faisalabad and Hyderabad in Pakistan. SUBJECTS: Households with 6-23-month-old children stratified by socio-economic strata. RESULTS: The lifetime social costs of iodine deficiency, iron-deficiency anaemia and vitamin A deficiency in 6-23-month-old children amounted to production losses of $US 209 million and 175 000 DALY. Poor households incurred the highest costs, yet even wealthier households suffered substantial losses. Wealthier households were more likely to buy FPCF. The net cost per DALY of the interventions ranged from a return per DALY averted of $US 783 to $US 65. Interventions targeted at poorer households were most cost-effective. CONCLUSIONS: Price subsidies on FPCF might be a cost-effective way to reduce the societal costs of micronutrient deficiencies in 6-23-month-old children in Pakistan. Interventions targeting poorer households are especially cost-effective.

Budget Impact Analysis of Oral Fisiogen Ferro Forte® versus Intravenous Iron for the Management of Iron Deficiency in Chronic Kidney Disease in Spain.

BACKGROUND: Iron deficiency is a frequent complication of chronic kidney disease (CKD) that is associated with a decrease in the quality of life of patients and an increase in the risk of other clinical complications. Iron therapy represents one of the fundamentals of patients with CKD. Sucrosomial® oral iron allows Fisiogen Ferro Forte® to be used in all patients who are intolerant to treatment by the oral route of administration, or who present with malabsorption of conventional oral iron preparations. OBJECTIVE: The main objective of this study was to assess the economic impact of the oral iron Fisiogen Ferro Forte® for the management of iron deficiency in CKD patients in Spain. METHODS: A 4-year budget impact model was developed for the period 2017-2020 for CKD patients with iron deficiency who were candidates for intravenous iron due to a lack of response to oral iron, from the perspective of the Spanish healthcare system. Three subgroups of CKD patients were included in the analysis: predialysis, peritoneal dialysis, and post-transplant. The intravenous iron formulations Ferinject®, Venofer®, and Feriv® were considered appropriate comparators to be used in the model. National data on the prevalence of CKD for the three subgroups of patients were obtained from the literature, and input data on drug utilization and outpatient hospitalizations associated with iron administration were obtained by consulting nephrologists. Nephrology experts were also asked about resources used during medical visits and monitoring tests. Based on the unit costs for each iron therapy and the resources used, the total treatment cost per patient associated with each product was obtained to estimate the global budget impact of increasing the use of Fisiogen Ferro Forte®. RESULTS: The average annual budget savings due to an increase in Fisiogen Ferro Forte® and a decrease in intravenous iron have been estimated at €398,685, €180,937, and €195,842 over 4 years for the predialysis, peritoneal dialysis, and post-transplant groups, respectively. CONCLUSIONS: The increase in the use of Fisiogen Ferro Forte® leads to overall budget savings of €775,464 for the Spanish National Health Service over 4 years.

Financial impact of intravenous iron treatments on the management of anaemia inpatients: a 1 year observational study.

Background Intravenous (IV) iron preparations bypass the difficulties (malabsorption and side effects) associated with oral iron for the treatment of iron deficiency anaemia (IDA). Ferric carboxymaltose (FCM) can be administered as a single infusion over short periods of time but is more expensive than iron sucrose (IS) when the patients are hospitalized. Objectives To evaluate the appropriateness of FCM prescriptions and to establish the economic impact of this management (including disease coding) compared to the use of IV IS. Setting This study was conducted for inpatients in all departments (orthopaedic department, gastroenterology department and two units of the internal medicine department) where FCM was widely prescribed. Method We retrospectively identified 224 patients, diagnosed with IDA using laboratory parameters and/or disease coding, who received FCM between January and December 2014. Main outcome measure The primary outcome was the rate of appropriateness of FCM prescriptions and the financial impact compared to IV IS. Results 89 Patients were included. The total additional cost for an inappropriate prescription of IV FCM (68% of cases) was of 6053 €. The total incremental cost of unsuitable disease coding was estimated at 31,688 €. Indications for IV FCM were categorized: intestinal bleeding (31%), malabsorption (17%), intolerance (9%) and refractory to oral iron (7%). The majority of patients (62%) received 1000 mg of FCM per week. The average length of hospital stay was of 10 days. Conclusion The prescription of IV iron was appropriate in most cases but did not necessarily require FCM. The use of IV IS, in many cases, could present a cost-saving option for inpatients with IDA. The lack of an IDA coding generated incremental costs.

Impact of iron deficiency diagnosis using hepcidin mass spectrometry dosage methods on hospital stay and costs after a prolonged ICU stay: Study protocol for a multicentre, randomised, single-blinded medico-economic trial.

BACKGROUND: Iron deficiency (ID) is frequent but difficult to diagnose in critically ill patients. ID may be responsible for prolonged post-ICU hospital stays, since it results in fatigue, muscle weakness and anaemia. Hepcidin, the key iron metabolism hormone, may be a good marker of ID in these patients. The aim of this study is to determine whether using mass spectrometry hepcidin determination to diagnose (and treat) ID after prolonged ICU stays may reduce patients' subsequent hospital stays and costs in comparison with conventional (ferritin) methods. METHODS: This is a randomised, controlled, single-blinded, multicentre medico-economic study. Hepcidin quantification will be performed in anaemic (WHO criteria) critically ill adults about to be discharged, after a stay ≥5days. In the intervention arm (hepcidin) results will be given to the ICU-physicians, and not in the control arm. ID Treatment will be recommended in intervention arm: IV iron when hepcidin is <20µg/L; IV iron+erythropoietin when hepcidin is between 20-41µg/L; in the control arm: IV iron when ferritin <300µg/L and Transferrin saturation <20%. The primary endpoint will be the number of days spent in hospital 90 days after ICU discharge and the direct hospital costs. Secondary endpoints will be anaemia and iron deficiency on D15, fatigue and the proportion of patients alive and at home on D30 and D90. DISCUSSION: The results of this study will show whether diagnosing iron deficiency using MS hepcidin determination methods is liable to reduce patients' post-ICU hospital stay and costs, as well as their anaemia and fatigue.

A fast-track anaemia clinic in the Emergency Department: cost-analysis of intravenous iron administration for treating iron-deficiency anaemia.

BACKGROUND: A fast-track anaemia clinic (FTAC) for the management of moderate-to-severe iron-deficiency anaemia (IDA) was established in our Emergency Department in 2010. In this FTAC, the replacement of packed red cell transfusion by ferric carboxymaltose administration was proven to be safe and effective. The aim of this study was a cost-analysis of IDA management in the FTAC, comparing this management with the previous standard care pathway consisting of packed red cell transfusion, if needed, and referral to outpatient specialised care. MATERIALS AND METHODS: A cost study was performed for patients with IDA who were at risk of requiring transfusion (haemoglobin <9 g/dL) but did not require hospitalisation. Total IDA treatment costs in the FTAC were compared to those theoretically incurred if these patients had been managed using the standard care pathway. In addition, a sensitivity analysis considering variations of up to ±30% in ferric carboxymaltose and packed red cell acquisition costs was performed (49 possible scenarios). RESULTS: Between 2012 and 2015, 238 IDA patients were treated in the FTAC. The average treatment cost was € 594±337/patient in the FTAC group and € 672±301/patient in the standard care pathway group, with a saving of € 78±28/patient (95% CI, 22-133; p<0.001). The sensitivity analysis showed that IDA treatment costs in the FTAC (€ 480-722/patient), compared with those of the standard care pathway (€ 550-794/patient), resulted in significant cost-savings for all studied scenarios (€ 51-104/patient; p<0.005). DISCUSSION: The administration of ferric carboxymaltose for IDA management in a FTAC may be cost-saving compared with the standard care pathway.