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.

Economic impact of ferric carboxymaltose in haemodialysis patients / Impatto economico dell'utilizzo di carbossimaltosio ferrico nei pazienti in emodialisi

Intravenous iron supplementation is essential in hemodialysis (HD) patients to recover blood loss and to meet the requirements for erythropoiesis and, in patients receiving erythropoietin, to avert the development of iron deficiency. In a recent real-world study, Hofman et al. showed that a therapeutic shift from iron sucrose (IS) to ferric carboxymaltose (FCM) in HD patients improves iron parameters while reducing use of iron and erythropoietin. The objective of this economic analysis is to compare the weekly cost of treatment of FCM vs IS in hemodialysis patients in Italy. The consumption of drugs (iron and erythropoietin) was derived from Hofman's data, while the value was calculated at Italian ex-factory prices. The analysis was carried on the total patient sample and in two subgroups: patients with iron deficiency and patients anemic at baseline. In addition, specific sensitivity analyses considered prices currently applied at the regional level, simulating the use of IS vs iron gluconate (FG) and epoetin beta vs epoetin alfa. In the base-case analysis, the switch to FCM generates savings of -€12.47 per patient/week (-21%) in all patients, and even greater savings in the subgroups with iron deficiency -€17.28 (-27%) and in anemic patients -€23.08 (-32%). Sensitivity analyses were always favorable to FCM and confirmed the robustness of the analysis. FCM may represent a cost-saving option for the NHS, and Italian real-world studies are needed to quantify the real consumption of resources in dialysis patients.

A patient-level cost-effectiveness analysis of iron isomaltoside versus ferric carboxymaltose for the treatment of iron deficiency anemia in the United Kingdom.

Objectives: Intravenous iron is the recommended treatment for patients with iron deficiency anemia (IDA) where oral iron is ineffective or rapid iron replenishment is required. Two high-dose, rapid-administration intravenous iron formulations are currently available in the UK: iron isomaltoside 1000/ferric derisomaltose (IIM) and ferric carboxymaltose (FCM). An indirect treatment comparison (ITC) recently showed that improvement from baseline hemoglobin was significantly larger with IIM than FCM. The objective was to use the ITC findings to evaluate the cost-effectiveness of IIM versus FCM from the UK healthcare payer perspective.Methods: A patient-level simulation model was developed in R to evaluate the cost per patient experiencing hematological response with IIM versus FCM. The model generated a simulated cohort from parametric distributions of baseline hemoglobin and bodyweight. Changes in hemoglobin were modeled based on data from the ITC, covaried with baseline hemoglobin based on patient-level data from a randomized controlled trial. Posological models of the iron formulations were developed based on the summaries of product characteristics. UK-specific costs were based on healthcare resource groups.Results: The proportion of patients experiencing hematological response was 9.0% higher with IIM relative to FCM (79.0% versus 70.0%), based on modeling of clinically realistic, correlated distributions of baseline hemoglobin and change from baseline hemoglobin. The mean number of infusions needed to administer the required dose was 1.92 with FCM, versus 1.38 with IIM, resulting in costs of £637 and £457 per treated patient with FCM and IIM respectively, corresponding to respective costs of £910 and £579 per responder.Conclusions: The analysis showed that using IIM rather than FCM in patients with IDA was dominant and would reduce the number of iron infusions required to correct iron deficiency, thereby reducing the costs associated with IDA treatment and simultaneously increasing the proportion of patients with IDA experiencing a clinically meaningful hematological response.

Development of a Resource Impact Model for Clinics Treating Pre-Operative Iron Deficiency Anemia in Ireland.

INTRODUCTION: Intravenous (IV) iron is typically the preferred treatment for patients with iron deficiency anemia (IDA) who cannot tolerate or absorb oral iron, or who require fast replenishment of iron stores pre-operatively. Several IV iron formulations are available with different dosing characteristics affecting infusion speed and maximum dose. The aim was to develop a resource impact model to calculate the cost of establishing an IV iron clinic and model resource impact of different IV irons to inform clinicians and service providers implementing innovative pre-operative IV iron services in Ireland. METHODS: A resource impact tool was developed to model resource utilization and IDA treatment costs. Two fast-administration, high-dose formulations of IV iron are available in Ireland: iron isomaltoside 1000/ferric derisomaltose (IIM) and ferric carboxymaltose (FCM). The tool modeled clinic throughput based on their different dosing characteristics in a specific IDA population, capturing fixed overheads, variable costs, clinic income from private and publicly-funded patients, and savings associated with IV iron. RESULTS: Based on a 70:30 split between public and private patients in a new pre-operative service with capacity for 12 infusion slots weekly, IIM would facilitate correction of iron deficits in 474 patients annually, resulting in a net annual clinic balance of €42,736 on income of €159,887 and net costs of €117,151. FCM would facilitate treatment of 353 patients, resulting in a net annual clinic balance of €36,327 on income of €116,050 and costs of €79,722, a difference of €6408 and 121 patients treated in favor of using IIM over FCM. CONCLUSION: Based on this provider-perspective analysis, IIM would maximize clinic throughput relative to other IV iron formulations, allowing clinicians in Ireland to optimize their current service provision and expenditure, and model the impact of introducing IV iron clinics for pre-operative patients with IDA.

Ferric carboxymaltose for patients with heart failure and iron deficiency in Italy: cost-effectiveness and budget impact.

Aim: To evaluate the cost-effectiveness of intravenous ferric carboxymaltose (FCM) versus placebo for the management of iron deficiency in patients with chronic heart failure in the Italian healthcare system and to estimate its impact on the national healthcare budget. Materials & methods: A Markov model was developed to project costs and health outcomes over 1 year, based on data from literature. Healthcare resources consumption was derived from an e-survey administered to clinicians. Costs were obtained from official tariffs. Results: Treatment with FCM represents a dominant strategy compared with placebo, leading to national budget annual savings of 20-97 million Euros, according to different increasing utilization rates. Conclusion: FCM is a cost-saving option for the treatment of chronic heart failure patients with iron deficiency in Italy.

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.

Do we have a magic bullet to treat moderate and severe anemia in pregnant women?

A desperate situation may evoke a fundamental question or suggestion of a radical solution. Hence, let us first examine whether the current situation of maternal anemia in India is really desperate and therefore merits a search for a "magic bullet" as a cure.

Budget impact of intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency in France.

AIMS: This analysis aims to evaluate the budget impact of intravenous iron therapy with ferric carboxymaltose for patients with systolic chronic heart failure and iron deficiency, from the perspective of the French public health insurance. METHODS AND RESULTS: A budget impact model was adapted to forecast the budget impact over 5 years, according to two scenarios: one where patients receive ferric carboxymaltose according to market share forecast and another where patients are not treated for iron deficiency. Clinical data were extrapolated from pooled data from four randomized controlled trials. The time horizon was extended to 5 years by applying transition probabilities estimated from the CONFIRM-HF trial. Epidemiological parameters for France were derived from the literature. Cost parameters were derived from national available databases. In the base case analysis, the modelled 5 year cost difference between the scenarios with ferric carboxymaltose vs. no iron deficiency treatment in a population of 189 334 prevalent and incident patients led to €0.8m savings. The cumulative savings resulted from a reduction in the hospitalization costs associated with worsening heart failure (€-35.8m) as well as a reduction in the follow-up costs (€-2.9m). These cost savings outweighed the costs of ferric carboxymaltose treatment (€37.7m). Sensitivity analyses showed that the budget impact varied from €-34m to €+146m. Parameters with the most impact on the budget were the hospitalization rate for patients not treated for iron deficiency, the number of ambulatory sessions needed, the absence of hospitalization cost differentiation between New York Heart Association classes, and administration settings costs. CONCLUSIONS: Iron deficiency treatment with ferric carboxymaltose in systolic chronic heart failure patients results in an improvement of New York Heart Association class and thereby increases the well-being of the patients, while providing an overall cost saving for the French national health insurance.

An Economic Evaluation of Iron Isomaltoside 1000 Versus Ferric Carboxymaltose in Patients with Inflammatory Bowel Disease and Iron Deficiency Anemia in Denmark.

INTRODUCTION: The incidence of inflammatory bowel disease (IBD) in Denmark is among the highest in the world, with Crohn's disease and ulcerative colitis occurring at rates of 9.1 and 18.6 per 100,000 person-years respectively in 2010-2013. Anemia is the most prevalent extraintestinal complication of IBD, most commonly caused by iron deficiency. In treating IBD-associated iron deficiency anemia (IDA), intravenous iron is more effective and better tolerated and shows a faster response than oral iron. The present study evaluated resource use and costs associated with using iron isomaltoside (Monofer; IIM) versus ferric carboxymaltose (Ferinject; FCM) in patients with IDA and IBD in Denmark. METHODS: A budget impact model was developed to evaluate the cost of IIM compared with FCM from a Danish healthcare payer perspective. Iron deficits were modeled using dosing tables and a joint distribution of bodyweight [mean 75.4 kg, standard deviation (SD) 17.4 kg] and hemoglobin (mean 10.8 g/dL, SD 1.4 g/dl) based on observational data from patients with IBD. Retreatment frequency was modeled using a pooled retrospective analysis of randomized trial data, and costs were modeled using diagnosis-related groups with an outpatient infusion cost of DKK 2855. RESULTS: Using IIM required 1.2 infusions (per treatment) to correct the mean iron deficit compared with 1.6 with FCM. Treating 2.54 patients with IIM would therefore avoid one infusion compared with FCM. Patients using IIM required multiple infusions in 25.0% of cases compared with 64.3% with FCM. Over 5 years, total estimated costs were DKK 21,406 per patient with IIM compared with DKK 28,137 with FCM, corresponding to savings of DKK 6731 with IIM. CONCLUSION: Using IIM in place of FCM markedly reduced the number of iron infusions required in patients with IBD and IDA in Denmark. The reduction in infusions was accompanied by reductions in cost compared with FCM. FUNDING: Pharmacosmos A/S.

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.

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.

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.

PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial.

BACKGROUND: Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes. METHODS/DESIGN: PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10-42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis. TRIAL REGISTRATION: ISRCTN67322816--registered 9 October 2012. ClinicalTrials.gov identifier: NCT01692418.

Cost-effectiveness analysis of ferric carboxymaltose in iron-deficient patients with chronic heart failure in Sweden.

OBJECTIVE: Iron deficiency is a common but treatable comorbidity in chronic heart failure (CHF) that is associated with impaired health-related quality-of-life (HRQoL). This study evaluates the cost-effectiveness of the intravenous iron preparation ferric carboxymaltose (FCM) for the treatment of iron deficiency in CHF from a Swedish healthcare perspective. METHODS: A cost-effectiveness analysis with a time horizon of 24 weeks was performed to compare FCM treatment with placebo. Data on health outcomes and medical resource use were mainly taken from the FAIR-HF trial and combined with Swedish cost data. An incremental cost-effectiveness ratio (ICER) was calculated as well as the change in per-patient costs for primary care and hospital care. RESULTS: In the FCM group compared with placebo, quality-adjusted life years (QALYs) are higher (difference = 0.037 QALYs), but so are per-patient costs [(difference = SEK 2789 (€303)]. Primary care and hospital care equally share the additional costs, but within hospitals there is a major shift of costs from inpatient care to outpatient care. The ICER is SEK 75,389 (€8194) per QALY. The robustness of the result is supported by sensitivity analyses. CONCLUSIONS: Treatment of iron deficiency in CHF with FCM compared with placebo is estimated to be cost-effective. The ICER in the base case scenario is twice as high as previously thought, but noticeably below SEK 500,000 (€54,300) per QALY, an informal average reference value used by the Swedish Dental and Pharmaceutical Benefits Agency. Increased HRQoL and fewer hospitalizations are the key drivers of this result.

A Cost-effectiveness Analysis of Ferric Carboxymaltose in Patients With Iron Deficiency and Chronic Heart Failure in Spain.

INTRODUCTION AND OBJECTIVES: Treatment with ferric carboxymaltose improves symptoms, functional capacity, and quality of life in patients with chronic heart failure and iron deficiency. The aim of this study was to assess the cost-effectiveness of ferric carboxymaltose treatment vs no treatment in these patients. METHODS: We used an economic model based on the Spanish National Health System, with a time horizon of 24 weeks. Patient characteristics and ferric carboxymaltose effectiveness (quality-adjusted life years) were taken from the Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure trial. Health care resource use and unit costs were taken either from Spanish sources, or from the above mentioned trial. RESULTS: In the base case analysis, patients treated with and without ferric carboxymaltose treatment acquired 0.335 and 0.298 quality-adjusted life years, respectively, representing a gain of 0.037 quality-adjusted life years for each treated patient. The cost per patient was €824.17 and €597.59, respectively, resulting in an additional cost of €226.58 for each treated patient. The cost of gaining 1 quality adjusted life year with ferric carboxymaltose was €6123.78. Sensitivity analyses confirmed the robustness of the model. The probability of ferric carboxymaltose being cost-effective (< €30 000 per quality-adjusted life year) and dominant (more effective and lower cost than no treatment) was 93.0% and 6.6%, respectively. CONCLUSIONS: Treatment with ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, is cost-effective in Spain.

Budget impact of parenteral iron treatment of iron deficiency: methodological issues raised by using real-life data.

OBJECTIVES: Iron deficiency is common in pregnancy, postpartum, inflammatory bowel disease, chronic kidney disease, chronic heart failure, heavy uterine bleeding, cancer and following surgery. We estimate the budget impact (BI) on the Swiss mandatory health insurance associated with substituting iron sucrose (standard) with ferric carboxymaltose (new treatment) using real-life data. METHODS: Resource use was based on recent primary data (Polyquest Prescriber Analysis, Anemia Patient Record Study in Switzerland). Personnel costs were estimated using the Swiss Tarmed fee-for-service reimbursement system. Drug costs and costs of materials used were based on official tariffs (Spezialitätenliste, MiGeL). Actual IMS sales data of both products were used to verify the BI model (1 CHF ≈ 1 USD, Jan 2013). RESULTS: Ferric carboxymaltose was associated with cost savings of 30-44 % per patient per treatment cycle compared to iron sucrose. Costs per 200/500/1,000 mg total dosage treatment cycle were CHF 101/210/420 for ferric carboxymaltose and CHF 144/375/721 for iron sucrose. This results in cost savings of CHF 22-31 million across all indications in 2009. Savings were driven by personnel cost reductions (application time and number of applications). Sensitivity analyses confirmed these cost savings, even for the higher application costs of ferric carboxymaltose, with minimum savings of CHF 17 million per year. CONCLUSIONS: Treating iron deficiency involves substantial costs to the Swiss MHI which may be reduced by substituting iron sucrose with ferric carboxymaltose. The use of real-life data raises methodological questions about the fundamental compatibility of this data with the conceptual framework of BI analysis.