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

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          Abstract

          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.

          Electronic Supplementary Material

          The online version of this article (10.1007/s12325-019-01089-z) contains supplementary material, which is available to authorized users.

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          Most cited references23

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          A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

          Marc Pfeffer, Emmanuel A. Burdmann, Chao-Yin Chen … (2009)
          Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
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            Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

            Iain C. Macdougall, Claire White, Stefan D. Anker … (2019)
            Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited.
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              FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia

              Iain C. MacDougall, Andreas H. Bock, Fernando Carrera … (2014)
              Background The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown. Methods Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400–600 µg/L) or lower (100–200 µg/L) ferritin or oral iron therapy. The primary end point was time to initiation of other anaemia management (ESA, other iron therapy or blood transfusion) or haemoglobin (Hb) trigger of two consecutive values <10 g/dL during Weeks 8–52. Results The primary end point occurred in 36 patients (23.5%), 49 patients (32.2%) and 98 patients (31.8%) in the high-ferritin FCM, low-ferritin FCM and oral iron groups, respectively [hazard ratio (HR): 0.65; 95% confidence interval (CI): 0.44–0.95; P = 0.026 for high-ferritin FCM versus oral iron]. The increase in Hb was greater with high-ferritin FCM versus oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase ≥1 g/dL with high-ferritin FCM versus oral iron (HR: 2.04; 95% CI: 1.52–2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups. Conclusions Compared with oral iron, IV FCM targeting a ferritin of 400–600 µg/L quickly reached and maintained Hb level, and delayed and/or reduced the need for other anaemia management including ESAs. Within the limitations of this trial, no renal toxicity was observed, with no difference in cardiovascular or infectious events. ClinicalTrials.gov number NCT00994318.
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                Author and article information

                Contributors
                Carla Rognoni:
                ORCID: http://orcid.org/0000-0002-6330-0591
                carla.rognoni@unibocconi.it
                Journal
                Journal ID (nlm-ta): Adv Ther
                Journal ID (iso-abbrev): Adv Ther
                Title: Advances in Therapy
                Publisher: Springer Healthcare (Cheshire )
                ISSN (Print): 0741-238X
                ISSN (Electronic): 1865-8652
                Publication date (Electronic): 5 September 2019
                Publication date PMC-release: 5 September 2019
                Publication date (Print): 2019
                Volume: 36
                Issue: 11
                Pages: 3253-3264
                Affiliations
                [1 ]GRID grid.7945.f, ISNI 0000 0001 2165 6939, Centre for Research on Health and Social Care Management (CERGAS), , SDA Bocconi School of Management, Bocconi University, ; Milan, Italy
                [2 ]GRID grid.411475.2, ISNI 0000 0004 1756 948X, Nephrology and Dialysis Division, , AOUI Verona, ; Verona, Italy
                Author information
                http://orcid.org/0000-0002-6330-0591
                Article
                Publisher ID: 1089
                DOI: 10.1007/s12325-019-01089-z
                PMC ID: 6822962
                PubMed ID: 31489572
                SO-VID: 3d56483f-ceda-484a-8af6-f8f2c0c5acd9
                Copyright © © The Author(s) 2019
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Date received : 7 August 2019
                Funding
                Funded by: Vifor Pharma Italia Srl
                Categories
                Subject: Original Research
                Custom metadata
                issue-copyright-statement © Springer Healthcare Ltd., part of Springer Nature 2019

                Keywords: budget,cost-analysis,healthcare,hemodialysis,ferric carboxymaltose,nephrology
                Data availability:
                Keywords: budget, cost-analysis, healthcare, hemodialysis, ferric carboxymaltose, nephrology

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