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

Darbà, Josep; Ascanio, Meritxell

doi:10.1007/s40261-018-0666-9

Cited by 5 publications

(7 citation statements)

References 10 publications

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“…Our cost minimization analysis is based on the main clinical trial result, that is the demonstrated same efficacy of oral iron and IV iron. Sucrosomial iron has demonstrated a similar effectiveness, with lower costs, in patients usually receiving IV iron (e.g., chronic kidney disease, cancer, bariatric surgery) in several studies published recently [25][26][27][28]. In particular, Darbà et al [26] conducted a budget impact analysis of an oral sucrosomial iron in the treatment of patients similar with those of our study.…”

Section: Discussionsupporting

confidence: 82%

“…Sucrosomial iron has demonstrated a similar effectiveness, with lower costs, in patients usually receiving IV iron (e.g., chronic kidney disease, cancer, bariatric surgery) in several studies published recently [25][26][27][28]. In particular, Darbà et al [26] conducted a budget impact analysis of an oral sucrosomial iron in the treatment of patients similar with those of our study. They conclude that increase in the use of oral sucrosomial iron leads to overall budget savings of €775,464 for the Spanish National Health Service over 4 years.…”

Section: Discussionsupporting

confidence: 82%

See 1 more Smart Citation

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

Riccio

Sabbatini²,

Capuano³

et al. 2020

BMC Nephrol

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Background: Oral iron is recommended as first line treatment of anemia in non-dialysis chronic kidney disease (ND-CKD) patients. Sucrosomial® iron, a new generation oral iron with high absorption and bioavailability and a low incidence of side effects, has shown to be not inferior to intravenous (IV) iron in the replacement of iron deficiency anemia in patients with ND-CKD. Besides the clinical benefit, it is also important to determine the comparative total costs of oral versus IV iron administrations. The aim of this study was to perform a cost-minimization analysis of oral Sucrosomial iron, compared with IV iron gluconate from an Italian societal perspective. Methods: Cost analysis was performed on the 99 patients with ND-CKD and iron-deficiency anemia of the randomized trial by Pisani et al. Human and material resources utilization was recorded during each iron administration. According to study perspective, direct and indirect costs were considered. Costs for each resource unit were taken from official Italian sources. Probabilistic sensitivity analyses were carried out to test the robustness of the results. Results: The base case analysis showed an average cost/cycle per patient of € 111 for oral iron and € 1302 for IV iron. Thus, the potential saving was equal to € 1191 per patient/cycle. The sensitivity analysis showed that the most sensitive driver is the time loss by patient and caregivers for the therapy and related-care, followed by the minutes of nursing care and the number of kilometres travelled to reach the referral centre. Discussion: This study showed that oral Sucrosomial® iron could offer specific advantages in terms of potential savings, and allowed identifying some implications for future research. Such advantages still persist with the new single dose IV iron formulation available in the market, although to a lesser extent.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionsupporting

confidence: 82%

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

Riccio

Sabbatini²,

Capuano³

et al. 2020

BMC Nephrol

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“…Recently, in 3 CKD patient populations (pre-dialysis, peritoneal dialysis, and post-transplant), who did not respond to conventional oral iron supplementation, Darbá et al [69] assessed the economic impact of switching from intravenous iron (FCM or IS) to SI. Using a 4-year budget impact model (2017–2020), the progressive increase of SI use (up to 10% of market shares) would lead to over €750,000 savings.…”

Section: Sucrosomial® Iron For the Management Of Iron Deficiency Imentioning

confidence: 99%

“…Most relevant evidence on the bioavailability, tolerability and efficacy of oral SI in different preclinical and clinical settings has been presented as lectures or communications in the 3rd, 4th, 5th and 6th International Multidisciplinary Courses on Iron Anemia and other international meetings. However, a growing number of studies have been already published as full peer-review papers [40,42,47,48,49,50,51,60,69,85,91]. Characteristics and results for a number of clinical studies are summarized in Table 2.…”

Section: Efficacy Of Sucrosomial® Iron: An Overviewmentioning

confidence: 99%

Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation

Gómez‐Ramírez

Brilli²,

Tarantino³

et al. 2018

Pharmaceuticals

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Iron deficiency (ID) is usually treated with oral iron salts, but up to 50% of patients complain of gastrointestinal side effects, leading to reduced compliance with treatment. Intravenous (IV) iron formulations are increasingly safe, but there is still a risk of infusion, hypersensitivity reactions and the need for venous access and infusion monitoring. Sucrosomial® Iron (SI) is an innovative oral iron formulation in which ferric pyrophosphate is protected by a phospholipid bilayer plus a sucrester matrix (sucrosome), which is absorbed through para-cellular and trans-cellular routes (M cells). This confers SI’s unique structural, physicochemical and pharmacokinetic characteristics, together with its high iron bioavailability and excellent gastrointestinal tolerance. The analysis of the available evidence supports oral SI iron as a valid option for ID treatment, which is more efficacious and tolerable than oral iron salts. SI has also demonstrated a similar effectiveness, with lower risks, in patients usually receiving IV iron (e.g., chronic kidney disease, cancer, bariatric surgery). Thus, oral SI emerges as a valuable first option for treating ID, especially for subjects with intolerance to iron salts or those for whom iron salts are inefficacious. Moreover, SI should also be considered as an alternative to IV iron for initial and/or maintenance treatment in different patient populations.

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“…However, data from previous studies in several conditions associated with ID show that SI is more efficacious in correcting ID and related anaemia than conventional oral iron salts and equally efficacious with intravenous iron preparations, with superior tolerability 5,14,15 . In addition, SI is associated with considerably lower cost compared to intravenous iron in conditions such as chronic kidney disease or myelodysplastic syndromes 8,13,16 . It should be stressed that the magnitude of improvement in exercise capacity and quality of life we observed herein was much lower than that conferred by FCM in previous randomized trials in HFrEF.…”

Section: Discussionmentioning

confidence: 58%

Oral sucrosomial iron improves exercise capacity and quality of life in heart failure with reduced ejection fraction and iron deficiency: a non‐randomized, open‐label, proof‐of‐concept study

Karavidas

Troganis

Lazaros

et al. 2021

European J of Heart Fail

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Aims Oral sucrosomial iron (SI) combines enhanced bioavailability and tolerance compared to conventional oral iron along with similar efficacy compared to intravenous iron in several conditions associated with iron deficiency (ID). Methods and results In this non‐randomized, open‐label study, we sought to evaluate prospectively the effects of SI on clinical parameters, exercise capacity and quality of life in 25 patients with heart failure (HF) with reduced ejection fraction (HFrEF) and ID, treated with SI 28 mg daily for 3 months, in comparison to 25 matched HFrEF controls. All patients were on optimal stable HF therapy. Patients were followed for 6 months for death or worsening HF episodes. There were no differences in baseline characteristics between groups. At 3 months, SI was associated with a significant increase in haemoglobin, serum iron and serum ferritin levels (all P ≤ 0.001) along with a significant improvement in 6‐min walked distance and Kansas City Cardiomyopathy Questionnaire (all P < 0.01), even after adjustment for baseline parameters; these differences persisted at 6 months. Over the study period, there were no deaths, while 10 patients (20%) in total (four in the SI group and six in the control group), experienced worsening HF (odds ratio 0.51, 95% confidence interval 0.41–6.79, P = 0.482). Drug‐associated diarrhoea was reported by one patient in the SI group and led to drug discontinuation; no other adverse events were reported. Conclusions In this proof‐of‐concept study, SI was well tolerated and improved exercise capacity and quality of life in HFrEF patients with ID. Randomized studies are required to further investigate the effects of this therapy.

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

Abstract: 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.

Cited by 5 publications

References 10 publications

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation

Oral sucrosomial iron improves exercise capacity and quality of life in heart failure with reduced ejection fraction and iron deficiency: a non‐randomized, open‐label, proof‐of‐concept study

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