Publicado 19/02/2020 11:01

New Data Show Oral Ferric Maltol (FERACCRU) May Be a Cost-effective Alternative to Intravenous (IV) Carboxymaltose With

- Ferric maltol (FM) was associated with substantially lower use of healthcare resources than IV ferric carboxymaltose (FCM)

- IV FCM was linked to greater productivity loss and disruption to patients' work and family life due to the need for clinic-based IV administration

- 50% of patients on IV FCM lost at least one full day due to treatment with 43% losing up to EUR387.51, as quantified for a German setting

- Mean total per patient drug costs were approximately 1.6 times higher for treatment with IV FCM compared to FM

AMSTERDAM, Feb. 19, 2020 /PRNewswire/ -- Norgine B.V. highlighted new data from three post hoc analyses of the randomised controlled, open label, phase 3b non-inferiority study of oral ferric maltol vs intravenous ferric carboxymaltose (NCT02680756), presented at the 15th European Crohn's and Colitis Organisation (ECCO) Congress in Vienna. Ferric maltol, a novel oral iron replacement therapy, was found to be a cost-saving alternative to intravenous (IV) ferric carboxymaltose (FCM) by reducing drug administration costs([1] )and productivity loss,([2] )with at least as great benefit to the health-related quality of life (HRQoL) of patients with iron deficiency anaemia (IDA) and inflammatory bowel disease (IBD).([3])

Dr. Stefanie Howaldt from the Hamburg Research Institute for IBD, HaFCED e.K., Germany presented the new research findings at ECCO and commented, "Iron deficiency anaemia is very common in inflammatory bowel disease and can significantly impair the quality of life of patients. Due to very common intolerance to standard oral iron products, IV iron is currently the main treatment alternative for IBD patients with IDA. These new data demonstrate that ferric maltol is not only a well-tolerated and effective therapy, which we previously knew, but also a cost-saving treatment for the healthcare system, representing an alternative oral treatment option with substantial health-related quality of life benefit for IBD patients with IDA.''

IDA can be a serious complication of IBD resulting from inflammation, chronic mucosal blood loss and iron malabsorption.([4] )Treatment of IDA involves iron-replacement therapy often with oral iron supplementation in the first instance.([4] )However, use of oral ferrous iron medications may be limited by poor absorption and adverse events([4,5] )which can lead to many unwell patients having to receive IV iron in hospital.

Patient-reported outcomes are an important way to measure health and wellbeing. Measures of HRQoL in IDA have the potential to reflect both IDA symptoms and treatment-related issues such as adverse effects, so are a useful tool to capture additional treatment benefits beyond those typically reported in clinical studies.([3] )

In the quality of life post hoc analysis, the HRQoL benefits of FM and IV FCM and their relationship to haematological parameters were analysed using data from a randomised controlled trial. The analysis showed that improvements in SF-36 PCS and MCS scores were slightly greater with FM than with IV FCM (difference not statistically significant). FM patients experienced at least as great benefit in all SF-36 domains such as general and mental health, bodily pain, vitality, physical, social and emotional functioning.([3] )

IDA imposes a substantial economic burden on the healthcare payer system resulting primarily from increased medical costs and hospital admissions. The second post hoc analysis looked at the impact on productivity comparing the associated productivity loss of oral FM vs. IV FCM. The study found that 50% of patients treated with IV FCM lost at least one full day due to treatment, with 1 in 15 losing 4-6 days. Productivity loss was quantified, with IV FCM treatment associated with losses between EUR0.00 and EUR107.21 in 50% of patients, EUR129.17 and EUR387.51 in 43% of patients and EUR516.68 and EUR775.02 in 7% of patients. As FM was administered orally by the patient and did not require any in-hospital treatment administration, there was no treatment linked productivity loss. FM did not have the indirect costs associated with IV FCM and as such may provide an oral alternative to IV iron in patients with IBD, enabling them to avoid the disruption of everyday life activities due to the need for in-hospital IV administration.([2] )

The third post hoc analysis compared the health care resource use (HCRU) associated with oral FM and IV FCM. The data showed that total per patient drug costs (acquisition and administration) were approximately 1.6 times higher for treatment with IV FCM than FM. The total cost of IV FCM is not only influenced by the higher drug cost, but additional costs associated with IV administration which was required to be carried out in a hospital or outpatient setting. FM has no additional costs or resource use associated with administration and is therefore less of a burden on local health care systems.( [1] )

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Notes to Editors:

About the post hoc analyses

Patients with IBD and IDA (haemoglobin [Hb] >=8.0 g/dL and <=11.0 g/dL for women or >=8.0 g/dL and <=12.0 g/dL for men, and ferritin <30 ng/mL or ferritin <100 ng/mL with transferrin saturation <20%) were randomised to FM (30 mg b.d.) or IV FCM (as per local Summary of Product Characteristics [SmPC] or prescribing information) in an open-label, Phase 3b non-inferiority study. The primary endpoint was Hb responder rate (proportion of patients achieving a >=2 g/dL increase or normalisation of Hb at week 12). 250 patients were randomised: 125 to FM (per-protocol [PP] n=86) and 125 to IV FCM (PP n=93). The Hb responder rate for oral FM was non-inferior to IV FCM in the PP population (74% vs 83%); risk difference was -0.1 (two-sided p=0.017; 95% CI -0.2, 0.0), within the pre-defined non-inferiority margin of 20% difference.

For the post hoc analysis 'Impact of oral ferric maltol and IV iron on health-related quality of life in patients with iron deficiency anaemia and inflammatory bowel disease, and relationship with haemoglobin and serum iron', patients with IBD and IDA were randomised to FM (30 mg b.d) or IV FCM (as per local SmPC) with primary endpoint Hb responder rate [proportion of patients with >=2 g/dL increase or normalisation of Hb at week 12; non-inferiority margin 20%]. HRQoL was assessed via the Short Form Health Survey (SF-36). In the post hoc analysis of patient-level data, Hb, serum iron and HRQoL at baseline and week 12 were summarised descriptively and correlations between HRQoL and haematological parameters were assessed via Pearson's correlation coefficient (PCC). Hb, serum iron and HRQoL all improved following both treatments at Week 12. Improvements in SF-36 physical component summary (PCS) and mental component summary (MCS) scores were slightly greater with FM (difference not statistically significant). HRQoL improved across all SF-36 domain scores with both FM and FCM, with no statistically significant differences between treatments. HRQoL (MCS and PCS) improvements were positively associated with increases in Hb and serum iron.( [3] )

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