|Year : 2021 | Volume
| Issue : 1 | Page : 17-21
Ferric carboxymaltose solution versus iron sucrose complex in treating Iron-deficiency anemia patients with heavy uterine bleeding: A cost-efficacy study from a tertiary care hospital in the Kingdom of Saudi Arabia
Ayman Hejazi1, Omneya Mohamed2, Mansour Alhowimel3, Maysoun AlAdham4
1 Department of Hematology/Oncology, King Abdulaziz Medical City Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
2 Real World Insights, IQVIA AG, Dubai, United Arab Emirates
3 Drug Policy and Economics Center, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
4 Department of Obstetrics and Gynecology, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
|Date of Submission||10-Aug-2020|
|Date of Decision||11-Sep-2020|
|Date of Acceptance||16-Oct-2020|
|Date of Web Publication||15-Mar-2021|
Dr. Omneya Mohamed
Real World Insights, IQVIA AG, Dubai
United Arab Emirates
Source of Support: None, Conflict of Interest: None
BACKGROUND: Heavy uterine bleeding (HUB) affects 4.0%–51.6% of women and is responsible for the high prevalence of iron-deficiency anemia (IDA). Ferric carboxymaltose (FCM) is a novel Type I polynuclear iron (III)-hydroxide carbohydrate complex that is highly stable and requires short administration time. The current study estimated the budgetary impact of adopting FCM to treat IDA in HUB patients from the perspective of a tertiary care hospital in the Kingdom of Saudi Arabia (KSA).
SUBJECTS AND METHODS: A budget impact model was adopted to compare the total annual costs of iron sucrose complex (ISC) versus FCM from a tertiary care hospital setting perspective in a 1-year time horizon.
RESULTS: The total annual cost in ”ISC” scenario was higher than in ”FCM” scenario (Saudi Riyal [SAR] 1,079,535 vs. SAR 724,981), resulting in a cost saving of SAR 355,000 over a 1-year time horizon with FCM. Lower expenditure on health professionals and lower costs of disposables and overhead were the main drivers to the cost savings accounting for nearly 96% of the savings. Although the direct IV iron cost was higher in ”FCM” scenario, the increase in pharmaceutical drug cost was offset by the savings in the cost associated with disposables (−SAR 232,000) and resource utilization (−SAR 451,195).
CONCLUSION: FCM was associated with cost savings as compared to ISC for the treatment of IDA in HUB patients from the tertiary care hospital perspective in the KSA.
Keywords: Ferric carboxymaltose, heavy uterine bleeding, iron-deficiency anemia, iron sucrose complex
|How to cite this article:|
Hejazi A, Mohamed O, Alhowimel M, AlAdham M. Ferric carboxymaltose solution versus iron sucrose complex in treating Iron-deficiency anemia patients with heavy uterine bleeding: A cost-efficacy study from a tertiary care hospital in the Kingdom of Saudi Arabia. J Appl Hematol 2021;12:17-21
|How to cite this URL:|
Hejazi A, Mohamed O, Alhowimel M, AlAdham M. Ferric carboxymaltose solution versus iron sucrose complex in treating Iron-deficiency anemia patients with heavy uterine bleeding: A cost-efficacy study from a tertiary care hospital in the Kingdom of Saudi Arabia. J Appl Hematol [serial online] 2021 [cited 2021 Aug 5];12:17-21. Available from: https://www.jahjournal.org/text.asp?2021/12/1/17/311333
| Introduction|| |
Heavy uterine bleeding (HUB) is a common disorder, affecting 4.0%–51.6% of women of reproductive age. In 2012, about 27% of women were affected by HUB in Europe. In premenopausal women, greater blood loss in HUB leads to iron deficiency, which may further progress to iron-deficiency anemia (IDA), if left untreated. HUB is likely responsible for the high prevalence of IDA that affects 38% of pregnant women and 29% of nonpregnant women worldwide. According to the World Health Organization, in Saudi Arabia, around 32.3% of women of reproductive age have anemia. IDA developed due to HUB negatively affects the quality of life of women and significantly disturbs their physical activity and work productivity as well as their social and emotional lives., In addition, the cost of treatment of women diagnosed with HUB-associated IDA is significantly higher than those without IDA. Overall, women diagnosed with IDA are more likely to have a blood transfusion, an emergency department admission, and higher hospitalization costs as compared to those without IDA diagnosis.
The loss of iron due to HUB can be replenished with iron therapy which has shown to decrease morbidity by improving physical activity and reducing fatigue and cognitive deficits., In general, an oral iron supplement is typically the first-line iron replacement therapy to manage and replenish body stores. However, sustained response to oral iron treatment may be complicated by iron loss from heavy menstrual bleeding., For patients who are intolerant or unresponsive to oral iron treatment, parenteral preparations (usually intravenous [IV]), including iron sucrose complex (ISC) and ferric carboxymaltose (FCM), are generally prescribed.
In patients with IDA, IV ISC is administered as an infusion in doses of 200 mg and requires at least six outpatient visits to achieve a loading dose of 1200 mg. As IV infusion, ISC is administered over at least 30 min/200 mg with 30 min observation period after each infusion. Furthermore, substantial use of currently available iron preparations in the market such as iron sucrose and iron dextran is also limited due to their high reporting rates of adverse reactions and need for multiple doses. The potential life-threatening conditions induced by iron dextran outweigh the risk compared to ISC.,
FCM is a novel Type I polynuclear iron (III)-hydroxide carbohydrate complex that allows the controlled delivery of iron to target tissues. The main advantage of FCM is its high stability and increased dosing capacity, delivering a replenishment dose of up to 1000 mg of iron during a minimum administration time of 15 min., This reduces the duration of infusion versus ISC and further reduces the number of venous punctures and hospital visits.
Considering the benefits associated with FCM, this study was conducted to estimate the budgetary impact of adopting FCM on the budget of a tertiary care hospital, King Abdulaziz Medical City Hospital, Riyadh (KAMC-R), in the Kingdom of Saudi Arabia (KSA) to treat IDA in HUB patients in their facilities.
| Subjects and Methods|| |
A Microsoft® Excel-based budget impact model (BIM) was adopted to estimate the budgetary impact of introducing FCM solution for the treatment of IDA in HUB patients treated in KAMC-R across the KSA. The model was adapted in accordance with data retrieved from literature and inputs from local experts in the KSA. The 1-year time horizon was used from a tertiary care hospital setting perspective.
Two scenarios were considered in the model:
- Scenario 1: Only ISC being administered for the treatment of IDA in HUB patients
- Scenario 2: Only FCM being administered for the treatment of IDA in HUB patients.
Outcomes measured in the model were as follows: overall annual budget savings, cost breakdown in terms of drug cost and nondrug costs, impact on resource utilization, and the number of hospital visits. [Table 1] and [Table 2] summarize the inputs modeled in BIM.
|Table 1: Patient population and treatment inputs for budget impact model|
Click here to view
Patient population and treatment inputs
The model sample size was based on the inputs from KAMC-R. Key experts reported that 800 patients were administered IV iron at their local hospital/department over the past 12 months for IDA management in HUB patients.
The baseline population characteristics and treatment requirements were based on the inputs from key experts. The mean patient weight used in the model was 70 kg. As per the expert's insights, the model considered an initial loading dose of 1200 mg and 1000 mg for ISC treatment and FCM treatment, respectively. The administration of a maintenance dose is not a common practice in KAMC-R; however, a repeat course of iron may be considered for patients who experienced a disease progression. Hence, the current model considered only the initial dose.
The total time required to administer either ISC treatment or FCM treatment was calculated after considering the time required for the total dose infusion, number of visits required to administer the total dose, and the additional turnaround time per infusion. [Table 1] summarizes the patient population and treatment inputs.
Cost and resource inputs
Only direct costs incurred by the hospital were included in this study. The total costs included the direct costs associated with drug acquisition, disposables, and the physicians and nurses' hours utilized for iron administration. All the costs were reported in SAR (1 SAR = $USD 0.27). Based on the inputs from KAMC-R experts, 30 health-care professionals including physicians and nurses were involved in managing the IV ward. Only 8% of the infusion ward's capacity (in terms of chairs and workforce) was used for iron infusion when the ward was running at 100% capacity. [Table 2] presents the costs and resource inputs.
One-way sensitivity analysis (OWSA) was carried out to measure the robustness of the results by varying the results by ±20%. The result of the OWSA is presented in the form of a tornado diagram that graphically depicts the impact of variation of selected inputs on the BIM result. Each line represents the calculated impact if the cost of the respective parameter was increased by 20% (blue bars) or decreased by 20% (orange bar) for the specific input.
| Results|| |
In scenario 1 (ISC), the total time needed for IV iron administration per patient per year is 30 h, while in scenario 2 (FCM), the total time needed for IV iron administration is 1.25 h per patient per year. The annual time need to administer ISC is 24 times the time needed to FCM per patient.
Net budget impact
The total annual cost for the management of IDA in 800 HUB patients treated at KAMC-R facilities with scenario 1 (ISC) and scenario 2 (FCM) was SAR 1,079,535 and SAR 724,981, respectively. Hence, the introduction of FCM would lead to cost savings of 33% (SAR 354,554). The reduction in the total costs in scenario 2 (FCM) was attributed to both lower health professional expenses and lower costs of disposables and overhead. However, the cost of IV iron in scenario 2 was approximately 2.5 times higher as compared to scenario 1. The costs of the two scenarios are presented in [Table 3].
|Table 3: Costs associated with the two modeled scenarios over a 1-year period in 800 heavy uterine bleeding patients|
Click here to view
The impact on resource utilization
With the introduction of FCM, the overall utilization of infusion was reduced by 95.8% compared to ISC scenario. The annual number of nurse hours utilized was reduced from 2,952 h (with ISC) to 123 h (with FCM). Similarly, the annual number of physician hours utilized was reduced from 1296 h in scenario 1 (with ISC) to 54 h in scenario 2 (with FCM). [Figure 1] shows the impact on resource utilization with the introduction of FCM versus ISC.
One-way sensitivity analysis
An OWSA demonstrated that the study results were consistent with all the parameter variations. With the variation of the input parameters by ±20%, the baseline cost savings of SAR 355,000 varied between SAR 314,000 and SAR 395,000. Assuming a 20% reduction in the number of senior nurses would mean additional overall cost savings of SAR 395,000, whereas a 20% increase in the number of senior nurses would mean overall cost savings reduced to SAR 314,000. The detailed result in the form of a tornado diagram is presented in [Figure 2].
[TAG:2]This is the first study to analyze the budgetary impact of treating IDA in HUB patients using FCM in the KSA from a tertiary care hospital perspective. The use of FCM is expected to be cost saving for the KAMC-R tertiary care hospital over a 1-year time horizon. The model results showed that the introduction of FCM for the treatment of IDA in HUB patients would reduce resource utilization and require fewer hospital visits.[/TAG:2]
In scenario 1 (with ISC), the model estimated that the cost associated with disposables (SAR 278,400) has the highest contribution to the overall budget, followed by the cost associated with the nurse utilization (SAR 246,375) and doctor utilization (SAR 224,438). However, in scenario 2 (with FCM), the cost associated with IV iron was the highest contributor to the overall budget. The added cost of IV iron (SAR 465,280) in scenario 2 (FCM only) was offset by the savings in costs associated with disposables (−SAR 232,000) and resource utilization (−SAR 451,195). OWSA showed that the number of resource utilization has a major impact on the results. In OWSA, the budget impact varied from −SAR 314,000, when the number of senior nurses was increased by 20%, to −SAR 395,000, when the number of senior nurses was decreased by 20%.
Although there is ample evidence on the efficacy and safety of FCM in the treatment of IDA in HUB patients,, none of these studies focused on evaluating the budgetary impact of adopting FCM for the treatment of IDA in the HUB patients.
The studies assessing the budgetary impact of adopting FCM for the treatment of IDA in other patient populations showed a similar trend.,,,, A budget impact study conducted in Austria for IDA management in heart failure patients suggested that FCM was cost saving over a 4-year period. Similarly, another study conducted from Swiss health-care perspective showed that the use of FCM for IDA management in heart failure patients was cost saving over a 6-year period.
While the model concept and outputs were validated by local key experts to minimize the discrepancies between the literature and local practices, the model may not be an accurate reflection of the treatment of IDA in the HUB patient's ”real life.” This was due to two main aspects: the primary limitation of this model was an underestimation of the number of patients' visits as this was based on the experts' opinion and accounted only for patients who sought initial treatment. Second, most HUB patients face challenges navigating the health-care systems and suffer a social stigma between being diagnosed and treated.
Despite these limitations, this analysis contributes to KSA-specific evidence of adopting the FCM in the treatment of IDA in the HUB patients from the tertiary care hospital perspective. The key strength of this analysis includes the ability to conduct detailed OWSA to vary assumptions on resource utilization over time.
| Conclusion|| |
The results of this study suggest that the treatment of IDA in HUB patients with FCM was associated with cost savings in comparison to ISC. This study provides a comprehensive summary of the budgetary implications of adopting FCM in KAMC-R tertiary care hospital in the KSA. These results could serve as evidence for policymakers and health advisors in decision making when recommending the optimum treatment option for the management of IDA in the HUB patients.
The authors would like to thank all contributors for their commitment and dedication to the goals of IDA management in HUB patients. The authors would also like to acknowledge Rajat Goel and Shreya Dam (IQVIA, India) for writing and editing support.
Financial support and sponsorship
Funding support for this study was provided by Vifor Pharma.
Conflicts of interest
There are no conflicts of interest.
| References|| |
National Collaborating Centre for Women's and Children's Health. Heavy Menstrual Bleeding. Clinical Guideline No. 44. National Collaborating Centre for Women's and Children's Health Commissioned by the National Institute for Health and Clinical Excellence. RCOG Press; 2007. Available from: https://www.nice.org.uk/guidance/ng88/evidence/full-guideline-pdf-4782291810
. [Last accessed on 2020 Feb 20].
Fraser IS, Mansour D, Breymann C, Hoffman C, Mezzacasa A, Petraglia F. Prevalence of heavy menstrual bleeding and experiences of affected women in a European patient survey. Int J Gynaecol Obstet 2015;128:196-200.
Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, et al
. Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: A systematic analysis of population-representative data. Lancet Glob Health 2013;1:e16-25.
De Benoist B, Cogswell M, Egli I, McLean E. Worldwide Prevalence of Anaemia 1993-2005; WHO Global Database of Anaemia; 2008.
Karlsson TS, Marions LB, Edlund MG. Heavy menstrual bleeding significantly affects quality of life. Acta Obstet Gynecol Scand 2014;93:52-7.
Peuranpää P, Heliövaara-Peippo S, Fraser I, Paavonen J, Hurskainen R. Effects of anemia and iron deficiency on quality of life in women with heavy menstrual bleeding. Acta Obstet Gynecol Scand 2014;93:654-60.
Morrison J, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reprod Med 2008;53:323-30.
Friedman AJ, Chen Z, Ford P, Johnson CA, Lopez AM, Shander A, et al
. Iron deficiency anemia in women across the life span. J Womens Health (Larchmt) 2012;21:1282-9.
Jimenez K, Kulnigg-Dabsch S, Gasche C. Management of Iron deficiency anemia. Gastroenterol Hepatol (N Y) 2015;11:241-50.
Goddard AF, James MW, McIntyre AS, Scott BB, British Society of Gastroenterology. Guidelines for the management of iron deficiency anaemia. Gut 2011;60:1309-16.
Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol 2016;91:31-8.
Zolezzi M. Intravenous Iron saccharate complex: Guidelines for its use in the management of anemia of renal disease. Saudi J Kidney Dis Transpl 2003;14:129-33.
] [Full text]
Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 2005;20:1443-9.
Keating GM. Ferric carboxymaltose: A review of its use in iron deficiency. Drugs 2015;75:101-27.
Mishra V, Verneker R, Gandhi K, Choudhary S, Lamba S. Iron deficiency anemia with menorrhagia: Ferric carboxymaltose a safer alternative to blood transfusion. J Midlife Health 2018;9:92-6.
Seid MH, Butcher AD, Chatwani A. Ferric carboxymaltose as treatment in women with iron-deficiency anemia. Anemia 2017;2017, PMID: 28487769.
Comín-Colet J, Rubio-Rodríguez D, Rubio-Terrés C, Enjuanes-Grau C, Gutzwiller FS, Anker SD, et al.
A cost-effectiveness analysis of ferric carboxymaltose in patients with iron deficiency and chronic heart failure in Spain. Rev Esp Cardiol (Engl Ed) 2015;68:846-51.
Theidel U, Väätäinen S, Martikainen J, Soini E, Hardt T, Doehner W. Budget impact of intravenous iron therapy with ferric carboxymaltose in patients with chronic heart failure and iron deficiency in Germany. ESC Heart Fail 2017;4:274-81.
Bourguignon S, Faller M, Champs FO, Moutier H, Levesque K, Caranhac G, et al
. Budget impact of intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency in France. ESC Heart Fail 2019;6:559-69.
Klip IT, Comin-Colet J, Voors AA, Ponikowski P, Enjuanes C, Banasiak W, et al
. Iron deficiency in chronic heart failure: An international pooled analysis. Am Heart J 2013;165:575-82000.
Ressl S, Walter E, Bauer M. Budget-impact-analysis of iron treatment using intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency in Austria. Value Health 2015;18:A384.
Brock E, Braunhofer P, Troxler J, Schneider H. Budget impact of parenteral iron treatment of iron deficiency: Methodological issues raised by using real-life data. Eur J Health Econ 2014;15:907-16.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]