by Bonnie Lai, PhD

Jul 27, 2017

Ask Lumere: Are the latest IV iron products worth the high cost?

As I’ve talked recently to health system leaders about Lumere’s Pharmacy Solutions, I’ve fielded a lot of great questions concerning the application of clinical evidence to specific drugs and drug categories. Over the next few months, I’ll highlight some of the most popular questions and answers, advice column–style.

DEAR LUMERE: The new drug application for ferric carboxymaltose (FCM) states:

“Treatment with FCM for iron deficiency anemia (IDA) is thought to be more stable than iron gluconate and iron sucrose (Venofer) due to its chemical structure, producing a slow delivery of the complexed iron to endogenous iron binding sites.”

Is it worth paying two or three times more for FCM, or are tried-and-true intravenous (IV) iron formulations good enough? – IRON DEFICIENT AT AN IDN

DEAR IRON DEFICIENT AT AN IDN: Pharmaceutical marketing departments often turn to “science stories” like this when there’s little else to differentiate various drugs within a category. While innovative mechanisms or delivery methods can be exciting (to the right audience, at least), what really matters is patient outcomes.

So, does FCM deliver? As my Magic 8-Ball would say, “Outlook not so good.” But rather than relying on marketing tactics or magic, let’s turn to the actual evidence, keeping in mind that for patients with IDA, an increase in hemoglobin level is what relieves symptoms and improves outcomes:

  • In multicenter randomized clinical trials, there was no significant difference between FCM and low molecular weight iron dextran at increasing hemoglobin levels in IDA patients.1
  • In studies of patients with IDA associated with chronic kidney disease, FCM was non-inferior to iron sucrose for increasing hemoglobin.2
  • In cancer and chemotherapy-induced anemia, FCM demonstrates suboptimal increases in hemoglobin concentration. Iron dextran, iron sucrose or ferric gluconate should be used as first-line therapy, with FCM reserved for treatment failure or intolerance.3

Clearly, it’s hard to justify paying a price premium for FCM when the evidence demonstrates only minimal incremental benefit. Low molecular weight iron dextran or iron sucrose are more than “good enough” and should be your first-line IV iron formulations when treating IDA.


To learn more about Lumere’s Pharmacy Solutions, email insights@lumere.com.

Lumere’s online Pharmacy Solutions combine your health system’s drug spend and utilization data with clinical evidence to uncover specific recommendations for optimizing costs and improving patient care.

The evidence insights, like the one I summarized above, are written by our team of PharmDs, PhDs, and other experts and apply the power of evidence to engage physicians and reduce variation in care.



This Article is provided “AS IS”, with all faults and without any warranty of any kind; any and all warranties are expressly disclaimed. No information in this Article is, or should be construed as medical advice, a guarantee of any product safety or any endorsement of any product or service; use of this Article is at your own risk. Lumere shall not be liable, in any way, for any use of this Article or decisions made and/or actions taken based upon the contents herein. Discussion of experimental uses of drugs as described in this Article is for informational purposes only, and is not to be interpreted as an endorsement or encouragement of off-label use of any product.

1 A multicenter randomized controlled trial evaluated FCM versus low molecular weight iron dextran for iron deficiency anemia of assorted etiologies. Most patients had either heavy uterine bleeding or gastrointestinal conditions, while a small portion had chronic kidney disease or were postpartum. There was no significant difference between groups in mean hemoglobin increase to highest value (2.8 g/dL for FCM vs. 2.4 g/dL for low molecular weight iron dextran, p=0.2).

Source: “Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose Versus Iron Dextran in Patients with Iron Deficiency Anemia.” Hussain I, Bhoyroo J, Butcher A, Koch TA, He A, Bregman DB, Anemia (8/2013)

2 The REPAIR-IDA trial evaluated the use of FCM in comparison to iron sucrose for the treatment of ID in 2,584 patients with non-dialysis dependent chronic kidney disease. FCM was non-inferior to iron sucrose with regard to change in hemoglobin (1.13 g/dL vs. 0.92 g/dL; difference: 0.21 g/dL; 95% CI: 0.13 – 0.28 g/dL)

Source: “Ferric Carboxymaltose in Patients with Iron-Deficiency Anemia and Impaired Renal Function: The REPAIR-IDA Trial.” Onken JE, Bregman D et al, Nephrology, Dialysis, Transplantation, (4/2014)

3 An observational study investigated the effectiveness of FCM in 420 anemic cancer patients who had absolute or functional iron deficiency. The median increase in hemoglobin concentration for all patients was 1.4 g/dL (range 0.2 – 2.3 g/dL), which falls below the definition of clinical hemoglobin response (ie, more than 2 g/dL from baseline or an increase above 12 g/dL)

Source: “Clinical Experience with Ferric Carboxymaltose in the Treatment of Cancer- and Chemotherapy-Associated Anaemia.” Steinmetz T, et al, Annals of Oncology, (2/2013)