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.
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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)