DRAWING FIRST BLOOD
and it means we are wasting a lot of money by using a drug
available only in a 750-mg vial.
If we had the luxury of having the European vial sizes of
500 mg and 1,000 mg available in the U.S., then this entire
argument goes away. In the U.S., a 750-mg vial of FCM costs
$538; in the U.K., a 1,000-mg vial costs approximately $156.
So, other high-resource countries are paying a fraction of what
U.S. clinicians are paying for the same drug.
I don’t understand why, in the U.S., we are stuck with a
750-mg vial of FCM. We are wasting a lot of money by using a
drug available only in a 750-mg vial, which costs $538, versus
giving a 1,000-mg dose of LMWID in one sitting, which will
cost $240.
”If we had the luxury of
having the European
vial sizes ... available in
the U.S., then this entire
argument goes away.”
—MICHAEL AUERBACH, MD
Dr. Boccia: FCM is a great, safe option, and it is nice to be able
to administer an iron therapy in 15 minutes. At times, I use
one vial of FCM, rather than using a second vial to deliver 750
mg. Also, in lighter-weight patients, I will administer 500 mg
of a 750-mg vial; then, if the patient appears to have an iron
deficit lower than 1,500 mg, I will give them one 750-mg dose
and monitor their response over time.
Dr. Auerbach: That’s a prudent clinical paradigm, and one
that we have to consider because of the pricing. I might argue
for the use of FCM in iron-deficient pregnant women, but,
because of the costs, I think we have to explore other options for
administering IV iron.
We recently compared the safety and efficacy of ferumoxy-
tol 1,020 mg and FCM 1,500 mg in nearly 2,000 patients with
iron-deficiency anemia and found that each product performed
similarly. 5 The safety was equivalent, with similar rates of
moderate-to-severe hypersensitivity reactions up to five weeks
after treatment (0.6% for ferumoxytol and 0.7% for FCM). The
efficacy also was equivalent, with baseline hemoglobin levels
improving by 1.4 g/dL and 1.6 g/dL, respectively, at week five.
These results were similar even though the FCM dose was nearly
50-percent higher than the ferumoxytol dose.
The trial also suggested that we are not able to use more than
1,000 mg in a short period of time. That is consistent with in vitro
8
Focus on Classical Hematology
data. Unfortunately, we don't know what happens to IV iron after
administration because we haven’t had any in vitro data to answer
these questions.
Dr. Boccia: At this time, research shows that we can correct
a patient’s anemia to a similar degree with different IV iron
formulations, but it doesn’t tell us whether the patient’s
underlying iron deficiency can be corrected better with one
form of IV iron over another or one dose over another, and
– importantly – if one dose might result in a more durable
correction in that population of patients with repeated need.
Dr. Auerbach: In the FIRM study, when we monitored Hb and
transferrin levels five weeks from baseline and there was no
difference between patients treated with FCM or ferumoxytol.
Dr. Boccia: And that is only at five weeks. To answer the clinically
important questions that would guide our therapy choice in this
population, we also need trials with longer follow-up. The cutoff
for follow-up in these studies ranges from 35 to 50 days.
If we measure the levels at a fairly short interval, are those
numbers going to be reflective of true iron stores? Or, has the
iron restoration not completely occurred yet? I would like to
have data through six months of follow-up to see when patients
required retreatment with iron. Without those data, all we can
do is speculate about the differences between doses.
Dr. Auerbach: That’s an extremely important question, but,
unfortunately, I’m not sure that we are going to get those data. I
can’t recall anything in the existing literature to support or refute
that claim.
I think our only disagreem