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The
Sickle Cell Disease
Association of America,
Inc. (SCDAA)
is very pleased with
the announcement by
the Food and Drug Administration
of the approval of
hydroxyurea
(under the brand name
Droxia)
for use in treating
adult patients with
sickle cell disease.
This
is the first time a
drug has been approved
specifically for use
in this disease that
affects tens of thousands
of Americans and hundreds
of thousands of others
throughout the world.
We
would like to congratulate
the investigators whose
work led to the trail
of
hydroxyurea
in sickle cell disease,
the National Heart,
Lung and Blood Institute
(NHLBI) of the National
Institutes of Health
for funding the clinical
trails which demonstrated
the safety and efficacy
of hydroxyurea in sickle
cell disease, the research
investigators who conducted
the trails, Bristol
Myers-Squibb for their
continued support of
these studies and the
brave patients whose
courage in participating
in these studies has
made it possible for
may others to be able
to benefit from the
new treatment. We hope
that work on the safety
of
hydroxyurea
in children with sickle
cell disease will show
soon that they can also
be treated safely with
the drug.
Hydroxyurea
is a well-known drug,
however its use in sickle
cell disease is relatively
new and must be approached
with caution. Short-term
side effects must be
carefully monitored
and long-term effects
are still unknown. Recognizing
that many physicians
are eager to provide
this therapy to their
patients, SCDAA feels
it is important to stress
that each physician
treating sickle cell
patients throughout
the country must be
educated about the proper
use and monitoring of
hydroxyurea
therapy prior to initiating
such treatment. Through
its 65 Member Organizations,
SCDAA
will be happy to work
with Bristol Myers-Squibb,
NHLBI and other health
agencies to ensure that
physicians and patients
are educated about this
new treatment.
POTENTIAL
SAVINGS FROM USE OF
HYDROXYUREA
Estimated
total U.S. sickle cell
patients
65,000 *
Percent
with severe pain 3-5
times per year
5.2%
Estimated
number with frequent
severe pain
3,380
Assuming
the average annual number
of episodes
4
The
total number of severe
pain episodes in these
patients
13,520
Assuming
that 50% episodes result
in hospitalization
6,760
Assuming
the average days of
hospitalization
5
Estimated
total number of hospital
days for these patients
33,800
Assuming
cost per day $800
Total
hospitalization costs
for these patients
$27,040,000
Potential
savings from use of
hydroxyurea in these
patients in one year
$13,520,000
*
Estimates of sickle
cell disease patients
in the U.S. is now over
70,000.
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