George A. Sprecace M.D.,
J.D., F.A.C.P. and Allergy Associates of New London,
P.C.
www.asthma-drsprecace.com
Xolair (omilazubab) and Bronchial Asthma
Bronchial asthma continues to be the most under-treated
serious disease in this country today, probably assuming that role from
high blood pressure...the long-time leader in that dubious category of
health care. At least 10% of the American population has asthma.
The costs of the disease and its treatment exceed $20 billion yearly.
And over 5000 sufferers die annually, mostly unnecessarily, from this highly
treatable disease.
The latest treatment approved for the treatment of asthma
is a "humanized anti-IgE antibody" available by injection to neutralize
the IgE antibody which in most cases is the allergic basis of the process.
So far its utility is restricted...if at all...the moderately severe and
severe cases in children (age 12 and beyond) and adults. But there
are "issues" yet to be resolved:
-
Its efficacy, in my opinion, has not been clearly established...based
upon the conduct of the studies (eg. by W. Busse, 2001) on which FDA approval
was based;
-
Its effectiveness as an anti-inflamatory agent, although
intuitive based on its mechanism of action, has in my opinion has not been
established to the degree necessary to support the resulting decreased
use of inhalational steroid treatment, a common measure of its effectiveness;
-
Its interplay with the allergic body's production of IgE
(it actually is associated with an increase of IgE, although mostly bound)
and with the extensive, indicated and proven use of allergy immunotherapy,
has not yet been reported;
-
Its effectiveness lasts only as long as it is given, and
for a few months afterwards, as contrasted with the long-term effectiveness
of allergy immunotherapy, long after its discontinuation in most patients;
-
Office preparation and administration are time-consuming
and not well reimbursed;
-
The average cost is $12, 000. per year. Its coverage
by third party payors is cumbersome at best, requiring prior approval based
on set criteria, and in Medicare and Medicaid cases (where approved at
all) requiring pre-payment by the treating physician.
Specialists like myself are trying to add this new modality,
where indicated, to our treatment approaches for bronchial asthma. But
the above issues must be addressed by the producing pharmaceutical company
and its surrogates if its total potential - whatever that is - is to be
achieved. Not the least of these issues is the need to have the
producer provide the product, pre-paid, to the physician
for use in his patient - the producer thereafter seeking reimbursment from
the managed care company.
GS