AAHomecare Comments on Need for Levalbuterol

ALEXANDRIA, Va.–On Friday, the American Association for
Homecare submitted comments to CMS regarding the agency’s current
review of levalbuterol in the treatment of COPD.

In a six-page letter directed to CMS Acting Administrator Leslie
Norwalk, the association said: “While it may be argued there is
only modest evidence demonstrating the benefits of levalbuterol
over racemic albuterol in COPD, it is important to note that the
absence of voluminous published clinical studies does not by itself
establish a lack of clinical efficacy or medical need. This kind of
extrapolation on limited data is purely speculative and conflicts
with current standards of clinical practice, which defer to the
patient’s physician the selection and prescription of the most
clinically appropriate drug therapies.”

After review of the relevant science by its members with
clinical expertise, the association said, it concluded that the
studies, as a whole, “demonstrate that the use of beta agonists,
including levalbuterol, for the treatment of lung disease is
reasonable and necessary and should by covered by the Medicare
program.”

AAHomecare made the following points:

–Approximately 15 million Americans have been diagnosed with
COPD, and an estimated 15 million more have undiagnosed COPD. The
disease is the leading cause of morbidity and mortality
worldwide.

–COPD is responsible for a significant part of all physician
office and emergency room visits and ranks third in acute hospital
admissions among Medicare-aged persons. The average length of stay
for a COPD admission is 5.1 days at the rate of $4,000 per day.
Medicare payments to hospitals for routine COPD admissions alone
exceed $1.5 billion, and the disease costs the U.S. economy more
than $18 billion a year in direct medical costs and an estimated
$11 billion in indirect costs.

–The scientific evidence, national and world-wide expert panel
recommendations and the current standards of care all recognize the
vital role inhaled bronchodilators play in the safe, effective, and
economically sound management of persons with COPD.

–While inhalation drugs do not specifically cure COPD, they can
effectively manage its core symptoms in the outpatient/home setting
and substantially reduce the need for more expensive and
comprehensive medical interventions requiring ER visits and acute
hospital admissions.