Concerns mount over trends in allergy and asthma drug use and coverage
With Claritin expected to become available over the counter, some
physicians are wondering about the long-term impact of patient
self-diagnosis and self-treatment.
By
Stephanie Stapleton, AMNews staff. Dec. 9, 2002.
Additional information
Washington -- Emerging trends related to the availability and insurance
coverage of some allergy drugs are causing allergy and asthma doctors to
breathe uneasily.
These physicians are expressing concern that changes in the drug
marketplace could severely impact patient care and access to high-tier
allergy medications, such as Claritin (loratadine) and other nonsedating
antihistamines.
Their anxiety, which was the subject of a Nov. 12 press briefing by the
American College of Allergy, Asthma and Immunology, stems from a
combination of market forces.
First, Schering-Plough Corp., the maker of Claritin, applied to the
Food and Drug Administration last spring to switch all indications and
market all formulations of the company's Claritin brand of nonsedating
antihistamines to over-the-counter status. The company's submission was
assigned a standard review by the FDA and, at press time, final action was
expected at the end of November.
Some health industry observers predict that health insurance carriers
may respond to this switch and other market factors by further limiting
coverage or charging higher co-payments for the next-phase drugs, such as
Clarinex (desloratadine).
The combined result, say physicians, will be more out-of-pocket costs
for patients. Ultimately, this added expense could trigger patient
noncompliance with drug regimens, undermine successful treatment plans,
and cause safety problems and quality-of-life issues as patients turn to
older, cheaper medications that cause drowsiness.
Allergies and asthma prompt an estimated 11 million doctor visits
and 2 million ED visits a year.
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The bottom line, according to Bobby Lanier, MD, a Fort Worth, Texas,
allergist and ACAAI president, is that these trends likely will have a
negative impact on allergy patients and trivialize allergy and asthma
disease.
These conditions annually lead to an estimated 11 million doctor
visits, 2 million emergency department visits, 30 million lost school or
work days, and direct and indirect costs of $13 billion.
"Our concern is for the patients," Dr. Lanier said. People already pay
a lot of money for insurance. Paying more for high-tier drugs could be a
hardship, especially for lower-income patients, he added.
Patients could begin relying on the older, OTC medications that,
although much less expensive, have side effects that could place patients
at risk. Moreover, the combined trends could disrupt the physician-patient
relationship.
"Probably more visits will be likely downstream as a result of
patients' efforts to self-medicate," said Bill Berger, MD, a Mission
Viejo, Calif., allergist who is ACAAI's incoming president.
"There's often a wrong diagnosis, wrong treatment. It is not until
things get out of hand that people see their doctor. We want to have a
more preventive role."
Experience shows that proper diagnosis and treatment can dramatically
reduce emergency visits and hospital stays associated with unchecked
asthma and allergies.
"People need control for chronic diseases," Dr. Lanier agreed. A
check-and-balance system needs to be applied to allergy and asthma
treatment, just like treatment plans used for illnesses such as diabetes,
he added.
Treatment options
But experts inside the industry say market demand is an important
consideration. According to survey data from Schering-Plough, allergies
affect an estimated 45 million people in the United States. It is
estimated that 77% of those with allergies use some form of medication to
treat their allergy symptoms. Of those who do, about 37% use only
prescription medication; 32% use a combination of prescription and OTC
medications; and 31% rely solely on OTC products.
"With the market introduction of Clarinex as the first and only
prescription nonsedating antihistamine approved for the treatment of
indoor and outdoor allergies, moving Claritin to OTC status would give
Schering-Plough an opportunity to establish brand leadership in both the
prescription and OTC categories," said Richard W. Zahn, president of
Schering Laboratories, the U.S. prescription pharmaceutical marketing arm
of Schering-Plough.
While the firm believes that self-diagnosis and self-treatment have a
role in health care, it also believes in the need for strong
patient-physician relationships, said company spokesman Bill O'Donnell.
The company plans to launch a consumer education program when Claritin
goes over the counter. It will provide information on allergies and
possible accompanying conditions, such as asthma, and recommendations for
when patients should be in close communication with treating physicians.
"Allergy is a serious disease that can involve significant
comorbidities. There is a subset of patients capable of self-treatment,"
O'Donnell said. But it is "imperative" that the health care system "not
erect financial barriers that disintermediate the physician from the
process" or interfere with patients' access to the medications they need,
he added.
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ADDITIONAL INFORMATION:
Weblink
Position statement on insurance coverage for H1-antihistamines by the
American Academy of Allergy, Asthma and Immunology; the American College
of Allergy, Asthma and Immunology; and the Joint Council on Allergy,
Asthma and Immunology; in pdf (http://wsm.sgsnet.com/references/0000000200002358.pdf)
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Copyright 2002 American Medical Association. All
rights reserved.
