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, amednews staff. Dec. 9, 2002.

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.

Links

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.

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.

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)