Making a Case for Easier Access to Allergy Drugs

Hoping to save tens of millions of dollars annually, one of the nation’s largest managed care plans is asking the federal government to convert three top-selling prescription allergy drugs--Allegra, Claritin and Zyrtec--to over-the-counter status.

In so doing, WellPoint Health Networks, based in Thousand Oaks, is essentially asking the federal government to take the unprecedented step of prematurely stripping the drugs of their patent protection, which shields drug makers from competition.

The three drugs have been heavily promoted by their manufacturers in magazines and television advertisements aimed at the estimated 50 to 60 million Americans who suffer from seasonal allergies. “These drugs,” says WellPoint Vice President Robert Seidman, “are marketed like candy on TV.”

Allegra, Claritin and Zyrtec had combined sales of more than $5 billion last year, with Claritin accounting for $3 billion of that total. They are popular because, unlike some over-the-counter allergy medications, they don’t cause sleepiness or drowsiness.

Claritin, which typically costs $85 a month if purchased directly at a pharmacy in the United States, is already available over the counter in Canada and some other countries that have stronger drug-price controls. In Canada, the medication costs about $15 for a month’s supply.

With so many millions at stake, it is unlikely that the drugs’ manufacturers would give up their patent protection without a fight.

WellPoint decided to take action “because having these three incredibly safe drugs only available by prescription places an unnecessary financial burden on the health-care system and on consumers,” said Seidman.

In June 1998, the California managed care firm filed a citizen’s petition with the Food and Drug Administration requesting that these three top-selling drugs be switched to over-the-counter status because the prescription requirements deprives patients of “ready access to quality medical care.”

The company’s action is extraordinary, said Dr. John Jenkins, director of the FDA’s Office of Drug Evaluation II in Rockville, Md. Usually, it is the drug makers themselves who request the over-the-counter switch when a drug is coming off patent. It’s seen as a way to protect profits by maintaining brand familiarity.

Claritin is due to lose its patent protection in December 2002. Zyrtec’s patent expires in June 2007, and Allegra’s in 2013.

Seidman contends that the three antihistamines meet the FDA’s criteria for converting to over-the-counter status. Simply put, those criteria are: Is the illness easy to diagnose? Is it difficult to comply with the treatment regimen? And is the drug safe?

“People know if they have a runny nose, they can certainly take one pill a day, and these drugs are very safe,” says Seidman.

Not surprisingly, the drugs’ makers think otherwise and insist these products should be used with a doctor’s supervision. “Allergies are a complex and potentially serious disease that require a high level of medical care,” said William O’Donnell, a spokesman for Schering-Plough, the New Jersey-based manufacturer of Claritin.

Currently, some earlier-generation antihistamines, including Benedryl and Chlor-Trimeton, are available without a prescription. They can cause drowsiness, however, and impair people’s ability to drive or operate machinery; pilots, for example, aren’t allowed to fly for 48 hours after they’ve taken one of those medications. In rare instances, these antihistamines can trigger life-threatening cardiac arrhythmia. In contrast, the newer generation of drugs are just as effective, but don’t have unpleasant side effects.

WellPoint and other health insurance officials have decried rising drug prices and complained that direct-to-consumer advertising is raising health costs in this country. They complain that all those ads extolling the virtues of Claritin, Allegra and Zyrtec have enticed record numbers of consumers to ask for the medications.

If the allergy drugs were moved to over-the-counter status, health plans such as WellPoint would no longer have to pick up the tab under their prescription drug programs. The expense would shift more directly to consumers.

WellPoint, which has 7 million members nationwide, estimates that it would save $45 million a year in direct drug costs and another $45 million in unnecessary doctor’s visits, said Seidman.

Kaiser Permanente, the giant HMO based in Oakland, spends $25 million to $30 million annually on antihistamines for its 6 million members in California, said Anthony A. Barrueta, a pharmaceutical policy analyst for Kaiser. “Prescriptions have jumped by as much as 40% to 50% in the past two years,” he says. “It’s incredible.” He blames advertising.

The FDA has scheduled a public hearing for May 11 at FDA headquarters in Rockville, to consider WellPoint’s petition. At that time, an advisory committee of scientists will weigh the risks and benefits of making the conversion and decide whether these drugs can safely be used if available over the counter.

But the process could take years, so don’t count on finding these allergy fighters at the drug store any time soon.