TUESDAY, Nov. 12, 2002 (HealthDayNews) -- With drug regulators poised to make the blockbuster antihistamine Claritin available without a prescription, a group of allergy specialists today warned that the move could force many patients to buy older, more dangerous drugs.
At issue is the structure of health plan formularies, which are lists of drugs that insurers will cover and levels of reimbursement for those medications.
The patent for Claritin is set to expire at the end of the month, opening the door for cheaper, generic versions of the drug. Its maker, Schering-Plough Corp., has made two moves in an attempt to hold on to its share of the allergy pill market. First it introduced a new drug, Clarinex, which is chemically and syllabically close to Claritin but which the company plans to sell by prescription. Then it petitioned the U.S. Food and Drug Administration to sell Claritin over the counter.
If, as is expected, the FDA allows Claritin to be sold without a prescription, some experts fear insurers will drop related non-sedating pills like Allegra or Zyrtec from their formularies to shift costs to consumers. That step, they argue, would force allergy sufferers to either pay more out-of-pocket for the newer drugs or settle for cheaper but older antihistamines that could make them drowsy and increase their risk of auto accidents and workplace injuries. Allegra and Zyrtec both require a prescription for now, and both still have patent protection.
Dr. Bill Berger, incoming president of the American College of Allergy, Asthma and Immunology, warned of "disastrous" consequences to consumers if formularies remove the second-generation antihistamines.
Allergies and asthma affect between 20 percent and 30 percent of the nation, Berger said, a figure that has doubled in the last 20 years. These conditions lead to as many as 11 million doctor visits a year, along with 2 million trips to the emergency room and a half million hospitalizations. Their economic toll: 30 million missed days of work and school and upwards of $13 billion in direct and indirect costs annually.
Allowing allergy pills like Claritin to be available without a prescription, and thus taking doctors out of the first stage of treatment, "is a very, very bad mistake," said Berger, who spoke at a teleconference with reporters.
Dr. Bob Lanier, current president of the college, said that allowing patients to buy potent antihistamines without a prescription "trivialized" conditions like asthma and hay fever. Lanier said he and his colleagues had doubts that patients could accurately diagnose and manage their allergies. Failure to do so delays appropriate treatment. "We know patients self-medicate for many diseases," Berger said. "It isn't until things get completely out of hand that patients finally see a doctor."
An FDA panel last year recommended approval of Claritin for nonprescription use, along with Aventis' Allegra and Pfizer's Zyrtec. The agency has yet to rule on the matter, but it rarely goes against the guidance of its expert panels. The drugmakers had threatened legal action, but Schering, with the patent expiration for Claritin looming, has since changed its mind.
WellPoint Health Networks, a division of Blue Cross, has urged the FDA to make all antihistamines available over the counter, arguing that the drugs are too expensive. The move would give the nation's allergy suffers "greater ownership of their health care," WellPoint has said.
Mohit Ghose, a spokesman for the American Association of Health Plans, a Washington, D.C. trade group, accused the allergy college of using "scare tactics" to complicate an issue that at bottom required only effective patient education.
"People should sit down and talk with their physician and find out what's best for them," said Ghose, who added that making the potent antihistamines available without a prescription would generate "tremendous cost savings" that plans would pass along to consumers. Ghose said his association's members were "seriously considering" what to do once Claritin can be bought over the counter, mulling measures like altering formularies and adjusting co-payments.
Dr. Stanley Fineman, an immunologist in Marietta, Ga., who also spoke at the teleconference, said that these maneuvers will affect patients above their wallets. "It really does impact the patients and how they manage their disease and how we're going to see their outcomes," Fineman said. When people have to pay more for drugs, they may be less compliant with the treatment, he said.
Lanier said his main concern is that patients retain a choice in treating their allergies. Removing drugs from formularies would deny them options, he added.
What To Do
For more on allergies, try the American Academy of Allergy Asthma and Immunology or the American College of Allergy, Asthma and Immunology.
