- The Washington Times - Thursday, November 28, 2002

NEW YORK (AP) The popular allergy medicine Claritin will be available over the counter by mid-December, a boon to insurers, a blow to the manufacturer and a convenience to consumers.
The switch, approved yesterday by the Food and Drug Administration, will save the government, employers and health insurers at least $1 billion a year because nonprescription drugs aren't covered by insurance.
But while Claritin will be a bit more affordable for millions of people without insurance coverage, a few may actually pay more. A month's supply now costs between $80 and $95 by prescription, and although manufacturer Schering-Plough Corp. wouldn't comment on price yesterday, it is expected to drop to between $17 and $20, about the same or slightly more than the typical drug co-payment.
The move, requested by Schering-Plough after the company initially opposed it, is unique in the pharmaceutical industry because it was precipitated by health insurer WellPoint Health Network, which has spent $40 million on Claritin this year. Acting on a petition by the Thousand Oaks, Calif.-based insurer, an FDA panel said last year that Claritin, Pfizer's Zrytec and Aventis' Allegra were safe enough to be sold over the counter.
Besides that ruling, Schering-Plough also faced moves by generic firms and other pharmaceutical companies to introduce their versions of Claritin after the medicine's major patent expires Dec. 19.
"This is Schering-Plough making the best of a bad situation," said Lehman Brothers analyst Trevor Polischuk.
Claritin accounts for about $2.7 billion of the $4 billion U.S. market for prescription non-sedating antihistamines.
Worldwide sales last year generated $3.2 billion almost a third of Schering-Plough's total revenues. Experts estimate that revenues from over-the-counter sales will drop to about $400 million.
In 2001, Schering-Plough introduced Clarinex, a successor to Claritin, in a bid to extend the franchise. The two drugs are similar, and even though Clarinex is less expensive than its predecessor, it hasn't created the same loyalty or sales.
Now Schering-Plough faces a huge marketing challenge: creating a demand for its over-the-counter product while still expanding the prescription market for Clarinex.
Consumers will have to weigh price against convenience.
Theresa Padulla, 25, of Hoboken, N.J., is thrilled she won't have to go to the doctor anytime she needs a refill, but she said she would get a prescription for Allegra if over-the-counter Claritin cost significantly more than her $10 co-pay.
"I obviously don't want to pay more, but paying more isn't a huge issue if it isn't too much," she said.
Competitive pressures also are involved.
Wyeth, Johnson & Johnson and various generic companies have filed applications with the FDA to sell generic Claritin, and Wyeth said it plans to debut its version, Alavert, on Dec. 20. The company wouldn't discuss pricing.
In August, a federal judge ruled that Wyeth and four other companies didn't infringe on a separate Claritin patent that expires in 2004. Schering-Plough is appealing, but Wyeth is introducing its product anyway.
Analysts said prescription sales of Clarinex, Allegra and Zyrtec are likely to suffer as patients self-medicate, insurers drop coverage and doctors suggest trying the over-the-counter medicines before writing prescriptions.
Yesterday, Aetna Inc., the second-largest health insurer, said it would no longer cover Allegra, Zyrtec and Clarinex unless doctors make a special request. Even then, patients would be charged the highest co-payment. WellPoint, which has never covered Clarinex because it is too similar to Claritin, had already said it would put Allegra and Zyrtec in its most expensive co-payment category.
"This was bound to happen. These drugs are used interchangeably and insurers want to cut costs," said Patrick McKercher, director at the University of Michigan's Center for Medication Use, Policy and Economics.
WellPoint said its move won't cost consumers more than $30 a month, and if a doctor says a patient needs Zyrtec or Allegra, the charge will be less. Still, some WellPoint patients are angry.
Natalie Henricksen, 37, of Trabuco Canyon, Calif., has used Allegra for about six years and says she can afford the $5 a month increase the new payment plan will cost her.
Nevertheless, she said: "You should be able to work with your doctor and decide what medicine is right for you. Medical decisions should not be made by insurance companies and should not be based on what is cheaper."
Doctors have also expressed dismay that both the FDA and the insurance companies are ignoring patients' welfare.
However, WellPoint's chief pharmacy officer, Robert Siedman, counters that all four drugs are very similar and safe enough to be sold over the counter. He said that with prescription costs rising so dramatically, insurers need to make cuts to preserve the overall benefit.

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