WASHINGTON -- Some of the nation's 40 million sniffling allergy sufferers soon won't have to choose between a doctor's visit or a drug that can zonk them out: The popular prescription allergy remedy Claritin will begin selling over the counter next month.
The Food and Drug Administration approved the long-awaited switch yesterday, making Claritin the first nonsedating allergy reliever available without a prescription.
The move is sure to save uninsured allergy sufferers money but will probably prove more costly for people with insurance that pays for prescription drugs.
The question is how much more costly: Manufacturer Schering-Plough Corp. refused to say how much it will charge for Claritin when it moves the pills next to the cough syrup on drugstore shelves in mid-December.
Today, a month's supply costs $60 -- although the insured may fork over only a co-payment, typically in the $10 to $15 range -- plus a doctor's visit to get the prescription. In Canada, where Claritin has long sold over the counter, it costs about $17.
Adding to the pricing pressure on Schering is that Claritin's patent expires in December, and potentially cheaper generic versions -- also nonprescription -- from Downtown-based Mylan Laboratories, Wyeth Pharmaceuticals and other companies are expected to start selling soon afterward.
Money aside, the FDA called its decision a milestone for drivers, because today's over-the-counter antihistamines can make people sleepy, dangerous if they're getting behind the wheel.
Making a nondrowsy option easier to get is good news for consumers, said Linda Golodner of the National Consumers League: "You can go to work, you can drive your car and you can function without thinking you might be falling asleep."
But allergists said some insurance companies were moving to block access to other prescription-only antihistamines -- Schering's successor to Claritin called Clarinex and the competitors Allegra and Zyrtec -- now that Claritin is available nonprescription.
Claritin doesn't work for everyone, so such moves could hurt many patients who find their allergies relieved by only one of the remaining prescription options that they consequently can't afford, said Dr. William E. Berger, president of the American College of Allergy, Asthma and Immunology.
"The decisions are being made in the boardroom and not in the exam room as to what's in the patient's best interest," said Berger, warning that such a move could extend far beyond allergy medications.
"Claritin OTC per se is not the issue," Berger added. "We could be having the same conversation in six months when they decide not to cover ... [the arthritis therapies] Vioxx or Celebrex and say, 'Just go buy some Advil.' "
Anticipating the Claritin switch, Blue Cross-Blue Shield of Massachusetts this told doctors this week that patients who want to stay on prescription Allegra would have to pay a $35 co-payment instead of the typical $10.
California-based WellPoint Health Networks -- which spurred Claritin's switch by petitioning the FDA to force nonprescription Claritin as well as Allegra and Zyrtec -- has ruled its customers will need a doctor's special authorization to maintain coverage for a prescription antihistamine. Those with certain plans will be charged a $20 to $40 co-payment for Allegra, Zyrtec or Clarinex, said chief pharmacy officer Robert Seidman.
WellPoint currently spends $40 million a year on Claritin alone, and with prescription drug costs rising, a drug benefit is one many employers may quit offering, he said.
Saving the Claritin money "allows us to extend the life of the prescription drug benefit," Seidman said. "That's the critical issue for me."
Schering vehemently fought Claritin's switch for three years, saying the insurance industry pushed the change merely because it doesn't pay for over-the-counter medicines and thus would save billions in drug costs as well as doctor fees.
But with Claritin's impending patent expiration and the debut of prescription-only Clarinex last January, Schering grudgingly changed course this year and asked the FDA to allow nonprescription Claritin after all.
The makers of Allegra and Zyrtec haven't made similar requests. While the FDA's scientific advisers ruled last year that they, too, should become nonprescription, the FDA still is debating those drugs' fate, said Dr. Robert Meyer, the agency's nonprescription drugs chief.
Analysts predict the Claritin switch will mean revenue from Schering's top-selling drug will shrivel, from worldwide sales of $3.1 billion last year to perhaps $400 million next year.
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