CLARITIN TO SELL OVER THE COUNTER

Some to Pay More, Some Less for popular Allergy Drug

New York Times, November 28, 2002

By MELODY PETERSEN  

If Federal regulators yesterday approved the nation's top-selling allergy drug, Claritin, as an over-the-counter medicine, a decision that will bring substantial savings for the uninsured and allow all patients to obtain the drug without a trip to the doctor.

The decision will raise costs for many allergy patients with insurance, however, because insurers will no longer cover most of the cost of Claritin.

Insured patients may also now pay more for other allergy medicines because some insurers say they plan to require co-payments as high as $50 for the remaining prescription antihistamines - Clarinex, Allegra and Zyrtec to prompt patients to take Claritin instead.

With prescription drug costs rising quickly, one insurer is already pressing regulators to also make a successor of Claritin available over the counter.  Wellpoint, the large California insurer that prompted the Food and Drug Administration's evaluation of Claritin, has also asked the agency to make Clarinex, Schering-Plough's newest allergy drug, available over the counter. Insurance companies typically do not cover the cost of nonprescription drugs. 

The approval of Claritin as an over-the-counter drug gives all patients easier access to one of the newer allergy medicines, which, unlike any of the older antihistamines, does not cause drowsiness.

"Today's action will enable many people to get les-sedating, effective relief for their allergy symptoms more quickly and at a lower cost," said Dr. Mark B. McClellan, commissioner of the F .D.A., in a statement announcing the approval.

For uninsured patients, a month's supply of Claritin now costs about $85 at the pharmacy, while analyst’s estimate that Schering-Plough will initially set the retail price for the over-the-counter drug at roughly $30. 

Mostver-the-counter medicines sell for far less than prescription drugs because they are older products that lack the protection of patents that ward off competition. Most consumers are also not willing to pay such high prices for a drug they can pick up from the shelf.

Schering-Plough, the maker of Claritin, said that the nonprescription drug would be available in five different forms in mid-December. That will be about the same time the drug's patent is expected to expire, allowing other companies to offer generic versions that could cost less.

Some doctors said yesterday that they worried that insurers could lobby federal regulators to make other types of drugs available without a prescription as well, shifting even more costs to patients.

“A bunch of bean counters at the insurance companies have learned they can make a lot of money here," said Dr. William E. Berger, president of the American College of Allergy, Asthma and Immunology. 

Dr. Berger said that Claritin did not work for all patients. Some of those patients may now turn to the: older, sedating drugs available over the counter, he said, rather than paying higher co-payments on Allegra, and Zyrtec and Clarinex. 

But the insurers said they were only trying to keep drug coverage affordable.

"We have prescription drug costs escalating at a rate that is not sustainable," said Dr. Robert C. Seidman,  Wellpoint's chief pharmacy officer. Employers may stop offering drug coverage, he said, if costs become too high.

Schering-Plough declined yesterday to say how much it would charge for the over-the-counter drug.

Analysts say that the price of Claritin may fall further when other companies begin selling their over-the- counter versions of loratadine, the generic name for the active ingredient in the drug.

Already, two heavyweights in the over-the-counter drug market - Johnson & Johnson, the maker of Tylenol, and Wyeth, which sells Advil - have said they plan to sell their own versions of the allergy drug.

Francis Sullivan, a spokesman for Wyeth, said the company planned to begin shipping its over-the-counter drug which will be called Alavert - within days of the expiration of the Claritin patent.

Mr. Sullivan declined to say how much Alavert would cost, but Mr. Seidman at Wellpoint said he had learned that the suggested retail price would be about $19 for 24 tablets.

Johnson & Johnson declined to discuss its plans.

The push to make Claritin avail- able over the counter began in 1998 when Wellpoint filed a petition with the F.D.A. asking that Claritin, Allegra and Zyrtec be sold without a prescription.

To be sold over the counter, a drug must meet several criteria, including being safe enough for a patient to use without a doctor's supervision.

Last year, an advisory committee to the F .D.A. overwhelmingly agreed that all three drugs should be made available without a prescription.

But the F .D.A., which often follows the advice of its advisory commit- tees, did not take any action. Schering-Plough and the makers of the two other drugs, fearing the loss of profits, had argued that the agency did not have the legal authority to force them to sell the drugs without a prescription.

But earlier this year, after Wyeth and Johnson & Johnson said they would try to sell an over-the-counter version of loratadine after its patent expired, Schering-Plough filed its own application to switch Claritin's status.

Ira S. Loss of Washington Analy- sis, which does research for invest- ors, said he did not believe that the insurers could push the F.D.A. to switch other drugs. In the past, he said, the F .D.A. has typically agreed to make a drug available without a prescription only after a request from the drug's maker.

Even then, the F .D.A. has turned down some requests, he said. For example, in 2000 the agency denied the request of two drug companies wanting to offer cholesterol-lowering drugs without a prescription.

At least one other top-selling prescription drug could also soon be available over the counter. In June, an advisory panel to the F .D.A. voted to recommend that the heartburn medicine Prilosec be sold over the counter. The F.D.A. is expected to make a decision soon.

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