Is Moving Drugs to OTC Bad for Patients' Health?
Science Feature -- November 2003
By Ken Ortolon
When Claritin began selling over the counter in December 2002, allergy sufferers with no health insurance saw a substantial savings over the price they paid when the drug was available by prescription only.
But the real winners from shifting Claritin to over-the-counter (OTC) status likely were the health plans that no longer had to pay for the popular antihistamine. Health care industry experts estimate that insurers have saved hundreds of millions of dollars since Claritin went over the counter.
Critics believe this is just the first step in a move by the health plans to push more prescription medications over the counter where the financial burden will fall totally on consumers.
Such a move, say some physicians, likely could have dire consequences for the quality of health care in America.
Beaumont allergist William Fawcett, MD, president of the Texas Allergy, Asthma, and Immunology Society, says some patients who rely on OTC medications rather than seeking a physician's diagnosis likely will end up sicker and with more complicating conditions. While the health plans might save on their prescription costs, he says, overall health care costs likely will go up.
"Health care is going to be more expensive because conditions will be detected later," Dr. Fawcett said.
Good Medicine Versus Good Economics
The Claritin saga began in 1998 when Blue Cross of California, a subsidiary of WellPoint Health Networks, one of the nation's largest health insurers, made the unprecedented decision to ask the U.S. Food and Drug Administration (FDA) to shift three so-called "second-generation" antihistamines -- Claritin, Allegra, and Zyrtec -- from prescription to OTC status. WellPoint later amended its petition to add a fourth antihistamine, Clarinex.
Officials with the FDA's Division of Over-the-Counter Drug Products say WellPoint's petition marked the first time a health plan had requested that a prescription medication be shifted to OTC status. Such requests usually come from the drug's manufacturer and usually come near the end of the company's patent exclusivity when generic competition is about to occur, they say.
In its petition, WellPoint argued that the second-generation antihistamines have fewer potential side effects than first-generation antihistamines, such as Actifed and Benadryl, which already have been approved for OTC sale.
In support of its petition, WellPoint said that while the first-generation antihistamines are effective, they have side effects such as drowsiness, dizziness, blurred vision, and dry mouth that generally are not associated with the second-generation drugs.
"Notwithstanding the side effects that are associated with the first-generation antihistamine products, the agency has determined that they are safe for use by the public without the supervision of a licensed medical practitioner," the company said. "Allegra, Allegra-D, Claritin, Claritin-D, and Zyrtec are newer products or second-generation products that are also effective in providing relief from symptoms associated with allergic rhinitis or other respiratory allergies such as runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes. However, these second-generation products have a much lower incidence of side effects, i.e., they are less sedating and exhibit a lower level of anticholinergic side effects than the first-generation antihistamine products that are currently available over the counter."
Following hearings in 2001, an FDA advisory panel recommended that the antihistamines be moved to OTC status. FDA, however, has not issued a final decision.
Claritin was nearing the end of its patent exclusivity, so its maker, Schering-Plough, chose to voluntarily allow the drug to go over the counter. But Schering, which also makes Clarinex, and the manufacturers of the other drugs are fighting WellPoint's petition. The companies object to moving Clarinex, Allegra, and Zyrtec to OTC status. Some of these drugs have more than a decade of patent exclusivity remaining, so Schering-Plough and the other manufacturers would lose huge amounts of money by the OTC shift.
Bringing Down the Price
WellPoint spokesperson Lisa Mee-Stephenson says the company's motives in filing the petition were twofold.
"The reason we did it is because we're focused on empowering the 40 million Americans who suffer from allergies who want greater ownership of their health care," she said. "The other reason is that prescription drug costs are increasing at a double-digit rate, which is unacceptable. It makes it more difficult for health plans to provide an affordable, broad-based prescription benefit."
Ms. Mee-Stephenson says uninsured consumers now can get Claritin at a tremendous cost savings, while insured consumers pay roughly the same as they would for a generic copay under most health plans.
But critics disagree. The OTC price of Claritin currently is between $1 to $1.20 per pill, putting the cost of a one-month supply at or above $30. That is more than the average generic copay, says Dr. Fawcett.
Other critics say the move was more about protecting WellPoint's bottom line than saving money for consumers.
"This situation is so blatant," said Jeffrey Mazzella, executive director for the Center for Individual Freedom Foundation, an Alexandria, Va.-based think tank that describes itself as a constitutional advocacy group concerned about both constitutional rights and free-market issues. "There are 50 million allergy sufferers in this country who use these drugs."
Mr. Mazzella says the entire cost of the drug has been shifted to consumers. "According to the New York Times , WellPoint alone has saved roughly $90 million by shifting the cost of Claritin from employee health plans directly to consumers."
Moving to a Higher Tier
And that's not all. Dr. Fawcett says WellPoint and other health plans are sticking it to consumers even more by making it harder to get the remaining prescription antihistamines. He says many health plans now are refusing to pay for Allegra, Zyrtec, and Clarinex, or have moved them to a higher tier on their drug formularies where precertification is required and patients have to pay a higher copay.
In July, the Chicago Tribune reported that Aetna Inc. is requiring physicians to get prior approval before prescribing the more expensive nonsedating antihistamines and has increased its copays. Humana Inc. is considering a similar move, the newspaper reported. That report also said some insurers were requiring copays as high as $70 for prescription drugs similar to the antiheartburn medication Prilosec, which also recently went over the counter.
"What that basically amounts to is they're denying care or denying medications to patients who may not respond to Claritin, or they're jacking the copays up so high they're almost equal to the cost of the medication," Dr. Fawcett said.
Added Mr. Mazzella, "This is an attempt by the insurers to line their pockets while sticking it to the very consumers they insure."
In addition, Dr. Fawcett believes moving Claritin and other drugs to OTC status could lead to more health complications for patients who otherwise would have seen a physician about their allergy problems.
"What you're doing is you're relying on the patient making the accurate diagnosis," he said. That may be fine if the problem really is an allergy, but what if it is a more serious condition, such as a nasal obstruction or nasal polyp, he asks.
"They're assuming that just because they have a problem in their nose that it's allergy, and they're proceeding on a course of treatment," Dr. Fawcett said. "Sometimes it may be a long period of time -- months or even years -- before they see a doctor to talk about it. You completely eliminate that conversation and dialogue and that opportunity to evaluate and discuss the management options with the physician when you're just turning these things loose over the counter."
Melissa Feltmann, a spokesperson for Aventis Pharmaceuticals, the maker of Allegra, agrees. "There's a great concern that a forced switch such as this could result in a lesser quality of care for patients," she said. "Physicians play a very important role in diagnosis and treatment. By forcing these products to go over the counter you are essentially taking the physician out of the equation. Self-diagnosis and self-treatment can occur, and that could potentially mask some more serious conditions that would have otherwise been diagnosed if the physician were continuously involved."
Setting the Precedent
Ms. Mee-Stephenson says WellPoint has not looked at other classes of drugs and has no current plans to seek OTC status for any other medications. They limited their petition to the allergy medications because the company felt they "truly fit" the requirements for OTC status, namely that a patient could safely self-diagnose and easily understand the drug regimen, and the drug was lacking in any significant side effects, she says.
But if the allergy medications are moved to OTC status, critics say it's just a matter of time before other health plans start eyeing similar status for other drugs.
"If WellPoint is successful in moving all of these drugs to over-the-counter status, it's our belief that other insurance companies are going to attempt to do the same thing," Mr. Mazzella said. "It's going to set a bad precedent, put the FDA in a bind so that with this precedent being set they're going to have to approve several drugs for over-the-counter status."
Dr. Fawcett says allergists are concerned that if the antihistamines go over the counter, health plans soon will push to get topical nasal steroids switched, as well. That, he says, could have serious consequences for patients.
"The feeling of most of the allergists has been that these medicines frequently can mask underlying, serious chronic sinusitis, nasal polyps, tumors in the nasal passageway, or underlying concomitant asthma," he said.
A report entitled "Rx Brand Erosion by OTC Switches" released in June by Enhanced Perspective Publications, a service of the health industry marketing research firm WWMR Inc., predicted that several other drugs likely would see a switch from prescription to OTC status in the near future. Among them are Vioxx, Mavacor, and Zocor.
"I think the writing is on the wall," Dr. Fawcett said. "The health plans' concern is the biggest increase in cost, which is pharmaceuticals. If they can control those costs, they want to do it. How better than to bring these things over the counter?"
Ken Ortolon can be reached at (800) 880-1300, ext. 1392, or (512) 370-1392; or by email at Ken Ortolon .
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