F.D.A. Approves Over-Counter Sales of Top Ulcer Drug

The Food and Drug Administration yesterday approved over-the-counter sales of Prilosec, the little purple ulcer and heartburn pill that not long ago was the top-selling prescription medicine in the world. The decision benefits those who pay for the drug – health insurers and people with no insurance – and could roil the pharmaceutical industry.

The Food and Drug Administration yesterday approved over-the-counter sales of Prilosec, the little purple ulcer and heartburn pill that not long ago was the top-selling prescription medicine in the world. The decision benefits those who pay for the drug – health insurers and people with no insurance – and could roil the pharmaceutical industry. Prilosec is expected to sell for less than $1 a pill when it becomes available without a prescription this fall, compared with $4 a pill now. But few consumers who have health insurance will see any savings, because many managed care plans will stop paying for the drug altogether, health care executives said.”We don’t cover over-the-counter drugs,” said Deborah Whitehead of Tufts Health Plan, a major insurer in the Boston area. But older people of limited means who have no health insurance other than Medicare, which does not cover prescription drugs, stand to save hundreds of dollars a year. Patients who take similar drugs, like Nexium, Prevacid, Protonix and Aciphex, may soon find that their health insurers have made the medications more expensive or harder to obtain, managed care executives said. That would parallel what has happened since Claritin, the widely used allergy drug, was switched to over-the-counter from prescription sales late last year. Millions more Americans will be affected this time. Prilosec and similar drugs, known as proton-pump inhibitors, had $13 billion in total sales last year, more than any other class of drug and more than twice that of Claritin and similar antihistamines, according to NDCHealth, a health information company. Unlike allergy drugs, whose effects vary somewhat, the proton-pump inhibitors all have nearly identical effects on patients. That may give health plans a freer hand to force patients to use over-the-counter Prilosec rather than the prescription versions.Health plans have already been increasing the co-payments that members must make to get the prescription ulcer and heartburn pills. Managed care executives say that over-the-counter medicines like Pepcid and even Tums work just fine for most sufferers. Among the 62 million Americans whose drug benefits are managed by Medco Health Solutions, the average out-of-pocket cost for Prilosec is $23.94 for a 30-pill bottle, said Ann Smith, a Medco spokeswoman. For the other proton-pump inhibitors, she said, the average is $28.50.Over-the-counter Prilosec is expected to have a retail price of $25 to $30 for a 30-pill bottle, and patients will no longer need to spend money and time seeing a physician to get it.Prilosec is made by AstraZeneca, which also manufactures Nexium. Under an agreement with Procter & Gamble, the giant consumer products company, AstraZeneca will manufacture the over-the-counter version of Prilosec and Procter & Gamble will distribute and market it.Any sweeping changes in the way ulcer and heartburn drugs are paid for could hurt the profits of manufacturers who depend on these highly successful drugs – AstraZeneca, Wyeth, TAP Pharmaceutical Products, Eisai and Altana. Prilosec alone has generated nearly $30 billion in sales since its introduction in 1988. Last year, more than three billion prescriptions were written for proton-pump inhibitors in the United States, according to data provided by NDCHealth.For the companies, the intentions of managed care executives like Alan Sokolow, chief medical officer of Empire Blue Cross and Blue Shield, are frightening. Dr. Sokolow said his company might impose a rule requiring any doctor who prescribes one of these drugs to get special permission from the health plan. Such requirements often result in huge drops in sales. Even if permission is granted, the co-payments for these medicines could be raised above the cost of over-the-counter Prilosec, Dr. Sokolow said.Ken Ferber, a spokesman for the health insurer Wellpoint, said his company might also use a prior-authorization rule and high co-payments to drive patients to use over-the-counter Prilosec.Richard Evans, an analyst with Bernstein Research, said: “Sales of this entire class of drugs are going to fall. All of these companies are going to get hurt – especially Wyeth and Altana,” the two companies that make Protonix. A spokesman for Wyeth declined to comment; an Altana spokesman could not be reached.A spokesman for AstraZeneca said the company was pleased with the government’s decision and was optimistic about sales of both Prilosec OTC, as the over-the-counter version will be called, and Nexium.Procter & Gamble has been pursuing the idea of selling Prilosec over the counter since 1997; it expects the drug to bring in $400 million in sales in the first year.The business prospects are more complicated for AstraZeneca, based in London. The company has heavily promoted Nexium, which is still protected by patent, as a substitute for Prilosec; together, sales of Prilosec and Nexium totaled more than $6.6 billion last year.But the two drugs are almost identical, and many managed care plans may refuse to pay for Nexium when Prilosec is cheaper. Thomas A. Scully, administrator of the federal Centers for Medicare and Medicaid Services, recently admonished doctors for prescribing Nexium when Prilosec is functionally identical and will soon be much cheaper. One generic version of Prilosec is already available from Kremers Urban, but legal wrangling has kept other generic versions off the market. As a consequence, the generic’s price at Drugstore.com is $100 for a bottle of 30 pills, just below the $116 charged for Prilosec. Other prescription versions could be introduced later this year, when prices may fall sharply, but none will be sold over the counter for at least three years.Procter & Gamble has had some false starts in its six-year effort to sell Prilosec over the counter. Two separate Food and Drug Administration advisory panels found the company’s application wanting. At first, the company tested a 10-milligram version of the pill half the usual prescription strength. But studies showed that the drug was not effective at that strength, and in 2000, an F.D.A. committee rejected it.Then, last June, the same committee approved Procter & Gamble’s revised application, provided the company made its proposed label less confusing. Most consumers who read Procter & Gamble’s original version assumed that the drug would cure their heartburn immediately. It does not.Antacid tablets like Tums and Rolaids, which neutralize stomach acid, do relieve symptoms almost immediately, but they are not very powerful or long-lasting. Earlier drugs like Pepcid and Zantac, which slow the production of acid, take about an hour to work and can last all day, but they help only about 70 percent of sufferers.By contrast, Prilosec and drugs like it bind themselves to the stomach cells that produce acid, keeping them from making any more. If taken for at least two days, Prilosec and its similar-acting cousins are extraordinarily effective at shutting down significant acid production in the stomach. In studies, nearly 90 percent of patients who took the drugs found complete relief. But the relief does not come quickly.Procter & Gamble’s problem was to find a way to make this clear to consumers. The company surveyed 1,842 people in 45 cities, according to Greg Allgood, a company spokesman.The company finally settled on a label saying the drug should be used by people who have heartburn at least two days a week, a description of about 54 million Americans, Mr. Allgood said. Consumers are told to talk to their doctor before using the drug for longer than two weeks.Procter & Gamble will soon be offering free samples to pharmacists to pass out in stores. A huge advertising campaign is planned for the fall. Competitors are gearing up their own ad campaigns. Kathy Widmer, a spokeswoman for the Johnson & Johnson- Merck joint venture that makes Pepcid, said that most people who buy heartburn pills want quick relief that continues all day and night. Pepcid provides that relief, she said, but “Prilosec may not be suitable for episodic heartburn.” (Source: New York Times, By GARDINER HARRIS, 21 June 2003)