HMOs Not Stoked Over COX-2 Drugs
By Robert Steyer
TheStreet.com Staff Reporter
12/22/2004 10:55 AM EST
URL: thestreet.com
[italics eliminated for your reading pleasure] ;-)
As the Food and Drug Administration prepares to make recommendations about Pfizer's (PFE:NYSE) Celebrex, the companies that ultimately pay for the drug aren't leaping to conclusions merely because one recent study showed patients taking the drug had a higher risk of cardiovascular problems than those on a placebo.
Indeed, managed care companies, pharmacy benefit managers and insurers say they are still making Celebrex available to their customers. Health care executives interviewed by TheStreet.com say they don't want to interfere with the doctor-patient relationship, adding that they prefer to wait for the FDA to act.
And, after all, they didn't dump Vioxx, which was the subject of more controversy for a longer period of time until its maker, Merck (MRK:NYSE) , removed it from the marketplace Sept. 30. (Vioxx and Celebrex belong to the same class of arthritis/pain relief drugs called COX-2 inhibitors.)
However, that doesn't mean these executives are exactly thrilled with any of the COX-2 inhibitors, saying that they provide few benefits over existing drugs. Consequently, the companies that establish multitier payment schedules for drugs place the COX-2 medications in the category requiring the highest out-of-pocket expense.
For example, at WellPoint (WLP:NYSE) , both Celebrex and Bextra, another COX-2 drug from Pfizer, are placed in the "non-preferred," or highest patient co-payment tier. The insurer also requires written authorization from a doctor. Before it was removed from the market, Vioxx received the same treatment, said Debbie Davis, a spokeswoman for Wellpoint.
Although each WellPoint plan is designed differently, Davis said the company's medical reviewers have determined that there are a number of other effective prescription drugs -- including generic drugs -- for which patients would pay less out-of-pocket.
At UnitedHealth (UNH:NYSE) , Celebrex is in the category requiring the highest co-payment by customers, as was Vioxx. "The appropriateness of a drug is made by the federal government or the physician and the medical community as a whole," said Mark Lindsay, director of public communications and strategy.
Measuring Effectiveness
"Evidence to support the effectiveness of COX-2 drugs has been very weak" vs. older pain relievers such as Motrin or Advil, said Dr. Sharon Levine, associate executive director of the Permanente Medical Group in Oakland, Calif.
Levine's organization also pays for COX-2 drugs; in fact, patients pay out-of-pocket the same for COX-2 as they would for any other brand-name prescription drug. But the medical group, part of the Kaiser Permanente system, encourages physicians to restrict the use of COX-2 drugs to patients who have experienced gastrointestinal side effects from the older medications called nonsteroidal anti-inflammatory drugs (NSAIDs).
When Celebrex and Vioxx were being developed, their makers hoped they could distinguish them from NSAIDs by showing that COX-2 drugs produced fewer gastrointestinal problems, a major concern for the elderly and other chronic users of pain relievers. But only Vioxx secured a label from the FDA saying tests showed some gastrointestinal benefits. That label enabled Merck's sales representatives to market the drug as having an advantage over other COX-2 drugs and over NSAIDs.
Kaiser reimbursed patients for Vioxx, but after the drug was removed from the market, Kaiser recommended that patients at risk for gastrointestinal problems take one of several NSAIDs, as well as a proton pump inhibitor like Prilosec for stomach protection.
Levine said COX-2 drugs represent 4% of prescriptions by Kaiser's doctors among all drugs for arthritis and pain relief. At other health plans, "nationally, it's about 50%," Levine said. "Our doctors are more judicious in their use."
But Levine said her organization's approach isn't based on automatically pinching pennies. When Kaiser assesses drugs, it looks at safety first, followed by drug quality and effectiveness. If a new drug is one of several drugs in a similar class, Kaiser will look at "relative cost effectiveness," Levine said. In the case of COX-2 drugs vs. traditional NSAIDs, "evidence for consumer benefit was weak."
Measuring Costs
In addition, pharmacy benefit management firm Express Scripts (ESRX:Nasdaq) has looked periodically at COX-2 drugs, and it hasn't liked what it found.
Its researchers examined physician-prescribing patterns and reported in late 2003 that COX-2 patients were using more stomach-protection drugs than were NSAID patients. That's contrary to the direct or implied claim that COX-2 drugs cause fewer gastrointestinal side effects.
"The harm from incorrect assumptions ... is that they undermine the efficient allocation of scarce health care resources," said the lead researcher on the Express Scripts study, which was published in The American Journal of Managed Care. And another company study, also published in the same journal, revealed that "most patients given new prescriptions [for COX-2 drugs] had no indication of being at risk for gastrointestinal events."
Other company research indicates that doctors and/or patients aren't paying close enough attention to their COX-2 prescriptions. Writing in the Archives of Internal Medicine in June, company researchers said more than half of patients taking COX-2 drugs over a long period also were taking aspirin.
This study looked at a "predominantly retiree population," and aspirin was used to guard against heart attacks. However, the researchers said, the aspirin reduced any alleged gastrointestinal benefit from the COX-2 drugs. "These findings have important implications for patient safety and cost," Express Scripts said.
For patients needing pain relief and protection against heart attacks, the company recommended that their doctors prescribe "an effective lower cost" NSAID instead of a COX-2 drug. And for older patients and patients with risks of gastrointestinal problems, Express Scripts said doctors should prescribe a stomach-protection drug, such as a proton pump inhibitor, rather than a COX-2 drug. |
