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© Copyright 2006 Rogers Publishing Ltd. The following article first appeared in the March 2005 edition of BENEFITS CANADA magazine.
The recall of Vioxx last year should serve as a warning for plan sponsors. Will it act as a catalyst for the establishment of managed formularies?

THE MARKET RECALL OF VIOXX ON SEPT. 30, 2004, inadvertently achieved what the painkiller had been created to do. It killed the pain—of plan sponsors. Since its introduction in 1999 by pharmaceutical firm Merck & Co., Vioxx had become a headache for employer-sponsored benefits plans across Canada. It was a costly painkiller prescribed for anyone experiencing pain instead of its intended recipients: arthritis patients with a history of gastrointestinal bleeds. Between 1999 and 2004, the annual number of prescriptions for Vioxx in Canada grew from 60,450 to an astounding 3.3 million.

In fact, the whole class of COX-2 inhibitors, to which Vioxx belonged, became a physician favourite, with a total of 7.9 million prescriptions written in that same period, for Vioxx, Celebrex, Mobicox, Bextra and Meloxicam. “The thing about these drugs is they were originally intended to be prescribed for people who were at risk of gastrointestinal bleeds,” says Barbara Martinez, a consultant in Mercer Human Resource Consulting’s healthcare and group benefits practice in Toronto. “Because they didn’t necessarily work any better to control pain than their alternative drugs. But they were 10 times more money.”

Martinez says that until Vioxx was pulled in the fall of 2004, due to studies indicating it increased the risk of heart attack or stroke, many employers had covered or still covered the drug or other COX- 2 inhibitors(at press time, only Vioxx had been recalled from the market). “Virtually all employers
were paying for these drugs,” she says. Adds Greg Forbes, a partner in Morneau Sobeco’s benefits consulting practice in Halifax, Vioxx was in most employers’ top 10 most expensive drug lists.

The immediate impact of the recall is cost reduction. Martinez estimates the percentage of spending on COX-2 inhibitors was 4% to 6% of total drug costs; with some other COX-2 drugs under review, employers could see significant savings. “What doctors might do is go back to prescribing the traditional nonsteroidal anti-inflammatory drugs(NSAIDs)—which should lower costs,” she says.

The good news is that NSAIDs are just as effective at controlling pain—albeit with gastrointestinal side effects for some patients. Martinez says media reports that arthritis patients in great pain are now left with no drug options are simply unfounded. “I think there are a lot of alternatives and patients should absolutely be able to find an alternative drug that works for them.”

What the Vioxx recall also demonstrates is the viability of managed formularies. Arguably, had Vioxx prescriptions been restricted to patients with a predisposition to bleeds—with doctors required to issue special authorizations—the rapid increase in Vioxx prescriptions would never have occurred.

And so it could be with new medications just coming on the market, approved by Health Canada, and considered for benefits plans. Restricting such drugs— while time tells the tale of whether they will cause adverse reactions—could save employers money.

“I think we need to recognize that when a new drug is approved by Health Canada, it doesn’t mean that it’s better than older drugs,” says Martinez. “What a managed formulary does, what some formularies are starting to consider, is to say: ‘before including this drug, does it work better than something else that is already covered?’”

Forbes is more skeptical that employers will see the recall as a green light to establishing formularies. “I think most organizations are still sitting there saying: ‘we’re not going to be in the business of secondguessing physicians.’”

Whether the Vioxx recall will act as a catalyst for the introduction of more restricted formularies is uncertain. But for those sponsors who always employed them for Vioxx, they have been vindicated. According to Martinez, those who required prior authorization for the drug had very few prescriptions to pay for. Painless indeed.

Anna Sharratt is associate editor of BENEFITS CANADA.