The Real Value of Drugs
By: Source: AARP Bulletin Today Date Posted: 2005-03-02 13:29:53
When the blockbuster painkiller Vioxx was abruptly pulled off the market last September, people were outraged. How could a drug that had been so heavily promoted as a "super-aspirin" and sold to 84 million patients worldwide turn out to increase the risk of heart disease?
Yet sales of Vioxx had already fallen sharply over the previous three years. A few state pharmacy programs and other health providers had cut back on paying for it, having concluded it worked no better for most patients than older, less costly drugs. That downturn intensified in 2002 after researchers picked up on what they call "noise" (red flags in the scientific evidence) that raised concerns about possible heart problems.
How did those providers know what others apparently missed? The short answer is that they had compared competing drugs. That is, they made use of "evidence-based" reviews—objective research that scrutinizes all clinical studies done by universities, drug companies and others on sets of drugs used to treat the same medical condition. Each review lays out the best evidence on how effective and safe each drug is.
This evidence-based approach is fast emerging as an important tool to assess the real value of medicines. It has already saved millions of dollars for the few states and health systems that use it. It offers doctors an unbiased alternative to their main source of information, the drug companies' own sales pitches. Some experts believe it has saved lives, too, in helping reduce the over-prescribing of Vioxx.
Now much of this same comparative information is available to consumers. Two new websites, one sponsored by Consumers Union and the other by AARP, each summarize the results of evidence-based reviews in an easy-to-read format. These sites also compare prices. Patients can use the information on common ailments—such as high cholesterol, heartburn and chronic pain—to talk more knowledgeably with their doctors about the best drug for their needs at the right price.
What consumers really want to know is: "If I have to pay more out of pocket for this drug as opposed to another one, is it worth it?" says Carolyn Clancy, M.D., director of the federal Agency for Healthcare Research and Quality, which helps fund 13 evidence-based medical research centers in North America. "It sounds [like] a simple enough question, but it's very hard to find the answer."
Both consumer websites rely on reports from the Drug Effectiveness Review Project, a leader in the field. This research group, based at the Oregon Health and Sciences University in Portland, has analyzed 18 separate classes of drugs, with seven more to come.
Begun in 2001, the project was the brainchild of Oregon's then-governor, John Kitzhaber, D. A former emergency room physician, he was appalled at how the cost of prescription drugs was eating up the state's Medicaid budget. Kitzhaber hustled a bill through the legislature that set up a preferred drug list—drugs the state would pay for based on effectiveness—against huge opposition from the drug industry. The bill passed only after Kitzhaber threatened to veto the state's human services budget and tell voters why. "It wasn't an elegant process," recalls Mark Gibson, deputy director of Oregon's Evidence-Based Policy Center, which Kitzhaber now heads. "But it worked."
The drug companies still oppose the evidence-based approach. Their trade group, PhRMA, calls it an attempt to justify cost cutting that prevents patients from getting all the medicines they need.
Gibson dismisses this argument. "Our research doesn't mention cost. Nowhere, no way," he says. "We just provide the evidence."
How the Oregon research is used varies among the project's 15 partners, including 13 states, that help fund it and use its results in their pharmacy programs. But in each case, Gibson says, the evidence-gathering process is kept separate from decisions on which drugs the programs will pay for. State committees—made up of doctors, pharmacists and others—make those decisions.
In Oregon, it was the Health Resources Commission that decided to drop Vioxx from the state's preferred drug list, based on evidence that included the possibility of increased heart and stroke risks. This was in June 2002, more than two years before the drug was withdrawn.
Washington state's committee does not know the cost of any drug before it decides which ones to cover, according to Siri Childs, head of pharmacy policy in the state Medicaid program. "It's decided only on the Oregon evidence," she says. The most expensive drug will make the list, she adds, "if it has the best side-effects profile and is the most effective."
Patients can still obtain any medicine dropped from the list if their doctors specifically request it. "The rule is that physicians always have the final say," Childs says. Otherwise, it makes tax-dollar sense "not to pay for a Cadillac when a Volkswagen will do," in cases where all drugs in a class work as well as each other.
This, in turn, has had an extraordinary impact on the price rebates the state gets from drug companies. "If the evidence says all these drugs are equal, they want to make sure their drug is the lowest cost so it will get selected," Childs says. "It’s not volume but our ability to shift market share that gets us excellent rebates. We've saved gobs of money."
Experts agree that the evidence-based system is not perfect. In some cases not enough evidence exists to compare drugs properly. The Food and Drug Administration does not require manufacturers to test new products against older ones on the market.
When there isn't good evidence, the Oregon reports say so. Identifying the gaps, in fact, spotlights what research still needs to be done, says John Santa, M.D., assistant director for health projects at the Oregon center. "We feel that making consumers aware of the evidence, or lack of it, is [equally] empowering."
Where good evidence does exist, the results can be surprising. For example, the Oregon report on the class of six drugs used to treat heartburn and gastric problems found no differences in effectiveness or side effects among them. But there are big differences in price. (See charts under "Resources" at right.) Prilosec, the most expensive prescription drug on this list, is now also sold over the counter, sometimes for less than $20 for a month's supply.
AARP's new website is intended to bring this kind of analysis to consumers who most often learn about drugs from advertising. "Making unbiased, scientific information available counteracts what people see on television every night," says AARP's Van Ellet, who directs the program.
The information, John Santa says, may be especially important next year when the Medicare drug benefit begins. "The benefit has a doughnut hole," he points out, referring to the gap in coverage of annual costs between $2,250 and $5,100. "There are lots of ways to use less expensive generics that will keep seniors from falling into that hole" too quickly. Nine out of 10 drug classes have good generic options, he says.
The private insurance companies that will provide the Medicare benefit will also use preferred drug lists. Using evidence-based information, "consumers can demand to know how insurers make their decisions," Santa says. "How much evidence have they used, how transparent is their process for choosing drugs?"
In the end, evidence and transparency are "twin bullets" that will help curb drug prices, Santa believes. "Government regulations can help, but clever companies can always work around regulations," he says. "Ultimately, consumers with good information are far more demanding than a government can ever be."
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