Quality Rounds
Recasting the Lowly Formulary
By Scott D. Smith
Some experts think drug formularies play a key role in patient safety because the committees that create them assess the effectiveness and safety of new drugs.
Minnesota physicians considered prescription drug formularies a hassle back in 1999, when an MMA survey found they had to deal with as many as six a day. Imagine what the hassle factor will be like as physicians start working with the formularies from the approximately 40 different Medicare Part D prescription drug plans.
Seniors not only have a plethora of drug plans to choose from, says Peter Wyckoff, executive director of the metropolitan region of the Minnesota Senior Federation, but they also will need to choose drugs in different cost tiers within those plans. “The average doctor is going to have to deal with dozens of systems,” he says.
This will likely add to the view that formularies are a confusing landscape of hoops and barriers that physicians struggle to navigate. Already, physicians frequently write prescriptions that later must be altered to fit a health plan formulary. This results in doctors and pharmacists spending a lot of time talking to each other about formulary matters and often that isn’t the best use of either’s time, says Stephen Schondelmeyer, Ph.D., a pharmacist and director of the PRIME Institute, an economics and policy research and consulting organization within the University of Minnesota’s College of Pharmacy.
But there is a competing view: that formularies provide a valuable safety check because formulary committees help compare the safety and effectiveness of new drugs with that of existing ones—something the Food and Drug Administration (FDA) doesn’t do.
Do Formularies Have a Safety Silver Lining?
The recall of Vioxx in 2004 illustrates that newer isn’t always better when it comes to drugs and that FDA approval doesn’t provide physicians with all the information they need to determine the value of a new drug, says William Korchik, M.D., director of the extended care center at the Veterans Affairs (VA) Medical Center in Minneapolis. Korchik has served on committees that develop formularies for the VA and Minnesota’s Medical Assistance program.
Two Doctors, One Drug Benefit
Physicians who care for veterans sometimes find it difficult to coordinate drug treatment with the Veterans Health Administration (VHA). Gail Welsh, M.D., has been on both sides of the issue. She has worked for the Veterans Affairs’ (VA) Edward Hines Jr. Hospital near Chicago and is now a general internist at Mayo Clinic in Rochester, where she treats a number of veterans who receive their pharmacy benefits through the VA. Welsh says working with the VA formulary amounts to a bit of extra work.
To use the VA drug benefit, veterans must be enrolled in the VA’s health system and a VA-employed physician must write the prescription. Prescriptions by community physicians must be rewritten by VA doctors who follow the VA’s national formulary and the formulary for their region. Regions have been allowed to create supplemental formularies, which include more drugs than the national one.
“What makes it difficult is you don’t know what drugs are on the formulary, and you don’t know what the other physician is going to prescribe,” Welsh says.
William Korchik, M.D., director of the extended care center at the Minneapolis VA, says the VA considers it the patient’s job to serve as the go-between and must arrange to have the information from their physician mailed or faxed to a VA physician. The VA physician can then prescribe any medication; but if the medication is off the formulary, the VA physician has to justify why the patient needs it.
The VA also has chosen preferred “workhorse” drugs in about a half-dozen categories, he says. For example, the evidence suggests that the statin drugs simvastatin and atorvastatin are equally effective. So the VA has negotiated deep discounts by choosing simvastatin as its preferred drug. “We know the two drugs are equivalent in terms of most clinical outcomes, so unless there’s some special reason, we’ll try simvastatin first,” Korchik says.
To help physicians in the community, the VA plans to put the midwest regional formulary online this month. However, Korchik cautions physicians not to get too used to it. He says that within the next year the VA intends to eliminate regional formularies and make all regions adhere to a single national formulary.—S.D.S. |
“Just because the FDA approves a new drug doesn’t mean it is superior therapy for a disease, when one also evaluates safety and efficacy,” he says. To win FDA approval, a pharmaceutical company must show the drug is effective compared with a placebo or no drug; however, the FDA doesn’t require that the new drug be compared with existing therapies, Korchik says. Determining a drug’s place in therapy is a role that formulary committees can play.
The VA designates physicians and pharmacist field researchers to compare a new drug with current therapies and to consider any safety concerns associated with the new drug, Korchik says. Formulary committees can also develop strategies, such as providing evidence-based educational materials to prescribers, to combat drug marketing materials that may hype a drug’s benefits and minimize its negative side effects.
“We took a tough stand on the [COX-2] inhibitors by not putting the drug on our national formulary and requiring prescribers to complete a risk assessment tool on each patient before a COX-2 inhibitor could be provided, and we were criticized up and down about our restrictiveness. But now I can say we were appropriately restrictive because there was not data [proving their safety],” he says. “Our focus was on risk stratification of patients for gastrointestinal bleeding, but it turned out concern over an increased cardiovascular risk was why the drug was removed from the market.”
The formulary review committee at Mayo Clinic also restricted access to Vioxx before it was pulled from the market in 2004. Likewise, a research group in Oregon, the Drug Effectiveness Review Project, reported the dangers of Vioxx, which led to Washington and Oregon removing the drug from their Medicaid formularies.
Such outcomes are helping give formularies a more positive image, sources say. Physicians, patients, and patient advocates recognize that formularies can promote safety and control costs as long as they include a process for managing exceptions and are based on scientific evidence rather than drug-company rebates.
“To me the big question is how do [health plans] come up with these things … Is it based on scientific evidence or on rebates?” says Gail Shearer, health policy analyst with the Washington, D.C., nonprofit Consumers Union, which publishes Consumer Reports magazine.
Private-sector health plans often use formularies to chase rebates and discounts offered by pharmacy benefit managers and pharmaceutical manufacturers, says Schondelmeyer.
But good evidence on which to base formulary decisions can be hard to find. With more than 5,000 prescription drugs available and about 80 to 100 new ones coming to the market each year, prescribing is complicated by a lack of reliable, statistically valid, impartial information that differentiates drugs in a particular class, according to an MMA report on pharmaceutical issues released in 2001.
The report also found that the picture gets worse when physicians attempt to factor price into prescribing decisions because cost-effectiveness data are “sorely lacking.”
The Drug Effectiveness Review Project in Oregon, which assigns research teams to evaluate the most commonly used drugs, has reviewed about 25 classes of drugs (the findings are available at www.ohsu.edu/drugeffectiveness). Fourteen states, including Minnesota, have helped fund the project, which is coordinated by the Oregon Health and Science University Center for Evidence-Based Policy. Those states have used the class reviews to select preferred drug lists for their Medicaid programs or to confirm previous decisions. The project has also sparked a public campaign by the Consumers Union to create a drug-buying guide for patients (www.crbestbuydrugs.org).
“There’s a growing awareness in some circles that if formularies are devised correctly, they can serve the consumer’s interest,” says the Consumers Union’s Shearer.
Can Formularies Hurt Patients?
Some researchers say overly restrictive formularies can harm patients by delaying their access to the latest drugs. In studies conducted in 1996 and 1998, Susan Horn, Ph.D., professor of medical economics at the University of Utah School of Medicine and the Institute for Clinical Outcomes Research, found that HMOs with strict drug formularies saw higher utilization of health care services such as emergency room visits, hospitalizations, and doctor visits than HMOs with less strict formularies.
In October 2005, economist Frank Lichtenberg, Ph.D., professor of finance and economics at Columbia University in New York, released the paper “Older Drugs, Shorter Lives? An Examination of the Health Effects of the Veterans Health Administration Formulary.” The study was funded by the conservative think tank the Manhattan Institute for Policy Research and has not been published in a peer-reviewed journal.
Lichtenberg found that only 38 percent of the drugs approved in the 1990s and 19 percent of the drugs approved since 2000 are on the VA’s national formulary. Furthermore, only 22 percent of the 77 priority-review drugs approved since 1997 are on the 2005 formulary. Lichtenberg has conducted several studies during the past decade that have found new drugs account for about 40 percent of the recent gains in life expectancy in the United States. Given that, he says, restricting access to newer drugs may actually shorten the lives of veterans.
Korchik takes issue with Lichtenberg’s conclusions, saying he used flawed research methods. For example, Lichtenberg based statements about the VA benefit on the life expectancy of the nation’s 25 million veterans, when only about 4.3 million veterans actually use the VA drug benefit, Korchik says. And he notes that in 2001 researchers from the Institute of Medicine studied whether the VA’s formulary, which was created in 1997, was too restrictive. They found it was not.
Korchik acknowledges that the VA’s formulary tends to include older drugs, but he doesn’t think that’s a bad thing. “We just think there needs to be a thoughtful process,” he says. “We err on the side of patient safety.” MM
Scott Smith is a staff writer for Minnesota Medicine.