Who picks your drugs?
Sunday, June 6, 1999
By LINDY WASHBURN Staff Writer
Margaret Falk's arthritis started a decade ago. Her legs hurt so much, she sometimes has trouble walking. Over the years, she has tried all sorts of prescription drugs to fight the pain -- including some that gave her an ulcer.
So she was surprised this spring to find that her managed-care company wouldn't pay for Celebrex, a new arthritis medicine her doctor had prescribed -- one advertised as being easier on the stomach.
These breakthroughs in prescription medicine mean nothing to Falk and patients like her if they can't get the drugs. And more and more patients are finding that it's tougher to get such medicine, even with insurance coverage.
"I got all the way to the drugstore, but no further," said the 49-year-old Northvale woman.
Controlling access to costly drugs is just one tactic in increasingly aggressive campaigns by most managed-care companies to contain the runaway costs of prescription drugs, the fastest-growing segment of health care expenditures.
Having focused on hospital and physician costs, private insurers are now zeroing in on prescription benefits. Expenditures for drugs climbed a steep 22 percent in 1995, followed by 18 percent in 1996, and another 18 percent in 1997.
The result: More and more patients find the medicine they receive is not what their doctor initially prescribed.
Aetna U.S. Healthcare, the state's largest HMO and the one that insures Falk, adopted a policy in February that has made it harder to get new drugs for arthritis and, coincidentally, ulcers -- two of the top five ailments for which drugs are prescribed. Before pharmacies can fill prescriptions for new "second-line" drugs such as Celebrex, which hit the shelves in January, the patient must try at least two weeks on an older, or "first line" -- and usually less expensive -- medicine. The policy is called "step therapy."
Aetna is not the only insurer to change the rules on prescription drug benefits. In addition to Aetna's step therapy, these measure are being taken by many insurance companies to cut costs:
Three-tiered copayments. Horizon Blue Cross and Blue Shield, Aetna U.S. Healthcare, United Health Group, and Oxford Health Plans have introduced policies that use three different co-payments. The lowest is for generics; the middle for brand-name drugs on the company's preferred list, or formulary; and the highest for drugs that are not on the company's formulary. Typical copayments are $5, $10, and $25; or $10, $15, and $30, with Oxford's top payment going as high as $50. Experts believe most prescription plans soon will have this structure.
Closed formularies. These plans, which are not widely used in New Jersey, pay only for the drugs on the company's preferred list; the patient pays for non-formulary drugs.
Prior authorization. For very expensive medicines, so-called "lifestyle drugs" such as Viagra, or those that may cause serious problems when taken in combination with other drugs, some plans require the doctor to get approval before writing a prescription. Plans sometimes limit the patient to a 30-day supply, with permission needed for a refill.
Many insurers also require prior authorization before paying for multiple sclerosis drugs, certain types of insulin, and other specific drugs.
More headaches
for physicians
Doctors say this micromanagement, by dozens of insurers with dozens of different lists of preferred drugs, is a waste of time. They say it's impossible to keep track of all the formularies, and they can't afford to look up each prescription they write. They resent the constant calls and letters from pharmacists or benefit managers asking for substitutions.
Dr. Howard Rothman, chief of cardiology at Englewood Hospital and Medical Center, opened 16 letters in a single morning recently from one pharmacy-benefit company recommending that he change prescriptions for 16 different patients to lower patients' copayments.
"I have to put the notice in each patient's chart, and in their next visit or prescription renewal, I now to have spend time to address this issue," Rothman said. "Why should I do that for a formulary choice that's economically driven, not clinically driven? If a medication is succeeding at keeping a woman's high blood pressure under control, why fool with it, just because she changed insurance companies?"
Dr. Sam Snyder, the orthopedist who prescribed Falk's Celebrex, says he had noted her inability to tolerate other medication during 10 years as her doctor. "What is most infuriating is I have to take my staff and have them call the insurance company, spend 20 or 30 minutes on the phone to get permission," he said. "Nine times out of 10, it's denied."
Aetna defends its policy, noting that Celebrex's claims about causing fewer stomach problems are not yet approved by the Food and Drug Administration. Raphael Tancredi Jr., the company's director of pharmacy for the mid-Atlantic region, says cost should be a factor in choosing among medications that are otherwise similar.
Older drugs, he said, will usually cost both the member and the company less. If those work, that leads to significant long-term savings -- savings that go toward keeping health care premiums under control, he said.
But patients are often confused: They think their prescription-drug coverage means they will be insured for whatever their doctor prescribes.
"I don't understand that restriction," Falk said. "They flat-out refused to fill my Celebrex prescription." She returned to her doctor to get a prescription for Naprosyn, which she asked the pharmacist to fill while she made do with Celebrex samples from Snyder.
Pharmacists, of course, are caught in the middle. "We bear the brunt of the anger," said Matthew H. Kopacki, who owns the Rock Ridge Pharmacy in Glen Rock. "I'm the one who gets to say, 'I'm sorry, it's not covered. That will cost you $87.' "
Managed-care companies say their careful attention to prescription drugs has a flip side: They're watching for underuse of drugs. If a doctor is not prescribing proper medication for a patient with hypertension or congestive heart failure, these HMOs will point it out and urge the doctor to change his habits.
Cost-cutting harms
patients, doctors say
Increased spending on prescription drugs is a logical outgrowth of better health care, experts say, as research advances and pressure increases to reduce hospital stays and surgery. Spending on inhaled steroids to control asthma saves money on emergency room costs. Drugs that slow the worsening of multiple sclerosis symptoms reduce the number of hospitalizations for MS patients. Control of cholesterol may slow the clogging of arteries, postponing or eliminating the need for costly and risky heart surgery.
One study, published in The Journal of Managed Care in 1996, found that when more restrictions were placed on prescription drugs, patients got sicker, spent more time at the doctor's office or hospital, and needed other drugs.
"From the patients' perspective, increased use of health care services means greater inconvenience and longer periods of illness and discomfort," said the lead researcher, Shirley D. Horn of the Institute for Clinical Outcomes Research of the University of Utah School of Medicine. She is a medical statistician who was on the faculty of Johns Hopkins University in Baltimore for 24 years.
So a managed-care plan, then, must strike a balance that makes effective drugs available while containing health care costs, the experts say.
But doctors have doubts about cost-cutting for its own sake and question whether the full medical consequences of some decisions are being considered. They are particularly concerned when they are asked to switch to drugs that are equivalent -- but not identical.
Some drugs, such as anti-seizure medications used by epileptics, are absorbed into the body differently, and the correct dosage of a substitute must be recalibrated through trial and error. Doctors wonder whether a seizure that occurs while a patient works out the right dosage of the new medication is an acceptable consequence of saving the insurance company money.
Other drugs may be similar in terms of their primary effect -- lowering cholesterol, for example -- but different when it comes to secondary effects, such as changing the way blood clots. A careful doctor will want to consider those secondary effects when choosing a medication, Rothman says.
Some doctors don't trust studies that measure the effects of a natural form of a drug when they will prescribe its synthetic form. Or they find the data "proving" equivalency to be weak. Financial considerations -- rather than scientific rigor -- may have swayed the managed-care company, they contend.
Even more important is that doctors build up hands-on experience with certain drugs over time and become familiar with their side effects and efficacy, said Dr. David Swee, who teaches family medicine at the University of Medicine and Dentistry of New Jersey's Robert Wood Johnson Medical School. If they constantly switch among a dozen different medicines of the same type, they won't have that opportunity.
But Paul R. Langevin Jr., president of the New Jersey Association of Health Plans, dismisses that argument. "A physician has to make a concerted effort to go out and learn about other drugs," he said.
The struggle to contain drug costs, Langevin said, represents the larger dynamic of today's health care system.
"We're trying to align incentives for members, physicians, and health plans in the same direction," he said "Everybody has got to work to keep costs down." Physicians and patients must understand the cost of their choices and decide whether the benefit is worth spending more, he said.
FDA collecting
reports of ill effects
As the switching of drugs to satisfy a managed-care company has become more common, the FDA has begun to monitor possible adverse consequences. So far, says Laurie Burke, branch chief for the division of drug marketing, "The jury is still out."
The agency began soliciting reports from health care providers about problems in March 1997, and by the end of that year had collected 108 reports, she said. It is impossible, she added, to estimate how widespread the practice is.
None of the problems reported to the FDA resulted in death. Nearly half were in people over age 65, and about 10 percent led to hospitalization or other medical intervention. The most common problems reported were for proton pump inhibitors -- prescription antacids.
In some ways, New Jersey has been insulated from the most restrictive drug-benefit policies because drug manufacturers are among the largest purchasers of health insurance in this state. To them, free access to drugs is an article of faith.
The Aetna U.S. Healthcare prescription plan that excludes coverage for certain drugs is least popular among four choices available in New Jersey, Tancredi said. The company insures 1.7 million New Jerseyans, 770,000 of them with drug coverage.
"We actually don't like formularies," said David Knowlton, president of the Health Care Payers Coalition, which represents the purchasers of insurance for 600,000 union members and other workers. "No drug is identical. . . . When the formulary is imposed based on cost considerations, rather than clinical considerations, we have a real problem."
Although some states have passed laws requiring managed-care plans to disclose which drugs are on their formulary and how exceptions can be made, New Jersey has not done so. Nevertheless, the New Jersey Association of Health Plans this year published a guide for physicians, comparing the formularies of nine major managed-care plans.
Few complaints have reached the state Department of Banking and Insurance about drug coverage, and no company stands out as a target of complaints, said spokesman Bill Heine.
The state Board of Pharmacy has not addressed the issue of switching drugs, and simply requires that pharmacists obtain the permission of the prescribing doctor before substituting one drug for another.
Copyright © 1999 Bergen Record Corp.
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