The new drug is out: Should you order it now?
Real-world use could expose hidden results
The new drug is available for use, and your physicians are eager to try it. Do you dare wait a few months to place your order?
It’s the smart thing to do — waiting will save you money and may improve overall patient outcomes, says Daniel Albrant, PharmD, president of Pharmacy Dynamics, a health care consulting business based in Arlington, VA. Albrant is not suggesting that a pharmacist deny a dying patient a new life-saving drug. Rather, he is suggesting that pharmacists consider the impact of real-world use on the effectiveness of a new drug.
Albrant advises his clients to wait six months or more before implementing many new drugs. "There is always something hidden," he says. "It’s usually an adverse effect. Or it really doesn’t work as well as it did in the trial because of the vagaries of real-world clinical practice. Or there is an immense learning curve with the drug, and there are a lot of errors."
Promptly using a new antibiotic is probably pretty safe, but some of the newer, more potent compounds have less room for error, continues Albrant. "It has been proven time and time again in my 15 years of practice that if you wait, it’s always better for your patient than it is to jump on the bandwagon and use every new thing that comes along. There’s always something that crops up that wasn’t seen in the clinical trials."
A look toward Lilly’s new sepsis drug
One drug that Albrant views with caution is Indianapolis-based Eli Lilly and Co.’s new drotrecogin alfa (activated), which is still under priority review by the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research for the treatment of sepsis with associated acute organ dysfunction.
The drug, recently given the brand name Xigris, was granted the priority review after promising results from the PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial. The results of the trial were published in the March 8, 2001, issue of the New England Journal of Medicine (344:699-709).
The buzz is strong on this drug, and many expect it to be a blockbuster. Lynn Uber, PharmD, clinical associate professor at the Medical University of South Carolina in Charleston is concerned primarily about its cost. "The drug hasn’t even hit the market, and we are already working on guidelines for use," she says. "We know we are going to use it. It’s just a matter of who is going to get it."
Uber has heard that it might cost about $10,000 for a course of therapy. "If every patient who is septic in the unit gets it, that will kill our budget," she notes.
The approval process has hit a bump, though. On June 13, Lilly announced that the FDA has extended the action date from July 27 to Oct. 27, 2001, for the completion of its review of the drug’s biologics license application. Yet the company expresses confidence that the extension of the action date does not signify concerns about the drug’s approvability.
Albrant thinks otherwise; serious bleeding events were the most common serious adverse effect found in the drug’s trial. "I don’t think the FDA will allow it to come out," he predicts. The main problem with studies on sepsis drugs is that the population chosen in the study is amorphous, he says. "It’s hard when it’s not being used under a study protocol to find those same patients."
These types of drugs are not easily put into use in the general population, he says. "According to the FDA’s language, once a drug gets approved for use for an indication, physicians can use it for anything — based on their best judgment. The thing that scares us the most about drugs for major infection is that they are typically targeted at specific cellular components or sometimes at the bacteria themselves." A physician, however, may think a patient is sick enough from the flu to try the drug, although the drug was never studied in that population and might not work.
Albrant and Uber take a different position on the drug’s odds. "If I were septic and there was a chance that it would help, I would want that drug," Uber says.
Albrant, however, is concerned that the drug has been shown to have only a 6% absolute reduction in mortality. "That means that if we give 100 patients that drug, we make a difference in six of those patients. We don’t make a difference in 94 of those patients, but we still spend the money," Albrant points out.
"Whatever amount of money is spent on the drug, whether it is $100, $1,000, or $10,000, we are still using it 94 times out of 100 based on the pivotal trials that are at the FDA now. And you are not making an effect. You may even be inducing an adverse effect. When you are doing that, not only is it costing you the amount of the drug, but now it is costing you an increased length of stay in the hospital and increased utilization for all of the other services," argues Albrant. "There are some added and potentially hidden costs that the system bears that the pharmacy may or may not bear."
These same issues should be addressed with other chemicals, too, Albrant says. "We don’t really have broad-enough studies or studies that replicate true clinical practice, so we can’t predict the therapeutic effects — or the adverse effect profile.
"That’s where we get burned a lot of times as a system," he continues. "It’s easy to eat up a lot of your health care dollar by doing these things when we don’t really understand the outcome and ramifications of use. We won’t know that usually for two to three years."
Albrant knows many physicians are eager to try the new drugs. He suggests that pharmacists advise them about the drug’s associated costs and how they relate to other financial needs of the institution. "[I would advise saying to them], Let’s evaluate the cost impact and what our usage pattern is going to be, so we can predict what we need to do as a system and as an institution.’" He also would recommend waiting to see what happens with the drug in real-world use. (For another example of the potential benefits of adopting a wait-and-see attitude on new drugs because of the impact of real-world use, see "Gleevec available to treat chronic myeloid leukemia," in this issue.)
If the physicians prefer not to wait to order the drug, Albrant suggests developing a protocol for use and perhaps limiting the drug’s use to a few physicians in a specialty. "These kinds of restrictions are more common today, although they certainly are not universal," he says.
Some larger systems are making the ordering process for expensive drugs similar to that of a capital request. This means that the request might have to be approved by the finance committee, the medical executive committee, and the board of directors. These kinds of barriers make physicians realize that the request has an impact, Albrant says. "Then they make better decisions overall and patients don’t suffer for the most part."
Fortunately, most compounds that come out of the FDA are not revolutionary, says Albrant. "From a purely clinical perspective, most are the evolution of products that we already have."
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