For the Love of Lipitor

For the Love of Lipitor

Lipitor’s hold on the cholesterol drug market keeps you from saving money, but not much

By Patrick Kenney

According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death in America. In 2008, the illness accounted for nearly 25 percent of all fatalities. Perhaps it should come as no surprise, then, that one of the most powerful pharmaceutical weapons against heart disease, cholesterol-reducing drug Lipitor, ranks as the highest-selling prescription drug in history. Sales peak at nearly $13 billion per year, with cumulative figures totaling more than $130 billion. But a major shift is happening in the marketplace. The introduction of generic drugs is causing sales to fall dramatically. What does this all mean for the future of pharmaceuticals, hospitals and, ultimately, the consumer?

Lipitor is the brand name of a drug called atorvastatin, a member of the statin family of drugs, which are proven to significantly reduce the risk of heart attack, stroke and other maladies of the cardiovascular system by limiting the body’s production of bad cholesterol and working to increase levels of good cholesterol. While Lipitor has garnered a reputation for efficacy unrivaled by other statins, the chemical makeup of similar drugs is actually quite close. Dr. Matthew Sorrentino, professor of medicine, Section of Cardiology at the University of Chicago Medicine, points out that “when you look at studies that have compared the statins at comparable doses—meaning doses that lower cholesterol to the same degree—there’s no difference in outcome.”

History plays a major role in Lipitor’s success. “When Lipitor first came on the market, it lowered cholesterol better than anything else,” Sorrentino says. Lipitor’s seniority brings with it another advantage: testing. As Sorrentino notes, Lipitor has been “studied pretty much across the disease spectrum, from patients who don’t have heart disease and just have risk factors, all the way to patients who are having an acute heart problem. And it’s been shown to work.”

To say that Lipitor has been good for Pfizer would be an understatement. The drug represents about a sixth of the revenue the company brings in each year. According to IMS Health, 2011 saw more than 20 million Americans taking statins to protect their hearts. Pfizer counted about half of these people among their Lipitor customers. But all good things must come to an end. When Pfizer’s patent on atorvastatin ran out in November 2011, its first competitor, Ranbaxy Laboratories, arrived on the scene. And more manufacturers of generic atorvastatin are expected to throw their hats into the ring this summer, when Ranbaxy’s exclusivity deal will expire.

In the meantime, Pfizer has aggressively fought to keep its market share, offering in-house programs such as Lipitor For You that reduce patient copays and provide information and support. “We can’t ignore the fact that marketing has played a role in making [Lipitor] very well known to patients and physicians,” Sorrentino says.

But when generic atorvastatin inevitably does reach a patient, how dramatic are the savings? In a nutshell? Not very. Until more manufacturers are allowed to compete, the market remains relatively set. In fact, if you’re covered by some major insurers, you might actually pay less for a Lipitor copay than you would for the generic.

These are atypical findings. Sandy Walsh at the FDA Office of Public Affairs notes that “generic products typically cost 50 to 70 percent less than their brand-name counterparts. Today, some 80 percent of all retail prescriptions filled in the United States are filled with generic drugs. In the past decade alone, the American public collectively saved more than $931 billion because of generic drugs.”

“Many of us in the field were waiting for Lipitor to go generic because there is an impression in the field that it [Lipitor] is the better product,” says Sorrentino. “I think you’re going to see a shift toward a lot of generic atorvastatin being used, especially when other generic companies start releasing it, making the price more competitive.” This is good news for patients. Pfizer is sure to disagree.

As more manufacturers emerge, Pfizer can be expected to rely heavily on brand recognition. “We know that about one third of current Lipitor patients would like to stay on branded Lipitor,” says MacKay Jimeson, a media relations representative with Pfizer.

Consumer Reports from late last year suggests that the drug had actually been overprescribed, recommending that only patients needing to lower their bad cholesterol (LDL) by 30 percent or more with a history of heart attack or acute coronary syndrome take Lipitor or the generic atorvastatin. In other situations where LDL is not as elevated, lovastatin or pravastatin might be more appropriate. The report recommended simvastatin for ailments of heart disease or diabetes.

Regardless of which statin you’re using, it’s widely agreed upon in the medical community that the drugs have saved and prolonged many lives. In the fight for profit and market share, however, consumers have yet to see the fruit of the generic atorvastatin hype. While this summer brings new competitors to the scene, a fact that is expected to bring the price of atorvastatin down, you can be sure that Pfizer won’t be giving up on Lipitor anytime soon. There’s still a long way to go in the fight for America’s heart.

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Published in Chicago Health Summer/Fall 2012