Statin Rules Change: Pharma's Winners And Losers

In a move that will greatly alter the use of the cholesterol-lowering pills known as statins, the American Heart Association and the American College of Cardiology have released new guidelines that change the calculus for prescribing these medicines. To the extent the changes will generate more prescriptions and, therefore, more revenue for the pharmaceutical industry, however, is unclear.

The biggest change dispenses with the idea that people with a specific cholesterol level should automatically be given treatment and puts an end to the notion of treating patients until their cholesterol level is lowered to a specific target, which greatly increased prescribing and helped propel several medicines into blockbuster sellers.

Instead, the guidelines create four categories for recommending treatment: patients who have cardiovascular disease; those with high LDL, or bad, cholesterol of 190 or more; patients with Type 2 diabetes who are between 40 and 75 years old, and patients with a risk of having a heart attack or stroke is at least 7.5 percent in the next 10 years and are also between 45 and 70 years old.

Previously, physicians were guided to consider a risk of heart attack or stroke of 20 percent for patients. The new guidelines also devised a new way of calculating the 10-year risk, which also counts strokes as well as heart attacks. The new method, which replaced a calculator based on the Framingham Heart Study, could mean that more people will be candidates for cholesterol pills.

“The likely impact of the recommendations is that more people who would benefit from statins are going to be on them, while fewer people who wouldn’t benefit from statins are going to be on them,” says Neil Stone, Bonow professor of medicine at Northwestern University Feinberg School of Medicine and chair of the expert panel that wrote the new guidelines, in a statement.

Nonetheless, there is divided opinion about the rate at which prescribing will change. For instance, Harlan Krumholz, a cardiologist and professor of medicine at Yale University, who was not a member of the guidelines committee, tells The New York Times that, “now one in four Americans over 40 will be saying, ‘Should I be taking this anymore?' ”

Indeed, by dispensing with specific targets, some physicians and patients may decide not to pursue treatment. At the same time, people who are younger than 40 years old may no longer be seen as candidates for treatment, even though the medications could maintain low levels of cholesterol for years to come. On the other hand, some physicians may not change their practices all that quickly.

“I worry about this causing confusion, because we’ve been telling patients for two decades: ‘Know your numbers’ and ‘treat to a certain level,’ “ Steve Nissen, who heads the cardiology department at the Cleveland Clinic Foundation, tells NPR. “There will be some significant confusion until we educate everybody about what we are asking them to do.

So will drugmakers win or lose? The answer may vary.

PFE Chart

PFE data by YCharts

Some of the biggest-selling cholesterol pills of the past two decades, such as Pfizer’s (PFE) Lipitor and Merck’s (MRK) Zocor, are off-patent and generics are available. However, AstraZeneca (AZN) does not face generic competition for its Crestor treatment until 2016 after the drugmaker reached a deal earlier this year with Actavis. And the drugmaker appears thrilled.

To read the remainder of this article, go to Pharmalot.

Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at Read the RIABiz profile of YCharts. You can also request a demonstration of YCharts Platinum.



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