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Sanofi

New cholesterol-lowering drugs hold promise, at a huge projected price tag

Liz Szabo
USA TODAY
This drawing depicts LDL cholesterol, the so-called bad cholesterol, in the blood.

Supporters of powerful new cholesterol-lowering drugs say they hold out hope for helping millions of Americans with heart disease, but critics note they could also raise spending on health care by tens of billions of dollars.

An advisory committee to the Food and Drug Administration will consider the high-tech drugs' medical merits Tuesday and Wednesday and vote whether to recommend approval. The FDA, which usually follows the advice of its committees, is scheduled to make a final decision this summer.

Although the FDA doesn't consider cost when approving drugs, some say the drugs' projected price tags – $10,000 a year for as long as a patient lives – could dramatically affect healthcare costs, leading to higher premiums.

Like statins, the new drugs, called PCSK9 inhibitors, lower LDL cholesterol, the so-called bad cholesterol, although the two types of drugs work in different ways. While statins are pills, the new drugs would require patients to inject themselves every two to four weeks, much like a diabetic would inject insulin.

High levels of LDL cholesterol increase the risk of heart attacks and strokes, said Elliott Antman, president of the American Heart Association. About a third of American adults have high LDL cholesterol, according to the Centers for Disease Control and Prevention.

Statins can reduce LDL by 30% to 50%. PCSK9 inhibitors may be slightly more potent, reducing LDL by 40% to 60%, said Daniel Rader, a professor at the Perelman School of Medicine at the University of Pennsylvania, who has served as an adviser to Sanofi, which makes one of the new drugs. Doctors could prescribe both drugs in tandem to dramatically lower cholesterol.

The new drugs could be used to help people who either can't tolerate statins' side effects, such as muscle pain, or who can't lower their cholesterol enough with statins alone, Antman said. The new drugs also help people with an inherited condition that causes very high LDL levels.

If approved, the injectable medications would be the first major new class of cholesterol-lowering drugs since statins were released in 1987, Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said.

"This is a very big development," said Nissen, who has consulted for the companies making the drugs but hasn't gotten paid for this work. "We are going to have a major new tool" to fight heart disease, the leading cause of death among Americans, he said.

Nissen cautions that unanswered questions remain about the drugs, known by the brand names Repatha, made by Amgen, and Praluent, made by Sanofi and Regeneron Pharmaceuticals. Pfizer is also developing a similar type of drug.

While PCSK9 inhibitors cut cholesterol, studies haven't definitely proved they prevent heart attacks or strokes, Nissen said. Those studies won't be completed for two or three years.

Drugs that lower cholesterol don't necessarily prevent heart attacks. Development of an experimental cholesterol-lowering drug called torcetrapib, for example, was halted in 2006 after studies showed patients who combined it with statins had higher death rates than those taking statins alone.

In a briefing prepared for this week's hearings, the FDA has asked the expert advisory panel to consider the new drugs' side effects, including potential effects on the liver and diabetes.

The drugs' cost total to the health-care system will depend partly on whether the FDA approves them for wide or limited use, said Steve Miller, senior vice president and chief medical officer at Express Scripts, a leading pharmacy benefit manager.

If the FDA approves the drugs for all high-risk patients, who number about 10 million, the cost could be as high as $100 billion a year, Miller said. Even if the FDA approves them for more limited use, the cost could still reach tens of billions of dollars a year, he said. In comparison, generic statins cost about $250 dollars a year.

Antman notes that the new drugs could reduce certain costs to society, such as the cost of major heart surgery or care in a nursing home after a stroke.

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