New cholesterol drug promising, but at high cost
FDA panel examines treatment that shows promise at a price
Supporters of powerful new cholesterol-lowering drugs 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 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 lead to higher health 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.
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, a major cause of heart attacks, 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 can’t tolerate statins’ side effects, such as muscle pain, or can’t lower their cholesterol enough with statins alone, Antman said.
If approved, the injectable medications would be the first major new class of cholesterollowering drugs since statins were released in 1987, said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.
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.