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Up to 10 million Americans will soon have a new option for lowering their cholesterol – at a price of $14,600 a year. The Food and Drug Administration surprised much of the medical community Friday by broadly approving a new cholesterol drug for a vast potential patient population. The agency approved Praluent for people with an inherited condition that causes very high levels of LDL, or bad cholesterol, as well as for the millions of Americans who have had heart attacks, strokes or other types of heart disease and whose LDL is higher than it should be. (Szabo, 7/27)

The newly approved cholesterol-lowering drug, Praluent, is powerful almost beyond belief. It can drive levels of LDL cholesterol, the dangerous kind, into the 20s or even the teens, numbers almost never before seen in adults. In general, it lowers cholesterol by 50 percent to 70 percent, compared with 25 percent to 55 percent with statins. The $14,600 yearly price of the drug, which is injected under the skin once every two weeks, is a stunner. Yet for some patients, that might actually be a bargain. (Kolata, 7/27)

The new drugs are expensive. And unlike a much cheaper class of pills called statins—which are proven to reduce cardiovascular risk—the jury is still out on whether the new drugs reduce serious events like heart attacks. For these reasons, many insurers plan to require rigorous evaluations before authorizing prescriptions, to make sure patients can’t get their cholesterol down with statins. An estimated 10% to 25% of people who have tried statins report having muscle pain, which limits the dose they can tolerate or precludes them from taking a statin at all. Doctors who specialize in the condition, known as statin intolerance, say by changing statins or trying other strategies, many patients initially considered intolerant can end up taking a statin after all—which is the aim of payers who plan to aggressively challenge claims of statin intolerance. (Winslow, 7/27)

High-cost specialty drugs, including a new class of cholesterol medications expected to come to market later this year, are key drivers of the need to raise health insurance premiums by nearly 10 percent, ConnectiCare’s chief actuary told state regulators during a public hearing Monday. (Levin Becker, 7/27)