WASHINGTON, July 25 — Federal regulators yesterday approved the first of a new class of drug that can sharply lower cholesterol levels, offering a new option for millions of Americans suffering from cardiovascular disease, the nation’s leading killer.

But the drug, Praluent, which analysts project will become a huge seller, is expected to become the next flashpoint in the growing controversy of escalating pharmaceutical prices, and health plans are expected to put in place strict measures to control which patients can use the drug and prevent it from becoming a budget-buster.

The list price of Praluent is about US$14,600 (RM55,626) a year, substantially higher than the US$7,000 to US$12,000 that some health plan executives and Wall Street analysts had been expecting. Typically insurers and government health programmes get discounts or rebates.

Sanofi and Regeneron Pharmaceuticals, which developed the product, said the price was justified by the potential benefits to patients and savings to the health care system that the drug would provide by preventing heart attacks and strokes — though the ability of the drug to do that has not been proved.

“We came to a price that is reflective of value, not what the market will bear,” said Elias Zerhouni, head of research and development at Sanofi, who said his brother had suffered three heart attacks and needed new options to control cholesterol.

In clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 per cent or more, even among patients already taking statins, the mainstay pills like Lipitor for controlling blood lipids. Some cardiologists say Praluent and similar drugs in the pipeline represent significant advances.

“I can tell you there is a lot of hope on the part of our patients,” said Dr Seth Martin, associate director of the lipid clinic at Johns Hopkins University. “There is such a high need for these medications.”

Praluent, also known as alirocumab, was endorsed last month by outside advisers to the Food and Drug Administration. So was Repatha, or evolocumab, a similar drug developed by Amgen that is expected to win FDA approval by the end of August.

But there was considerable debate among the advisers as to how broadly the drugs should be used. In its decision yesterday, the FDA approved Praluent for patients who have had heart attacks, strokes, chest pain or related conditions, or have a genetic condition that causes high cholesterol and who require additional lowering of LDL despite taking the highest dose of a statin they can tolerate.

Executives at Sanofi and Regeneron estimate that 8 million to 10 million Americans in those categories need to further lower their cholesterol. But they said they did not know how many of them were already taking a maximally tolerated dose of statins.

Health plans are worried that so many patients might use the drugs, which might be taken for life, that it would cost billions or even tens of billions of dollars a year. The health care system is still smarting from the experience with Sovaldi, a rapidly adopted drug for hepatitis C from Gilead Sciences that cost US$1,000 a pill. Gilead sold US$12.4 billion worth of Sovaldi and a related drug in 2014, the first full year on the market, straining the budgets of insurance companies and Medicaid programmes.

Lessons learned, payers appear much better prepared for Praluent. “We will limit it to those select individuals at the highest risk,” said David Lassen, chief clinical officer at Prime Therapeutics, a pharmacy benefit manager.

One way health plans will do that is to keep patients on statins, which are mainly inexpensive generics.

So the new drugs could improve public health indirectly, by increasing use of statins, which are proved to prevent heart attacks. “We’re going to help some people without even taking our drug,” said Leonard S. Schleifer, chief executive of Regeneron.

Dr Troyen Brennan, chief medical officer of CVS Health, which owns a pharmacy benefit manager, said his company would demand evidence through blood tests if a patient claimed to be unable to tolerate statins because of side effects and wanted to switch to one of the expensive new drugs. Brennan said he was disappointed in the price set by the companies.

Express Scripts, the largest pharmacy benefits manager, has told its clients that it would switch patients getting statins to mail delivery because patients served this way were less likely to quit taking their medicines than those who pick up prescriptions at the drugstore.

Pharmacy benefit managers and health plans might also pit Amgen and Sanofi against each other, choosing to use only the least expensive drug and shut out the other. That tactic worked well to wring discounts from Gilead, once it faced competition in hepatitis C from AbbVie starting late last year.

Zerhouni of Sanofi said there would not be a repeat of what happened with Sovaldi.

“Gilead shocked the system by US$12 billion a year the first year,” Zerhouni said. “In our wildest dream we don’t see that happening” with the cholesterol drugs.

Wall Street analysts estimate sales of several hundred million dollars for Praluent in 2016, though eventually sales could climb to several billion dollars annually. — The New York Times